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.
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31 December, 2023
Consent of the Governed, Where Art Thou?
When authority-loving do-gooders run wild
Dr. Robert Malone
I am often asked some form of the question “What caused you to come out of the closet and start criticizing the vaccines?” On a related note, when interviewed by a reporter from the infamous Atlantic August 2021 hit piece, Stan Gromkowski (a former Vical colleague of mine) prophetically opined, “He’s [expletive] up his chances for a Nobel Prize.”
The answer to this persistent question is nicely summarized in the first essay which I wrote in objection to what was being done, titled “COVID Vaccine Deployment under EUA: It’s time we stop and look at what’s going down,” published in Trial Site News on May 30, 2021 (three months before the defamatory Atlantic attack). I guess that article struck a nerve, because it currently has over 19,000 likes; pretty good for an article on a specialty paid site targeting the clinical research industry.
The essay was prompted by a midnight Saturday evening Zoom call with a Canadian physician who was pleading for me to help intervene with the Canadian authorities overseeing the “vaccine” campaign. This specific physician later had his office raided and office computers damaged by the Canadian government for prescribing early treatment and writing vaccine exemptions, and has now being required to submit to the Canadian government re-education and contrition program for his sins if he wishes to retain the ability to practice medicine, just as has been required of Jordan Peterson. But that was all in the future.
Talking until midnight Saturday, he had described what was being done in Canada to force toxic COVID “vaccines” on an unwitting population including children, imploring me to somehow intervene with Health Canada to stop the madness. I told him I did not have the necessary connections, and there was nothing much I could do to help.
Waking early the following Sunday, I realized there was something I actually could do to advance his cause. I could dip into my extensive training in bioethics and write about the fundamental breaches of established biomedical ethics that were going on in Canada, and would soon migrate to the United States, Australia, New Zealand, the United Kingdom, and across the western “democracies.”
The following is the core of my argument back then (May 2021), which I assert has withstood the test of time much better than the notorious Atlantic hit piece published three months later.
* * *
I believe that adult citizens must be allowed free will, the freedom to choose. This is particularly true in the case of clinical research. These mRNA and recombinant adenovirus vaccine products remain experimental at this time. Furthermore, we are supposed to be doing rigorous, fact-based science and medicine. If rigorous and transparent evaluation of vaccine reactogenicity and treatment-emergent post-vaccination adverse events is not done, we (the public health, clinical research and vaccine developer communities) play right into the hands of anti-vaxxer memes and validate many of their arguments.
The suppression of information, discussion, and outright censorship concerning these current COVID vaccines which are based on gene therapy technologies cast a bad light on the entire vaccine enterprise. It is my opinion that the adult public can handle information and open discussion. Furthermore, we must fully disclose any and all risks associated with these experimental research products.
In this context, the adult public are basically research subjects that are not being required to sign informed consent due to EUA waiver. But that does not mean that they do not deserve the full disclosure of risks that one would normally require in an informed consent document for a clinical trial. And now some national authorities are calling on the deployment of EUA vaccines to adolescents and the young, which by definition are not able to directly provide informed consent to participate in clinical research—written or otherwise.
The key point here is that what is being done by suppressing open disclosure and debate concerning the profile of adverse events associated with these vaccines violates fundamental bioethical principles for clinical research. This goes back to the Geneva convention and the Helsinki declaration.
There must be informed consent for experimentation on human subjects. The human subjects—you, me, and the citizens of these countries—must be informed of risks.As a community, we have already had a discussion and made our decision—we cannot compel prisoners, military recruits, or any other population of humans to participate in a clinical research study. For example, see the Belmont report, which provided the rationale for US federal law Code of Federal Regulations 45 CFR 46 (subpart A), referred to as “The Federal Policy for the Protection of Human Subjects” (also known as the “Common Rule”).
Quoting from the Belmont Report:
“Informed Consent. — Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.
While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.”
Information, comprehension, and voluntariness. To my eyes, it appears that in many regions public health leadership has stepped over the line and is now violating the bedrock principles which form the foundation upon which the ethics of clinical research are built. I believe that this must stop. We must have transparent public disclosure of risks—in a broad sense—associated with these experimental vaccines. It is either that, or the entire modern bioethical structure which supports human subjects research will have to be re-thought.
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This was not a major intellectual leap. It was a simple restatement of the training in clinical research bioethics which I had received and which had been repeatedly reinforced over the prior decade. No big deal, except that few if any were willing to make such a statement at that time. Long before the infamous Dark Horse or Rogan podcasts.
The failure to disclose the risks of the gene therapy-based COVID vaccines by the U.S. and other “Western” governments became widespread, chronic, and well-documented. Fast forwarding to the present, on Dec. 22, 2023 investigative journalist Greg Piper of the alternative “Just the News” published yet another chapter in the abundant library of documented government withholding of key information concerning COVID genetic “vaccine” harms.
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Misinformation for thee, not me? FDA had similar concerns as COVID vaccine skeptics, docs suggest
FOIA production shows the agency wasn’t impressed by Pfizer’s plan to mitigate “endotoxins,” complained about insufficient cleaning in manufacturing, and had no basis to claim post-vax heart inflammation was rare.
If an outsider raises questions about contamination of COVID-19 vaccines or how closely the Food and Drug Administration monitors for severe adverse events, the agency considers it a boon to misinformation that lowers vaccine uptake and hence kills people.
If the FDA itself raises these issues, that’s a different story ....
The FDA documents, some heavily redacted under the FOIA exemption for trade secrets, show less daylight than may be thought between the agency and critics of federal COVID policy such as Florida Surgeon General Joseph Ladapo.
