This document is part of an archive of postings by John Ray on Dissecting Leftism, a blog hosted by Blogspot who are in turn owned by Google. The index to the archive is available here or here. Indexes to my other blogs can be located here or here. Archives do accompany my original postings but, given the animus towards conservative writing on Google and other internet institutions, their permanence is uncertain. These alternative archives help ensure a more permanent record of what I have written.
This is a backup copy of the original blog
Below is the backup of this blog for February, 2024. To access the backups in earlier years, click here
30 April, 2024
AstraZeneca admits to rare, deadly side effect of Covid jab as lawsuits mount
I had two shots of AstraZeneca and didn't even get a sore arm out of it -- nothing. So your mileage may vary
AstraZeneca has admitted that its Covid-19 vaccine could cause a rare but deadly blood-clotting condition, potentially exposing the UK pharmaceutical giant to lawsuits brought by loved ones of those injured or killed as a result of the jab, according to court documents.
Lawyers representing “dozens” of class-action claimants say some of their clients’ cases could be worth as much as $38 million, calling the Cambridge-headquartered pharma firm’s vaccine was “defective,” according to the Daily Mail.
Recent research from RMIT University and Monash University found Australia’s Covid-19 vaccination campaign likely prevented the death of 17,760 people aged over 50 in New South Wales between August 2021 and July 2022.
The AstraZeneca inoculation, which was also administered in Australia, has proven to be effective in combating Covid-19 with some estimates suggested it saved as many as six million lives worldwide. But it has also produced rare side effects in some people, reports the New York Post.
AstraZeneca, which is contesting the claims, acknowledged in a February legal document that its vaccine can “in very rare cases,” cause a condition called thrombosis with thrombocytopenia syndrome, or TTS.
TTS can cause patients to suffer from blood clots as well as a low blood platelet count, which in some cases have seriously harmed or even killed recipients of the company’s vaccine.
The potential complication was listed as a possible side effect from the time of the vaccine’s release, but AstraZeneca’s acknowledgment in February marks the first time the pharmaceutical titan has admitted it in court, according to the UK newspaper The Telegraph.
So far, 51 cases have been filed in London’s High Court, estimated to be worth around $190 million (GBP100 million) total, the outlet writes.
Due to a bargain AstraZeneca struck with the UK government at the height of the pandemic to indemnify the drugmaker against potential lawsuits, taxpayers will be on the hook for any payouts resulting from the claims.
One of the claimants who filed suit is Jamie Scott, an IT engineer and father of two left with a permanent brain injury resulting from a blood clot after he received the vaccine in April 2021.
His wife, Kate, told The Telegraph she’s hopeful the company’s admission will accelerate the outcome of their case.
“We need an apology, fair compensation for our family and other families who have been affected. We have the truth on our side, and we are not going to give up.”
In a statement, AstraZeneca expressed sympathy for anyone who was allegedly harmed by the vaccine, but defended it as a net positive and pointed out that complications are exceedingly rare.
“Patient safety is our highest priority, and regulatory authorities have clear and stringent standards to ensure the safe use of all medicines, including vaccines,” the statement reads in part.
“From the body of evidence in clinical trials and real-world data, the AstraZeneca-Oxford vaccine has continuously been shown to have an acceptable safety profile and regulators around the world consistently state that the benefits of vaccination outweigh the risks of extremely rare potential side effects.”
The AstraZeneca Covid vaccine was first approved for emergency use in December, 2020.
Of the 50 million doses administered in the UK during the crisis, 81 people have died from blood clots potentially linked to the jab, according to health data compiled by UK pharmaceutical watchdog the Medicines and Healthcare Products Regulatory Agency.
The odds of a recipient developing TTS as a result of the vaccine is calculated as somewhere in the range of 1 in 50,000.
In Australia, the government said the rate of TTS linked to the jab was around two people per 100,000 vaccinated.
In all, the AstraZeneca vaccine is credited with saving as many as six million lives globally during the pandemic, according to the University of Oxford, which partnered with the company in developing the jab.
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Small Chinese sample suggests link between Pfizer-BioNTech mRNA COVID-19 Vaccine and Kidney-Related Disease
A team of nephrologists and associated physician-scientists from Zhengzhou University in Zhengzhou, a city with over 10 million people in Northern China extracted the gene expression data of Peripheral Blood Mononuclear Cells (PBMCs) from 15 controls (day 0 post the second dose of Pfizer-BioNTech BNT162b2 COVID-19 mRNA vaccine) and 29 vaccinated samples (day 1–10 post second dose also of the same BNT162b2 COVID-19 mRNA vaccine) (GSE201535) from what is known as the Gene Expression Omnibus (GEO) dataset and normalization of the counts by log(x + 1) using Sangerbox.
Meanwhile, the gene expression data of glomeruli from 21 controls (living donors) and 27 IgAN were collected (GSE104948). Also in this study, focusing on the keyword “COVID-19 vaccine” was used to search the GeneCards database to screen the associated genes supporting this investigation into cases of glomerulonephritis, a kidney condition reported after the mass-scale use of COVID-19 countermeasures with IgA nephropathy (IgAN) emerging as particularly prominent.
The recent study results were published in Karger Kidney and Blood Pressure Research, and the study was conducted with the help of Henan Provincial People’s Hospital.
What is IgAN and glomerulonephritis?
Glomerulonephritis is a group of kidney diseases that cause inflammation of the glomeruli, the tiny filters inside the kidneys that remove waste and extra fluids from the blood, this condition can come on quickly or slowly, and mild cases often don’t cause any noticeable symptoms.
IgAN or IgA nephropathy is considered a rare kidney disease occurring when the body’s immune system generates antibodies in the kidneys, leading to inflammation and kidney damage. The inflammation makes it harder for the kidneys to filter waste and fluid from the blood. IgAN is also known as Berger disease.
Background to this study
The Chinese researchers point to “accumulating evidence” disclosing the risk of IgA nephropathy (IgAN) presenting shortly after the second dose of the COVID-19 mRNA vaccine. But not surprisingly, the undying mechanism remains unclear. Thus, the investigation here better understands potential molecular mechanisms.
The team downloaded both gene expression datasets of COVID-19 mRNA vaccination (GSE201535) and IgAN (GSE104948). Weighted Gene Co-Expression Network Analysis (WGCNA) in a bid to identify co-expression modules related to the second dose of COVID-19 mRNA vaccination and IgAN. Differentially expressed genes (DEGs) were screened, and a transcription factor (TF)-miRNA regulatory network and protein-drug interaction were constructed for the shared genes.
What did they find?
The use of WBCNA led to the identification of one module linked to the second dose of the Pfizer-BioNTech mRNA vaccine, with four modules linked to IgAN. Further analysis employing gene ontology (GO) uncovered “enrichment of cell cycle-related processes for the COVID-19 mRNA vaccine hub genes and immune effector processes for the IgAN hub genes.”
With 74 DEGs identified in relation to the second Pfizer dose, plus 574 DEGs for IgAN, “Intersection analysis with COVID-19 vaccine-related genes led to the identification of two shared genes, TOP2A and CEP55. The TF-miRNA network analysis showed that hsa-miR-144 and ATF1 might regulate the shared hub genes.”
Summary
The team shares in this paper a “common pathogenesis of COVID-19 mRNA vaccination and IgAN. The identified pivotal genes may offer new directions for further mechanistic studies of IgAN secondary to COVID-19 mRNA vaccination.”
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29 April, 2024
Mainstream Starts to Cover: NBC Affiliate Covers COVID-19 Vaccine Injured, Cautiously
Mainstream media has started to cover the topic of COVID-19 vaccine injury. Most recently, KARE 11 in Minneapolis thanks to Craig Norkus, a 22-year photojournalist at the media who became ill after receiving the COVID-19 jab in November 2022.
While the NBC affiliate for the Twin Cities area first acknowledges that the overall general safety of the COVID-19 vaccines has been established, this doesn’t necessarily mean that a “small group of Minnesotans claiming vaccine injury” aren’t hurting, in some cases, severely due to rare but real COVID-19 vaccine injuries.
Another TrialSite subscriber and vaccine-injured person sent the story to TrialSite, noting the NBC affiliate loaded the content with lots of accompanying vaccine-friendly information but points out that the local media finally covered the topic of COVID-19 vaccine injury.
Pointing out that recent studies evidence an overall safety profile, some questions remain unanswered. To date, KARE 11 states that no study has been able to prove that mRNA vaccines can induce neurological problems, the reality is that numerous such problems can and do ensue after vaccination.
Patient advocacy group React19, a TrialSite partner, established the Scientific Publications Directory for example. In this repository set up via a collaborative effort with TrialSite’s support, React19 now maintains 3,580 peer-reviewed studies (mostly case series) tracking various adverse event incidents post-COVID-19 vaccination.
How many of the studies involve neurological conditions? 656 studies cover some form of neurological condition associated with COVID-19 vaccination. This does not mean that each one of these studies prove that the vaccine caused the condition.
In fact, most of the studies in the online directory are case series, meaning a type of medical research design that involves the detailed examination of a small group of individuals (or just one patient) who share common characteristics or experiences. In a case series, researchers typically report on the clinical features, treatment, and outcomes of a series of patients with similar conditions or who underwent similar interventions. However, unlike a randomized controlled trial, these investigations are not designed to establish causation.
Unfortunately, the NBC affiliate doesn’t cite the React19 database, although they should. The media does refer to the recent study tracked by TrialSite involving the recent study from the National Academy of Sciences, Engineering and Medicine finding that only one adverse event with a proven link to the Pfizer and Moderna shots-- myocarditis—inflammation of the heart. The experts in the study determined the two mRNA vaccines do not cause Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS) or heart attack. Researchers determined there's not enough evidence to accept or deny a link to any other neurological issues studied. Although, it’s clear from the React19 publication directory that incidence of GBS for example as well as Bell’s palsy are associated with these vaccines.
According to Norkus, who was a key force in getting this coverage of the COVID-19 vaccine injured after receiving the COVID-19 vaccine, “I felt like I was dying,” said Norkus. “I was lost, looking for answers, and no one had any.”
The injury presented just two days following a booster dose of the Pfizer COVID-19 vaccine. The photojournalist started suffering head and body aches, severe exhaustion, and confusion, along with cool and hot tingling in his fingers and legs.
As reported by Chris Hrapsky blood tests revealed his immune system was under attack, but five separate specialty doctors could not explain the source of his symptoms.
Yet by April last year, an osteopathic doctor diagnosed Norkus with immunosuppression and small fiber neuropathy. And Norkus’ physician now believes that Norkus’ conditions were triggered by the vaccine.
While the local media claims no study can prove an mRNA connection to Bell’s palsy, the React19 online database includes 45 peer-reviewed studies involving COVID-19 vaccination and Bell’s palsy. See the link.
TrialSite’s Brandon Bushong recently interviewed vaccine injury activist Wayne Rohde, author of “The Vaccine Court 2.0 Revised: The Dark Truth of America’s Vaccine Injury Compensation Program” who elaborates on all the ways bias impacts the system, to the detriment of those injured and in urgent need of care.
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COVID-19 mRNA Vaccines Linked to Cutaneous [skin] Adverse Events—Most Non-Significant, However, Severe in Rare Cases
Dermatologist from the Department of Dermatology, Kagoshima City Hospital and University Graduate School of Medical and Dental Sciences Kagoshima, Japan investigate cutaneous adverse events (AEs) manifesting after COVID-19 vaccination.
Frequently described, the investigators led by Atsunori Baba M.D., and colleagues report the need for a larger case series and literature review and hence this specific study. Calling out for the urgent need for an extensive investigation of new cases and previous reports to better capture the unfolding evidence concerning post-COVID-19 immunization cutaneous AEs, the team sought to analyze patients with cutaneous AEs after COVID-19 vaccination in their specific hospital located in deep southern Japan on Kyushu island.
The team of physicians also reviewed studies of cutaneous AEs. Analyzing post-COVID-19 vaccination cutaneous AEs in the Kagoshima City Hospital department, the Japanese Registry, and previous literature, the investigators also enrolled 30 patients with cutaneous post-vaccination AEs in the department over 2 years (April 1, 2021, to March 31, 2023). Confirming cases registered in the Ministry of Health, Labor, and Welfare COVID-19 vaccine side effect reporting system (February 17, 2021–March 12, 2023), the study team reports 587 retrieved records, plus 93 articles were included for data extraction.
Dr. Atsunori Baba and colleagues report on the identification of a total of 28 non-injection-site cutaneous AEs and two injection-site AEs. Six (20.0%) patients developed new-onset erythematous eruptions, and five (16.7%) patients developed urticaria. Pruritic eruption, eczema, shingles, and sweating symptoms have also been reported.
Published in the peer-reviewed Journal of Dermatology, Atsunori Baba and colleagues point out that in previous studies on non-injection-site cutaneous AEs, individuals who received the BNT162b2 vaccine were older than those who received mRNA-1273 (P < 0.01).
Cutaneous AEs were mostly nonsignificant and self-limiting reactions; but the study authors report on rare, severe, or life-threatening AEs also linked to COVID-19 vaccination.
The findings lead the authors of this study to conclude that “Physicians should be aware of the various possible cutaneous AEs associated with the COVID-19 vaccination.”
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Western Vaccines Outperform the Chinese with Significant More Protection Against Breakthrough Infection
A team of pharmacy researchers from University of Cyberjava in Persiaran Bestari, Selangor Malaysia and Serdang Hospital conducted a retrospective cohort study at a multispecialty tertiary hospital in Selangor, including 200 fully adult vaccinated patients, with confirmed SARS-CoV-2 infection, admitted from September 2021 to February 2022.
Participants were selected by simple random sampling. Infection severity was categorized as CAT 2–3 (mild–moderate) and 4–5 (severe–critical). Vaccinated with the Pfizer-BioNTech mRNA vaccine known as BNT162b2, the Malaysian team sought to learn more about mRNA vaccine performance. What were the clinical outcomes (time to breakthrough infection, intensive care unit [ICU] admission, and in-hospital mortality) of hospitalized patients with SARS-CoV-2 breakthrough infection concerning the Pfizer-BioNTech jab?
With results published in Heliyon, the authors report:
“The time to breakthrough infection was significantly longer for BNT162B2 recipients (128.47 ± 46.21 days) compared to CoronaVac (94.09 ± 48.71 days; P = 0.001) and ChAdOx1-S recipients (90.80 ± 37.59 days; P = 0.019).”
Also, the authors reported no associations involving SARS-CoV-2-related ICU admission, mortality, and the vaccines.
Based on a statistical multivariable analysis, the study’s authors point to the following as significant predictors of severity:
Vaccine type
Variant of concern
Ethnicity
Hypertension
Evidencing superior performance for the Western COVID-19 vaccines, “BNT162b2 and ChAdOx1-S recipients had significantly (81% and 74%, respectively) lower odds of CAT 4–5 infection compared to CoronaVac recipients.” The latter was developed in China.
Interestingly, from an ethnicity perspective, Indian patients faced a (83%) lower chance of CAT 4–5 infection compared to Malay patients.
For breakthrough infections, the Delta surge was more dangerous than Omicron. Patients with breakthrough infections during the latter period had a significantly (58%) lower risk of CAT 4–5 compared to those in the former (Delta). The CAT 4–5 risk was significantly (nearly threefold) higher in hypertensive patients.
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28 April, 2024
Long COVID Condition Resolves Over Time, Study Suggests
Research led by the University of New South Wales (UNSW) and St Vincent’s Hospital in Sydney has found that the immune abnormalities in most people with mild or moderate long COVID had largely resolved two years after infection.
In a cohort of patients suffering from long COVID, biomarkers present in patients eight months after contraction largely resolved by 24 months, suggesting that long COVID can settle over time.
Biomarkers are biological molecules that can indicate diseases or health conditions, the U.S. National Cancer Institute states. Long COVID clinical symptoms are consistent with biomarkers exhibiting a sustained inflammatory response.
Details of the Study
The study participants included people who had contracted COVID-19 in Australia’s first wave and a corresponding control group. The study considered the health information systematically reported by patients and detailed blood tests.
The exact scale of immunological improvement is difficult to quantify because immune function significantly varies from person to person. However, after 24 months there were no observable differences between the study’s control and long COVID group.
Chansavath Phetsouphanh, co-author of the paper and senior lecturer at UNSW’s Kirby Institute, said in a news release that significant improvements have been found.
“Almost one and a half years later, we are pleased to see that among this same group, significant improvements were found in blood markers,” he said. Blood markers are an easily accessible, cost-effective, and accurate biomarker.
“For the majority of samples we analysed in the laboratory, the biomarkers previously indicating abnormal immune function have resolved,” Mr. Phetsouphanh said.
This trend was also observable in the self-reported data with 62 percent of participants indicating improvements in health-related quality of life.
Study Limitations
The study is one of a small number that measures clinical data, self-reported health information, and intense blood sampling of the same group over an extensive period.
Professor Anthony Kelleher, director of the Kirby Institute, said that immunology is a complex science.
While the finding was encouraging, he noted it involved just one cohort that experienced an early strain of COVID-19 and whose initial COVID-19 infection was generally considered mild or moderate.
Prof. Kelleher said they cannot say for certain that outcomes in the unvaccinated clinical cohort will be true for vaccinated people. He also said that it’s uncertain whether those infected with a different strain of COVID-19 will experience the same outcomes.
“What we do know is that for most people with long COVID, both their symptoms and their biomarkers improve significantly over time, and this is a cause for optimism,” he said.
“Importantly, we will continue to undertake research to understand more about why some people don’t improve, and what can be done for those people.”
Ongoing Impact on their Life Quality
“While this is very encouraging and a reason for optimism, there are still around one third of patients who identify some ongoing impact on their quality of life,” said Professor Gail Matthews, head of infectious diseases at St Vincent’s Hospital.
Prof. Matthews said some patients may have a range of underlying causes for their long COVID symptoms.
She added that not all of these causes are driven by immunological abnormalities and that some are likely to persist even when the immunological environment has largely returned to normal.
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Can nasal Neosporin prevent COVID-19?
Four years ago, when COVID-19 first began to spread globally, it didn't just damage our physical health, but also the health of our information ecosystem. Ever since, the internet has been rife with health misinformation on ways to treat or protect oneself against the coronavirus.
First, internet healers falsely suggested that gargling salt water and vinegar could prevent a coronavirus infection. Then, despite multiple studies debunking the effectiveness of ivermectin, an anti-parasitic drug used in horses (and less commonly in humans), Joe Rogan fans continued to cling onto it as a potential treatment.
Health misinformation is a symptom of a lack of certainty. When there is no guaranteed preventative measure or treatment, people are bound to find solutions on their own. Thanks to cognitive biases like confirmation bias, they might even appear to work. But what if a way to reduce exposure to COVID-19, and treat it, was hiding in our medicine cabinets all along — and it wasn’t pseudoscience?
A new study published in the journal Proceedings of the National Academy of Sciences suggests that neomycin, an ingredient in the first aid ointment Neosporin, may prevent or treat a range of respiratory viral infections such as COVID-19 and influenza when applied to the nose.
In the study, researchers found that mice who had neomycin in their nostrils exhibited strong antiviral activity against both SARS-CoV- 2 and a highly virulent strain of influenza A virus. It also mitigated contact transmission of SARS-CoV- 2 between hamsters.
“We decided to see if neomycin applied into the nose can protect animals from infection with COVID as well as the flu,” Dr. Akiko Iwasaki, the lead author of the study and a professor of immunobiology at the Yale University School of Medicine, told Salon in a phone interview. “And what we found is that treatment with neomycin significantly prevented infection and also reduced disease burden in animals.”
Iwasaki described the work as “encouraging” because it shows that neomycin can trigger an antiviral response in animals by creating a localized immune response. “That’s resulting in this protection that we see,” Iwasaki said.
The results are encouraging for mice and hamsters. But what about humans? The researchers proceeded to recruit healthy volunteers and asked them to apply Neosporin with a cotton swab to their nose, twice a day. The placebo for some was vaseline. The researchers measured their antiviral response and found similar results.
“When we compared the gene expression in the nose, Neosporin stimulated genes whereas those people who had Vaseline did not,” Iwasaki said. “So this suggests that we might be able to use Neosporin or neomycin in humans to induce this antiviral state that we also saw in animals.”
Does that mean we should all be applying Neosporin to our noses in high-risk situations? Not exactly, but it probably wouldn’t hurt either — as long as someone isn’t allergic to the cream, which is a combination of the antibiotics bacitracin, neomycin and polymyxin B. Notably, details around the dosage remain unclear.
“We know from the dose response that we did in animals that we probably need to give humans more Neosporin, or neomycin,” she said. “Because Neosporin has very little neomycin compared to what we were able to achieve in the animal model.”
Iwasaki added they know that Neosporin can produce a similar effect in humans as it did in animals, but whether or not it can reduce transmission has yet to be determined.
“For that, we need different kinds of study and a much larger study to determine that,” she said.
Amesh Adalja, a senior scholar at the Johns Hopkins Center and infectious disease doctor who wasn’t involved in the study, told Salon via email that the research could have broader implications that extend beyond COVID-19.
“This could be a potential broad spectrum antiviral treatment and prophylaxis,”Adalja said. “The molecules in the topical antibiotic cream induce certain antiviral compounds to be made by cells where the ointment has been applied; these antiviral compounds produce non-specific immunity that impacts various viruses.”
Iwasaki cautioned against the idea that people swabbing their noses with Neosporin will be a cure-all in the future. Instead, she said she sees this as another possible layer of protection.
“We know how important it is to layer protection against infections,” Iwasaki said. “Vaccines and masks and other measures are very important, but this type of strategy where we can trigger the host to produce antiviral factors may be another layer that we can add on to the existing ones.”
The more layers a person has, Iwasaki said, the less likely a person is to get infected.
“And that's really important for preventing diseases like long COVID,” Iwasaki said, referring to a condition in which COVID symptoms last for months or even years. “So I think it's definitely worth kind of moving forward with an approach like this.”
An approach that was right under our noses all this time.
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Supreme Court Win for Police Constable Who Refused the COVID-19 Jab
A senior constable in Victoria who faced charges for not taking the COVID-19 vaccine has won his battle in a landmark ruling by the Supreme Court. This decision could set a precedent for others impacted by vaccine mandates in the state and around Australia.
The case centered on whether the requirement to provide evidence of vaccination status necessitated receiving a dose of the COVID-19 vaccine.
Constable Simon Peter Shearer had been charged with a breach of discipline for failing to comply with the COVID-19 vaccination requirements outlined in the Victoria Police Manual.
The officer’s decision not to receive any dose of the COVID-19 vaccine by Aug. 16, 2022, led to an internal disciplinary inquiry initiated by the Victorian Police chief commissioner.
However, Victorian Supreme Court Justice Michael McDonald concluded this charge was unjust and should be quashed.
“The plaintiff’s failure to receive a dose of COVID-19 vaccine by 16 August 2022 did not constitute a breach of the Victorian Police Manual,” Judge McDonald said.
“Consequently, the DIO [disciplinary inquiry officer] did not have power to reprimand the plaintiff for a breach of discipline.”
In addition, the judge said the plaintiff was denied procedural fairness for two reasons.
“First, the charge did not provide adequate notice of the case the plaintiff was required to meet,” Judge McDonald found.
“Second, the DIO failed to disclose to the plaintiff issues critical to his decision to find the charge proven.”
Constable Shearer, who had been working in the legal services department of Victoria Police as a lawyer since 2013, had a medical exemption for vaccine requirements due to Graves’ disease, an autoimmune condition impacting the thyroid.
According to court documents, this exemption expired in 2021.
Further, the constable went on long service leave from December 2021 to July 2022. In July 2022, Victoria’s chief police commissioner issued a new policy manual on vaccine requirements.
The constable argued that he was not required to provide his vaccination status to the police or be vaccinated to perform his duties in order to return to work.
However, on September 21, 2022, he was charged with a breach of discipline for failing to comply with the vaccine requirements of the Victorian Police Manual.
The judge has now nullified the charge, and both parties will have the opportunity to make submissions on costs.
“My provisional view is that the defendant should pay plaintiff’s costs on a standard basis, to be taxed in default of agreement,” the judge stated.
Case ‘Reaffirms Our Faith in the Justice System’: Lawyer
Principal lawyer Irene Chrisopoulidis described the result as a significant win for the plaintiff and the individuals and families affected by such policies. She said many of these individuals were unfairly and unjustly treated during one of the most challenging times in our history.
“The lives of these employees and their families, impacted by such organisational policies and decisions, resulted in lifelong effects,” Ms. Chrisopoulidis added in a LinkedIn post.
“This case not only reaffirms our faith in the justice system, it reflects the courageous and tenacious character it takes to stand up for your rights in pursuing justice. It has been our honour to represent the Plaintiff in this matter.”
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25 April, 2024
COVID-19 Vaccine Emails: Here’s What the CDC Hid Behind Redactions
The U.S. Centers for Disease Control and Prevention (CDC) hid how a woman who suffered chest pain and other symptoms following COVID-19 vaccination received a shot because of a mandate at work, newly obtained documents show.
The agency also redacted how multiple children were diagnosed with Kawasaki Disease after receiving a COVID-19 vaccine, according to the documents.
The Epoch Times obtained more than 1,400 pages of emails from the CDC concerning its Clinical Immunization Safety Assessment (CISA) project, which analyzes post-vaccination problems reported by health care providers. The tranche included numerous redactions.
While redactions are allowed under the Freedom of Information Act, there were signs that too much information was being hidden.
The Epoch Times appealed some of the redactions.
The CDC agreed to remove some of them, revealing what the agency initially shielded.
In one email, a provider reports a 30-year-old woman who suffered chest pain and leg twitching following COVID-19 vaccination. The original copy of the email stated in part that she “got vaccine due to [redacted].”
In the updated copy, the CDC removed the redaction, showing that the woman received a vaccine because of a mandate at work.
Several other portions of the emails that are now unredacted show the CDC hid how multiple children, including a 2-year-old, were said to have suffered from a serious inflammatory illness called Kawasaki Disease shortly after receiving a shot.
One girl suffered inflammation around the eyes, swollen lips, high fever, and a rash, and “was admitted last week with Kawasaki,” one of the girl’s parents wrote on Dec. 5, 2021, the new documents show. She received a dose of the Pfizer-BioNTech vaccine two weeks prior.
Dr. Matthew Oster is a cardiologist who works for the CDC.
“The biggest question, of course, here, is whether this was truly [redacted] or whether this was [redacted] related to the vaccine,” Dr. Oster wrote after hearing about the case.
The cleaner copy of the email showed that the redactions covered “KD,” or Kawasaki Disease, and “MIS-C,” or multisystem inflammatory syndrome in children.
“We do now have a small number of cases like this one,” Dr. Oster said.
The CDC has portrayed MIS-C as only being caused by COVID-19, but studies have found that there were MIS-C cases before the COVID-19 pandemic and that some people suffered the syndrome after vaccination without evidence of COVID-19. The CDC says on its website that the agency is “investigating reports of multisystem inflammatory syndrome in children (MIS-C) associated with coronavirus disease 2019 (COVID-19), which may present with Kawasaki disease-like features.”
Another email originally hid the age of a male child and what his doctor suspected he suffered after receipt of a second dose of Moderna’s vaccine.
The boy was 2 years old, the newly obtained documents show, when he was admitted with what a pediatric infectious disease doctor suspected was “atypical Kawasaki Disease.” The documents show that the doctor also considered MIS-C as a diagnosis in light of how the boy’s sister tested positive for COVID-19 on the same day the boy started showing symptoms of fever, although multiple COVID-19 tests on the boy returned negative.
The doctor said he had a “low suspicion” for a COVID-19 vaccine reaction but still submitted a report to the Vaccine Adverse Event Reporting System (VAERS), which the CDC helps run.
Kawasaki Disease was detected as a safety signal for the Pfizer and Moderna vaccines among children aged 5 to 11 when the CDC first ran an analysis on VAERS data in 2022, according to files previously obtained by The Epoch Times. The analysis did not include children younger than 5. Kawasaki disease after COVID-19 vaccination has been reported in the literature, although a study on patients with a history of the disease who contracted COVID-19 or were vaccinated uncovered no signs of problems.
An internal CDC message, now fully unredacted, showed that an official described there being “another CISA ‘inquiry’ about a child with atypical Kawasaki Disease.” Another official said the reports were “very rare” while a third said the normal CDC processes were sufficient to monitor for the disease post-vaccination “unless there’s a specific ask or data need.”
Other removed redactions show that:
A person reporting symptoms after COVID-19 vaccination was reporting that the symptoms included Coxsackievirus and that he himself was the patient. The provider wrote, “I ... don’t know whether to fear another vax more or less than the risk of infection.”
A patient who was reported as suffering heart inflammation after a third Pfizer dose, and came back with the inflammation one year later, was 17 and a male.
The CISA expert who said the woman who suffered chest pain could get additional vaccine doses was Dr. Oster. Previously disclosed emails showed the program repeatedly said people with post-vaccination symptoms should receive more doses.
A patient with “intense malaise” and other symptoms about six months after a Pfizer shot had an elevated heart rate, per a portable electrocardiogram, and sinus tachycardia per a cardiology consultation.
Words and phrases that were redacted originally, but not any longer, include “your daughter”, “hospitalist”, “the parents”, “cardiac workup”, “a physician”, “I believe”, “patient was started on a course of Prednisone”, and “does not drink, smoke, or use any drugs.”
Every single email chain for which redactions were protested was returned with at least some redactions cleared.
The original version claimed that the redactions were appropriate under exceptions outlined in the Freedom of Information Act, including an exception that protects “personnel and medical files and similar files” if their disclosure “would constitute a clearly unwarranted invasion of personal privacy.”
A CDC official told The Epoch Times in an email that the agency, after receiving the appeal, conducted a “careful review” and removed some of the redactions. The official did not explain why the CDC wrongly redacted so much information.
The CDC “has provided modified records for the pages listed in your appeal,” an official with the U.S. Department of Health and Human Services, the CDC’s parent agency, told The Epoch Times in an email. Appeals of CDC Freedom of Information Act requests are lodged with the department.
Fits Pattern
Any person can request information through the Freedom of Infection Act (FOIA), and agencies across the government typically redact portions of responsive documents or withhold them entirely. Agencies “often use FOIA exemptions improperly, withholding records simply because they may reveal problems at the agency or just ‘paint the agency in a bad light,’” Melissa Wasser, a lawyer at the Project On Government Oversight, told senators in 2022. People “consistently receive large swaths of arbitrarily redacted information,” she added.
When presented with signs that information was improperly redacted or withheld, people primarily have two options: lodge an appeal or sue.
Both methods have worked to extract information from the CDC during the pandemic.
An Epoch Times appeal in another case, for example, returned a copy that removed significant redactions that were applied to an internal email describing what Pfizer and Moderna told them about studies that were being done regarding heart inflammation and COVID-19 vaccines.
The unredacted information showed that Moderna had not tested samples from vaccine recipients for subclinical myocarditis because it was waiting for a “specific cardiac biomarker [to] be identified.” An outside study from Switzerland later found signs of subclinical heart inflammation in about one out of 35 people.
The CDC acknowledged that the information had been wrongly redacted. It reasoned that the information “cannot be considered confidential” because it was shared before and “is readily available to the public,” although some of the details had never been made public previously.
Among other lawsuits, meanwhile, one led to the release by the CDC of answers from its V-safe surveillance survey while a second prompted the disclosure of what participants wrote in free-text fields after the CDC left off adverse events of special interest from the survey. Some of the data had never before been described publicly, while other information from the system had only been outlined in CDC-authored studies and presentations.
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U.S Government Continues to Ignore COVID-19 Externalities--Injured Suffer with Abysmal Compensation Record
Vaccine injury activist Wayne Rohde reports that the track record for COVID-19 vaccine injury compensation continues to demonstrate a complete lack of support for the many people adversely impacted by the COVID-19 countermeasures. For example, take the Countermeasures Injury Compensation Program (CICP), the organization mandated to help individuals hurt by such countermeasures. How many claims have they awarded and reimbursed in 2024—just one.
According to Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program,” this abysmal result derives from HRSA’s just released April CICP compensation statistics.
Rohde's, whose son was impacted by a vaccine injury, reports in his blog that “…we should not expect anything positive. Just a pathetic operation. They continue to disappoint.”
In fact, Rohde reports the only compensated petition (accurately described as medical expense reimbursement) marks the 12th comp case overall.
“Just one comp since March 5th. A COVID-19 vaccine causing syncope. A fainting injury. It is still serious. The injured petitioner fainted, fell to the ground, maybe suffering a concussion, highly possible jaw and dental injuries.”
What’s the total for this latest injury? $4,493.00 to cover unreimbursed medical expenses. That makes 12 petitions compensated for a total of $39,203 since 2021.
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24 April, 2024
Pfizer ‘Chose Not to’ Tell Regulators About SV40 Sequence In Covid Shots
A senior Health Canada official says pharma giant Pfizer made a conscious decision to not advise regulators that its mRNA COVID-19 vaccine contained a DNA sequence from the Simian Virus 40 (SV40).
This information appears among multiple emails between staff from key drug regulators, including Health Canada (HC), the U.S. Food and Drugs Administration (FDA), and the European Medicines Agency (EMA). The information was obtained through an access-to-information request.
On Aug. 23, 2023, Dr. Dean Smith, a senior scientific evaluator in HC’s Vaccine Quality Division, wrote an email to a colleague at the FDA about SV40.
Health Canada had obtained confirmation two weeks earlier from Pfizer that SV40 DNA sequences were present in its COVID-19 vaccine.
“I understand that there have been internal discussions at CBER [Center for Biologics Evaluation and Research] regarding the presents [sic] of an SV40 enhancer/promoter sequence, noting that its presence is unrelated to the purpose of the Pfizer’s plasmid as a transcription template for their mRNA COVID-19 vaccine,” wrote Dr. Smith.
“Pfizer has communicated to us recently, that they apparently chose not to mention this information to EMA, FDA or HC at the time of their initial or subsequent submissions.”
Dr. Smith added the information had been independently made public in April 2023, via a pre-print study from U.S. scientist Kevin McKernan.
Mr. McKernan, a genomics expert, had found quantities of DNA in the mRNA shots above the regulatory threshold set out by the health agencies. Dr. Smith wrote that the study had resulted in “questions coming to agencies.”
The Epoch Times had contacted HC on the matter on July 17. The first email related to SV40 within Health Canada released in the access-to-information package was sent two days later, on July 19.
In that email, Dr. Tong Wu of HC’s Vaccine Quality Division reached out to his colleague Dr. Michael Wall, a senior biologist evaluator.
“Co [Pham, executive director of HC’s Centre for Vaccines, Clinical Trials and Biostatistics] agreed to have an IAS for the SV40 promoter sequence as we discussed today. We can talk about it tomorrow,” Dr. Wu wrote. “IAS” could be a reference to an Issue Analysis Summary to evaluate a new regulatory affair.
As first reported by The Epoch Times in October, Health Canada was not aware of the SV40 enhancer presence. Since then, the FDA and the EMA have both confirmed they also weren’t aware of its presence.
Health Canada has since maintained that the SV40 enhancer/promoter sequence is a “residual DNA fragment” in Pfizer-BioNTech COVID-19 vaccine. “The fragment is inactive, has no functional role, and was measured to be consistently below the limit required by Health Canada and other international regulators,” the agency has repeatedly said.
‘ZERO Checks’
This view has been challenged by Mr. McKernan and others, including Dr. Philip Buckhaults, professor of cancer genomics and director of the Cancer Genetics Lab at the University of South Carolina.
In response to the information released by Health Canada, Mr. McKernan posted a thread on the X platform. “No prior vaccine in Canada has been approved with such a sequence contaminant,” he said.
“Pfizer assured [HC] the sequence is not material to plasmid manufacturing,” he added. “This is an overt lie. You cannot make plasmids without the promoter for the antibiotic resistance gene. It is active in mammalian cells. If it’s not needed, why is it in there?”
Mr. McKernan also noted how HC has asked Pfizer for its Polymerase Chain Reaction (PRC) protocol, saying this means “they have performed ZERO checks on this DNA contamination themselves and are entirely relying on the word of the manufacturer.”
A response to a Canadian Member of Parliament’s question tabled in the House of Commons by Health Canada appears to be line with this observation. “It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots are comparable to lots shown to be safe and efficacious in clinical studies,” said Health Canada in December.
Concerns related to the presence of unintended DNA in the mRNA shots pertain to their potential to integrate into the human genome and cause issues like cancer. The Florida State Surgeon General Dr. Joseph A. Ladapo has called for a halt of mRNA shots over these risks.
Health Canada said in March in a document tabled in Parliament that “any claims that the presence of the SV40 promoter enhancer sequence is linked to an increased risk of cancer are unfounded.”
Dr. Buckhaults has started a scientific study to ascertain those integration risks. On April 23, he wrote on X that he had confirmed previous findings that the amount of DNA in mRNA shots exceeds the limit set by regulators.
“Yes, there was more than 10 ng/dose. I am sure of it now,” he wrote while posting his methodology. This is the same threshold applied by Health Canada.
Even if the amount of DNA was below, there are still concerns the threshold was set for regular vaccines and not the new technology using lipid nano particles (LNP).
Dr. Buckhaults wrote that the “10 ng limit is not appropriate for LNP encapsulated DNA,” adding that “as far as I know there have been no safety studies for this situation. It was not possible because of the abbreviated timeline during the emergency you saw authorization.”
Seeking ‘Remedy’
In his August 23 email to the FDA employee, Dr. Smith said HC Canada did not view the SV40 issues as an “urgent risk topic.” However, the official responsible for evaluating the safety of vaccines expressed concerns about how news of the SV40 could impact the upcoming fall 2023 vaccination campaign.
“It would be unfortunate if the information circulating had a negatively [sic] impact on public acceptance of the vaccine this year or in the future,” he said.
Despite being of this view, Dr. Smith said regulating agencies should work to encourage Pfizer to “remedy the situation” before the campaign.
In the email, Dr. Smith said HC believed the upcoming rollout of the fall COVID-19 vaccine campaign meant the agencies should be “on the same page.”
Mr. Smith’s email was written a day after Pfizer provided a response to a Quality Clarifax submitted by HC around the SV40 promoter. If deficiencies are identified in Clinical Trial Applications, HC may request additional information, which is known as a Clarifax.
On August 29, HC senior biologist Dr. Wall wrote an email to senior evaluator Dr. Tong Wu, where he said he and Mr. Smith agreed they should not inform Pfizer of their interaction with the EMA and U.S. FDA on the SV40 promoter, “especially they [sic] do not seem to care much at this moment.”
“However, we can not say nothing! Please see the following text that Julie and I worked out,” Mr. Wall added, before providing a draft comment to Pfizer’s response that was blacked out.
The same day, Dr. Wall also sent an email to Dr. Wu with a draft of the Clarifax questions to be sent to Pfizer, which included the statement, “Health Canada would continue to work with international regulatory partners to achieve harmonisation regarding removal of these sequence elements from the plasmid for future strain changes.”
Pfizer did not respond to a request for comment from The Epoch Times
Commenting on DNA contamination, Health Canada reiterated its previous position on the matter.
“Based on its evaluation of the data and scientific information for the vaccine, Health Canada has concluded that the risk/benefit profile continues to support the use of the Pfizer-BioNTech vaccine,” said spokesperson Anna Maddison.
Dr. David Speicher, a Canadian virologist who replicated the findings from Mr. McKernan and Dr. Buckhaults with Canadian mRNA vials, told The Epoch Times he’s preoccupied about what’s been revealed in the internal Health Canada emails. He notes that while Health Canada has dismissed the DNA fragments as biologically inactive with no functional role, they judged worthy to hold discussions with other regulators.
“We know from testing several vials that the level of SV40 enhancer-promoter in the XBB.1.5 booster is at similar levels as the others Pfizer COVID modRNA vaccines, making it just as problematic,” he says. “Pfizer has not cleaned up the vaccine, yet the regulators are sadly more concerned about vaccine uptake in the population rather than the health risks from these vaccines.”
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23 April, 2024
COVID-19 Vaccine Protection Among Children Plummets Within Months: CDC Study
Children who received an original COVID-19 vaccine have little protection against hospitalization just months after vaccination, according to a new study from the U.S. Centers for Disease Control and Prevention (CDC).
Children initially have 52 percent protection against hospitalization but that estimated effectiveness plummeted to 19 percent after four months, according to the paper.
Protection against so-called critical illness also dropped sharply, from 57 percent to 25 percent, researchers found.
The researchers include CDC employees and the paper was published in the CDC’s weekly digest on April 18.
The study covered children who received two or more doses of the original Pfizer-BioNTech or Moderna COVID-19 vaccines from Dec. 19, 2021, through Oct. 29, 2023.
The study involved children aged 5 to 18 who were hospitalized with acute COVID-19 and tested positive for the illness and compared them to a control group of children hospitalized with COVID-19-like symptoms but who tested negative for COVID-19.
Researchers drew data from the Overcoming COVID-19 Network, which includes health care sites in most of the United States, and ended up with 1,551 case patients and 1,797 in the control group.
The study found that “receipt of ?2 original monovalent COVID-19 vaccine doses was associated with fewer COVID-19–related hospitalizations in children and adolescents aged 5–18 years; however, protection from original vaccines was not sustained over time,” Laura Zambrano, a CDC epidemiologist, and her co-authors wrote.
It also recorded a similar drop in protection against critical illness, defined as being placed on mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, or dying.
The researchers asserted that the results highlighted the current CDC guidance that all people aged 6 months and older receive one of the newest COVID-19 vaccines, which were introduced in the fall of 2023 with clinical data from just 50 humans and no efficacy estimates. The CDC only publishes papers in its weekly digest, the Morbidity and Mortality Weekly Report, after they’re shaped to “comport with CDC policy.” The papers are not peer-reviewed.
Ms. Zambrano did not respond when asked for data suggesting that the currently available shots provide longer-lasting protection than the original vaccines.
The CDC’s website says, in promoting vaccination, that COVID-19 vaccines are “effective at protecting people from getting seriously ill, being hospitalized, and dying” but the hyperlink that ostensibly supports the statement goes to a page that is not live.
U.S. authorities have been moving COVID-19 vaccines to a once-a-year model, similar to influenza vaccines. The model features updating the formulation of the vaccines on an annual basis, in an acknowledgment that any protection the vaccines give quickly wanes. The formulation is typically updated in the fall.
Just 14 percent of children, and 23 percent of adults, have received one of the newest vaccines as of April 6, according to CDC estimates. The available vaccines are messenger RNA (mRNA) shots from Pfizer and Moderna and an alternative from Novavax.
Dr. Jane Orient, executive director of the Association of American Physicians and Surgeons, noted that, according to the new paper, the maximum effectiveness estimates against hospitalization were 61 percent, regardless of how the data were sliced, that more deaths were recorded among the case patients, and the median hospitalization duration was four days for both groups.
“I do not see how a clinician whose concern is treating patients and whose job does not depend on pushing mRNA vaccines would find this a basis for recommending shots—quite the contrary,” Dr. Orient, who was not involved in the research, told The Epoch Times in an email. “It reeks of conflict of interest.”
Stated limitations of the paper include not assessing post-infection immunity and a lack of sequencing data.
The conflict of interest section runs 688 words and includes some of the authors reporting funding from Pfizer and Moderna or ownership of Pfizer stock.
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UC Riverside Breakthrough: Novel Live-Attenuated RNA Virus Vaccine Eliminates Chasing Strains?
According to a recent University of California, Riverside (UCR) media release, scientists at the Inland Empire-based Southern California research center recently demonstrated a novel RNA-based vaccine strategy that is effective against any strain of a virus and can be used safely even by babies or the immunocompromised.
This would be a monumental breakthrough, one that would eliminate the current “chasing of strains” involved with the flu and now COVID-19 shots. Specifically, the team led by Rong Haia Ph.D. and Shou- Wei Ding, Ph.D. characterized a unique live-attenuated RNA virus vaccine, where attenuation resulted from the elimination of the viral RNAi suppressor and enhanced the production of virus- targeting small- interfering RNAs.
The UCR team demonstrates that single-dose immunization with the vaccine just 2 days in advance induced full protection in neonatal and adult mutant mice lacking adaptive immunity. Also, the immunized mutant mice remained protected against lethal challenge for at least 90 days postvaccination.
Human enterovirus- A71, influenza A, and dengue viruses all encode a similar RNAi suppressor, suggesting potential for developing a distinct type of virus vaccine to confer rapid and effective protection in infants and other immune- compromised individuals.
TrialSite this week purchased the study, reviewing below in conjunction with the UCR News media entry.
The Problem
Researchers on an annual basis make attempts to predict the four influenza strains that are most likely to be prevalent during the upcoming flu season. And every year, people line up to get their updated vaccine, hoping the researchers formulated the shot correctly.
Ditto for COVID vaccines: these vaccine products are reformulated to target sub-variants of the most prevalent strains circulating in the U.S.
What’s the Breakthrough?
Based on a recent breakthrough published earlier in the week in Proceedings of the National Academy of Sciences (PNAS), the new strategy would eliminate the need to create all these different shots, because it targets a part of the viral genome that is common to all strains of a virus.
“What I want to emphasize about this vaccine strategy is that it is broad,” said UCR virologist and paper author Rong Hai. “It is broadly applicable to any number of viruses, broadly effective against any variant of a virus, and safe for a broad spectrum of people. This could be the universal vaccine that we have been looking for.”
The Novel Vaccine
With traditional vaccines contain either a dead or modified, live version of a particular virus, with these products the body’s immune system recognizes a protein in the virus and mounts an immune response. Eliciting T-cells to attack the virus, thereby inhibiting the spread of the pathogen. It also produces “memory” B-cells that train your immune system to protect you from future attacks.
Interestingly enough, this novel vaccine discovered at UCR uses not mRNA, but actually also a live, modified version of a virus. The difference, however, from others; this novel candidate does not rely on the vaccinated body having this traditional immune response or immune active proteins — which is the reason it can be used by babies whose immune systems are underdeveloped, or people suffering from a disease that overtaxes their immune system. Rather, the experimental vaccine relies on small, silencing RNA molecules.
According to Shouwei Ding, distinguished professor of microbiology at UCR, and lead paper author “A host—person, a mouse, anyone infected— will produce small interfering RNAs as an immune response to viral infection. These RNAi then knock down the virus.”
Jules Bernstein reported on this finding for UCR News, educating that viruses typically generate RNAi response blockers in the form of proteins. According to Ding, “If we make a mutant virus that cannot produce the protein to suppress our RNAi, we can weaken the virus. It can replicate to some level, but then loses the battle to the host RNAi response.” Elaborating on this concept, Ding shared with the UCR reporter, “A virus weakened in this way can be used as a vaccine for boosting our RNAi immune system.”
Validating in Early-Stage Study
When the researchers tested this strategy with a mouse virus called Nodamura, they did it with mutant mice lacking T and B cells. With one vaccine injection, they found the mice were protected from a lethal dose of the unmodified virus for at least 90 days. Note that some studies show nine mouse days are roughly equivalent to one human year.
There are few vaccines suitable for use in babies younger than six months old. However, even newborn mice produce small RNAi molecules, which is why the vaccine protected them as well. UC Riverside has now been issued a US patent on this RNAi vaccine technology.