* * *
Mr. Piper went on to summarize a range of recent Freedom of Information Act (FOIA) and court-ordered document disclosures which clearly demonstrate a systematic and intentional failure by the U.S. government to properly inform the public of the risks associated with accepting gene therapy-based COVID “vaccine” products.
• The CDC had no scientific research to back its public claim in January that people can safely get their COVID, flu, and monkeypox vaccines “at the same time.”
• “Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, didn’t just tell Florida Surgeon General Joe Ladapo last week his concerns about DNA contamination were ‘quite implausible’ but also shamed him for feeding what he considered misinformation that will cause preventable deaths. Yet an Aug. 6, 2021 email to Pfizer from CBER Senior Regulatory Review Officer Mike Smith about ‘endotoxins’—potential contaminants introduced in pharmaceutical manufacturing—shows the feds had similar concerns as they considered full approval for Pfizer’s Comirnaty.”
• “A month before then-acting FDA Commissioner Janet Woodcock told the media that post-vaccination heart inflammation ‘appears to be very low,’ a CBER ‘surveillance’ scientist made clear that the leader was not relying on the agency’s own data. Joyce Obidi reviewed how well CBER’s Sentinel Program, created under a 2007 law to monitor drug safety through electronic healthcare data, could ‘evaluate the serious risk for myocarditis and pericarditis’ following Pfizer COVID vaccination in recipients 16 and older, the first population authorized for emergency use.
‘Post-authorization safety data identified serious risks for myocarditis and pericarditis after COMIRNATY, with increased risk in males under 30 years of age,’ Obidi wrote in the May 18, 2021, memo, which is also buried in the agency’s 246-document public folder on materials related to Comirnaty’s approval.”
• Obidi also stated that “Available data sources in the CBER Sentinel Program are NOT sufficient to identify the outcomes of myocarditis and pericarditis” and not “sufficiently powered to assess the magnitude of risk” for ages 12-30. She wrote. The program would need a minimum of 3-6 months follow-up data to check for “long-term sequelae,” and it cannot study subclinical myocarditis “because of the absence of a definition of subclinical myocarditis and unknown background incidence of troponin abnormalities,” according to Obidi. Sentinel’s data sources at full approval of Comirnaty did not have “sufficient power to assess the magnitude of risk in patients 12-30 years of age” and hence cannot assess the “serious risks of myocarditis and pericarditis, and subclinical myocarditis” associated with the vaccine.
• “In another May 18, 2021, memo reviewing Pfizer’s proposed pharmacovigilance plan for its vaccine, Analytic Epidemiology Branch Medical Officer Deborah Thompson evaluated the company’s claim that ‘vaccine-associated enhanced disease’ is just a ‘theoretical risk.’ She cited Vaccine Adverse Events Reporting System reports of deaths in ‘fully vaccinated’ patients at that early stage of vaccination. ‘Severe manifestations and death from COVID-19 raise the possibility’ of VAED because it has ‘overlapping clinical manifestations with natural SARS-CoV-2 infection, making it difficult to differentiate VAED from severe’ infection in VAERS reports.”
• Despite assurances otherwise from Peter Marks in his letter to the Florida Surgeon General, major manufacturing process good practices were breached. “In a Form 483 to Pfizer following inspections that uncovered possible or actual product adulteration, FDA investigators made 13 observations about procedures at Pfizer’s Andover, Massachusetts, manufacturing facility. They include “insufficient data to support product quality prior to the release” of vaccine batch FA8057. The observation says “a deviation [redacted] was initiated due to the multiple control limit excursions during [redacted]” and the “affected batch was manufactured with a process that deviated from the validated process parameters” and was “not put on stability until July 22, 2021.” It was released on a redacted date.
An observation on “inadequate quality oversight” implies that Pfizer was late in adding a notation to a batch record that “[redacted] exceeded the allowable [redacted].” The company’s quality assurance does not review “electronic data/reports” from a redacted manufacturing process “during batch record review or prior to batch release.” [Note: No clinical trial I have ever been involved in has been associated with an FDA 483 warning letter. This is no small matter.]
• Just the News asked the FDA prior to publication of this report on Dec. 22 for its characterization of the FOIA-disclosed and related documents in light of Marks’ comments to Ladapo about feeding misinformation. A spokesperson responded two days later, saying the agency was working to provide an answer. As of Dec. 27, the FDA still has not provided a response.
At this point, the burden of publicly available documentation clearly demonstrates multiple examples of intentional breaches of informed consent by both the U.S. government and the pharmaceutical industry manufacturers of these products. It is difficult to dispute that the U.S. government and the pharmaceutical industry sponsors are colluding in a public-private partnership to suppress information concerning risks of these products. Likewise, there has been an agreement between the UK and U.S. governments to suppress disclosure of information concerning risks and adverse events associated with these products.
In a normal, historic regulatory and bioethical environment, this breach of international bioethical norms concerning informed consent would rise to the level of a clear-cut crime against humanity. But in the “through the looking glass” world of COVID post-late 2019, established legal, moral, and ethical norms concerning patient and citizen rights to proper informed consent have all been turned upside down. All of these clear-cut breaches ostensibly being actively “justified” by mockingbird media, the massive censorship-industrial complex, and government officials as being in service of the public interest and the greater good.
The western Five Eyes alliance participants, deferring to the leadership of the U.S. government, are all acting in coordination and cooperation to disregard and hide the implications and consequences of their illegal and unethical actions. This is being justified based on the following oft-repeated catechism, each element of which is demonstrably false or opposed to established Western bioethical consensus:
1. COVID-19, the disease caused by infection with SARS-CoV-2, is highly pathogenic with a case fatality rate of 3.4. [The actual case fatality rate was approximately 0.02 percent when this disease was first “modeled” in 2020 and is much lower now.]