In 2013, the same research team published a paper showing that flu infections also induce us to produce RNAi molecules. “That’s why our next step is to use this same concept to generate a flu vaccine, so infants can be protected. If we are successful, they’ll no longer have to depend on their mothers’ antibodies,” Ding said.
Their flu vaccine will also likely be delivered in the form of a spray, as many people have an aversion to needles. “Respiratory infections move through the nose, so a spray might be an easier delivery system,” Hai said.
Additionally, the researchers say there is little chance of a virus mutating to avoid this vaccination strategy. “Viruses may mutate in regions not targeted by traditional vaccines. However, we are targeting their whole genome with thousands of small RNAs. They cannot escape this,” Hai said.
Ultimately, the researchers believe they can ‘cut and paste’ this strategy to make a one-and-done vaccine for any number of viruses.
“There are several well-known human pathogens; dengue, SARS, COVID. They all have similar viral functions,” Ding said. “This should be applicable to these viruses in an easy transfer of knowledge.”
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22 April, 2024
Fighting an invisible illness: the curse of Long Covid
Note that she fell ill AFTER being vaccinated
By MILANDA ROUT
The first time I got Covid it landed me in hospital on Christmas Day. It was 2022 and my husband dropped me off outside Emergency, our two worried kids watching from the car. I didn’t want to leave them but I had no choice: I’d been experiencing wave after wave of horrible nausea, and I had never felt my heart beat so fast. I felt on the verge of collapse. Being Covid positive, I was told by hospital staff to wait on a bench outside and that’s where I sat, miserably, until a nurse came to see me.
“So you have Covid,” she said. “Well, what did you come here for? Do you think I have a magic pill that’s going to make you feel better?” The rational, fact-finding journalist part of my brain knew what she said was correct – there wasn’t a quick fix, and being Christmas the hospital was operating with skeleton staff who were overworked and exhausted at this point in the pandemic. But I had never felt so sick in my life, and I simply did not know what else to do. Surely there was someone who could help me?
What I didn’t realise in that moment was that, 16 months later, I would still be struggling with this same feeling of utter desperation, hopelessness and fear. Because since the acute phase of the infection ended, I have been struggling with the mysterious and debilitating condition known as Long Covid.
I am not alone: it is estimated that one in 10 people who contract Covid develop Long Covid, which is defined in Australia as being symptomatic three months after the original infection. According to research publishedlast year, as many as 65 million people have Long Covid worldwide, with numbers increasing with each new wave of the viral infection. In Australia, there is no national registry keeping tabs on the number of cases but a recent federal parliamentary inquiry into Long Covid heard there could be anywhere between 200,000 and two million sufferers.
What is clear from data collected globally since the pandemic began is that Long Covid affects more women than men, especially women in their thirties and forties. (Being a 45-year-old woman, I am a fairly typical case.) As a patient, and as a journalist, I wanted to understand why Long Covid remains largely a mystery, even though scientists and physicians have had more than four years to get to grips with it. The first key question, for me: why are women getting Long Covid more than men?
“I wish I could tell you but we just don’t know yet,” says Professor Steven Faux, who co-founded one of the first Long Covid clinics in Australia, at St Vincent’s Hospital in Sydney. “There are a handful of reasons [being explored]. One is psychosocial, that we put women in harm’s way when it comes to caring for people because most nurses are women. “
There is another issue, he says. “A group of researchers in the US said, ‘We think it is happening in that period because they’re perimenopausal and no one is looking at that. Is that possible?’”
But, Faux says, the most fascinating theory is US immunologist Professor Akiko Iwasaki’s research around the hormonal response – that the female’s immune system is more aggressive than the male’s, and turns on faster and stronger to protect any potential unborn child. But it then exhausts itself and it can’t keep fighting against the virus and stop it from developing reservoirs in different organs.
Faux sees more women than men at St Vincent’s Long Covid clinic (55 per cent female patients compared with 45 per cent male). The most common age group is 31-45 years, followed by 46-60 years. This echoes the experience of other clinics in Australia and overseas and was also noted as a concern by the parliamentary committee inquiry into Long Covid. “There’s just a lot more women,” Faux says.
The reason I am talking to Faux in his tiny office at St Vincent’s between clinic appointments on a Thursday afternoon is not only because is he one of the leading Long Covid experts in Australia and I selfishly want to pick his brain, but because he is the first person in this country to have written a comprehensive guide to the illness. To be published in May, Long Covid: Expert Advice, from Diagnosis to Treatment and Recovery is aimed at patients, people just like me, who have been struggling to get better. It also advocates for us. And it does so in a particularly empathetic way.
“If you are living with Long Covid, we know that in your own ways you try to keep going, try to be the person you were, while battling the fear that you will never be the same,” Faux writes early on, setting the tone. “This book is an attempt to say to all of you: we see you.”
Those few sentences in the book encapsulate my experiences in a way that no other doctor has been able to. It’s comforting to simply read Faux’s acknowledgment of the awful symptoms – the erratic heartbeat, the exhaustion, the brain fog, the doctors’ appointments, the specialists’ appointments, juggling work, juggling children and the heavy weight of waking up every morning and not feeling any better.
“One of the things about Long Covid is that it’s a largely invisible illness,” Faux writes. “When you have it, you don’t necessarily look any different. It is not like you’ve lost a limb or have a cast on your harm. Fatigue or cognitive impairment is often subjective; it’s hard to show people you are fatigued because the only way to do that is to complain about the symptom.”
Faux is the Director of Pain Medicine at St Vincent’s, and previously spent 22 years as the director of rehabilitation. He has spent almost 30 years helping people recover from injury and illness. He and his colleagues recognised early on in the pandemic that there was a need to plan beyond the acute infection stage. And after working on the front line in the Covid wards for months, he saw first-hand what was coming. “What I knew of previous pandemics, and the effects of viral illnesses such as HIV and polio, was that the pandemic was about to deliver thousands of people who would be damaged by this infection and who would require rehabilitation,” he writes.
His unit soon started getting referrals for Covid patients who still had symptoms after three months. They called themselves “long haulers” on social media and were reporting breathlessness, coughing and exhaustion.
“We initially thought it was because the virus was destroying their lungs and they needed pulmonary rehab – but then a lot of the people we were seeing couldn’t go back to work because they couldn’t concentrate,” Faux tells me.
“I had colleagues emailing me saying, ‘Are you using brain injury rehab for these people?’ and it was then I realised that if we didn’t do something proactively, we were going to end up with an army of people who were disabled for some time.”
More than 200 different symptoms are now ascribed to Long Covid. According to a 2021 review quoted by Faux in his book, the most common is fatigue (45.1 per cent), followed by breathlessness, then insomnia, difficulty waking, anxiety, depression, brain fog, muscle pain, palpitations, headaches and a loss of taste and smell. But it can be hard to pin down. “People with Long Covid often say they don’t feel themselves, or are unable to get on with things as they used to, but many can’t really articulate what they feel,” he writes. “At the St Vincent’s clinic I’ve seen people lose their jobs as a result of Long Covid. I’ve seen it place stress on relationships and cause untold anxiety.”
Faux estimates there could be as many as one million Australians living with Long Covid, given that around one in ten people who get Covid develop Long Covid and more than 11 million Australians are thought to have contracted Covid since the pandemic began. “This figure would place Long Covid high on the list of the most significant medical conditions affecting the Australian population,” he points out. “Compare this with type 2 diabetes at 1.3 million, asthma at 2.7 million, heart disease or stroke at 1.2 million and cancer at 1 million.”
I managed to avoid Covid for the first two years of the pandemic, and I was beginning to think I was one of the lucky ones until I finally tested positive. This, of course, was well after the peak of the pandemic, after lockdowns, and after almost every Australian had been vaccinated. By then, we had certainly heard of Long Covid. The Weekend Australian Magazine had reported on the condition back in 2020 – a growing army of Covid “long-haulers”, many of whom had only a mild case of Covid-19, describing “a medley of lasting symptoms”.
When I fell ill, three days after my son tested positive in December 2022, I wasn’t too worried. I was fully vaccinated. The symptoms were initially mild: I had a temperature for a few days, a slight cough and felt generally unwell. But the symptoms dramatically escalated one evening when I was cooking dinner for my family. A wave of nausea and dizziness hit, my heart started beating fast and erratically and I thought I was going to faint. I immediately stopped what I was doing and lay down on the couch, waiting for it to pass. It didn’t.
During my first hospital visit on Christmas Day, they checked my heart and found nothing wrong, then hooked me up to a bag of IV fluids. I overheard the doctor ask a nurse whether I was eligible for antiviral drugs. “No, she’s too young,” came the reply. I was discharged a few hours later as there was nothing more they could do. I was back in hospital on New Year’s Eve with the same frightening symptoms. This time I underwent exhaustive tests and spent a night in the Covid ward before being discharged. Two weeks later, I finally tested negative to Covid – though my symptoms remained.
“They will lift,” a close friend reassuringly messaged me. But even as time went by, there was no easing of the symptoms. The godawful nausea meant I had no appetite and lost five kilos, and I couldn’t do anything physical without feeling dizzy. My husband had to take care of me and keep the kids occupied during a month of school holidays. Worst of all, my heart was behaving very strangely. All of a sudden I would feel it beating as if it would leap out of my chest, then I would get this horrible jittery feeling like when you’ve had too much coffee. Sometimes this would last for days.
I attempted to go back to my job as a journalist for The Australian’s WISH magazine in the middle of January 2023. I was working from my parents’ house – they were helping look after my children. One day I’d been working for about two hours when another wave of nausea and dizziness hit. I remember crying in despair in front of my husband and kids, frightened that this illness would rob me of my career.
Then came the dreaded “brain fog” reported by many Long Covid sufferers: I kept forgetting words and confusing things. The words and memories were there, I just couldn’t access them. It took away my confidence to write – a key part of my job – as well as my ability to function day-to-day as a mother and wife with school-age children.
Many studies have found that Long Covid affects the brain, and it’s a key part of the rehabilitation program at the St Vincent’s clinic – even though Faux admits the medical profession is at a loss to explain what causes the fog. “It’s unclear whether the effects on the brain are due to the persistence of the virus or to the immune system’s response, but brain imaging studies have shown that the parts of the brain involved include the orbitofrontal areas (above the eyes) close to where the olfactory (smelling) nerves enter the brain, and near some of the areas of the memory centres (the hippocampus and limbic systems),” he writes. “There is also evidence of thinning of the brain’s grey matter in those with Long Covid who have brain fog.”
The other debilitating symptom Faux sees that has also changed my life is post-exercise malaise. It means you can’t tolerate any type of exercise, and your body tells you afterwards – not during – with a swift return of symptoms. We’re not talking about the serious exertion of running or lifting weights in the gym; it can be triggered by the expending of energy in almost any way. Carrying too many groceries one evening meant I woke up the next day to find my nausea had returned powerfully, and I found getting out of bed incredibly difficult. The day before, I’d felt fine.
As I grew to understand, people living with Long Covid don’t have a linear recovery. You can have a good day, or even have a good week – and then you can overdo it physically, without realising, and be back to square one. For me, this was when the fear crept in and I found myself panicking that I might never recover.
“Living with uncertainty is one of the big issues for Long Covid,” explains Faux. “We always advise people with Long Covid a bit like we approach cancer rehabilitation – if you’re having a good day, enjoy it and don’t expect it to be the same tomorrow. And if you are having a shit day, then ride it out and maybe tomorrow will be completely different.”
While I was undergoing a series of tests last year to find out why my heart was beating erratically, a doctor helpfully told me that Long Covid is a post-viral syndrome much like Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, and the sheer volume of cases mean the symptoms cannot be dismissed as psychosomatic. “One of the things that people were initially saying with Long Covid is that these people are histrionic, they are putting it on,” Faux says. “But it became clear to me when we opened the clinic and talked to the first patients that they were not.
“The patients we see can’t work and they want to work. They need money and they have to put bread on the table. They don’t have a history of chronic pain or diagnosable illnesses. These are people with very little to gain by being sick.”
There is a six- to nine-month waiting list to get into the St Vincent’s Long Covid clinic. Faux and Associate Professor Anthony Byrne, a respiratory physician, set up the team that includes nurses, physiotherapists, a sleep specialist, a neurological rehabilitation expert and a psychologist. Each patient who is referred by their GP gets an assessment and a tailored rehabilitation program. It’s a slow process, but it does work. “If patients are identified early and they get a psychologist and a physio, or a physio and occupational therapist, whatever they need, and they start treatment early, the evidence from overseas is that they recover faster,” explains Faux. “And the evidence from our clinic is that there is a substantial return to work at six months following the commencement of rehabilitation.”
Last April, a federal parliamentary committee made nine recommendations following its inquiry into Long Covid. Among them was that the government should partner with state health departments to develop and fund more multidisciplinary Long Covid clinics. Yet when Health Minister Mark Butler released the federal government’s response to the inquiry, this was not one of the recommendations it supported. In the same month, the government committed $50 million of funding for research into Long Covid and established a national database on the disease. In fact, despite the demand for Long Covid clinics and the committee’s recommendations, governments appears to be withdrawing their support for them. In an RMIT study published last October co-lead author Dr Shiqi Luo stated: “We have insufficient Long Covid clinics to meet the demand”. An ABC investigation last December found five of the country’s 23 clinics have either been scaled back or closed.
Unlike me, Julie Lamrock contracted Covid early in the pandemic, in 2019, when a passenger she collected in her shuttle bus from the Overseas Passenger Terminal disembarked from the Ruby Princess cruise ship.When The Weekend Australian Magazine reported on Covid “long-haulers” in 2020, Julie was still experiencing pain, fatigue and brain fog. Her symptoms have never abated. Today, she describes her now four-year battle with Long Covid as a “living nightmare”. “Only last year did I start to go out again,” she says. “but the pain is always there. The fatigue is always there. I actually go to sleep in pain and I wake up in pain … and I’m living this every day.”
She says her treatment includes visits to a pain specialist and a pain psychiatrist, but after Nepean Hospital ceased its Covid-19 follow-up service she was no longer being treated as any part of a cohesive Long Covid treatment plan. “There’s nothing happening. Why haven’t I been told to go and see a [particular specialist] doctor? Why isn’t there a system where every doctor can turn around and say, ‘Well, here’s a number you can call and yes, here’s a referral to this clinic, get this done, get that done’?”
I was referred to a Long Covid clinic by my cardiologist last April. I received a call in June asking me what I needed help with; I told them. I didn’t hear anything back until October last year when I received another call saying the clinic was moving online and Long Covid case management was going back to GPs. I have since learned that what was once my Long Covid clinic is now an eight-week online education program and a support group.
When, in writing this article, I asked Health Minister Mark Butler about the future of Long Covid clinics, he did not directly respond, noting only the need for “multidisciplinary team-based healthcare for people with chronic and complex conditions like Long Covid.” The Department of Health and Aged Care released a plan in February this year addressing Long Covid, now referred to in government circles as PASC (Post-Acute Sequelae of COVID-19). There is no mention of Long Covid clinics. “States and territories decide the mix of the services and functions delivered in their jurisdiction … some have used funding to establish clinics for the management of people with PASC,” the plan states. “People with PASC will be able to benefit from the Government’s … commitment” to “expand general practices”.
Faux thinks this approach is flawed, and Long Covid patient care should be done in multidisciplinary rehab clinics because it’s not easy to treat. “The GPs are doing their best, but there’s not enough GPs and it’s very complicated because you’ve got to rule out everything else first,” he says.
People are not going to stop getting Covid and, in turn, Long Covid. “In January of this year, 100,000 positive cases were registered in the country. 100,000 people got Covid. That means about 10,000 people got Long Covid,” Faux tells me. “And every month there’ll be another 10,000. There’s lower vigilance with respect to Covid vaccinations and so we expect that people will get it a little bit more. There’s been no decrease in demand at the clinic.”
Faux quotes research in his book that shows 91 per cent of Long Covid sufferers have improvement in symptoms within 12 months; I was also told this by my cardiologist, who urged me just to hang on, as it was most likely I would get better within a year. And I did. I remember cycling with my family to a pool in February this year and feeling totally fine – fit, even. I had also gone back to reformer pilates. “Finally, I’m properly myself again,” I said to my husband.
But three days later, I tested positive for Covid. This time I was prepared.
After multiple conversations with my kind GP, I found out that even with Long Covid I wasn’t eligible for the antiviral drug Paxlovid as I was too young and was not severely immunocompromised. But I could get a course of antivirals privately for $1200.
It was an extraordinary amount of money, but I was willing to pay it in order to avoid a repeat of what I’d been through before. I dispatched my husband to get the antivirals that night; within two days I’d tested negative to Covid and my symptoms were almost gone. I was due to finish the five-day antiviral course on a Sunday, and I was already planning to go back to work on the Monday. But as soon as I finished the antivirals, my Long Covid symptoms came back: the crippling nausea, the irregular heartbeat, the exhaustion. I started to panic. How could I be back here again?
Five weeks later, I’m sitting in Faux’s office. “The statistics say you will get better,” he kindly reassures me. I tell him how I’m still struggling with nausea, fatigue and post-exercise malaise. I’ve stopped all exercise and I am back mostly working from home. “It’s going to be slow, and that will be very frustrating – but you have to try and look after yourself in that time,” he says. The empathy and understanding he shows me during our hour-long interview is also apparent in every single chapter in his book. Faux not only truly sees me and all people living with Long Covid, he has compiled a comprehensive management plan to help. “Your road to recovery may be a long one, unfortunately, but you are not alone and you are already one step closer to your destination,” he writes.
As for the future, Faux is full of hope. He says there is a lot of research being done around the world on the condition, from examination of its causes to trials of drugs to treat it. “It is already better now than it was a year ago, and we’re optimistic that this trajectory will continue,” he notes. “The more we know, the better the outcomes for people with Long Covid will be.”
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21 April, 2024
Japanese Real-World Observational Study: mRNA Vaccines how Low efectiveness
From February 1 to March 17, 2022, Epidemiological, public health and health economic researchers representing Hiroshima University in Japan along with Japan’s Ministry of Health, Labor and Welfare, Health Insurance Bureau, Medical Economics Division conducted a test-negative case-control study using a dataset of 117,335 individuals, collected through the COVID-19 J-SPEED form in the PCR center at Hiroshima Prefecture, Japan.
The study team, represented by corresponding author Yui Yumiya, Ph.D., MPH, Assistant Professor in the Graduate School of Biomedical and Health Sciences (Medical), estimated a propensity score matching for vaccine status based on participants’ demographic characteristics. Thereafter, the team calculated the odds ratio from logistic regression to determine any association between COVID-19 vaccination status and test positivity rate adjusting for symptoms, exposure to close contact, as well as previous history.
The Hiroshima University-led team of researchers established vaccine effectiveness as a formula (1 –aORs) ×100%). The team concluded that the data generated points to the protective effect of the COVID-19 vaccines against the Omicron strain. However, that’s interpreted in such a way because more unvaccinated are infected than vaccinated. If measured against the World Health Organization standard for vaccine approval, the mRNA vaccines as assessed in this study would fail the WHO 50% vaccine effectiveness test, as even boosted vaccine effectiveness equaled 26.4%.
The results of this AMED-funded observational study were published in PLOS, Global Public Health.
The authors of this study emphasize some strengths, such as the comprehensive data collection conducted across all PCR centers in collaboration with the Hiroshima prefectural office. Considered an “extensive and unique epidemiological survey,” it represents a material contribution, “with no comparable large-scale study conducted in other prefectures of Japan.”
Of course, many limitations with such a study exist (and are mentioned below), but the authors promote their use of detailed information representing occupation and various risk factors (likelihood of close contact and pre-existing conditions) that they articulate enhancing the study’s robustness. Such factors, adjusted within the model, account for potential confounding influence.
PCR Positivity Rates by Vaccination Status: the X axis represents the study period; y axis represents the test positivity rate. The figure displays PCR positive rates for three distinct groups: non-vaccinated, vaccinated with two doses and vaccinated with three doses (booster).
Finding
Reporting PCR test positivity rates were 7.9%, 4.5%, and 2.8% for the non-vaccinated (non-vaccinated, vaccinated with a single dose, and vaccinated with two doses less than 14 days ago), vaccinated with two doses (vaccinated over 14 days ago), and three doses, respectively.
Presenting both unadjusted and adjusted analyses, vaccine effectiveness of two doses against infection were 38.5% (95% confidence interval [CI]: 32.8%–43.8%) and 34.7% (95%CI: 28.4%–40.4%), respectively, compared to the non-vaccinated group. Vaccine effectiveness of three doses was 33.8% (95%CI: 25.0%–41.5%) and 26.4% (95%CI: 16.4%–35.2%), respectively, compared to those vaccinated with two doses.
While the authors cite these results in the positive (vaccine affords protection), not only should the actual vaccination effectiveness rate be questioned, but also noted that three dose rates is lower than the VE for two jabs. The authors emphasize the protective influence of the vaccine countermeasures.
Limitations
All observational studies fall short in terms of evidentiary strength as compared to randomized controlled trials. Consequently, the team’s findings should be interpreted with caution and consideration of such inherent limitations, which include:
No specified estimation of VE for individual vaccine types, booster types (heterologous or homologous), time-sensitive effectiveness (effectiveness at different intervals post-vaccination), or the interval between vaccine doses.
The generalizability of our results may be affected due to the nature of this study population. For example, PCR test recipients who visited a PCR center may have a higher level of health consciousness compared to those who didn’t visit a PCR center.
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Another finding of low vaccine effectiveness
How durable was the original monovalent mRNA vaccine when measured against prevention of COVID-19 Omicron-associated hospitalization involving children and adolescents? The Overcoming COVID-19 investigator network recently reported on this data between 2020 and 2023.
The results are challenging, evidencing rapidly waning vaccine effectiveness (VE) based on the known confluence of factors from mutating viral pathogens to the possibility of immunological imprinting (antigenic sin), and frankly, vaccines not engineered for breadth or durability results.
How severe is the waning VE? It is significant. For example, when measuring against hospitalization, VE should be substantially high, as the threshold is different for this class of product than preventing transmission. When the hospitalization incidence occurs a mere four months or more after the hospitalization event the VE rate equals 19% and ranges from as low as 2% to up to 32%. This is a remarkably weak rate evidencing serious concern about the longer-term viability of the COVID-19 countermeasures. The targeted threshold of effectiveness needs to be significantly higher for our children and adolescents.
Background
Authoring this study paper was the Overcoming COVID-19 investigators, part of a study seeking to characterize the development of COVID-19 complications in children and young adults as a consequence of exposure to COVID-19 including the Multisystem Inflammatory Syndrome in Children (MSI-C).
MIS-C emerged as a significant concern during the SARS-CoV-2 delta surge but waned during Omicron.
A real-time surveillance and observational study, the investigation included prospective enrollment of study participants with collection of blood and respiratory samples. What were the risk factors and outcomes of COVID-19 critical illness in the pediatric population? What defined complications in this young vulnerable court and linked to SARS-CoV-2? What about predictive markers of these complications? Finally, what characterized the development and maintenance of adaptive immunity? The Overcoming COVID-19 investigators sought to answer these, and other questions.
How durable is pediatric vacation with use of mRNA COVID-19 vaccine countermeasures? This was a central question driving this investigation. Overall, parents have increasingly opted to keep their children away from the COVID-19 countermeasures.
The authors, represented by corresponding author Laura Zambrano, Ph.D., M.D., senior epidemiologist at the Centers for Disease Control and Prevention (CDC), report that during December 19, 2021–October 29, 2023, the Overcoming COVID-19 Network evaluated vaccine effectiveness (VE) of ?2 original monovalent COVID-19 mRNA vaccine doses against COVID-19–related hospitalization and critical illness among U.S. children and adolescents aged 5–18 years, using a case-control design.