2. The gene therapy-based COVID-19 “vaccines” are safe and effective, are effective as prophylactics, are effective in preventing infection and spread of COVID-19 disease, and if taken by a sufficient fraction of the population [a moving goalpost] can be used to achieve herd immunity. [All of these previous claims are now clearly demonstrated unsupported falsehoods.]
3. The gene therapy-based COVID-19 “vaccines” are effective at preventing severe disease and death from SARS-CoV-2, and have saved 14 million lives. [This 14 million lives saved claim turns out to be based on flawed mathematics, and all cause mortality data analysis indicates something more like 17 million lives lost globally due to the products.]
4. Fully disclosing actual risks, morbidity and mortality data concerning the COVID-19 genetic vaccines will result in “increased vaccine hesitancy” and avoidable harm due to reduced “vaccine” (booster) uptake. [At this point in the outbreak, multiple data sources indicate that acceptance of boosters is associated with “negative effectiveness,” meaning that after a 2-3 month lag period (shorter in some studies) you are more likely to suffer death or severe COVID-19 disease—and other diseases—if you accept injection with these products than if you do not.]
This fourth point is a clear-cut example of flawed logic. Flawed both in terms of the data on morbidity, mortality, and immune imprinting, as well as flawed bioethical reasoning.
Think this through with me. The essence of the statement is essentially the governments’ assertions that “if the public knew about the risks that we know about, then they would choose not to accept those risks based on their assessment of the effectiveness of the product and the clinical risks of infection with the virus. Therefore there would be much more avoidable disease, disability, and death from COVID-19 than would be saved from vaccine products not administered.”
And on the basis of this ill-logic, governments and Pharma are withholding adverse event data, and thereby are unilaterally making medical decisions for sovereign individuals and their children. This is what we have come to. The ultimate embodiment of the nanny state, with corporatist allies. The State knows best, and will withhold medical information from the public which would cause members of that public to question its wisdom and decision-making.
Basically, the State is asserting that it has the right to sentence you to increased risk of death and disease by purchasing (using tax dollars), mandating (vaccines for children program), distributing, enticing, and marketing an injectable product while censoring or defaming (using modern psychological warfare technologies) any and all who disagree or even have the temerity to question the decisions and rights of the State to do so.
https://www.theepochtimes.com/opinion/consent-of-the-governed-where-art-thou-5555833
********************************************************28 December, 2023
NY Times Reports on a “Possible” Myocarditis Death Due to the Covid Vaccine
Throughout the pandemic, TrialSite News investigated, corroborated and reported on the reported side effects of the Covid vaccine. To support a group that had little to none, the media’s leadership sought out partnerships to be supportive, such as patient advocacy group React19, as well as enabling a censor-free Covid injury support group while also focusing on the incidence of Covid vaccine-related myocarditis in young men.
One example was an Israeli doctor who reported the ailment directly to Pfizer, yet he was ignored. It was only after the doctor had his findings published in The New England Journal of Medicine when the pharmaceutical company finally took notice and realized they might have a problem.
Additionally, TrialSite covered Wisconsin Senator Ron Johnson and his concerns on those injured by the vaccine and the hearings Johnson conducted on the vaccine injured as well as physicians who opposed the vaccines and vaccine mandates. Also there have been articles on parents who’ve lost children due to post vaccine heart ailments a celebrity pro-vaccine doctor in Mexico who mysteriously died after getting the shot as well a professional basketball player who claimed, before his death, the Covid vaccine was responsible for his decline. The point is these stories were published and available for reference. But, it seems, one major news outlet has just discovered the story.
The New York Times
In a story published on December 13, The New York Times reported on the death of a 24-year-old man “caught the attention of the movement of vaccine opponents”. The article tells the story of George Watts, Jr. of Elmira, NY, who died a month after his second shot of the Covid vaccine. The medical examiner in nearby Binghamton, NY discovered Watts’ heart muscle, the myocardium, was losing some of its strength and sagging. After examination under a microscope, parts of the heart were inflamed. These symptoms are indications of myocarditis. The article went on to say myocarditis is a slight risk of the mRNA vaccines, but doctors conclude the benefits of the serums outweigh the risks.
Additionally, according to the Times, “There were 224 verified cases of myocarditis among vaccinated children and young adults in the United States from late 2020 to mid-2022, out of the nearly seven million vaccine doses that were administered, according to one study.” And, according to the article, deaths from myocarditis due to the Covid vaccine worldwide are “extremely rare” among the millions of people who’ve been vaccinate. However, the Times does point out the Centers for Disease Control (CDC) changed its guidelines increasing the amount of time males, 12-39 years old should wait between their first and second vaccine dose. The agency increased the time between shots from 3 to 4 weeks to 8 weeks.
NY Times Makes the Story Political
The Times claims after the death of George Watts Jr., anti-vaxxers picked up his story and made it political because the medical examiner blamed the death on the Covid vaccine. According to the article, “Noticing that George Jr.’s story could yield some political influence, a collection of anti-vaccine influencers sought out the Watts family, introducing them to large platforms and even larger goals.” This was especially after George’s father posted the pain of his loss on Facebook. The social media platform then limited how much George Sr. could post. Not an uncommon dynamic, blatant censorship TrialSite reported on frequently.
Other groups came into the picture including Children’s Health Defense, the group founded by Robert F. Kennedy, Jr. (now an independent presidential candidate growing in popularity) Doctors also came out in support of the vaccine saying the medical examiner may have jumped to a conclusion blaming the death on the Covid jab.
What the article seems to ignore and what has been bought into light is the relationship between Big Pharma and government regulatory agencies like the CDC and the National Institutes of Health (NIH). In other countries such as Germany, some groups suspect Covid vaccination deaths have been under counted.
The Times article also ignores groups like the aforementioned React-19, a science-based support group for people who’ve suffered from long term effects of the Covid vaccine.
However, a report is being prepared by the CDC on the death of George Watts, Jr. If the agency agrees with the medical examiner’s report that the cause of death was Covid vaccine myocarditis, it would be a first for the CDC. But, given the relationship between the current White House which bet the house on these vaccines, Big Pharma and the government agency the outcome of the report may not satisfy anyone. Broader state-agency-industry entanglements become larger, more complex and influential.
But a larger question, however, centers on the reality that legitimate reports of myocarditis and vaccine injury have been available since the beginning of the mass countermeasure response to the pandemic. Where has The New York Times been with their reporting? Can they even be considered a legitimate news organization after Covid?
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Study looks at association between vitamin C consumption and duration, severity of the common cold
In a study recently published in BMC Public Health, researchers conducted a meta-analysis looking at trials linking vitamin C supplementation and common cold severity and duration.
The use of antibiotics to treat a common cold is common, but futile, as almost all colds are caused by viruses. Yet, results from surveys carried out in the USA found that about half of all common cold patients received antibiotics. Overuse of antibiotics contributes to antibiotic resistance, a significant concern. Given this, alternative treatment options for the common cold have substantial public health relevance. Vitamin C, which has various effects on the immune system, is one such alternative.
The common cold has been associated with temporarily lowered levels of vitamin C levels in the urine, plasma, and leucocytes of infected people.
Despite compelling evidence from randomized control trials and meta-analyses that vitamin C supplementation can reduce the duration and severity of colds, disproportionately influential publications (some of which were subsequently retracted) led to a persistent belief that it is not beneficial.
For the current study, researchers compared the effect of vitamin C on mild symptom duration versus severe symptom duration across trials that reported both effects. The two outcomes of focus were (1) common cold severity in terms of symptoms, duration of severe symptoms, and days spent indoors or absent from work and (2) how long the cold lasted overall.
Trials were included in the analysis if they were placebo-controlled, and a minimum of 1g of vitamin C per day was orally administered over the study period to people who were healthy at baseline.
These criteria allowed researchers to examine how regular supplementation would affect the colds that occurred during the study. The minimum dose was determined by previous findings that indicated a dose-response relationship in that range.
The researchers identified fifteen comparisons from 10 trials which reported both mild and severe symptoms. All trials were randomized and double-blind.
Results indicated that vitamin C supplementation reduced days absent from school (for students) and confined at home by 15%. The groups receiving the supplement also showed decreased common cold severity by 13%.
Across all 15 comparisons, the pooled effect of 1g or more of vitamin C was 15%, indicating a significant reduction in severity.
In terms of the duration of severe symptoms, the analysis found a reduction of 26% as compared to no significant effect of vitamin C supplementation on mild symptoms. There were some indications that effects could be stronger for males compared to females.
The findings strengthen existing evidence of the efficacy of vitamin C in reducing the symptoms of the common cold, particularly in people with severe symptoms. Further research on the therapeutic effects of vitamin C on the common cold should measure outcomes of differing levels of severity, the authors conclude.
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24 December, 2023
COVID-19 Vaccines Can Potentially Worsen Cancer: Review
COVID-19 vaccines can trigger genetic changes in cancer patients that could aid in the further development of the disease in such individuals, according to a recent peer-reviewed analysis.
The review, published in the Cureus medical journal on Dec. 17, looked at the relationship between COVID-19 vaccines and cancer. A review of multiple studies led the authors to conclude that certain COVID-19 vaccines may create an environment that predisposes some cancer patients, including survivors, to “cancer progression, recurrence, and/or metastasis.”
The conclusion was based on two factors. First is the “multi-hit hypothesis” of cancer, which suggests that cancer is the consequence of several genetic mutations.
The second is the “growing evidence and safety reports” in the Vaccine Adverse Effects Report System (VAERS), which suggested that some cancer patients who took COVID-19 vaccines saw their conditions worsen.
“In light of the above and because some of these concerns also apply to cancer patients infected with SARS-CoV-2, we encourage the scientific and medical community to urgently evaluate the impact of both COVID-19 and COVID-19 vaccination on cancer biology and tumor registries, adjusting public health recommendations accordingly,” the review said.
The review focused on mRNA vaccines, Pfizer/BioNTech and Moderna, and adenovirus-vectorized vaccines, Johnson & Johnson and Oxford/AstraZeneca, as these products were most widely used in global COVID-19 vaccination campaigns.
mRNA vaccines have the potential to trigger a set of biological mechanisms that could lead to the progression of cancer, it said.
These effects are attributed to factors like the “pro-inflammatory action” of lipid nanoparticles (LNPs) and tumor-causing effects of the vaccines’ antigens, namely the spike protein.
LNPs are nanoparticle drug delivery systems that can be used to deliver DNA and mRNA into a body. The spike protein, found on the surface of the COVID-19 virus, facilitates the entry of the virus into healthy cells.
The authors who wrote the review are Raquel Valdes Angues from the Oregon Health and Science University School of Medicine in Portland and Yolanda Perea Bustos from the education department in the Government of Catalonia, Barcelona, Spain. They declared “no financial support” from organizations that might have an interest in their work and no other relationships or activities that could have influenced the review.
The analysis outlined several genetic effects that COVID-19 vaccines could have on cancer cells and thereby potentially negatively impact the lives of patients suffering from the illness.
Lymphopenia
The review noted that COVID-19 vaccination has been associated with lymphopenia—a condition in which there is an abnormally low count of lymphocytes, a type of white blood cell that helps the immune system fight against foreign bacteria and viruses.