The authors report, “Too few children and adolescents received bivalent or updated monovalent vaccines to separately evaluate their effectiveness” which most certainly is a telling data point as to the reality of demand for COVID-19 vaccines among parents and their children and adolescents.
For this particular study, the authors led by Zambrano point out that a majority of individuals tested positive for SARS-CoV-2 fell in the unvaccinated category, “despite the high frequency of reported underlying conditions associated with severe COVID-19.”
Findings
So, what was the vaccine effectiveness of the original monovalent vaccine against COVID-19–related hospitalizations?
According to the findings here, VE equaled 52% (95% CI = 33%–66%) when the most recent dose was administered <120 days before hospitalization, and 19% (95% CI = 2%–32%) if the interval was 120–364 days. TrialSite suggests the rate of 19% VE in preventing hospitalization 4 months and on represents an incredibly weak record.
Another measure, or slice of the data, was a vaccine administered any time within the previous year, which looks at least somewhat better than the pathetic 19% figure, especially for this category of the original monovalent vaccine against COVID-19–related hospitalization was 31% (95% CI = 18%–43%).
When looking at the definition of hospitalization with more granularity, diffident VE rates emerge. For example, looking at the category “COVID-19-related illness” defined as receipt of noninvasive or invasive mechanical ventilation, vasoactive infusions, extracorporeal membrane oxygenation, and illness resulting in death and VE rates equaled the following:
VE Scenario
VE was similar after excluding children and adolescents with documented immunocompromising conditions.
The CDC authors emphasize that the receiver of ?2 monovalent mRNA COVID-19 vaccines are associated with fewer COVID-19 hospitalizations during the Omicron period in children and adolescents aged 5–18 years. But this
“protection from original vaccines was not sustained over time, necessitating increased coverage with updated vaccines.”
A majority of hospitalized kids were unvaccinated, and few had received updated vaccine doses despite a high prevalence of underlying comorbidities associated with more severe disease.
The social determinants of health continue to be a factor in vaccination trends, with vaccination rate decline associated with social vulnerability.
The authors acknowledge carefully the overall dismal VE rates, stating:
“VE of original monovalent doses against COVID-19–related pediatric hospitalizations were lower than previous VE estimates reported by the Overcoming COVID-19 Network before Omicron emergence.”
The CDC does not include any risk-benefit analysis within its recommendations, e.g., avoids discussion of myocarditis/pericarditis risk to young adolescent males and avoids the topic of natural immunity when recommending that “all children and adolescents receive updated COVID-19 vaccines to protect against severe COVID-19.”
Limitations
Not surprisingly, many limitations suggest any interpretation done so with caution. Dr. Zambrano and team identify four major limitations including:
SARS-CoV-2 infection-induced immunity was not assessed
Limited viral sequencing data prevented consideration of subvariant-attributed immune evasion
Limited coverage with bivalent vaccines and currently recommended updated monovalent vaccines precluded the estimation of VE of these formulations
Previously healthy children and adolescents accounted for <20% of case-patients, limiting generalizability
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18 April, 2024
Japanese Epidemiological Bombshell: Investigators Link Mass mRNA Vaccination and Adverse Cancer Outcomes
Physician-Epidemiologist Miki Gibo affiliated with Matsubara Clinic and National Health Insurance Yusuhara Hospital in Yusuhara, Kochi, Japan and colleagues recently had a disturbing paper published in Cureus. Peer reviewed, the team for Japanese researchers look into the question of excess deaths during and after COVID-19 and incidence of cancer mortality after the third MRNA COVID-19 vaccine.
While talk or “turbo cancer” is rampant on social media such as X any such claims require significant evidence. TrialSite has chronicled real world data and tracked the growing number of case series involving some form of cancer in association to COVID-19 vaccines. But case series-based studies are not designed to establish causation. In collaboration with React19, TrialSite supported that patient advocacy’s development of the Scientific Publications Directory. Now managed by React19, approximately 200+ studies involving cancer and COVID-19 vaccination are available in this online study hub.
Dr. Gibo and colleagues discuss in their Cureus piece excess deaths including cancer in Japan, a population that was heavily exposed to mRNA COVID-19 vaccines, and one that is rapidly aging. Their recent output was published just days ago in Cureus. Importantly, while the findings herein raise profoundly disturbing questions, this study output does not equate to confirmatory evidence that COVID-19 vaccines and cancer have some causal linkage. More investigation is necessary.
The Study
The team in this study evaluated how age-adjusted mortality rates (AMRs) for different types of cancer in Japan changed during the COVID-19 pandemic (2020-2022).
Tapping into official Japanese statistics and employing logistic regression analysis, the investigators compared observed annual and monthly AMRs with predicted rates based on pre-pandemic (2010-2019) figures.
What are the findings?
Interestingly, the team observed no significant excess mortality during the first year of the pandemic (2020). This data point resonates with other national data TrialSite reviewed in the United States, for example.
Disturbingly, Dr. Gibo and colleagues observed excess cancer mortality in 2021, after mass vaccination with the first and second vaccine doses. This data includes what the medical researchers report observations involving “significant excess mortalities” for all cancers, along with upward trends with select types of the disease.
This study discusses possible explanations for these increases in age-adjusted cancer mortality rates but is not designed to prove causation.
Conclusion
The Japanese medical researchers raise disturbing questions with this significant study. For example, as published in the peer-reviewed Cureus the team observed in 2022, after mass population exposure to COVID-19 mRNA vaccines “statistically significant increases in age-adjusted mortality rates of all cancer and some specific types of cancer, namely, ovarian cancer, leukemia, prostate, lip/oral/pharyngeal, pancreatic, and breast cancers.”
Declaring that the data exhibit “particularly marked increases in mortality rates of these ER?-sensitive cancers,” Dr. Gibo and colleagues suspect that the findings “may be attributable to several mechanisms of the mRNA-LNP vaccination rather than COVID-19 infection itself or reduced cancer care due to the lockdown,” the latter of which could just as well be an explanation.
But the former could be an explanation as well, and that’s a real problematic proposition needing immediate investigation. Gibo and colleagues certainly recommend more research.
Limitations
Not clinically validated, the team taps into official data sources employing descriptive statistics. The authors suggest more statistical investigation associated with vaccination status is necessary to bolster any evidence.
The Study Authors’ Questions
Why are AMRs of ovarian cancer, leukemia, prostate, lip/oral/pharyngeal, pancreatic, and breast cancers increased significantly beyond the predicted rates, especially in 2022, in Japan?
Does the research of Solis et al. on the binding ability of S-protein of SARS-CoV-2 against over 9,000 human proteins matter here? In that research, the authors point out that S-protein specifically binds to ER? and upregulates the transcriptional activity of Er?. Importantly, all of the identified cancers are known as estrogen and estrogen receptor alpha (ER?)-sensitive cancers.
The present study points out more estradiol (E2) to human breast cancer cells can lead to proliferation of the cancer cells, whereas the addition of raloxifene, a selective ER? modulator, inhibits proliferation.
Could ER?-mediated transcription induce endogenous DNA double-strand breaks (DSBs) in ER-sensitive cancers? According to some research, “Transcriptionally activated ER? induces DSBs by topoisomerase II and the recently known R-loop/G-quadruplex structures formation, significantly increasing the need for BRCA1 for their repair in breast cancer cells.”
Dr. Gibo and colleagues point out that in their study they present “nuclear translocation of mRNA and S protein with the nuclear localization signal [90], and an in silico bioinformatic analysis showed interactions between the S2 subunit of S-protein and BRCA1, BRCA2, and P53 [91], possibly resulting in their sequestration and dysfunction.”
Could it be the case that a possible co-occurrence of high BRCA1 demand to repair DNA damage triggered by activated transcription via ER? bound with S-protein along with dysfunction of BRCA1 sequestrated by S-protein raises concerns about increased cancer risk in ER?-sensitive cells in mRNA-LNP SARS-CoV-2 vaccine recipients?
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Reportedly, During Covid, The Elderly Were the First to be Sacrificed
Last month, it was reported former New York State governor Andrew Cuomo had been subpoenaed by Congress over elderly Covid deaths under Cuomo’s administration. The ex-governor was accused of using under-reported numbers to bolster his handling of COVID-19 especially with the number of deaths which occurred in 2020, when Cuomo required nursing homes to accept elderly Covid positive patients. As a result of this policy, Cuomo has been accused of causing the death of over 15,000 New Yorkers. His deposition in front of the Republican led House Select Subcommittee on the Coronavirus Pandemic is scheduled for May.
“After misleading the public and filtering the truth from the American people regarding how many COVID-19 deaths occurred in nursing homes, Andrew Cuomo has been dodging our committee, delaying our investigation and refusing to take accountability,” New York Rep. Nicole Malliotakis (R-Staten Island), one of the panel’s members, said in a statement. Malliotakis added, “His misguided policies led to the deaths of more than 15,000 New Yorkers. His testimony is crucial to helping us prevent a tragedy like this from occurring ever again.” But the bigger question is, was this the only occurrence of Covid neglect? Apparently not.
United Kingdom
In 2023, TrialSite reported on a lawsuit against the British Government by the families of elderly patients who died in nursing homes. The families claimed not enough was done to take care of their loved ones and infected patients were transferred into nursing homes and spread the virus. This is eerily similar to the events which will soon have former New York State governor Andrew Cuomo appearing in front of a Congressional committee. It seems, however, there are more instances of Covid elder abuse in the UK.
DNR’s
In a recent article in the Daily Mail, there is a report of Do Not Resuscitate (DNR) papers being forged. Relatives of elderly patients say their loved ones were left to die against the wishes of the families. This is now being investigated by the Scottish Covid-19 inquiry which has named the use of DNRs as one of the primary reasons for its investigation. According to one relative of an elderly woman who died, the relative’s name and signature were on a DNR authorization but the relative never saw nor signed the document.
The Scottish government insisted there was no change in advice given to clinicians during the pandemic regarding the use of DNRs, but the evidence in this area has shown, so far, this not to be true. Administrators at some elder care homes in Scotland have been accused of having a culture where health professionals urged nursing homes to update their “anticipatory care plans” for residents. One administrator says she was told, “You need to look at who doesn't have DNRs because they will now need to have one.” Allegedly, after this conversation DNRs were in place for all residents of the nursing home and the administrator wondered to what extent family members had been consulted. The impression the administrator had was if an elderly resident became ill with Covid, they wouldn’t go to the hospital. The administrator added, “You could clearly see that, if they went to hospital, they had a really good chance of improving, of getting over what was making them unwell in the first place. But it was almost like, you were not playing God, but it was just 'no, you can't go, so you just have to stay.” According to the administrator it was difficult for the nursing home to access ambulances, paramedics or hospital beds.
It is alleged the Scottish government allowed this practice. In January, TrialSite reported Scottish police were looking into the possibility of an “industrial sized’ cover up by Scottish ministers regarding deaths of elderly patients in nursing homes due to Covid. Twenty-two official internal complaints were raised concerning the Scottish government’s official response to the nursing home deaths. Again, on this issue, DNRs were involved.
Covid Devastated Nursing Homes
The pandemic neglect in nursing homes wasn’t limited to the UK. According to an article by the Kaiser Family Foundation in 2022, Covid deaths in elder care facilities accounted for at least 23% of all Covid deaths in the United States as of January 2022. Canada was ranked last for the amount of deaths caused by Covid in nursing home facilities.
The Centers for Medicare & Medicaid Services (CMS) (2021) reported 570,626 nursing home residents' infections and 112,383 residents’ deaths in the USA before the wide availability of COVID-19 vaccination in 2020 for nursing home residents (e.g., Pfizer, Moderna, and Johnson and Johnson). Since the mass vaccination program another 57,808 residents have died, at least a percentage of them, fully vaccinated against COVID-19.
TrialSite chronicled disproportionate morbidity and mortality among the nation’s most vulnerable, sick and elderly residents.
According to the Centers for Medicare data 170,191 elderly died in long term care during the pandemic. In what seems a low rate, only 43.3% of long-term care residents are up to date with their COVID-19 vaccines. Why would this be the case?
What is truly unfortunate is it seems the elderly have become political pawns and tragically, easily dispensable. It is problematic when a politician actually admits he covered up elderly deaths because the political data would be used against him. The shame of all of this remains the reality that this represents a worldwide problem (at least in developed nations in English speaking countries) and a sad comment on health care, politics and the world when the elderly—that is our parents and grandparents-- are so easily tossed away.
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17 April, 2024
Rand Paul Pulls Back Curtain on the ‘Great COVID Cover-up’
In an explosive new op-ed, Sen. Rand Paul (R-Ky.) claimed that at least 15 separate federal agencies knew that attempts to create a COVID-19-like coronavirus were being undertaken at the Wuhan Institute of Virology as early as January 2018.
Yet heads of these agencies did not reveal this information to the public; for years, they actively refused to release information on the project to lawmakers such as Dr. Paul, who were attempting to provide congressional oversight.
“For years, I have been fighting to obtain records from dozens of federal agencies relating to the origins of COVID-19 and the DEFUSE project,” Dr. Paul, who in March revealed he was formally launching a bipartisan investigation into the virus’s origins with Democratic Sen. Gary Peters of Michigan, wrote.
The DEFUSE project refers to a proposal submitted by EcoHealth Alliance, a U.S.-based nongovernmental organization headed by British zoologist Peter Daszak, and the Wuhan Institute of Virology. The purpose of the proposal was to “insert a furin cleavage site into a coronavirus to create a novel chimeric virus.”
Dr. Paul also identified two additional parties that were part of the original plan to create chimeric coronaviruses at the Wuhan lab: the National Institute of Allergy and Infectious Diseases, the federal agency formerly headed up by Dr. Anthony Fauci, and Dr. Ian Lipkin, a professor of epidemiology and one of the authors of the now-disgraced “Proximal Origin” paper. The authors of the paper, which was published in Nature in March 2020, stated that evidence clearly indicated that SARS-CoV-2 emerged naturally, even though privately, the authors expressed clear concerns that evidence suggested the virus was genetically designed.
Some scientists have already raised ethical concerns in response to the revelation.
“We now know Ian Lipkin was part of the initial DEFUSE proposal,” Bryce Nickels, a professor of genetics at Rutgers University, said in response to the revelation. “Everything he has said about COVID origins and his role in the fraudulent ‘Proximal Origins’ paper must now be reconsidered in the wake of these new revelations.”
It’s not just Lipkin, of course.
All of these parties failed to speak up when COVID-19, one of the deadliest viruses in a century, emerged from Wuhan, Dr. Paul said, and details of the DEFUSE project may not have come to light at all if not for a whistleblower (identified as Lt. Col. Joseph Murphy).
More details of what the Kentucky senator calls “the Great COVID Cover-up” are likely to materialize as Dr. Paul and Mr. Peters continue their investigation. But an abundance of evidence already shows it’s no exaggeration to use that word: coverup.
Dr. Paul is hardly the first government official to use the term.
Nearly a year ago, David Asher, a bioweapons specialist who led the State Department’s investigation into the origins of COVID-19, sat down with New York magazine journalist David Zweig and explained why there has been so little progress made in discovering the origins of COVID: Those with institutional power don’t want answers.
“It’s a massive coverup spanning from China to DC,” Mr. Asher said. “Our own state department told us, ‘Don’t get near this thing; it’ll blow up in your face.’”
Other government whistleblowers have also attempted to expose the coverup.
In August, the CIA confirmed that the agency was “looking into” allegations from a CIA whistleblower who claimed that analysts tasked with determining the origins of COVID were offered “significant” financial incentives to change their assessment that COVID likely emerged accidentally from the Wuhan lab. (It’s worth noting that Dr. Fauci allegedly was admitted to agency headquarters “without a record of entry” while the CIA was conducting its investigation into COVID’s origins.)
The reason the government would cover up DEFUSE becomes obvious when one analyzes the nature of the proposal, which British author Matt Ridley weeks ago noted included a great many “wacky” (and reckless) ideas such as spraying vaccines into bat caves to immunize them.
“In the end, what they were doing was making more dangerous viruses, with a view of understanding them,” Mr. Ridley said. “It looks very strongly as if in trying to prevent a pandemic they may have caused one.”
While we still do not know this for certain, it looks increasingly likely that COVID-19 was born of gain-of-function research that was partially funded by the U.S. government.
Though this result would be shocking to many, especially those who see the state as virtuous and infallible, it’s far less surprising to students of history and economics.
“The worst evils which mankind ever had to endure were inflicted by bad governments,” Ludwig von Mises wrote in “Omnipotent Government.” “The state can be and has often been in the course of history the main source of mischief and disaster.”
The reason for this is obvious. The more power is concentrated, the less accountable it becomes, and power without accountability is a recipe for disaster.
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Australia: Senator Claims TGA ‘Overriding’ Experts While Processing Vaccine Injury Claims
Senator Gerard Rennick has alleged—under parliamentary privilege in the Senate—that the Therapeutic Goods Administration is “overriding the decision of the specialists” in refusing claims for vaccine injury from people who received COVID-19 vaccinations.
Services Australia administers the scheme, which offers people a way to seek a one-off compensation payment, instead of going through legal proceedings, if they experienced harm from a vaccine.
The Scheme was designed to “compensate for losses due to the harm ... suffered” and not for “pain and suffering.” The compensation covers lost earnings, out-of-pocket expenses, paid attendant care services, and “deceased ... vaccine recipient payments and funeral costs.”
To meet the criteria for the payment, Services Australia’s website says a person must have:
received an approved COVID-19 vaccine.
met the definition of harm, for example, an administration-related injury or one of the clinical conditions listed in the policy.
been admitted to hospital as an inpatient, or seen in an outpatient setting for an eligible clinical condition.
been admitted to hospital as an inpatient for an administration-related injury.
experienced losses or expenses of $1,000 or more.
The site also lists the eligible conditions including myocarditis (inflammation of the heart muscle) and the autoimmune disorder Guillain Barre Syndrome.
A claimant must have their condition verified by “a medical specialist in the relevant field of practice” (for instance, a cardiologist for myocarditis), and then send the medical report and evidence of the expenses being claimed for assessment by Services Australia.
Senator Claims to Have ‘Insider’ Informant
Mr. Rennick told the Senate that he had spoken to “an insider from the TGA” who had since resigned, and who “played a big role in designing this scheme.”
“The whole point of that scheme was that once the injured person got a specialist to say that the person was injured by the vaccine, he or she would be entitled to compensation. Now that is not happening,” the senator said.
“What is happening is Services Australia make these people wait [on average] 297 days to get a decision. Many of them can no longer work. They are seriously ill. They have to do all the legwork of trying ... see a specialist, a cardiologist or a rheumatologist, and that takes a lot of work. It’s very expensive. You’ve got to go and get MRIs or something to back [it] up. And then they’ve basically been neglected.”
He alleged that, once the claim came up for a decision, “what they do is [refer it] back to the TGA, [and the] TGA is a turning around and saying ‘we are overriding the decision of the specialists who actually examined the patient.’”
“Now my insider tells me these doctors at the TGA are not qualified to be overriding specialists. And I believe that if you haven’t examined the patient who you decide this isn’t actually a vaccine injury, how would you know?”
Mr. Rennick said he had talked to scientists—whom he did not name—who told him that “you will never know while a person’s leaving because you can’t take tissue samples from living people. So we are operating in the dark here in regards to our ability to examine what’s really going on as a result of these vaccine injuries.”
Only 14 Deaths Recognised as Vaccine-Related
Senator Rennick claimed there were 1,000 reports of suspected deaths due to the vaccines in the country.
“And how many have the TGA recognised? 14,” he said.
“When you press the TGA and you say to them, ‘Can you actually prove this wasn’t a vaccine?’ They say, ‘No, we can’t.’
He also claimed there were 10,000 unexplained excess deaths during the period between May and December 2021 when the vaccines were being administered.
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16 April, 2024
Esteemed Australian Immunologist/Virologist on Long COVID & Long Vax: Spike Protein Pathogenicity
An author with the Australian Journal of General Practice, Emeritus Professor in Immunology, University of Queensland, Faculty of Science, now retired and independent to speak his mind, Robert Tindle, Ph.D. is no lightweight. Heavily published deep into the science of virology and immunology, he presently educates his peers about the plight of long COVID and long Vax patients.
Elaborating on the scope and severity of the crisis while directing attention to the patient's plight, Prof Tindle explains to the Australian medical establishment the mechanism of action now evidenced by mounting scientific literature concerning both long COVID and the vaccine injured, or long-Vax, the latter being not yet accepted, at least overtly, by medical establishments of the West. To alleviate patient suffering, a growing economic toll and a debilitated medical establishment, we must open our eyes to science, embrace the truth, and forge a new path forward.
Anywhere from 2% to 20% of individuals who are infected with SARS-Cov-2, the virus behind COVID-19, end up with post-acute sequelae of COVID-19 (PASC or long COVID), according to the World Health Organization (WHO), European Union and the UK and US governments. This condition occurs >12 weeks after the initial COVID-19 infection and can endure for many months, even years. Recently the University of Queensland Australia Emeritus Professor elaborates on the condition millions of people struggle with worldwide, with hundreds of thousands of people in Australia coping with either long COVID or long Vax.
The recent paper was published as a viewpoint in the Australian Journal of General Practice, emphasizing that the plight of long COVID patients cannot be underestimated. Prof Tindle reports the presence of long COVID digital support groups emerging as a civil society safety net, but the lack of institutional scientific and medical support leads to a mounting crisis for patients. They are not listened to, and health systems are not prepared for delivering the right care, meaning long COVID patients resort to self-prescribed medication with use of over-the-counter remedies for example, diet changes and the like.
A heterogeneous disease with myriad of symptoms (cardiac, pulmonary, hematological and neurological), the retired Australian scientist points to overlap with myalgia encephalomyelitis/chronic fatigue syndrome, postural orthopedic tachycardia syndrome (POTS) and other post-viral manifestations.
What’s behind lingering COVID-19 symptoms despite the clearing of the infection? No one can be certain and according to the Australian scientist, “Public officials are flying blind when it comes to long COVID and vaccination.” But Tindle introduces some of the unfolding science for explanations.
While patients are not able to find a trustworthy diagnosis, they are often required to seek multiple medical positions, and these patients are often told they are merely struggling with anxiety or post-pandemic mental health issues.
What’s the medium duration of long COVID symptoms? According to Tindle, it is five months, however, 10% of long COVID patients may experience symptoms at month 12. In fact, fatigue, shortness of breath and difficulty concentrating can persist with this patient cohort still by year two after infection.
Still what is up in the air is whether some people may never recover.
What are some biomarkers involved?
Patients struggling with long COVID may present elevated inflammatory biomarkers, such as interleukin-6, C-reactive protein, tumor necrosis factor-?), possibly functioning as a core set of blood biomarkers that can be used to diagnose and manage long COVID patients in clinical practice.
Economic Contagion
Prof Tingle reports that 20% of long COVID patients in the UK either stopped working or were not able to return to work six months after their initial infection. In Australia, 240,000 persons with long COVID can no longer work full time. Meanwhile, absenteeism on the job only grew, accelerated with long COVID.
Make no mistake, economies are impacted. From reduced working time to loss of earning capability, and the lack of diagnosis in countries like Australia, this means that many won’t be eligible for disability schemes.
With no guidelines for how long COVID patients can access social security and employment protection, the working classes are particularly vulnerable.
Nowhere to Turn?
Efforts at establishing long COVID clinics have not translated into sustained access to care. Without substantive treatment guidelines or support they become “little more than incident report centers.” Moreover, waiting times in such long COVID clinics can equate to many months. In fact, in places like Australia, Prof. Tindle informs us that many GPs are not even aware of such clinics!