Clinical trials of the Pfizer and AstraZeneca vaccine described a “decrease in plasma lymphocytes 6-8 days post-vaccination in 45 percent-46 percent of participants.”
“Lymphopenia has long been associated with increased cancer incidence and risk of malignancy,” said the review. “Lymphocyte alterations are frequent in patients with cancer and strongly impact prognosis and survival.”
Given that lymphopenia contributes to creating an environment favorable to the progression of cancer, “extreme caution” must be observed when recommending COVID-19 to cancer patients—“especially those undergoing anticancer treatment.”
Spike Proteins
The spike protein present in COVID-19 coronaviruses has two key functional subunits—S1 and S2. S1 helps the virus in infecting human cells and has been found to affect the mechanism of cell growth.
Meanwhile, the spike protein has been shown to influence a mechanism that regulates several key cellular behaviors, specifically inflammatory responses and cellular growth. When activated in cancer cells, this specific mechanism promotes chemoresistance and proliferation. In a tumor microenvironment, it stimulates immune suppression.
As COVID-19 vaccines introduce spike proteins into the body, “it is hence imperative to monitor the mid-and long-term consequences” of such vaccination, the review stated.
Compromising Immunity
Researchers suggested that mRNA vaccines are “designed to deactivate” an individual’s innate immunity.
The innate immune system of mammals is stimulated through the activation of a class of proteins called Toll-like receptors (TLRs). TLRs are known to trigger several signaling pathways for the production of various cytokines that play an important role in many diseases, including cancer.
The signaling pathways involve IFN regulatory factors (IRFs) critical in several aspects of immune response. The review cited research showing that Pfizer COVID-19 vaccines “significantly decreased” the production of type I IFN and type II IFN.
TLRs are not only expressed in immune cells but also in tumor cells, in which they can either promote or inhibit malignancy. Type I IFN has also been found to be important in controlling the growth of tumors and in the response to anti-tumor therapies.
The review notes that the “exceedingly complicated” role of TLR and type I IFN responses in tumor biology “prompt caution” when using synthetic mRNAs for therapeutic applications.
Inflammatory
The lipid nanoparticles (LNP) used in the mRNA vaccines have been found to be “highly inflammatory” in mice, the review said, citing a report.
Injection of LNPs led to “rapid and robust activation of diverse inflammatory pathways” as well as the production of various inflammatory cytokines and chemokines in the mice. Cytokines and chemokines regulate responses to injuries and infections.
In the context of cancer, inflammation is conducive to the development of the disease and promotes all stages of tumorigenesis—the initial formation of a tumor in an individual.
“Around 15 percent-20 percent of all cancer cases are preceded by infection, chronic inflammation, or autoimmunity at the same tissue or organ site,” the review stated. “In such cases, cancer-promoting inflammation is induced and exists long before tumor formation.”
Such extrinsic inflammation—referring to inflammation caused by outside sources—can result in immunosuppression, where the immune system becomes temporarily dysfunctional. This immunosuppression can provide the environment for the development of tumors.
“Given that LNPs often accumulate in tumors, due to enhanced permeability and retention effect (EPR), protecting cancer cells from transformation-related stress stimuli, including inflammation …. is of paramount importance,” the authors wrote.
Genomic Integration
The review highlighted a study discussing the possibility that certain parts of the COVID-19 virus might undergo “genomic integration within infected cells.”
The study found copies of the virus in human cells and speculated that the same phenomenon could occur once human cells are exposed to COVID-19 mRNA vaccines.
Another study found that a “retrotransposon” called long interspersed nuclear element-1 (LINE-1) was affected following cellular exposure to the Pfizer COVID-19 mRNA vaccine. Retrotransposons are genetic elements that replicate and integrate the DNA into new sites in a genome.
The review speculated that the mRNA vaccine’s impact on LINE-1 might “enhance the risk of mutations in tumor suppressor genes and lead to sustained DNA damage in cells and tissues targeted by the vaccine.”
The researchers insisted that there is a “pressing need for clarity on the potential COVID-19- and COVID-19 vaccine-induced activation of LINE-1 and its repercussions in cancerous and/or precancerous cells with intrinsic high levels of LINE-1 expression.”
Tumor Suppression
An October 2020 study showed that the S2 subunit of the COVID-19 virus “strongly interacts” with tumor suppressor proteins p53 and BRCA1/2, said the review.
Proteins like p53 and BRCA1/2 act as a “major barrier” to tumor progression. The possibility that the virus’ spike protein can interact with tumor suppressor protein is critical since both mRNA and adenovirus-vectorized vaccine contain the “genetic material that instructs the host cells to express spike.”
Studies on the Pfizer vaccine have shown that it accumulates in various organs within 48 hours of vaccination. In addition, lipid nanoparticles “preferentially accumulate” in the tumor tissue rather than the healthy tissue.
Given these findings, the review suggested a detailed look into the potential interactions between S2 and tumor suppressor proteins p53 and BRCA1/2 in both COVID-19 patients and those who have received COVID-19 vaccination.
Such an analysis is necessary to determine if the interactions provide a “selective advantage” for cancer or precancerous cells, the researchers wrote.
Mutations to TP53, the gene that provides instructions for making p53, can lead to cancers of the breast, bone, soft tissue, and brain. Less frequent cancers include stomach cancer, leukemia, and colorectal cancer. Impaired BRCA1 activity is associated with cancers of the breast, ovaries, uterus, and prostate.
‘Dubious’ Vaccination Benefits
The researchers noted that they have shown COVID-19 spike protein-based vaccines to “have the potential to interact with tumor suppressor proteins, promote inflammation, activate oncogenic pathways, and disrupt the fine-tuning of the immune response.”
“These dysregulated mechanisms and signaling pathways underlie most types of cancer.” A more “balanced risk/benefit evaluation is urgently needed” regarding COVID-19 vaccination and people with or at high risk of cancer.
For people with poor immune responses, “the benefits of vaccination are dubious, and the cumulative risks of successive boosters are unknown.”
An area of concern is that the co-administration of anticancer treatments and COVID-19 vaccines could pave the way for “toxic effects.” The review cited an article that found that when cancer patients were given Pfizer’s COVID-19 vaccine, there was a “constant and variable increase of all COVID-19 vaccination side effects.”
“There is thus a concern that the simultaneous use of immunotherapy and COVID-19 vaccines boosts the body’s immune response, resulting in enhanced immune-related adverse events,” the researchers wrote.
The review stated that between Jan. 7, 2018, and July 2, 2022, there were approximately 13,000 cancer deaths per week in the United States, with peaks occurring in January 2021 and January 2022. While public health agencies have admitted a rise in cancer deaths, they have mostly attributed the excess deaths to the COVID-19 infection.
Even though cancer mortality peaks in 2021 and 2022 correlate with COVID-19 winter surges, “they also follow two major COVID-19 vaccination and booster campaigns,” the researchers pointed out.
“As noted earlier, both SARS-CoV-2 and SARS-CoV-2 spike protein-based vaccines promote the production of spike within human cells, which, in light of the above, might facilitate malignant transformation.”
The authors noted that even though many institutions and experts promote COVID-19 vaccines as safe and effective in patients with cancer, “these claims are unsupported.”
“Our suggestion is that individuals with cancer or a history of cancer should receive the genetic COVID-19 vaccines only if the benefits clearly outweigh any risks and after careful evaluation case by case,” said the review.
“Most importantly, there is the possibility that cancer risk is dose-dependent.” As such, only individuals who have taken multiple COVID-19 immunizations may be at higher risk of cancer malignancy.
“The success of the novel mRNA-based vaccines against COVID-19 has created a widespread interest in mRNA technology as a solution to some of the deadliest infectious diseases (i.e., malaria, tuberculosis, and HIV/AIDS) for which an effective and easily deployable vaccine is urgently needed,” the authors wrote.
However, “current safety concerns should be promptly addressed before mRNA-based nanomedicines further transform the way diseases are managed and prevented in the future.”
https://www.theepochtimes.com/health/covid-19-vaccines-can-potentially-worsen-cancer-review-5552341
********************************************************21 December, 2023
Is this the smoking gun for the Covid lab leak? Blueprint for creating a 'SARS-CoV' virus with an altered spike protein in Wuhan was published in 2018, bombshell new records show
A newly-uncovered trove of documents detailing plans to create a Covid-like virus in China months before the pandemic make the 'lab leak almost certain', experts say.
The records - obtained now by FOIA requests - lay out a plan to 'engineer spike proteins' to infect human cells that would then be 'inserted into SARS-Covid backbones' at the infamous Wuhan virology lab from December 2018.
Just a year later, in late 2019, the Covid-19 virus emerged with a uniquely adept ability to infect humans, going on to cause a global pandemic.
The proposal was made by the now-notorious EcoHealth Alliance, a New York nonprofit that channels US government grants abroad to fund these types of experiments.
Ultimately, the application was denied by the US Department of Defense, but critics say the plans laid out in the proposal serve as a 'blueprint' for how to create Covid, and inadvertently start a pandemic.
The documents also show how EcoHealth deliberately tried to mislead the Pentagon on how risky the experiments were to secure funding.
Sen Rand Paul - who has been a vocal supporter of the lab leak theory - added the documents further support of the 'deception' used by players tied to the Wuhan lab.
Matt Ridley, a biologist and science writer who has written extensively about the potential lab leak in the past, said: 'This latest [document] leak makes the case for a lab leak almost certain.
'A reckless experiment, known at the time to be reckless, probably caused the death of millions of people. 'Scientists and the media conspired to conceal the evidence. Let that sink in.'
The documents were obtained by nonprofit public health research group US Right to Know, which has previously been accused of fueling anti-vaccine sentiments.
The grant proposal was entitled Project DEFUSE: Defusing the Threat of Bat-borne Coronaviruses.
It proposed engineering high-risk coronaviruses of the same species as the original SARS to preempt a human spillover and develop vaccine technology and strategies.
The team sought to synthesize spike proteins with furin cleavage sites that had been designed to bind to human receptors more easily.
The furin has been one of the focal points of debate about Covid-19's origin, with some experts claiming it could only have been acquired through lab experiments.
The grant then proposed attaching the furin to coronavirus strains and infecting mice to see how ill it would make them.
The plan was then to use drugs and vaccines to treat the disease.
Dr Richard Ebright, a chemical biologist at Rutgers University in New Jersey, told DailyMail.com: 'These revelations are important because the experiments in the grant proposal likely - indeed highly likely - led to the creation and release of SARS-CoV-2.'
The grant proposal has raised concerns and some say it serves as further support of the Covid lab leak theory - that the virus was borne out of gain-of-function research bankrolled by the US taxpayer through Dr Anthony Fauci's former department, a theory the FBI and other government agencies now subscribe to.
The principal investigator on the project is listed as Peter Daszak, president of EcoHealth, a now-notorious health agency that uses US government money to sponsor there's types of experiments abroad.
Other team members listed on the proposal include researchers from Duke-NUS Medical School, University of North Carolina, the USGS National Wildlife Health Center, Palo Alto Research Center and the Wuhan Institute of Virology, the lab where Covid is believed to have originated from.
The proposal listed Professor Shi Zhengli - been dubbed the 'bat lady' for her extensive work on bat coronaviruses at the WIV - as the lead on the project in Wuhan.