However, some progress has been made in Europe, reports Tindle. Some European nations and the UK offer more established long COVID clinics offering everything from online recovery platforms to GP training and even specialty access for children.
Bombshell: COVID-19 Vaccination & Long COVID
While TrialSite has reviewed some study results suggesting that vaccination may have put a dent in long COVD, other credible studies imply no such connection. Frankly, the evidence is both mixed, and not strong enough for any claims that the COVID-19 vaccines inhibit long COVID.
But Prof. Tindle goes on the record, expressing his concern that “COVID-19 vaccination per se might contribute to long COVID, giving rise to the colloquial term ‘Long Vax.”
Importantly, while most national medical establishments in the West such as the United States or the UK don’t yet accept the premise that the spike protein manifested from mRNA vaccines can lead to damage, Tindle in this established Australian General Practitioners journal expresses his viewpoint that “the spike protein of SARS-CoV-2 exhibits pathogenic characteristics and is a possible cause of post-acute sequelae after SARS-CoV-2 infection or COVID-19 vaccination.”
Supporting the mRNA vaccine-induced spike protein as a pathogenic agent hypothesis, Tindle continues, “COVID-19 vaccines utilize a modified, stabilized prefusion spike protein that might share similar toxic effects with its viral counterpart.”
The Australian virologist/immunologist proffers, “A possible association between COVID-19 vaccination and the incidence of POTS have been demonstrated of 284,592 COVID-19 vaccinated individuals, though at a rate that was one-fifth of the incidence of POTS after SARS-CoV-2 infection.” He points to Kwan et al.
Hammering on a topic deemed taboo for at least a while in medical establishments, the vaccine induced spike protein pathogenicity represents a real problem, pointing to very real-world, well-established links to myocarditis risk.
And what about the problem of mRNA biodistribution? Throughout the pandemic, medical establishment actors and representatives informed that the COVID-19 vaccination was safe and effective, and that there were no risks of the mRNA-induced spike protein circulating in the body for longer periods of time, and in the process, ending up in far flung tissues and organs. The mRNA would simply flush out via the lymphatic system in a matter of days, maybe a week at the most.
Of course, TrialSite has chronicled the incidence and studies disproving this continuous myth, at least in a percentage of individuals receiving COVID-19 mRNA vaccines. Prof Tindle verifies this reality, reporting, “mRNA vaccines can result in spike protein expression in muscle tissue, the lymphatic system, cardiomyocytes and other cells after entry into the circulation,” citing Trougakos et al.
Moreover, growing evidence suggests, and Tindle confirms in his viewpoint that individuals receiving at least two doses of mRNA vaccine “display a class switch to IgG4 antibodies.” Citing Uversky et al., Tindle articulates an important point as “abnormally high levels of IgG4 might cause autoimmune disease, promote cancer growth, autoimmune myocarditis and other IgG4-related diseases (IgG4-RD) in susceptible individuals.”
Long Vax, Another Crisis
Tindle steps into the controversial topic of COVID-19 vaccine injured, or long vax, seamlessly and with ease and backed by the unfolding science, comparing it to long COVID in many ways.
Reaffirming a growing body of evidence observing COVID-19 vaccination, including boost courses, with “incidence of long COVID-like symptoms, adding further to public health officials’ concerns.”
And key to any resolution, including therapeutic options, would be to scientifically comprehend the cellular and pathological effects of COVID-19 vaccination with and without infection. Yet vaccine approvals, accelerated during the pandemic crisis, lacked any long term-safety data, a growing concern according to Prof Tindle given the possibility of immune dysfunction.
A key point Tindle seeks to make here is that it’s quite likely at least among susceptible individuals COVID-19 vaccinations could be associated with long COVID. Put another way, “It is perhaps, premature to assume that the past SARS-CoV-2 infection is the sole common factor in long COVID.”
Where to Go from Here?
From expressing hope that $50 million in Australia’s Medical Research Future Fund may help advance practical medical and scientific knowledge into the matter, Tindle also seems somewhat hopeful about a national center for disease control providing a national interrogative repository for what have been to date, “fragmented incidence and outcome data for long COVID.”
Tindle also points to a promising study last year led by scientists at QIMR Berghofer Medical Research Institute in Brisbane, Australia demonstrating in a preclinical study involving a model of peptide inhibitor of nuclear angiotensin-converting enzyme 2. The scientists reported in the prestigious peer-reviewed journal Nature Communications that this led to reversing “persistent inflammation driving long COVID” while also “reducing the latent viral reservoir in monocytes/macrophages” while associated with “reduced SARS-CoV-2 spike protein expression in monocytes from individuals who are recovered from infection.” Clinical trials were pending at the time last year, and TrialSite will do a follow up article on that discovery.
The message from this important viewpoint published in GP’s journal in Australia--more clearly needs to be done to help struggling patients, whether they are diagnosed with long COVID or long Vax.
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15 April, 2024
Censored again
Google have just deleted my post of 24 March about myocarditis in children. It is however still available at its original source:
https://www.theepochtimes.com/health/pfizer-finally-releases-myocarditis-study-for-children-who-received-covid-19-vaccine-5611209
COVID Infection Not the Only Cause for Long COVID: Immunologist
Long COVID may not be solely caused by a COVID-19 infection given the lack of long-term safety data associated with the COVID-19 vaccine, an immunology professor has said.
In an externally peer-reviewed op-ed published by the Australian Journal of General Practice, Emeritus Professor Robert Tindle said that public health officials are “flying blind” when it comes to linking long COVID to post-COVID-19 vaccination.
“There is no consensus on what causes lingering COVID-19 symptoms long after the acute infection has cleared,” Mr. Tindle opined, adding that patients who are unable to secure a diagnosis for long COVID have sought multiple medical opinions only to be told the condition is due to “anxiety or post-pandemic mental issues.”
Long COVID is described by the World Health Organisation as the continuation or development of new symptoms three months after the initial SARS-CoV-2 infection, with these symptoms lasting for at least two months without any alternative explanation. This definition is now accepted by the Australian government.
The median time for long COVID symptoms is five months, with 10 percent of patients having symptoms at 12 months, according to a study.
Fatigue, shortness of breath, and difficulty concentrating have been reported in patients up to two years post-infection.
Mr. Tindle said that the spike protein of SARS-CoV-2 exhibits pathogenic characteristics, and is a possible cause of acute symptoms after a COVID-19 infection or post-vaccine.
“COVID-19 vaccines utilise a modified, stabilised prefusion spike protein that might share similar toxic effects with its viral counterpart,” Mr. Tindle said.
“A possible association between COVID-19 vaccination and the incidence of POTS (postural orthopaedic tachycardia syndrome) has been demonstrated in a cohort of 284,592 COVID-19-vaccinated individuals, though at a rate that was one-fifth of the incidence of POTS after SARS-CoV-2 infection.”
Mr. Tindle listed other associations with long COVID following the uptake of the COVID-19 vaccine, including an increase in myocarditis post-vaccination, elevated spike proteins in muscle tissues, the lymphatic system, and the circulatory system, and elevated levels of IgG4 antibodies that are linked to the promotion of cancer.
“There are clear implications for vaccine boosting where these and similar observations relating to COVID-19 vaccination and the incidence of long COVID-like symptoms are substantiated, adding further to public health officials’ concerns,” he said.
“Understanding the persistence of viral mRNA and viral protein and their cellular pathological effects after vaccination with and without infection is clearly required.
“Because COVID-19 vaccines were approved without long-term safety data and might cause immune dysfunction, it is perhaps premature to assume that past SARS-CoV-2 infection is the sole common factor in long COVID.”
Moreover, Dr. Aseem Malhotra—Britain’s high-profile cardiologist and previous supporter of mRNA COVID vaccines—previously told The Epoch Times that heart complications—such as cardiac arrhythmia, heart failure, cardiac arrest, myocarditis, and pericarditis—have seen an uptick since the vaccine rollout.
“Long vax” is the colloquial term used to describe long COVID caused by vaccination.
Long COVID From Omicron Variant
Meanwhile, a study by the Australian National University (ANU) has found the risk of developing long COVID from the Omicron variant is higher than originally thought.
The Australian study found that in a highly vaccinated population not broadly exposed to earlier SARS-CoV-2 variants, 18 percent of people infected with the Omicron variant reported symptoms consistent with long COVID 90 days after infection.
“Despite reports that the risk of long COVID may be lower following Omicron infections than with earlier SARS-CoV-2 variants, we found that the burden of long COVID may be substantial 90 days after Omicron infections,” lead researcher Mulu Woldegiorgis said.
Additionally, the study found that 90 percent of the study participants with long COVID reported experiencing multiple symptoms, such as tiredness and fatigue (70 percent), followed by difficulty thinking or concentrating (brain fog), sleep problems, and coughing. A third of women in the study reported changes in their menstrual cycle.
However, a study by Germany’s Martin Luther University Halle-Wittenberg has shown that unvaccinated people infected with the Omicron variant had the lowest risk of long COVID.
The study found that while previous infections reduce the risk of long COVID by 86 percent, vaccination status prior to COVID infection is irrelevant to a person’s risk of developing long COVID.
However, the authors of the German study acknowledged that none of the participants were given an actual diagnosis of long COVID or tested for comorbidities.
Long COVID Presents Health and Financial Challenges
Mr. Tindle outlined the health and financial challenges faced by Australians who have long COVID, saying that support measures need to be in place for those who suffer from the chronic condition.
According to a 2022 study (pdf) by the Australian National University (ANU), approximately 500,000 adult Australians, or 4.7 percent have experienced long COVID.
Mr. Tindle described the frustrations expressed by long COVID support groups, such as the Australian Long COVID Community Facebook Support Group, including inadequate health system responses in dealing with long COVID.
“The outcome for some of those experiencing long COVID is self-prescribed medication using over-the-counter remedies and dietary changes based on potentially conflicting or misleading online information. Some speak of a substantial proportion of their income being used this way,” he said.
However, Mr. Tindle did acknowledge the listings of antiviral drugs for COVID such as Paxlovid (nirmatrelvir and ritonavir) and Lagevrio (molnupiravir).
An estimated 240,000 of those with long COVID no longer work full time, thus affecting the economy, Mr. Tindle said.
“Reduced to working part-time to cope with unwellness, those with long COVID commonly report having to wait a year or more before receiving a diagnosis,” he said.
“Without a definitive diagnosis, those with long COVID are not eligible for Job Seeker, the Disability Support Pension and National Disability Insurance Scheme (NDIS) protection under the Fair Work Act, thereby conferring long-term financial difficulties for themselves and their dependents.
“There is a need for guidelines on how those with long COVID can access social security and employment protection.”
Mr. Tindle added that both the federal and state health departments need to provide more guidance to primary healthcare providers on handling long COVID.
“Although some states have established long COVID clinics, some of these at least are of little help to the patient in providing substantive treatment guidelines or support and are little more than incident report centres,” he said, adding that the wait time for a long COVID clinic is usually months, with some GPs unaware of the clinics’ existence.
“Long COVID is not an easy medical condition for clinicians, health administrators, support systems, or patients. The Australian health system is already stretched in coping with other chronic medical conditions,” he said.
“Nevertheless, we must do better than in the approximate three years since long COVID was first reported.”
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14 April, 2024
Washington Post sides with the vaccine establishment
The Covid pandemic opened up a new era, one that likely has significant implications across medicine. Because of the worst epidemic in modern history, there is no longer a blind acceptance of the pharmaceutical industry, or at least some of the players within that industry, which, because of the coronavirus, appeared to put profit over care.
From the onset of the pandemic, TrialSite chronicled how Pfizer not only cut corners concerning regulatory matters (e.g., no IND-enabling studies, no sufficient pharmacodynamics) but also shamelessly exploited the pandemic for profit, a form of profiteering during the worst breakout of a disease in a century. Additionally, the imposition of vaccine mandates which led to deepening political divisions within the United States.
Compounding this is the behavior of Big Pharma with their seemingly relentless crusade to avoid price oversight for medications in any possible way and the additional effort to deny and deflect responsibility for possible Covid vaccine injury, or “long-vax.”. Even U.S. government agencies mandated with protecting the public seem stubbornly steadfast in aligning with industry over the people on the issue of vaccine injury.
Given history and the controversy surrounding the politicization of the Covid pandemic it is, perhaps, a given the “vaccine wars” could persist as an ongoing political hot potato topic. And what a topic for instilling tension and divisiveness, all helpful in ensuring advertiser interest.
Mainstream Media’s Rush to Judgement?
Recently, The Washington Post ventured into the vaccine wars when it published an article on Robert F. Kennedy Jr.’s newly announced running mate, Nicole Shanahan. A tech lawyer who was once married to Google co-founder Sergey Brin, Shanahan has a history of being involved in Democratic politics, but not anymore.
Also, a mother, Shanahan has opened up that her own child has been vaccine injured, or so she believes. It turns out Shanahan’s daughter was diagnosed with autism and as reported in the Washington Post this led the very successful mother to investigate the disease.
Shanahan doesn’t deny the importance of the pharmaceutical sector, quoted by the fourth largest daily in the U.S. by circulation “Pharmaceutical medicine has its place, but no single safety study can assess the cumulative impact of one prescription on top of another prescription, and one shot on top of another shot on top of another shot, throughout the course of childhood. We just don’t do that study right now and we ought to. We can and we will. Conditions like autism used to be one in 10,000. Now here in the state of California it is one in 22.”
While Shanahan has expressed serious skepticism about certain vaccines, she and Robert F. Kennedy Jr. are not “anti-vaxxers” as she has explained. The VP choice referred to an interview Kennedy did with Newsweek magazine saying he is only concerned with vaccine injuries. The New York Times also did a profile of Shanahan in which she also expressed her concern about vaccine injuries.
Checked with Experts
The Washington Post checked in with five autism experts to question the view of Shanahan, and the group concluded Shanahan’s views are “misguided, wrong or lacking context.” The article then goes on to accuse Kennedy of being a long purveyor of falsehoods about vaccines, spreading misinformation, particularly about a measles outbreak in Samoa.
Clearly not objective, any questioning of the autism rates of today has nothing to do with any vaccines, goes the Ministry of Truth. Yes, Wakefield was proven to be wrong, and despite the fact that the childhood vaccination schedule has exponentially increased, and there have been no longitudinal studies tapping into observational real-world data, doesn’t seem to matter to The Washington Post.
The article concludes “Shanahan does not quite say that vaccines cause autism, but she implies it, demanding a study that is not feasible because it would be unethical. Not true at all. Real-world evidence are used frequently to study medical and health-related trends, less the need for randomized controlled trials and the use of a placebo.
Does The Washington Post’s immediate dismissal of any of Shanahan’s concerns evidence the true bias associated with this media?
The media points out that Shanahan cites numbers that claim that autism has spiked, without acknowledging it as the main reason for this trend: the very definition of autism has expanded over time. But how do we know this latter point is the only answer? Should it not be investigated?
Assuming the role of arbiter of truth The Washington Post effectively establishes that anybody that dares question vaccine policy equals a proponent of anti-vaccine rhetoric. Meaning according to the Jeff Bezos owned asset (via Nash Holdings) “The overall effect is to cast doubt on the safety of vaccines.”
Whether or not Shanahan is right or wrong doesn’t appear to be an issue for the Bezos’ controlled media.
Yet the childhood vaccination schedule continues to grow, along with waiver of liability since the 1986 Vaccine Act. That initial waiver was put in place to ensure vaccine makers were incentivized to step into what were at the time low margin businesses.
However, times have changed. Vaccines can be quite profitable, and with limited liability along with advancing science uncovering new targeted opportunity this has led to a growing supply of vaccines. Pfizer generated nearly $100 billion on COVID shots alone.
Denying what vaccines have done for modern health is silly. One only needs to look at smallpox, polio, measles and the associated morbidity and mortality figures pre- and post-vaccination, to get an appreciation of the progress.
But raising targeted questions is most certainly what science should be all about, and while Kennedy can seem slippery on some of the issues, he has also consistently taken on corporate power in the courts on the behalf of consumers--in the spirit of consumer rights activist Ralph Nader.
Some recent polls evidence an appreciation for Kennedy’s message, which to a great extent seems to align with an interesting fusion of the traditional social democrats of yesteryear challenging both corporate power and the polarization of socio-economic class division yet the whole campaign is infused with both libertarian and national populist strains.
In some recent polls, Robert F. Kennedy, Jr. polls in the double digits, not seen since the independent candidate Ross Perot made his run.
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Biden quietly revokes COVID executive order requiring masks in federal buildings
President Biden retracted several COVID-19 executive orders Friday — including one imposed on his first day in office to require people to wear masks in federal facilities.
Biden’s Executive Order 13991 — titled “Protecting the Federal Workforce and Requiring Mask-Wearing” — was issued after the wearing of face masks became heavily polarized, with outgoing President Donald Trump and his aides rarely wearing them and focusing on “reopening” from lockdowns.
The order is “hereby revoked,” the White House said in a Friday afternoon announcement more than four years after the virus brought mobile morgues to New York and shut down schools and businesses across the country.
Under the prior order, federal agencies were told to “immediately take action” to “require compliance with CDC guidelines with respect to wearing masks, maintaining physical distance, and other public health measures by: on-duty or on-site Federal employees; on-site Federal contractors; and all persons in Federal buildings or on Federal lands.”
The enforcement of mask requirements long ago subsided, with the White House lifting its own internal mask requirements more than two years ago in March 2022 after the CDC adjusted its mask recommendations to account for local risk reflected by hospitalization rates.
Biden on Friday also retracted Executive Order 13998, adopted on Jan. 21, 2021, that sought to impose mask mandates on flights, trains and buses, and Executive Order 13910, adopted by Trump on March 23, 2020, to forbid the hoarding of medical supplies.
The announcement additionally terminated federal positions created to manage the pandemic.
“The positions of COVID-19 Response Coordinator [vacant since June 2023] and Deputy Coordinator of the COVID-19 Response… are hereby terminated,” Biden decreed.
The developments mark a near complete return to pre-pandemic rules after a gradual easing of enforcement.
Biden in June 2022 ended requirements that travelers entering the US — including American citizens — present negative COVID-19 tests. That rule was announced in January 2021 in the final days of the Trump administration.
Biden in May 2023 ended his mandate, imposed in September 2021, that all federal workers submit to COVID-19 vaccination or lose their jobs unless they had a qualifying religious or medical exemption.
Other pivots back to the pre-pandemic status quo have worried Biden’s critics, including his administration’s April 2023 decision to resume funding for the EcoHealth Alliance, a group that did risky US-financed “gain of function” research on coronaviruses at a lab in Wuhan, China, before the pandemic’s origin in the same city in late 2019.
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11 April, 2024
Decision Reserved in Case of Ontario Doctor Who Questioned COVID Lockdowns
An Ontario doctor who was critical of COVID lockdowns argued her case in court on April 10.
Dr. Kulvinder Kaur Gill was trying to quash three cautions placed on her public file by the College of Physicians and Surgeons of Ontario (CPSO). The cautions were made after two tweets in 2020 by Dr. Gill, in which she questioned COVID lockdowns. Dr. Gill became well known during the COVID-19 pandemic for her online challenges to the government’s public health restrictions.
The panel of three judges of the Divisional Court of the Ontario Superior Court reserved their decision on the judicial review, which means there is no set date on which the decision will be released.
Dr. Gill, who specializes in pediatrics, allergy, and clinical immunology, amassed a significant following on X, formerly known as Twitter, where she expressed opinions and concerns about government’s pandemic response, including the potential negative effects of lockdowns and other mandates.
Because of that, she became the subject of seven public complaints lodged with the CPSO, along with a separate investigation by the college’s registrar.
All eight cases were reviewed by the CPSO committee known as the Inquiries, Complaints and Reports Committee (ICRC) in February 2021.
While the committee dismissed five of the complaints, it issued orders for three separate cautions to be placed on her public file.
On March 24, Elon Musk’s X announced that it would help pay her legal bills in trying to get the cautions overturned, saying in a post, “X is proud to help defend Dr. Kulvinder Kaur Gill against the government-supported efforts to cancel her speech.”
That prompted a heartfelt thank you on X from Dr. Gill: “elonmusk’s @X contacted me directly confirming Elon’s committment to pay remainder of campaign to reach $300K AND Elon has committed to assisting my appeal of 3 CPSO cautions, for my 2020 tweets opposing lockdowns, to the very end (ONCA&SCC if needed) May Waheguru bless you.”
Dr. Gill is represented by Libertas Law. In a news release from Libertas, lawyer Lisa Bildy said, “The CPSO issued guidance that doctors’ opinions during Covid-19 had to align with the government and took steps to censure ethical physicians who raised alarm bells about public health policies.”
“But the stifling of scientific debate, especially on novel measures being imposed on a massive scale, is not reasonable, in our submission, nor is it in the public interest,” Ms. Bildy continued.
The two tweets from August 2020 that were the subject of the cautions questioned if there were valid reasons for the lockdowns.
The first said, “There is absolutely no medical or scientific reason for this prolonged, harmful and illogical lockdown.”
The second tweet said, “If you have not yet figured out that we don’t need a vaccine, you are not paying attention.”
In a series of posts on X from the judicial review on April 10, JRwatch_ON said Dr. Gill’s lawyer argued that her client’s tweets were based on evidence, and that debate is important in a democratic society.
In the news release, Libertas Law said while some have portrayed Dr. Gill as an “anti-vaxxer,” it is not true.
“She has always been a proponent of routine childhood vaccines in her clinical practice,” adding that “she also supports Covid vaccines for high-risk individuals with informed consent.”
It says there was no COVID-19 vaccine authorized anywhere in the world in August 2020 when Dr. Gill posted the tweet about vaccines.
“The comment was in relation to a press conference that day by Dr. Theresa Tam in which she stated that, despite the anticipated authorization of a vaccine, possibly by that year’s end, it would not be a silver bullet and lockdowns and restrictions could persist for at least another two or three years,” said the release.
In addition, it said that “the use of widespread and prolonged lockdowns of healthy and low-risk people was contrary to all prior pandemic planning and principles of public health,” adding “evidence of lockdown harms has continued to mount.”
For its part, the CPSO has argued that the evidence indicated lockdowns in China and South Korea were having an effect, and said Dr. Gill was making misinformed and misleading statements, adding it was irresponsible to make such statements on social media during a pandemic.
The hearing is the latest in Dr. Gill’s legal battles. Last fall, she was scheduled for a disciplinary hearing by the CPSO, which was suddenly dropped in September, without the CPSO providing any specific reasons.
In a post at the start of the April 10 judicial review, Dr. Gill posted to X, “I’m at the Divisional Court of the Superior Court of Ontario today with my brilliant lawyer @LDBildy and the support of @elonmusk’s @X.”
And at the end of the hearing, Dr. Gill posted: “and that’s a wrap. A sincere thank you to all who sent their prayers & well wishes, & all who followed along the @JRwatch_ON live-tweets.”
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High Dose Spirulina Regimen Remarkably Reduces COVID-19 Mortality, Improves Hospital Discharge Rate in 7-Day Window
A biomass of cyanobacteria, meaning blue-green algae, spirulina (arthrospira platensis), a cyanobacterium is consumed by both humans and animals, cultivated worldwide. Purported to have anti-inflammatory, antiviral and antioxidant effects, in Western society any claims must be backed by well-designed, randomized controlled trials.
The form Arthrospira is used as a dietary supplement or whole food. What’s the effect of high-dose Spirulina supplementation on hospitalized adults with COVID-19? With not a lot of research backing such a question, a Persian team of scientists affiliated with Pasteur Institute of Iran, Bahalrloo Hospital at Tehran University of Medical Sciences and even one of the scientists affiliated with Tufts University in the U.S. sought to evaluate the efficacy and safety of high-dose Spirulina platensis for SARS-CoV-2 infection.
The results are frankly remarkable, but the study has limitations—the open-label introduces the opportunity for biases, and the study size suggests the need for larger confirming studies, the results published in the Frontiers in Immunology peer-reviewed journal point to a significant finding. Western medicine would not accept these findings as particularly earth shaking but nonetheless, TrialSite points out some possibly intriguing outcomes.
Brief Background
The general class of product is used as feed supplement across aquaculture, aquariums and poultry industries. The use of this natural product started in the Americas—actually in present day Mexico by the Aztecs and other Mesoamericans until the 16th century. Upon the Spanish conquest soldiers of Cortes documented its use. Fast forward to modern day in addition to use as a supplement and for the industries mentioned above, spirulina is under investigation to address food security and malnutrition, plus as dietary support in scenarios such as space flight or even the Mars mission. With less need for land and water than livestock, the supplement represents an economical source of protein and energy.
What’s the basis for this Persian study?
In many societies, dietary supplements are reportedly helpful as supplements in response to viral infections. Take Spirulina, the filamentous, gram-negative cyanobacterium—a blue-green microalga that is a non-nitrogen-fixing photoautotroph according to the authors of this study recently published in Frontiers in Immunology.
Rich in protein (over 70%), plus vitamins, minerals (e.g., D, B12, provitamin A (beta carotene) and iron), numerous other ingredients are present such as phycocyanobilin (PCB), according to the Persian authors, which is a blue pigment protein with anti-inflammatory, anticancer and antioxidant properties.
Citing previous research, the authors of this study articulate that Spirulina consumption boosts B-group vitamins, especially B6, while decreasing interleukin-4 (IL-4) levels in persons with allergic rhinitis. But the substance also increases immunoglobulin A levels in saliva, suggesting that it could possibly enhance mucosal immunity. The supplement is also known to increase function of natural killer (NK) cells while boosting interferon-y (IFN-y) secretion, thus in aggregate overall better innate immune system health.
Finally, with a substance known as calcium spirulan (Ca-Sp) also present, the Iran-based investigators cite in vitro studies suggesting that this substance inhibits growth of select enveloped viruses, such as mumps virus, measles virus, influenza A (IAV), HIV-1, human cytomegalovirus and herpes simplex type 1. But in Western society, this is not widely touted, at least not in medical establishment circles. Evidence requires well-designed randomized studies.
Corresponding authors for this study included Seyed Ahmad Seyed Alinaghi, M.D., M.Phil, Ph.D. with Tehran University of Medical Science, Iranian Research Center for HIV/AIDs, Iranian Institute for Reduction of High-Risk Behaviors.
The Study
The Persian team designed a randomized controlled trial (IRCT20210216050373N1) investigating the research hypothesis: can high dose Spirulina supplement reduce COVID-19-related mortality or accelerate hospital discharge within seven days; secondary endpoint involved overall discharge or mortality?
This study was an open-label trial, conducted in a multi-center environment involving both Ziaeian Hospital and Baharloo Hospital, both affiliated with Tehran University of Medical Sciences. The trial site team recruited patients from July 27, 2021, through to February 17, 2022.
Importantly, the trial site team had to change the study from single-blind trial due to the patients in the Tehran hospitals not trusting the placebo, meaning recruitment was too challenging. This is why the investigators had to remove the placebo. The authors appeared to have followed good clinical practices, triggering protocol change, etc.
Randomized and controlled, the study team’s trial involved 189 patients with COVID-19, randomly assigned in a 1:1 ratio to an experimental group receiving 15.2g of Spirulina supplement plus standard of care (44 non-intensive care units and 52 ICU).
Conducted over a six-day period, the trial site team monitored immune mediators on days 1,3,5 and 7.
What were the study findings?
By day 7 of the study, no deaths associated with COVID-19 were reported in the Spirulina group. 15 deaths (15.3%) occurred in the control group. Within seven days, the Persian study team reported, “A greater number of patients discharged in the Spirulina group (97.7%) in the non-ICU compared to the control group (39.1%) (HR, 6.52; 95% CI, 3.50 to 12.17).”
The study team reports mortality was overall higher in the control group (8.7% non-ICU, 28.8% ICU) compared to the Spirulina group (non-ICU HR, 0.13; 95% CI, 0.02 to 0.97; ICU, HR, 0.16; 95% CI, 0.05 to 0.48).
Additionally, the team reports those patients in the ICU and in the Spirulina, arm evidenced “significant decrease in the levels of MIP-1? and IL-6.” Meanwhile, in those subjects in the intervention group (Spirulina) across ICU and non-ICU subgroups as intervention time increases reported IFN-y levels were significantly higher. Of course, this latter observation represents a cytokine playing a critical role in the immune response against both viral and bacterial infections, as well as in regulating immune response, inflammation and tumor surveillance.
The study authors report no presentation of side effects related to the Spirulina supplements.
Conclusion
The Persian team finds that high-dose Spirulina combined with the standard of care regimen in that part of the world targeting COVID-19 “may improve recovery and remarkably reduce mortality in hospitalized patients with COVID-19.”
Limitations
The Western medical world will not respond to this study result for a number of reasons. First, as the Persian authors self-declared, the study was not blinded, but as mentioned above, the investigators had to adjust to ensure sufficient level of recruitment.
TrialSite points out that non-blinded studies introduce several issues into interpreting the study result. From the potential of bias (selection bias, performance bias and detection bias) to placebo effect to observer bias and less objectivity, to mention some issues, blinded status becomes important for medical establishment acceptance.
Also, because use of traditional and herbal medicine is widespread among Persian (Iranian) peoples, the data obtained from follow-up post discharge can easily be unreliable. Importantly the authors point out this use of traditional and herbal medicines markedly increased during the COVID-19 pandemic. While follow-up was not part of the study protocol, the physician-scientists running this study to their credit “tried our best to follow up with patients long term.”
But many patients were not interested in follow-up post discharge due to a confluence of standard reasons one would find across much of the world.
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10 April, 2024
As an Epidemiologist, I Could See Straight Away That Covid Was Being Over-Hyped
BY DR EYAL SHAHAR
It was an evening in mid-March 2020. Almost two years had passed since I retired from the University of Arizona, where I was a Professor of Epidemiology in the College of Public Health.
I was watching the news from Israel, the country in which I lived during the first three decades of my life. The reporters were broadcasting a forthcoming catastrophe, a doomsday in the making. It was all about a new coronavirus epidemic which erupted in China and had reached Israel, Europe and parts of the U.S.
Like everyone, I have been following the news from the Far East since the beginning of the year. Although infectious diseases were not my subject matter research, epidemiologists are trained to think critically, to question what many accept at face value. The picture that emerged was far from clear. A few observations did not fit well with the apocalyptic predictions.
So, I decided to write a short article in Hebrew and submit it as an op-ed to a newspaper in Israel. That’s how the series of essays now published as The Covid Pandemic: Unconventional Analytical Essays (2020-2023) started. It was supposed to have ended about three years later with my summary of what has actually happened in Israel (as opposed to the official narrative), but I added a few more later articles on Covid vaccines. In between, I wrote about many aspects of the pandemic, drawing upon data from Sweden, Denmark, Europe, Arizona, the US, the U.K. and Israel.
Forty essays are included in the book. The first one was titled ‘Hold off on that Apocalyptic Consensus About the Coronavirus’ (March 24th 2020). All of them were written for the public at large and were data driven. They were not based on ‘opinion’ or ‘intuition’. They are science, as best as I know it. If written in a formal, academic style, many of these essays could have been submitted to epidemiology journals. Whether they would have passed the guards of official narratives is a different question.
What will you find in the book?
Back in 2020, I devoted several essays to lockdown-free Sweden and showed, unequivocally, the futility of lockdowns and the misleading comparison of Sweden to neighbouring Nordic countries. The last one in this series, published in 2022, was titled ‘Sweden or the World: Which was a Cautionary Tale?’, paraphrasing headlines that claimed the opposite in the spring of 2020.
Several essays have estimated the death toll of panic-triggered responses to the pandemic. By September 2021, before the return of the flu, between 15% and 30% of the excess mortality in the U.S. may be attributed to the so-called mitigation efforts (‘The Mystery of Unaccounted Excess Deaths in the U.S.’). These were lives that were lost in vain — at least 115,000 deaths and possibly twice as many. The consequences of lockdowns and disruptions of normal life did not end in 2021. Lives have continued to be lost in many countries, including the U.K. Some of the mechanisms are described in my essay ‘Covid: The Death Toll of Panic’.
In numerous essays, I studied excess mortality and explained why trends should be examined over an entire winter (‘flu years’), not by calendar years. Using this approach, I estimated the excess mortality in Europe (‘How Severe was the Pandemic in Europe?’). In the first year (2019-2020), it was only somewhat higher than in a previous season with severe flu (2017-2018). The second year (2020-2021) was very harsh but far from apocalyptic – about twice as severe as 2017-2018. In both years, all-cause mortality would have been lower without lockdowns.
Over a dozen essays cover various aspects of Covid vaccines. I showed severe biases in influential studies from Israel and estimated the correct effectiveness against Covid death, which ranged from mediocre to zero or sometimes negative, in the frail elderly. Using data from the U.K., I showed the questionable effectiveness of the first booster and the futility of the second (fourth dose). In three essays, I estimated the short-term fatality rate of Covid vaccines, which was unacceptable but fortunately not as high as others had suggested. Long-term fatality is difficult to estimate. One essay describes unacceptable rates of side-effects, as found in a largely unknown official survey in Israel (‘Downplaying the Side Effects of Boosters’).
Did Covid vaccines save millions of lives? Not according to a comparative analysis of Israel with Sweden in the winter of 2020-2021 (‘Thousands of Averted Covid Deaths in Israel: Science Fiction’). Nor did they reduce the delayed death toll of Covid in Denmark (‘Lockdown and Vaccines: Lessons from Denmark’).
In the last essay, which imagines a future perspective on Covid vaccines, I wrote:
Twenty years later, we are still studying the long-term morbidity and mortality consequences of disseminated lipid nanoparticles (the mRNA carriers), self- manufactured toxic spike protein and aberrant proteins in various tissues, elevated levels of IgG4 antibodies after repeated injections, and the integration of foreign DNA fragments into the genome.
These days, a group of scientists is studying cancer cells from vaccinated patients to determine if foreign DNA is present there. Chances are that you will not find much on this topic or on other vaccine-related effects in mainstream media. So, keep following the Daily Sceptic and Brownstone, as I have been doing for a long time. No end is in sight to the saga of Covid vaccines.
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UK Watchdog Accuses Pfizer of Promoting ‘Unlicensed’ COVID Vaccine on Social Media
A UK pharmaceutical watchdog said that Pfizer has breached its regulatory code five times, including “promoting an unlicensed medicine,” due to a social media post made by a Pfizer employee.
The Prescription Medicines Code of Practice Authority (PMCPA) issued the ruling after receiving a complaint in February 2023 regarding a post on X that was made by a Pfizer employee in the United States.
The post included Pfizer’s press release announcing the conclusion of the Phase 3 Study of its COVID-19 vaccine candidate, which was later shared by a Pfizer senior employee in the United Kingdom.
PMCPA ruled that Pfizer has breached its regulatory code, including “bringing discredit” on the pharmaceutical industry, promoting an unlicensed medicine, and making a misleading claim.
The pharmaceutical company was also accused of “making claims that did not reflect the available evidence regarding possible adverse reactions,” and failing to maintain high standards.
The complaint raised concerns about “Pfizer’s misuse of social media to misleadingly and illegally promote their COVID vaccine,” alleging that the post lacked safety information about the vaccine.
According to the complainant, “such misbehavior was even more widespread than they had thought, extended right to the top of their UK operation and was apparently continuing to this very day.”
The complainant argued that the post has remained visible on the Pfizer UK senior employee’s X feed for over two years.
“In the circumstances the complainant thought that the British public had the right to expect Pfizer UK to have conducted some sort of audit of its social media accounts (at least of its significant accounts, amongst which they would include its UK senior employees) to ensure that anything which was similarly in breach of the code was removed—even to the extent of deleting accounts if necessary. This clearly was not done,” the complaint stated.
Social Media Post Was Not Intended to Be Promotional
Pfizer told the PMCPA that it took its commitment to the regulatory code “extremely seriously” and that it had conducted a thorough investigation into the matter.
The company claimed that the post “was not intended to be promotional in nature” and that it contained “a statement of fact of the efficacy endpoints of the study.”
Pfizer also said that there was no intent by the UK senior employee to promote or to advertise its vaccine candidate, adding that the post was re-shared “in error.”
According to the company, the senior employee was an infrequent user of X and has only 321 followers, the majority of whom are professional individuals involved in, or with an interest in, the UK healthcare and research sector.
“Pfizer UK had a comprehensive policy on personal use of social media in relation to Pfizer’s business which prohibited colleagues from interacting with any social media related to Pfizer’s medicines and vaccines,” it said.
In its response to the PMCPA, Pfizer said it has taken actions to address the complaint, including issuing a UK company-wide instruction urging employees to check their social media accounts to ensure their activity complied with the Pfizer social media policy.
“Pfizer accepted that these colleagues acted in error and these errors regretfully were likely to have resulted in the promotion of an unlicensed vaccine to the UK public in a manner that was not consistent with the requirements of Clause 2,” it stated.
However, the PMCPA stated in its report that the post has resulted in “an unlicensed medicine being proactively disseminated on Twitter to health professionals and members of the public in the UK.”
The watchdog considered that the corrective and preventative actions taken following previous breaches of the code with respect to employee activity on social media “had not been implemented to the standard which was expected or required.”
It also stated that the post made no reference to adverse events of the vaccine.
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9 April, 2024
Scientist’s Video on Vaccination Status in Pregnancy Censored for ‘Misinformation’
A mathematician has had a YouTube video taken down after pointing out that the government is counting women who had the COVID-19 vaccines before conceiving as “unvaccinated,” effectively obscuring any potential link between the jabs and negative pregnancy outcomes.
Professor Norman Fenton, who specialises in risk analysis and decision making at Queen Mary University, London, used the example of Olympic gold medal-winning cyclist, Dame Laura Kenny, who has spoken publicly about suffering a miscarriage and ectopic pregnancy.
In the video, he speculated that Dame Laura, who is married to fellow Olympic champion Sir Jason Kenny with whom she has two sons, is likely to have received two doses of the vaccines in order to be allowed to compete at the Toyko Olympics in August 2021.
Dame Laura, 31, whose first son was born in 2017, revealed she had suffered a miscarriage at nine weeks in November 2021, shortly after the delayed Tokyo games in August. She also had an ectopic pregnancy in January 2022, before going on to have her second child in July 2023.
Mr. Fenton told The Epoch Times it was not his intention to upset Dame Laura, but she had not been in touch with him to make any comment or clarification about the video.
Women Jabbed Before Pregnancy Labelled Unvaccinated
According to the way the UK Health and Security Agency (HSA) records vaccine status, if Dame Laura did not receive any COVID-19 shots during her pregnancies, she would be counted as “unvaccinated” along with the “never vaccinated” women, even if she had received the jabs before conceiving.
Mr. Fenton said, “The way they were doing that particular pregnancy statistic is one of the worst examples of data obfuscation—to lump the never vaccinated in with the vaccinated, who in theory could have been vaccinated a day before (they got pregnant) is absolutely outrageous.”
“If there is a safety signal, it would just be hidden. You wouldn’t see it.”
In the video, he said: “She would’ve had to be double vaxxed shortly before the games to be allowed to take part. While there may be no reason to suspect this had anything to do with Laura’s two unfortunate outcomes, both would be classified in the UKHSA ‘no doses in pregnancy’ category.”
Mr. Fenton posted the censored video on YouTube at 5:30 p.m. on Good Friday, where he said it received 2,000 views within an hour. The platform took the video down after just 80 minutes, claiming it was a violation of its policy on “medical misinformation.”
‘Obfuscating Possible Vaccine Adverse Reactions’
YouTube said the “violation” occurred at three minutes and 47 seconds into the video, when Mr. Fenton said, “Once again we are reminded not just of the extent to which the government has gone to obfuscate possible vaccine adverse reactions, but also the insanity that led to the strongest and fittest people in Great Britain being forced to take a useless vaccine that they never needed and for which—even then—there were many known safety signals, and even to this day, the full vaccine pregnancy safety data has never been released.”
The platform sent Mr. Fenton a message saying he had been censored because anything that contravenes advice by the World Health Organisation is considered to be “medical misinformation.”
The British Olympic Association (BOA) said in May 2021 that “all athletes and support staff will be fully vaccinated against COVID-19 before leaving for Japan ahead of this year’s Tokyo 2020 Olympic and Paralympic Games.”
“The BOA is set to secure the vaccines after the International Olympic Committee struck a deal with Pfizer BioNtech to donate doses to athletes heading to the Games.”
Mr. Fenton shared the video on other platforms, including Odyssey, Rumble, and Bitchute.
Dame Laura is the most successful British female Olympian of all time, with only her husband, Sir Jason, and fellow cyclist Chris Hoy winning more gold medals. She retired from the track in March 2024, having suffered a series of injury problems as well as becoming a mother for the second time.
She shared her sadness over her baby losses in an Instagram post in April 2022, revealing that she had conceived just after the Tokyo games.
“Since the Olympics we haven’t had much luck and it’s been the hardest few months I’ve ever had to go through,” she wrote.
“Jason and I fell pregnant immediately after the Games and we were absolutely chuffed to bits. But unfortunately in November when commentating at the track champions league I miscarried our baby at nine weeks. I’ve never felt so lost and sad. It felt like a part of me had been torn away.”
“I then caught COVID in mid-January and found myself feeling really very unwell. I didn’t have typical COVID symptoms and I just felt I needed to go to hospital. A day later I found myself in A&E being rushed to theatre because I was having an ectopic pregnancy. Scared doesn’t even come close. I lost a fallopian tube that day.”
The government maintains the jabs are “safe and effective” for everyone, including for pregnant women, in spite of concerns raised by doctors and in several studies that women were suffering menstrual irregularities and linking the jabs to higher rates of miscarriage.
A peer-reviewed report from February suggests mRNA in the vaccines does not remain at the injection site but can “spread systemically” to the placenta and umbilical cord blood of the fetus.
The HSA said in a statement to The Epoch Times it has worked with a range of partners, “to document the benefits and safety of vaccination with respect to pregnancy, with surveillance clearly suggesting that women who have been vaccinated (both before and during pregnancy) have better COVID-19 disease outcomes than unvaccinated women for themselves, the pregnancy and for their baby.”
“The vaccination in pregnancy table in the UKHSA COVID-19 vaccine surveillance report were set up to compare the rate of adverse outcomes in women who received the vaccine during pregnancy with those who had not received the vaccine during pregnancy.
“As the report sets out these rates were estimated for “women giving birth between [the report dates], who received one or more COVID-19 vaccination doses during their pregnancy compared with those who did not (either because they were unvaccinated or had only received vaccine doses prior to pregnancy).”
The HSA pointed to research done by the University of Edinburgh, and added: “More detailed analysis taking other factors into account, including timing of vaccination, as published for Scotland, is underway.”
In its latest COVID-19 vaccine surveillance report, published in January this year, the HSA said that pregnant women are still advised to have booster shots and that this is “strongly recommended” by the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives.
‘A Statistical Illusion’
Mr. Fenton referred to the “statistical illusion” of many studies which claim to show the jabs are “safe and effective” by miscategorising partially vaccinated people as unjabbed.
He and two other academics carried out a study—accepted as a pre-print but not yet peer-reviewed—in which they examine such “miscategorisation bias” across 39 papers.
“We’ve been arguing that most of these big, well cited studies that claim 95 percent efficacy and that the vaccines are saving lives, anything claiming vaccine efficacy published in the big journals, every time we have looked at them, there [are] systemic flaws in them.
“The most common one is the miscategorisation one, where they are simply classifying people who had got COVID and hadn’t had every booster shot as unvaccinated, which obviously creates bias where you could show efficacy even with a placebo.”
“In some cases, we have written to the journals asking them to either make a clarification or correction to the paper, but they never did.”
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Some Questions Australia’s COVID-19 Inquiries Must Ask
The Australian Senate will soon release its report on the proper terms of reference for a COVID Royal Commission to be established in 2024.
During the inquiry, held by the Legal and Constitutional Affairs Committee, a large volume of submissions were submitted, while the government’s own COVID-19 Response Inquiry received over 2,000 submissions.
This indicates high public interest in getting to the truth of what happened, why particular decisions were made, and what the right lessons for the future.
This is especially important so Australia can be better prepared next time and also to put the WHO’s new pandemic accords in perspective.
Contrary to dire warnings, there have been only five pandemics in the last 105 years: the Spanish, Asian, Hong Kong, swine flus, and COVID-19.
In that time, great strides in medical knowledge, training, and technology have expanded disease response toolkits along the spectrum of prevention, treatment, and palliative care.
Average life expectancy has improved dramatically as a result. Countries have exchanged best practices on disease prevention and management.
Despite these gains in understanding and treatment protocols, when COVID-19 struck, many countries including Australia abandoned existing well-prepared plans to deal with pandemics, and instead, reacted with panic.
This is never a good basis on which to make either individual or public policy decisions.
Yet the public health messaging deliberately tried to spread panic to the population to increase compliance with pandemic management measures.
The herd panic of early 2020 led to an abandonment of good process, an abandonment of preparedness plans, and a centralisation of decision-making in a narrow circle of heads of government, ministers, and health experts.
The damage to physical health, mental health, social, educational, and economic problems will continue to impact public life for many years into the future.
Did Australia’s COVID-19 policy interventions represent the greatest triumph of public policy, with an unprecedentedly high number of lives saved as a result of timely, decisive, and appropriate measures instituted by governments acting on the science- and evidence-based advice of experts?
Or will they prove to be the biggest public policy disaster of all time?
Why Were Established Practices Swept Aside?
These are big questions that deserve a rigorous, independent, and impartial inquiry.
The first question is: why exactly were the existing pandemic preparedness plans and medical decision-making practices abandoned?
Suspect data from one city, Wuhan, in one country should not have been deemed sufficient to overturn a century of data, experience, and scientific research.
In particular, rather than responding to herd panic elsewhere to order mass house arrests for the entire population, did Australian scientists and public health officials test overseas claims against hard data locally on the extent, virulence, and lethality (the infection and case fatality rates) of the new virus?
Until these facts, as they apply to Australia, are authoritatively and credibly elucidated by a duly-empowered independent inquiry, public trust in health experts and institutions is unlikely to be restored to pre-pandemic levels.
How Was the Threat Level Assessed?
Another set of questions is about assessing the threat of a disease outbreak against other killer diseases, and the opportunity costs of allocating human, financial, and hospital resources to the different health risks.
The standard metric used to assess one side of this equation is the quality-adjusted life years (QALY) measure that, logically and sensibly, holds that the death of a healthy child, adolescent or young person is a greater tragedy and loss to society than that of someone above the average life expectancy.
From the start, it was known that the average death of those dying with COVID was higher than the average life expectancy.
That being the case, were standard cost-benefit analyses undertaken of the different policy interventions, including the risks of side effects and collateral harms?
If so, why were they not published? If not, why not?
More here:
https://www.theepochtimes.com/opinion/some-questions-australias-covid-19-inquiries-must-ask-5623457
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Popular Paper on Ivermectin and COVID-19 Contains False Information
Meta analyses are very open to abuse.. I reported recently on another dubious meta-analysis of Ivermectin use. See:
https://dissectleft.blogspot.com/2024/02/effect-of-higher-dose-ivermectin-for-6.html
A popular study that claims ivermectin has shown no effectiveness against all-cause mortality contains false information but remains uncorrected.The meta-analysis, published in 2021 by the journal Clinical Infectious Diseases, explores how groups in randomized, controlled trials fared after receiving ivermectin compared to control groups.