Additionally, Dr Ralph Baric was listed as a subcontractor on the project. Dr Baric is a known expert in making recombinant coronaviruses.
The documents show the experiments were proposed to take place at the WIV, which has fewer safety precautions for working with pandemic-potential specimens than the US, which was advertised to the DoD as cost-saving.
The American scientists concealed the lack of safety precautions from DARP in order to avoid national security concerns about conducting high-level biosafety research in China.
In initial proposals for DEFUSE, the lab work was to be done in a biosafety-level 2 lab, which researchers said would appeal to DARPA grant-makers as 'highly cost effective' despite the fewer safety precautions taken in lower-level labs
Dr Baric acknowledged in an edited version of the proposal US researchers would 'freak out' if they knew novel coronavirus engineering and testing was being done in a BSL-2 lab.
Similar experiments in the US are conducted in BSL-3 labs.
A later version of the proposal changed BSL-2 to BSL-3.
Biosafety levels range from one to four, with four being the strictest and experimenting on the most dangerous pathogens.
Dr Baric wrote: 'In the US, these recombinant SARS-CoV are studied under BSL3, not BSL2, especially important for those that are able to bind and replicate in primary human cells.'
BSL-2 labs feature ventilated safety cabinets and researchers must wear surgical masks and lab coats. Experts say pathogen with the possibility of being transmitted through the air should be, at a minimum, performed in a BSL-3 lab, which has researchers in more protective respirators.
Dr Ebright told DailyMail.com: 'The new documents reveal that EcoHealth Alliance planned to use US Department of Defense funds to perform high-risk virus experiments at WIV at a biosafety level that was inadequate for research with a potential pandemic pathogen.'
He added: 'The new documents also reveal that EcoHealth Alliance deliberately concealed these plans - both the plan to perform high-risk experiments at WIV and the plan to perform them using inadequate biosafety protections - from the US Department of Defense in order to improve the chances of receiving funding.'
Dr Ebright tweeted: 'At this point, there is sufficient evidence to conclude, beyond reasonable doubt, that SARS-CoV-2 entered humans through a lab accident.'
While people who believed and promoted the lab-leak origin were initially accused of being xenophobic and pushing a conspiracy theory, the FBI and several other governmental agencies ascribe to this theory.
The formal DEFUSE grant proposal states the engineering of the coronavirus spike protein would be carried out by Dr Baric in North Carolina.
However, in an earlier comment on the proposal, Daszak said WIV will actually be doing most of the work but this fact was left out of the proposal to make DARPA more 'comfortable' with the details.
Dazsak said in an email: 'If we win this contract, I do not propose that all of this work will necessarily be conducted by Ralph, but I do want to stress the US side of this proposal so that DARPA are comfortable with our team.
'Once we get the funds, we can then allocate who does what exact work, and I believe that a lot of these assays can be done in Wuhan as well.'
In another comment, however, Daszak reiterates his desire to stress the US-focus of the project.
He wrote: 'I am planning to use my resume and Ralph's [Baric]. Linfa/Zhengli, I realize your resumes are also very impressive, but I’m trying to downplay the non-US focus of this proposal so that DARPA doesn’t see this as a negative.'
In a statement Tuesday, EHA called the documents ' incomplete' and said the 'allegations are false based on misunderstanding of edits and comments on the document, and based on misleading out-of-context quotations and a lack of understanding the process by which federal grants are awarded.'
Justin Goodman, president of The White Coat Waste Project, a watchdog group fighting to stop sending American tax dollars overseas to fund dangerous virus research, told DailyMail.com the documents prove US tax dollars have 'footed the bill for the shady EcoHealth Alliance and their comrades at the reckless Wuhan lab to supercharge coronaviruses in dangerous gain-of-function experiments.'
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High Incidence of Long COVID in Africa, but NOT Among Black Ethnic Groups
Although the continent of Africa was spared much of the fatality rates experienced by other continents, a recent comprehensive review of previous studies and analysis tracking a total of 29,213 people, about 50% of the COVID-19 cases in Africa involves residual long COVID cases. A substantially higher number than in America, for example, which is about 10%, but some studies show higher. With improved ability to track long COVID, this review of the evidence suggests long COVID represents a far bigger problem than previously understood.
Does long COVID emerge as a far bigger problem in the African continent than elsewhere? While estimates of long COVID varied from 2% in Ghana to 86% in Egypt, the most recent study Prevalence and risk factors for long COVID and post-COVID-19 condition in Africa: a systematic review - The Lancet Global Health published in The Lancet Global Health reports the incidence of COVID-19 is in fact, underestimated. With 12 million documented cases and likely, many more un-documented cases, the German and Africa-based study team looks into the evidence on prevalence, associated risk factors for long COVID, and systemic or sociocultural determinants of reporting long COVID.
The Study
Conducting a systematic review incorporating data from PubMed, the Living Overview of Evidence platform, and grey literature sources for publications from Dec 1, 2019, to Nov 23, 2022, the authors included articles published in English, French, Spanish, or Portuguese that reported on any study type in Africa with participants of any age who had symptoms for 4 weeks or more after an acute SARS-CoV-2 infection.
The authors excluded secondary research, comments, and correspondence. The study protocol called for two reviewers to both screen and extract data. Extracting summary estimates, such as sociodemographic factors, medical history, prevalence of persistent symptoms, and symptoms and associated factors, the authors performed a descriptive analysis registering the whole investigation on the results which were analyzed descriptively. The study was registered on the Open Science Framework platform.
Findings
Out of 294 articles, (including 24 peer-reviewed manuscripts) the fully vetted patient count equaled 9712 patients from eight African countries.
Out of the entire set of studies, one investigation focused exclusively on children, and one other study included children as part of their study population.