Among five trials included for the portion on all-cause mortality, none showed an effect for ivermectin, the authors claimed.
Ivermectin “did not reduce all-cause mortality,” they wrote.
But the claim is wrong. One of the five trials was described as finding ivermectin recipients were more likely to die, but actually found that ivermectin recipients were less likely to die. “The risk base estimation ... confirmed that the average mortality obtained in all of ivermectin treated arms was 3.3%, while it was about 18.3% in standard care and placebo arms,” the authors of that paper said.
Dr. Adrian Hernandez, an associate professor at the University of Connecticut’s School of Pharmacy, and other authors of the meta-analysis are aware of the false information. The group released their study as a preprint before the journal published it. The first version included the false information. A corrected version properly portrayed the trial’s results for all-cause mortality in a figure summarizing the results, but still falsely said none of the trials showed a benefit against all-cause mortality.
Dr. Hernandez and Clinical Infectious Diseases did not respond to requests for comment.
The lingering false information is in a paper that has attracted numerous citations in other studies, in the press, and on social media. Altmetric, which tracks engagement, scores it at 5,900. A score of 20 or means a paper is doing “far better than most of its contemporaries,” according to the company.
Morimasa Yagisawa of Kitasato University and other researchers pointed out the issue in a March review of ivermectin trials, saying they were “concerned about the spread of misinformation and/or disinformation” about trial results.
“The articles on systematic reviews and meta-analyses are often erroneous or misleading. This is perhaps because the authors were not involved in the clinical trials or patient care and only searched for and analyzed articles and databases on clinical trial results,” they wrote. The problems are “particularly serious” in the paper for which Dr. Hernandez was the corresponding author, the researchers said.
“Although it was a clear error, the wrong content of the preprint was published as a major article in Clinical Infectious Diseases, the official journal of the Infectious Diseases Society of America, without being changed,” they wrote. “Many comments were made questioning the insight of the reviewers and the Editor-in-Chief for publishing a paper with such inconsistencies, but the paper is still published without correction. Since this is a prestigious journal of a prestigious society, an early corrective action is required.”
“There have been several fraudulent meta-analyses, and this is a striking one,” Dr. Pierre Kory, president and chief officer of the FLCCC Alliance and author of the book The War on Ivermectin, told The Epoch Times in an email.
“In this meta-analysis, they selected only 10 of the 81 controlled trials, 33 of which were randomized, on ivermectin that were available at the time. Eight of the ten they selected involved mild COVID-19. Typically, mild COVID does not lead to death. And here they were looking at death rates and, as expected, saw very few. The inclusion criteria they used were intended to show no effect. And they succeeded. Conflicted researchers have been doing this to hydroxychloroquine and ivermectin since the beginning of the pandemic,” he added.
Issues in other meta-analyses include the improper inclusion of papers that did not describe clinical trial results, Mr. Yagisawa and his co-authors said.
They noted that a number of trials have found ivermectin recipients were better off. That includes trials cited by the U.S. Food and Drug Administration (FDA) in its position that ivermectin is not effective against COVID-19.
The FDA recently settled a lawsuit over that position, agreeing to take down several web pages and social media posts.
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Jacinda Ardern’s zero Covid madness has finally come home to roost
When The Guardian goes into rhetorical overdrive, we can be confident the person, party or policy railed against will finish on the right side of history.
In March 2020, The Guardian lectured Swedish Prime Minister Stefan Lofven on his “Russian roulette-style” Covid-19 strategy. It reported “leading experts” were critical of Lofven for prioritising economic activity over public health. The country’s Covid death toll had reached the alarming total of 25. “How many lives are they prepared to sacrifice so as not to risk a greater impact on the economy?” asked epidemiologist Joacim Rocklov.
By contrast, The Guardian and other pro-lockdown news outlets were fulsome in their praise of Jacinda Ardern and her plan to eliminate the virus in New Zealand. Ardern had responded “with clarity and compassion”, The Guardian gushed back in April 2020.
“New Zealand isn’t just flattening the curve. It’s squashing it,” wrote Washington Post correspondent Anna Fifield.
Fifield had just been to South Korea, where she was “shocked” that airport officials had failed to take her temperature. “I was told simply to self-isolate for 14 days,” she said.
Ardern’s announcement in June 2020 that the virus had been eliminated in New Zealand proved to be somewhat premature. The curve wasn’t flattened. That was delayed until March 2022, when the country eventually crawled out from under the bed.
The chart measuring Covid cases in New Zealand from April 2022 mirrors the chart for Sweden two years earlier: a steep rise to around 2.5 million cases within the first six months, at which point it begins to flatten. New Zealand’s official tally of Covid deaths per million is 1163, 40 per cent higher than it is among the thermometer-dodging South Koreans. It is higher than every state in Australia, except Victoria. It is three times higher than Singapore and 40 per cent higher than the global average.
In October 2021, Ardern told New Zealanders “there is clear evidence the virus finds it harder to spread in vaccinated environments”. Yet in New Zealand, as in Australia, all but a handful of deaths occurred after the rollout of the vaccines, which suggests, at the very least, they were not all they were cracked up to be.
The health benefits of lockdowns were marginal at best. The costs to our social fabric and wellbeing were incalculable.
Among the hundreds of submissions to the federal government’s Covid inquiry released last week are gruelling personal testimonies that speak to the human cost: Australians trapped in India and banned from returning home; forced imprisonment in mediocre hotel rooms upon return; increases in mental illness and family violence, and; unvaccinated Australians treated as lepers.
Human Rights Commissioner Lorraine Finley concludes that Australians endured “some of the most significant restrictions of our human rights ever imposed during peacetime”.
The Commission received 2662 complaints, the biggest response to a single issue since it was established.
It would be nice to put this horrible period behind us and move on. Yet the fiscal burden of Covid will be on our shoulders for some time. Somewhere along the line, we have forgotten that closing borders and social distancing are inherently expensive. Businesses and individuals must be compensated, and even the most ridiculous regulations must be enforced.
So it is hardly surprising government spending in Australia and New Zealand was among the highest in the world. Australian governments, both state and federal, spent the equivalent of 18.2 per cent of GDP to fight Covid, according to data compiled by the International Monetary Fund.
New Zealand was second in the Covid spending rankings at 19.3 per cent of GDP. The US was in first place at 25 per cent of GDP. By contrast, South Korea spent 6.4 per cent of its GDP on pandemic management, and Sweden spent just 4.2 per cent. It would be unfair to criticise Ardern based on hindsight. Like Scott Morrison, she was not to know the path the pandemic would take, nor that attempts to flatten the curve would eventually be futile.
It seemed reasonable to use their countries’ advantages of distance, secure borders and expertise in quarantine procedures to keep the virus out. Equally, however, we must now be honest enough to acknowledge that our governments made the wrong call, unless we are determined to make the same mistakes next time around.
The New Zealand economy will be burdened with the long fiscal tail of the 2020-2022 pandemic for years, if not decades, to come. Australia’s strong economic recovery has masked the fiscal cost of Covid. It vindicates the Morrison government’s decision to direct spending to temporary programs to keep people in jobs and businesses trading rather than bake in permanent welfare spending.
In part, it stems from the good fortune of a resource-driven economy. New Zealand, however, is in a world of pain. Its debt-to-GDP ratio has risen from 27 per cent in 2019 to 37 per cent today. The cost of servicing debt is a significant budget item.
Worse still, it has the second-highest structural deficit in the world, according to the World Bank’s data. The gap between what the government is committed to spend and the revenue it can raise has considerably widened.
The country’s new Prime Minster, Christopher Luxon, has made strong progress in unwinding Ardern’s woke legacy, as the leader of a three-party coalition between the Nationals, Winston Peters’ New Zealand First and David Seymour’s ACT party.
He has reversed the Maorification program, insisting English should remain the country’s first language, begun refocusing the curriculum and banned smartphones from schools, repealed Ardern’s ute tax, scrapped the prisoner reduction target and introduced legislation to crack down on crime gangs.
But the fiscal burden remains his biggest challenge. Fixing it will need far deeper cuts to public spending than Luxon has so far countenanced. Not fixing it will place a drag on the New Zealand economy for years.
Meanwhile, lockdown-phobic Sweden’s economy isn’t exactly roaring, but it’s doing OK by European standards. Sweden’s Covid death toll is on par with or even lower than that in comparable European countries that pursued a lockdown strategy.
In 2019, its debt-to-GDP ratio was eight points higher than New Zealand’s, at 35.6 per cent. Now, it’s five points lower at around 32 per cent. Making trade-offs between health and economic goals turned out to be not such a wicked thing after all.
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7 April, 2024
The biggest challenge in vaccinology: Countering immune evasion
The claim below that Covid will evolve into something that is once again novel seems reasonable but we have coped with novel viruses before so it may not be as big a problem as he prophesies. We cope with novel flu strains every year
Dr. Geert Vanden Bossche
People are rightfully concerned, some even outraged, by my predictions of how this Covid-19 pandemic will end. Understandably, some also blame me for the timeline I proposed not being accurate. Of course, not everyone understands that the interplay between the virus/pathogen and the host population's immunity is complex and constantly determined by the pressure exerted by the population's adaptive immunity on the virus and the virus's adaptation to the changing immune environment. This game of cat and mouse continues because highly Covid-19 (C-19) vaccinated populations cannot develop herd immunity.
What we will eventually observe is that this highly effective process of viral adaptation will ultimately confer an absolute fitness advantage to a Coronavirus (CoV) that is both structurally and functionally completely different from SARS-CoV-2 (SC-2) and its variants. It will be featured by many changes in spike and other viral proteins and have additional O-glycosylation sites while being resistant to neutralizing antibodies (Abs), virulent and highly productive/ replicative. It will use polyreactive nonneutralizing Abs (PNNAbs) to cause Ab-dependent enhancement of infection, thereby causing enhancement of severe disease (basically, as a result of rapid virus dissemination and replication in all organs). It will spread as a ‘strange’ but dominating lineage as a kind of ‘extraterrestrial dictator’ that outcompetes all previously circulating SC-2 lineages.
The ongoing phenomenon of immune escape runs parallel to the increasing incidence of acute (IgG4 Ab-mediated) and chronic (CD8+ T cell-mediated) immune pathology (including cancers), both of which stem from dysregulation of the adaptive immune system in C-19 vaccine recipients.
The unvaccinated individuals who are in good health and have not previously suffered from severe C-19 disease will not be affected by this new CoV (I call it ‘HIVICRON’: a highly virulent CoV that will replace the entire Omicron family). This is because, unlike those who are fully C-19 vaccinated, they have managed to train their cell-mediated innate immunity through exposure to increasingly infectious variants (through epigenetic reprogramming).
As the immune escape pandemic will transition from its ‘chronic’ phase (i.e., characterized by a high prevalence of ‘Long COVID’!) to its final, hyperacute stage, we will observe a reduction in circulating Omicron descendants, and cryptic lineages will become increasingly undetectable in wastewater. Despite low virus concentrations in wastewater and low C-19 hospitalization and C-19 mortality rates, cases of Long COVID will continue to steadily increase. Given the insidious nature of the current evolution, I am referring to the current period as 'the calm before the tsunami’ and warning that ‘societies in highly C-19 vaccinated countries will be caught off guard’.
Those who naively believe that the pandemic will simply die out without major casualties or will be controlled by regular (updated) vaccine booster doses fail to grasp that it is no longer the C-19 vaccination itself but rather the recurrent vaccine breakthrough infections (even if largely asymptomatic in terms of acute C-19 disease!), initiated by Omicron as a result of mass vaccination (hence why Omicron has been a scourge, not a blessing!), that are fueling the progression of viral immune escape and immune pathology.
In other words, neither an extended period of vaccine abstention nor a recently updated shot will affect the remaining evolutionary trajectory of this immune escape pandemic (Hence the title of my book: ‘The Inescapable Immune Escape Pandemic’).
I can't help but conclude that all pieces of the puzzle are fitting nicely together and that the science behind all this is undeniably compelling. My analysis is the result of a thorough, prolonged, and painstaking exercise in deep diving into these matters, leaving no stone unturned. My journey through this pandemic has been quite different from that of our health authorities, so-called health experts, and leading scientists. To summarize the mess they have made of it, I prefer to use a quote from a good friend: “They have been throwing shit against a wall to see what sticks”! Some of that shit did indeed stick to the wall at the very beginning of the C-19 mass vaccination campaign, but then dripped off, first as watery diarrhea, then as pure bloody diarrhea…
I seriously doubt the stakeholders of this mass vaccination program were clever enough to realize that their ‘shit’ experiment would quickly emerge as the most spectacular gain-of-function experiment ever conducted in the history of biology (one that was directly conducted on our very own human species!!!). Whether intentional or not, I won't judge. The fact remains that soon it will become evident how, due to their actions, a fairly harmless virus was transformed into a bioweapon of mass destruction.
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Experts call for more research into long COVID, as study reveals high prevalence in Western Australia
Researchers say more support is needed for patients suffering from long-term illness associated with a COVID-19 infection, with new data showing a large number of West Australians have been left unable to work due to their crippling symptoms.
The Australian National University (ANU) study surveyed 11,000 people who tested positive to COVID during a significant outbreak of the Omicron variant in WA in 2022.
The study published in March found almost 20 per cent of those patients were still suffering symptoms of fatigue, memory loss and concentration difficulties three months after they first became sick.
Lead researcher Mulu Woldegiorgis said there was little pre-existing data available on the topic, but that the new research suggested there was a high rate of long-term COVID-19 symptoms in WA.
"It is more than double the prevalence reported in a review of Australia data from earlier in the pandemic, and higher than similar studies done in the UK and Canada," she said.
In their report, Dr Woldegiorgis and her colleagues acknowledged one of the limitations of the ANU survey was that it relied on subjective symptom descriptions from patients, and the reported impact of their symptoms on work or study was not independently verified.
Dr Woldegiorgis said it was important for patients' symptoms to be taken seriously. "I think it's real and it needs more investigation," she said.
"When we see its impact on work or study, more than one in six of those who used to work before their infection were not able to fully return to work or study due to their ongoing symptoms."
'Life has become small'
Joanna Lewis caught COVID almost two years to the day. When she still had symptoms weeks later she thought she might have contracted Ross River virus again. "I could be standing at the kitchen bench and I'd feel short of breath," she said.
"It was almost like my body had forgotten to breathe, which is really bizarre."
She experienced tachycardia and POTS – postural orthostatic tachycardia syndrome – which meant her heart rate shot up more than 30 beats a minute when she sat or stood up.
She had to take leave from work and suffered financially, burning through her savings and taking on students as boarders to bring in enough money to survive.
These days the 42-year-old is most afflicted by fatigue.
"I do have, I've found, about six hours on average … upright, I do have to spend probably most of my day lying down and resting," she said. "It just means life becomes very small."
Government urged to do more
Rural GP Michael Livingston said he was seeing large numbers of people through his practice in Narembeen, in WA's Wheatbelt, with unexplained fatigue and brain fog. "I'm seeing younger people who just aren't bouncing back the way they thought they would do," he said.
"Some people think they have dementia, such is their concern about their memory and ability to recall simple tasks."
Dr Livingston suspects long COVID could be to blame and urged people not become complacent about COVID prevention. "We really need to be questioning the why of this and what personal choices we're making and how complicit we are being around this," he said.
Dr Livingston said authorities should develop a "clean air policy", and could consider fitting classrooms, workplaces and public transport with specialised air filters.
WA Health Minister Amber-Jade Sanderson said the government was keeping a close eye on any evidence relating to long COVID. "I think there's some conflicting views globally around the impact of long COVID but we continue to watch it closely," she said at a press conference on Tuesday.
https://www.abc.net.au/news/2024-04-03/research-finds-long-covid-rates-high-in-wa/103647042
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Will NIH & Industry Consider Universal Coronavirus Vax Developed by Scientists in Georgia/Wisconsin & Tokyo?
Georgia Institute of Technology Scientists, in collaboration with investigators from University of Wisconsin—Madison as well as University of Tokyo continued pursuing the optimal coronavirus vaccine since the Covid-19 pandemic started. The mRNA vaccines developed through the federal government's "Operation Warp Speed" program were a massive innovation; however, annually updating those boosters for specific SARS-CoV-2 variants is inefficient for scientists and patients, although the spin given to the public by the leadership at the time at the National Institutes of Health and the companies was the opposite.
Now, the collaborators have developed a new vaccine that offers broad protection against not only SARS-CoV-2 variants, but also other bat sarbecoviruses. The groundbreaking trivalent vaccine has shown complete protection with no trace of virus in the lungs, marking a significant step toward a universal vaccine for coronaviruses. Findings were recently presented in “Broad protection against clade 1 sarbecoviruses after a single immunization with cocktail spike-protein-nanoparticle vaccine,” published in the February edition of Nature Communications.
For context, SARS-CoV-2 is just one member of the Sarbecovirus (SARS Betacoronavirus) subfamily (others include SARS-CoV-1, which caused the 2002 SARS outbreak, as well as other viruses circulating in bats that could cause future pandemics).
According to Ravi Kane, professor in the School of Chemical and Biomolecular Engineering, “We had been working on strategies to make a broadly protective vaccine for a while.” Professor Kane continued, “This vaccine may protect not just against the current strain circulating that year, but also future variants.”
Research goes back in time
Kane and his research group have been working on the technologies to develop more widely protective vaccines for viruses since he joined Georgia Tech in 2015. Although the team didn’t specifically foresee Covid-19 arising when it did, pandemics have regularly occurred throughout human history. While the team pivoted their vaccine research to address coronaviruses, they were surprised by how rapidly each new variant arose, making their broader vaccine even more necessary.
Once they realized the challenge inherent in how fast SARS-CoV-2 mutates, they had two options for how to build a vaccine: design one to be widely preventative against the virus, or use the influenza vaccine, which updates annually for the anticipated prevalent variant, as a model.
Considering Durability, Breadth
Making a broad vaccine is more appealing because it enables patients to get one shot and be protected for years. To create their general vaccine, Kane’s team capitalized on the key to the original mRNA vaccines — the spike protein, which binds the virus to healthy cells. Their vaccine uses three prominent spike proteins, or a trivalent vaccine, to elicit a broad enough antibody response to make the vaccine effective against SARS-CoV-2 variants as well as other sarbecoviruses that have been identified as having pandemic potential.
“If you know which variant is circulating, you can immunize with the spike protein of that variant,” Ph.D. student and co-author Kathryn Loeffler said. “But a broad vaccine is more difficult to develop because you’re protecting against many different antigens versus just one.”
It Starts with Preclinical Animal Research
Collaborators in the Kawaoka group at the University of Wisconsin tested their vaccine in hamsters, which they had previously identified as an appropriate animal model to evaluate vaccines and immunotherapies against SARS-CoV-2. The vaccine was able to neutralize all SARS-CoV-2 omicron variants tested, as well as non-SARS-CoV-2 coronaviruses circulating in bats. Even better, the vaccine provided complete protection with no detectable virus in the lungs.
Kane hopes that the vaccine strategy his team identified can be applied to other viruses — other coronavirus subfamilies as well as other viruses such as influenza viruses. They also expect that some of the specific antigens they describe in this paper can be moved toward preclinical trials. Someday, a trivalent vaccine could comprise a routine part of people’s medical treatment.
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Australia: COVID-19 Vaccine Side Effects Under Scrutiny: Ralph Babet initiates Senate Inquiry Targeting Excess Mortality
Babet is the lone libertarian senator so it is good to see him having an effect
Australians concerned about excess deaths in recent years are now able to have their voice heard by the parliament as a new Senate inquiry has gone online.
Following the establishment of a Senate inquiry into excess mortality in the week ending March 31, the Australian parliament has opened a new page for the inquiry on its website, allowing concerned individuals and organisations to make submissions.
According to Australian Bureau of Statistics data, excess mortality rose from minus 3.1 percent in 2020 to 1.6 percent in 2021 and 11.7 percent in 2022 before dropping to 6.1 percent in 2023.
Notably, there were almost 20,000 cases of excess deaths in 2022 alone.
The inquiry was established after the parliament narrowly passed a motion moved by United Australia Party Senator Ralph Babet with a 31-30 vote on Feb. 26.
Mr. Babet had the support of the Opposition, One Nation Party, and some independent senators, while the Labor and the Greens opposed the motion.
In a social media post, Mr. Babet said this was an opportunity for Australians to have a say on the issue.
“Many submissions are expected to be received from both individuals and professional organisations, with the opportunity for public hearings to follow later this year,” he wrote.
“This is your opportunity to have your say. If you have a personal story, knowledge, or expertise in this space, please prepare a submission for the committee.”
Australians can make submissions online via the parliament website, or they can send letters and emails to the Senate Community Affairs References Committee, which is responsible for investigating the matter.
Mr. Babet also said the committee was expected to finalise a report by the end of August. “May this committee process give a voice to the family members of the deceased and deliver the answers that our nation so desperately needs,” he wrote.
In an interview with 2GB Radio, Mr. Babet said the inquiry would look into the side effects of COVID-19 vaccines to determine whether they were connected to excess deaths.
“There would have to be at least a part of this, which is due to the vaccine,” he said.
“I want an answer at the end of this to say hey, that vaccines were a part of this, or the vaccines were not a part of the sport, or we don’t know, let’s investigate more.”
At the same time, the senator mentioned the challenges he faced during the process of establishing the inquiry, alleging that many politicians did not want to investigate the issue.
“For the last two or three years, none of the other senators … most of them have not wanted to take a look,” he said.
“They want to sweep things under the carpet. That’s what they’ve wanted to do.
“It’s not okay. It’s not how you do things. This is Australia. This is not a communist dictatorship.”
Meanwhile, Labor Senator Tim Ayres criticised the idea of having the parliament investigate excess deaths, saying it was opportunistic behaviour.
“Some people in the political system, of course, where they see fear, see opportunity. Where they see a capacity to divide people, to isolate them, and to frighten them, that is an opportunity,” he said.
While independent Senator David Pocock did not believe in COVID-19 vaccine “conspiracies,” he said there was a need to investigate the issue of excess mortality.
“I don’t accept the conspiracy theories that have been featured so heavily in Discord around COVID-19 vaccines,” he said.
“However, I do acknowledge there is data showing excess mortality rates that have increased in recent years.”
https://www.theepochtimes.com/world/inquiry-into-excess-deaths-now-open-for-submissions-5620720
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Doctors Force FDA To Remove False Statements About Ivermectin
The U.S. Food and Drug Administration (FDA) has agreed to remove social media posts and webpages that urged people to stop taking ivermectin to treat COVID-19, according to a settlement dated March 21
The FDA has already removed a page that said:
“Should I take ivermectin to prevent or treat COVID-19? No.”
Within 21 days, the FDA will remove another page titled, “why you should not use ivermectin to treat or prevent COVID-19,” according to the settlement announcement, which was filed with federal court in southern Texas.
“The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in humans or animals,” the page currently states. It also says that data do not show ivermectin is effective against COVID-19, despite how some studies it cites show ivermectin is effective against the illness.
The FDA in the settlement is also agreeing to delete multiple social media posts that came out strongly against ivermectin, including one that stated:
“You are not a horse. You are not a cow. Seriously, y’all. Stop it.”
In exchange, doctors who sued the agency are dismissing their claims, the filing states.
“FDA loses its war on ivermectin and agrees to remove all social media posts and consumer directives regarding ivermectin and COVID, including its most popular tweet in FDA history,” Dr. Mary Talley Bowden, one of the doctors, said in a statement. “This landmark case sets an important precedent in limiting FDA overreach into the doctor-patient relationship.”
“We are extremely pleased with the outcome of the settlement as it is a victory for every doctor and patient in the United States,” added Dr. Paul Marik, chief scientific officer of the FLCCC Alliance and another plaintiff.
“The FDA interfered in the practice of medicine with their irresponsible language and posts about ivermectin. We will never know how many lives were affected because patients were denied access to a lifesaving treatment because their doctor was ‘just following the FDA.’”
An FDA spokesperson told The Epoch Times in an email that the agency:
“has chosen to resolve this lawsuit rather than continuing to litigate over statements that are between two and nearly four years old.”
“FDA has not admitted any violation of law or any wrongdoing, disagrees with the plaintiffs’ allegation that the agency exceeded its authority in issuing the statements challenged in the lawsuit, and stands by its authority to communicate with the public regarding the products it regulates,” the spokesperson said.
“FDA has not changed its position that currently available clinical trial data do not demonstrate that ivermectin is effective against COVID-19. The agency has not authorized or approved ivermectin for use in preventing or treating COVID-19.”
Ivermectin was approved by the FDA in 1996 to treat several conditions, including onchocerciasis, a tropical disease caused by a parasitic worm.
In the United States, it’s common for doctors to prescribe medicine off-label, or for a different purpose than the one for which the medicine is approved.
After some doctors began prescribing ivermectin for COVID-19, the FDA ramped up its campaign, including the Aug. 21, 2021, post on Twitter, now known as X.
Dr. Bowden and two other doctors sued the FDA, arguing the agency’s actions went beyond its authority, as conferred on it by Congress.
U.S. District Judge Jeffrey Brown dismissed the case in 2022, ruling that the FDA did not act outside the authority. But an appeals court in 2023 ruled in favor of the doctors, finding that the agency “has identified no authority allowing it to recommend consumers ‘stop’ taking medicine.”
Between the time of the ruling and the settlement, the FDA refused to change any of its statements on ivermectin, and asked for a fresh dismissal of the suit.
The Case
Drs. Robert Apter, Bowden, and Marik brought the case in 2022. They said they suffered repercussions after prescribing ivermectin to patients with COVID-19, and that the FDA was to blame.
Dr. Apter, for instance, said that pharmacists refused to fill the prescriptions, citing the FDA.
“This refusal delays his patients in obtaining their prescribed treatment—when early intervention is paramount—while they look for a pharmacy to fill their prescription, if they can find one at all,” the suit states.
He also said that insurance companies were refusing to pay for ivermectin to treat COVID-19.
The suit said the FDA illegally interfered with the relationships between the doctors and patients. The doctors said with regard to ivermectin, the FDA overstepped the authority conferred on it in the Federal Food, Drug, and Cosmetic Act.
Government lawyers argued that the FDA was acting within the confines of the law, and succeeded in getting the dismissal.
Judge Brown, appointed under President Donald Trump, said the FDA’s powers were only limited with regard to medical devices.
“As there is no statute limiting the FDA’s actions here, it cannot have acted outside of any statutory limitations,” he wrote in his ruling. “Further, it cannot be said that the FDA had no colorable basis of authority. The FDA is charged by Congress with protecting public health and ensuring that regulated medical products are safe and effective, among other things.”
A three-judge panel of the U.S. Court of Appeals for the Fifth Circuit disagreed, finding that the law did not authorize the FDA to give medical advice.
“FDA can inform, but it has identified no authority allowing it to recommend consumers ‘stop’ taking medicine,” U.S. Circuit Judge Don Willett, appointed under President Trump, wrote for the court.
The appeals court remanded the case back to the district court.
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Another Outlandish Overreach by the CDC
Easter weekend was lovely in every way.
And yet I could not stop thinking about the strange manner in which the Centers for Disease Control and Prevention (CDC) has had such an outsized role in the ruination of American rights and liberties. This agency is supposed to be tracking infectious disease and finding ways out. This mandate became the leverage to allow them to impose nationwide mask mandates, a rental moratorium, a shutdown of the cruise industry, and otherwise send the whole country into fits of hysterics for two years and more.
So it occurred to make an inquiry into how the CDC handles questions of election processes. This is rather important in a democracy. This is how we select our leaders and the central way in which we can claim that the people have some influence over the regime that rules us. It is because of elections that we can claim to be better than ancient despotisms or medieval feudalism. We rule ourselves through the vote. That’s the whole idea.
As it turns out, the CDC had quite a large role in guiding election processes. Not that you can find the evidence on their website now. Nope, it’s all been scrubbed. However, if you look at the Wayback Machine, you can find an interesting little point. The CDC strongly recommended mail-in, absentee, and early voting as a means of disease control.
The theory was that people gathering in a polling place would be a super-spreader event. What science did they cite to demonstrate this? None at all. So far as I know, and I’ve looked far and wide, there is not a single study anywhere that purports to show some relationship between disease spread and in-person voting. The CDC just made that up... for whatever reason.
The day was March 12, 2020. This was the same day that President Trump went on national television in the evening to announce that there would be no more travel from the United States to Europe, the UK, and, later, Australia and New Zealand. He further said that all Americans living abroad needed to come home right away or be stuck.
That was a pretty shocking announcement. Nothing like this had ever happened in American history, not even this broadly in wartime. It seemed to come out of nowhere, our rights to travel suddenly deleted.
It seems that President Trump was following the advice of his scientific advisors who later turned out to be snake oil salesmen. Indeed, he seemed extremely uncomfortable making this announcement, almost like he knew that it was weird and probably unwarranted. Strange night.
As it turns out, earlier that day, the CDC decided that the whole country really ought to be voting by mail. They went into the website and edited the page that very day and produced the following checklist.
You can see for yourself at the Archive link. So far, the CDC has not proven itself powerful enough to scrub also its bread crumbs from the archive source, not yet in any case. The time might come. If they succeed, their role in creating the biggest voting scandal in a hundred years might never have been known by future generations.
There is simply no way that the CDC could not have known about the uncertainties and vagaries created by absentee ballots. They are banned by half the countries in the world for that reason. Those that do allow them govern them very strictly. You have to request a ballot. They are sent to your home. You have to provide extensive identity verification. You have to have a darn good excuse. It’s only for hardship cases and never the norm.
It was the CDC that decided to throw all that in the trash. Who even cares about the whole history of democracy, because, after all, there is a virus floating around! It’s amazing that this happened. But just as amazing is the idea of throwing out property rights, which they also did. But there it is.
To be sure, they could not actually force this result. But they sure could grant some scientific heft behind the idea. It also helped that only 10 days later, the U.S. Congress voted $2 trillion in payments to the states, a portion of which was to implement CDC recommendations. Most states were happy to do so, again, with full knowledge that this strategy would yield results that were sketchy at best.
As it turns out, of course, it was the mail-in ballots that might have made the difference in the election, or seemed to in any case. Everything got so much mixed up that it’s hard to say. And it’s not like people did not have warning signs of trouble. The primary season of that spring and summer yielded a slew of controversies about what was and was not true. There were more than enough controversies swirling about by the time of the general election.
The crucial point here is that the CDC massively overstepped the bounds of its mandate by intervening in the processes by which Americans select its leaders, strongly pushing a method that was a known source of fraud. Nor has the CDC ever been held to account for this, not to my knowledge in any case.
They were sued over the rent moratorium and the evil nationwide mask mandate. They lost both cases. But there has been no litigation against the CDC for disrupting the whole system by which we regulate elections. One might suppose that if an executive agency were to do something like this, they would have needed some permission from somebody. Surely such a gigantic change would and should require more than a low-level employee with logins to change a website text.
Speaking of which, who actually did this and why? Aren’t these interesting questions? Why is no one asking them? Where are the investigations? Where is the outrage?
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2 April, 2024
Study Finds New Drugs Effective Against COVID-19 and Other Viruses
Studying the ways viruses impact cellular pathways during infection may help in developing treatments for infectious diseases such as COVID-19.
A new study, conducted by researchers at the University of Alberta and published in the npj Viruses journal found that certain cancer treatment drugs can promote cells to secrete antiviral interferons. These drugs target the SARS-CoV-2 virus, which causes COVID-19, and are also effective against multiple pathogenic RNA viruses.
Interferons are natural proteins that bolster the body’s immune system in combating infections and diseases like cancer. They earned their name because they interfere with viruses, stopping them from spreading.
Both COVID-19 and some cancers activate the Wnt/beta-catenin pathway—a chain reaction inside the cell. Drugs that block this pathway, originally made to treat cancer, might also help fight COVID-19.
When the Wnt/beta-catenin pathway gets activated, it slows down the production of interferons. This pathway also negatively impacts the immune system.
In a study, scientists tested two drugs, KYA1797K and E7449, that block the Wnt/beta-catenin pathway. They found that these drugs reduced the amount of virus in the lungs of mice. The drug E7449 was especially good at preventing weight loss and lung damage in the infected mice.
Tom Hobman, a professor of cell biology at the University of Alberta’s Faculty of Medicine and Dentistry and one of the study authors, explained in a press release that after using these drugs, cells produced interferons in response to viral infections at levels four to six times higher than before. Additionally, experiments also revealed that the virus was inactivated to less than one-ten-thousandth of its original levels.
He pointed out that interferons prevent infected cells from producing more viruses primarily in two ways, “It shuts down the infected cell, often resulting in cell death, and it also acts on the surrounding cells to prevent them from being infected.”
The researchers also tested viruses other than COVID-19 and found that the drugs exhibit broad-spectrum activity against a variety of RNA viruses. These include coronaviruses, responsible for seasonal respiratory infections, as well as mosquito-borne viruses like Zika and Mayaro.
Ongoing Drug Trials for COVID-19
In addition to drugs targeting the Wnt/?-catenin pathway, other drugs are also being explored for the potential to alleviate the COVID-19 virus.
A clinical trial published in February, which involved 1,821 mild to moderate COVID-19 patients, indicated that a drug called ensitrelvir significantly shortened the duration of symptoms in patients with COVID-19.
A phase II to III clinical trial of the anti-COVID-19 drug Simnotrelvir, involving 1,208 patients with mild to moderate COVID-19 infection, was published in the New England Journal of Medicine. The results showed that patients who received Simnotrelvir treatment within 72 hours of COVID-19 symptom onset had their “time to sustained resolution of symptoms” shortened by 35.8 hours. In a subgroup with risk factors for severe COVID-19, Simnotrelvir reduced the time by 60 hours.
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Immunologists Call Out mRNA Vaccines—The Good, Bad & Ugly: Time to Go Back to Science
More data and analysis from various peer-reviewed journals raises serious concerns about the externalities associated with the mass countermeasures developed by the United States government in response to COVID-19. While the mRNA COVID-19 vaccines have been positioned as modern marvels of medicine—safety, effective and representative of the future of medicine, mounting literature not widely touted by American media implicates a different point of view.
Microbiologist and immunologist Botond Z. Igyártó, Ph.D., from Jefferson University in Philadelphia and immunology researcher Zhen Qin in the most recent edition of the peer-reviewed journal Frontiers in Immunology suggest the latest, accumulation of data points to the need for concern covering both safety and efficacy of the mRNA vaccines developed by Moderna in partnership with the National Institutes of Health and Pfizer in partnership with Germany’s BioNTech.
TrialSite has published article after article over the past couple years hinting at considerable challenges with mRNA platforms. The literature in the peer-reviewed journals amasses leading to questions for investors in the platform developers.
The authors herein call out for a security that represents an absolute must for the scientific community. With an unprecedented mass vaccination scheme via the use of an investigational product “that minimally protects from getting infected and spreading the virus during a pandemic,” the need for critical reflection becomes of paramount concern.
Was the strategy sound? Was her immunity a realistic expectation? Did the strategy as proposed by Geert Vanden Bossche lead to an actual acceleration of mutations? Should governments have focused on more vulnerable populations during the pandemic? Why was a novel mRNA platform opted for in the emergency over more known methods? Why focus on a single virus protein with a high mutation rate as TrialSite called out early on? Were the vaccine’s benefits (supposedly faster production, ease of updating for new variants, etc.) beneficial? Why did research leadership at the NIH for example ignore basic immunology knowledge during the pandemic?
Igyártó and Qin in this latest peer-reviewed output identify safety considerations, seeking to better understand the mechanisms of observed adverse events related to the mRNA jabs. Can such identified risk factors be mitigated by altering the mRNA platforms?
Describing the standard and non-standard components of the mRNA-LNP COVID-19 vaccines, Igyártó and Qin then address what the pair of authors describe as “concerning” assumptions made in regard to this technology.
While formally, the public has been told that mRNA vaccines do not allow for reverse transcription into DNA, meaning that there is no risk of insertion into the human genome, the authors raise some questions for consideration.
In particular instances, RNA can in fact be reverse transcribed into DNA. The authors note, “With the Pfizer mRNA-LNP vaccine, it has been shown experimentally that the vaccine mRNA can be reverse-transcribed into DNA in an immortalized human hepatocyte cell line.”
Also, the pair of authors note other possibilities for this concerning action, plus localization of the spike protein. A series of studies suggest the possibility of transcribed possibilities.
The authors point out:
“While to our knowledge similar studies have not been performed with COVID-19 mRNA vaccines that code for full-length pre-fusion fixed form of SARS-CoV-2 spike protein, comparable transport of spike protein/mRNA to the nucleus could be expected. Because the mRNA can enter the nucleus, where it might be reverse-transcribed into DNA, this increases its potential to integrate into the genome.
Furthermore, the mRNA-LNP diffuses throughout the body and can accumulate in both the testes and ovaries and is reported to alter the menstrual cycle in women. Therefore, it could potentially be reaching the stem cells of the reproductive organs. These findings highlight the need to take these data and concerns seriously and conduct specific experiments to address them.”
On the topic of the mRNA vaccine product degrading in vivo in hours or a matter of a few days, the authors challenge this misinformation to argue that the vaccines do not disrupt normal cell biology.
While it’s likely that this assumption (rapid product degradation) likely arose given that unmodified mRNAs have overall short in vivo half-life, real-world since points to a very different situation.
For example, “…human lymph node biopsies taken at different time points post-exposure to the mRNA-LNP revealed detectable levels of vaccine mRNA and spike proteins up to eight weeks.” And of course, TrialSite has reported on peer-reviewed data featuring the distribution and circulation of spike protein derived from the mRNA vaccines in humans for periods over a year.
Also, the effects of modified ribonucleotides (incorporated into the vaccine products to lower innate reactogenicity) just recently became more apparent.
Igyártó and Qin point out, “Incorporation of N1-methylpseudouridine into mRNA resulted in +1 ribosomal frameshifting in vitro and cellular immunity in mice and humans to +1 frameshifted products from BNT162b2 vaccine mRNA translation occurred after vaccination.”
A key message from the authors on the overall topics: it’s dangerous to “assume and extrapolate in science” then apply existing paradigms to novel, untested platforms and technologies.
And just how safe and effective are the COVID-19 mRNA countermeasures?
Reviewing many of the same recent peer-reviewed journal entries, case reports and publicly available adverse event database as TrialSite, the current authors argue that this fact “cast doubts on the safety and effectiveness of these products.”
For example, on the topic of safety the authors point to a range of formidable entries calling out one concern to another. As TrialSite has editorialized many of the studies cited by Igyártó and Qin on the topic of COVID-19 mRNA vaccine safety suggest concern.
Similar outcomes can be found when probing efficacy. As the authors point out, “The effectiveness of these therapeutics in preventing infections and limiting the spreading of the virus has been highly eroded from the early reports, and nowadays, their efficacy is mainly limited to potentially decreasing the disease severity and death in susceptible people.” Pointing out that the efficacy that has been reported likens to the immune suppressive characteristics of these mRNA products, the authors urge for a “rigorous pre-clinical studies to limit potential unexpected consequences for novel platforms.”
Final Thoughts
Pointing out that “several fundamental questions persist surrounding the pandemic measures and the adoption of this new vaccine platform,” the scientists cogently argue “rather than advocating for retraction and censorship” rather there should be a movement in science to foster for open dialogue, considering all perspectives.
And for those that despite the findings above would still justify all that was done during the pandemic as the efforts saved lives, Igyártó and Qin point out that “the robustness of supporting data raises important inquiries.”
True trust is necessary to not undermine science and foster vaccine hesitancy, argue the authors of this important peer-reviewed paper. Seek to rebuild trust? Then, the authors argue it’s “crucial to return to the fundamental principles of scientific inquiry
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1 April, 2024
COVID-19 Vaccines Performance Decline--Only 38% of At Risk Immunocompromised Kept out of Hospital
TrialSite continues to monitor the observational study output of the Centers for Disease Control and Prevention (CDC) funded VISION Network, a research collaboration involving multiple hospitals/sites with integrated electronic health records (EHR) across America. This is part of an ongoing real-world data effort to evaluate how well vaccines protect against seasonal viruses such as influenza or COVID-19.
In this latest study, the substantial VISION team utilizes a test-negative design to estimate COVID-19 vaccine effectiveness (VE). And the outcomes are not great, in fact, some could argue this latest vaccine bombed.
Why? Any commercial vaccine designed to keep people, especially at-risk cohorts out of the hospital, should perform at least at 50% vaccine effectiveness. At 38% between days 7-59 and 34% in the 60-119 days after the receipt of the updated dose, the only reason CDC can justify recommending the product includes A) because they are not considering full safety risks for this cohort and B) the logic that 38% protected is better than no one and for this latter point there is some rationale. Only 14% of immunocompromised opted to get the vaccine suggesting a near collapse in market demand for COVID-19 vaccines given the risks associated with this demographic.
The data reported herein results from the CDC’s latest Morbidity and Mortality Report (MMWR) titled “Interim Effectiveness of Updated 2023-2024 (Monovalent XBB.1.5) COVID-19 Vaccines Against COVID-19–Associated Hospitalization Among Adults Aged ?18 Years with Immunocompromising Conditions — VISION Network, September 2023–February 2024.
Background
By September 2021, the CDC’s Advisory Committee on Immunization Practices recommended updating 2023–2024 (monovalent XBB.1.5) COVID-19 vaccination for all persons aged ?6 months to prevent COVID-19, including severe disease. The agency did not consider a risk-based approach like in most other nations at this point given the following:
Omicron has become much milder (e.g., case fatality rate at the level of influenza for most)
Large segments of the U.S. population have pre-existing immunity at some level
Growing recognition that some safety signals present (e.g., risk of myocarditis/pericarditis in young males, etc.).
Available treatments such as Paxlovid—while not accepted yet by the National Institutes of Health or the CDC,
accumulation of data that vitamin D supplementation very important to avoid more severe symptomatic COVID-19
The CDC suggests additional boosters for immunocompromised conditions should be considered, in this case representing a risk-based approach to public health.
In this latest observational study, the study team assesses how well the COVID-19 vaccines perform at helping immunocompromised persons infected with COVID-19 avoid hospitalization based on the data linked to hospitalization during the period September 2023-February 2024.
Findings
Few persons (18%) in this high-risk study population had received the updated COVID-19 vaccine. All persons aged ?6 months should receive updated 2023–2024 COVID-19 vaccination; persons with immunocompromising conditions may get additional updated COVID-19 vaccine doses ?2 months after the last recommended COVID-19 vaccine.
Out of 14,586 patients with immunocompromising conditions who were hospitalized with COVID–19–like illness, the study team included 1,392 case patients and 13,194 control patients.
The most common immunocompromising conditions among both case patients and control patients were solid organ malignancy (36% and 43%, respectively) and other intrinsic immune conditions or immunodeficiency (38% and 35%, respectively).
A total of 195 (14%) case patients had received an updated COVID-19 vaccine dose compared with 2,401 (18%) control patients. VE against COVID–19–associated hospitalization was 38% in the first
More Specifics
The CDC-funded VISION team reports only nine persons who received >1 updated COVID-19 vaccine dose were included!
The team estimated Odds ratios (ORs) using multivariable logistic regression comparing persons who received an updated COVID-19 vaccine dose with those who did not, irrespective of the number of previous original or bivalent COVID-19 vaccine doses received (if any), among case- and control patients.
They adjusted their regression models for age, sex, race and ethnicity, calendar time, and geographic region. While they calculated VE as (1 ? adjusted OR) × 100%. Analyses were conducted using R software (version 4.3.2; R Foundation). This activity was reviewed by CDC, deemed not research, and was conducted consistent with applicable federal law and CDC policy.†† VISION activities were reviewed and approved by the Westat and site institutional review boards.
How does CDC rationalize this VE?
According to the VISION team, “Effectiveness estimates in this report were slightly lower than those in a recently published analysis from VISION and another CDC VE network showing COVID-19 VE against COVID-19-associated hospitalizations in adults without immunocompromising conditions was approximately 50%, but this report includes the analysis of an additional month of data compared with the previous report.”
The group still implies recommended vaccination because “persons with moderate or severe immunocompromising conditions are at higher risk for severe COVID-19 and might have decreased response to vaccination.” (2).
Limitations
The VISION team discloses two primary limitations to this study. These include the following:
The use of selected discharge diagnoses as surrogates for presumed immunocompromised status and the absence of medication and other relevant data might have led to misclassification of immunocompromise status, which might have biased estimated VE in either direction
Immunocompromising conditions are heterogeneous and likely to create differential risk for severe COVID-19, as well as differential response to vaccination
CDC suggested implications
Although the VE of 38% to keep immunocompromised individuals out of the hospital evidences a waning performance (in fact under 50% and regulators used to question the overall value of the vaccine), the CDC team argues that “receipt of an updated COVID-19 vaccine dose provided increased protection against COVID-19–associated hospitalization among adults with immunocompromising conditions compared with no receipt of an updated dose.”
And the CDC takes the increasingly unpopular and isolated decision to continue to recommend that all Americans age ?6 should get the 2023-2024 COVID-19 vaccine, regardless of fundamentally changing risk-benefit calculus.
That only 14% of the immunocompromised population opted to get this latest vaccine is most certainly telling of the market’s proclivity to go out and opt for this vaccine. At TrialSite, we have reported on a growing number of peer-reviewed studies evidencing instability in the current mRNA platforms. Is it a good idea to vaccinate children 6 months and above en masse given the risk-benefit calculus factors discussed above? Even the New York Times recently reported on the fact that the U.S. was now an outlier in recommending systematic COVID-19 vaccination of young children, especially when we factor in risks for myocarditis/pericarditis in young healthy males.
We suggest this latest vaccine effectiveness performance portends an ominous future for this class of vaccine.
TrialSite Critical View
The protection of mRNA vaccines is so transient TrialSite suggests a new metric for their assessment, at least when it comes to protection against infection. Peak efficacy in the first few weeks’ post immunisation is clearly completely irrelevant. What about calculating average 6- or 12-month efficacy?
This would be akin to measuring area under survival curve. Hence depending on the shape of the curve a vaccine that had 90% efficacy at two weeks and 10% efficacy at six months, may have an overall 6-month efficacy of say 20% if the curve falls steeply at the start or 60% if it falls steeply at the end.
We know from the Israeli data in July 2021 that Pfizer had fallen to just 12% efficacy at 6 months so its true overall 6-month efficacy must have been less than 50% even although they continued to quote >90% efficacy in the media.
Also say a vaccine drops from 90% efficacy at two weeks to 0% efficacy at 4 months – how then to describe its overall efficacy over 6 months – intuitively it should be 0% not the average as over the last two months no one is protected, so everyone will now get infected if exposed, even if they got some protection over the first 4 months – i.e. their infection was just delayed.
This requires sophisticated biostatistician input. After all, COVID-19 infections are not linear over time, but highly clustered into outbreaks. If an outbreak occurs at the 5-month post vaccine point in the previous example, then true vaccine efficacy is 0% or may even go negative at least when measuring protection against infection.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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