The authors report a low risk of bias associated with the selected studies. The findings suggest an extremely low prevalence of long COVID in the West African nation of Ghana (2%) to extremely high incidence in the northern African nation of Egypt (86%).
What are some indicators of a higher frequency of Long COVID?
Female sex
Age
Non-Black ethnicity
Low level of education
Severity of COVID-19 infection
Underlying Co-morbidity
Interestingly, HIV and tuberculosis were not pegged as factors.
Importantly, other studies have also demonstrated the lack of COVID-19 incidence in sub-Saharan Africa, a fascinating ongoing observation further validated in this study. No one can be certain why, but explanations range from the younger average age in sub-Saharan Africa to different microbiome dynamics to mass exposure to ivermectin at least in some countries (part of anti-parasitic regimen program).
To broaden African observations in this study, the factors influencing reporting included absence of awareness, inadequate clinical data and diagnostics, and little access to health-care service.
Regardless, this study advances the collective knowledge somewhat as to long COVID and the African continent.
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20 December, 2023
Uncovering COVID-19 Origins: Why Congress Must Breach Biden’s Stonewall
Next month, the House Select Subcommittee on the Coronavirus Pandemic will interview Dr. Anthony Fauci, the former director of the National Institute of Allergy and Infectious Diseases. After two days of behind-closed-doors interviews, the subcommittee will schedule a public hearing to take his sworn testimony.
Fauci’s testimony will doubtless cover a wide variety of topics, ranging from masking to vaccine mandates. But rest assured that congressional investigators will zero in on Fauci’s knowledge of, and response to, crucial information concerning the origins of the pandemic in China.
To secure a fully transparent accounting, House and Senate investigators are also pressing the administration to release key details about what Fauci and his colleagues knew about the origin of the pandemic, and when they knew it. But Biden administration officials continue to stall the release of relevant information, offering transparently lame excuses, to block congressional access and public disclosure of unredacted documents.
Team Biden’s persistent lack of transparency on COVID-19 has been nothing short of scandalous. Here is the latest proof:
Exhibit A: Blocking Document Disclosure. In October 2017, well before the outbreak of the COVID-19 pandemic, Dr. Ping Chen, an NIAID official, visited the Wuhan Institute of Virology and prepared a trip report for top NIAID officials.
Sens. Rand Paul, R-Ky., and Ron Johnson, R-Wis., learned of the trip four years later and, in August 2021, wrote Health and Human Services Secretary Xavier Becerra and acting National Institutes of Health Director Lawrence Tabak asking them to release unredacted records of Chen’s visit to Wuhan. In response, the Department of Health and Human Services instead provided a heavily redacted copy of Chen’s report, plus redacted emails.
In a subsequent briefing for Senate staff, Dr. Melanie Egorin, HHS assistant secretary for legislation, said the redactions were for “security” reasons. But that excuse was clearly incorrect because, as the senators noted, HHS had already conceded that national security was not at issue and the documents themselves were unclassified.
As Johnson remarked, “Given HHS’s extensive redactions of unclassified documents, I can only assume that the true nature of HHS’s ‘security’ interest is to protect itself from additional embarrassment over its handling of the COVID-19 pandemic.”
Johnson has since renewed his request to interview Chen and asked for a complete and unredacted copy of her report and related documents. Thus far, no response.
Exhibit B: Flaunting Federal Records Rules. On June 11, 2021, Johnson, Paul, and three other Senate colleagues sent Becerra a letter requesting documents relating to NIH officials’ response to the pandemic’s origins.
The senators had learned that Dr. David Morens, senior scientific adviser to Fauci, had emailed Dr. Peter Daszak, president of EcoHealth Alliance, on Jan. 9, 2020, asking Daszak for any “inside info” on the novel coronavirus. Daszak replied that NIAID had been funding coronavirus research for “the past five years” and taxpayer monies had been funneled to the Wuhan Institute of Virology.
For several years, Daszak’s controversial firm had indeed gotten substantial NIAID funding; and the Wuhan Institute of Virology, which had been a center of China’s coronavirus research, had been a subcontractor of the EcoHealth Alliance.
According to Johnson’s account, upon receipt of the June 2021 letter, Morens told Daszak and a small group of his colleagues that he had retained “very few” documents on these “matters.” Morens cautioned the group to correspond with him outside of official channels at his Gmail address, adding, “I have tried to make sure I have retained no documents that might lead other members of ASTMH to be approached for similar document production.” (ASTMH stands for the “American Society of Tropical Medicine and Hygiene,” Morens’ little group).
Among those receiving this Gmail warning were three prominent virologists, Dr. Kristian Andersen, Dr. Robert Garry and Dr. Edward Holmes, who had published a prominent 2020 article in Nature Medicine arguing that a COVID-19 lab origin was “improbable.” That article was a sharp and rapid reversal of their original assessment of an “unnatural” origin of the coronavirus.
When Johnson learned in August 2023 that Morens was apparently using his personal Gmail in communications concerning COVID-19 origins, he wrote Christi Grimm, HHS inspector general, asking her to investigate the apparent attempt to use to evade requests for public information under the Freedom of Information Act.
Johnson also told Grimm that an unnamed whistleblower claimed that NIH officials may have destroyed sensitive federal records related to the Wuhan Institute of Virology, a serious criminal offense with severe penalties.
For their part, NIH officials claimed they conducted an internal investigation of that allegation, and determined to their own satisfaction that the charge was without merit. Satisfied that there was nothing more to it, the National Archives and Records Administration, the agency charged with the preservation of official records, also dropped its inquiry into the matter.
Remarkably, Grimm rejected Johnson’s request for a Senate staff briefing on the controversy, claiming that it is standard practice to “neither confirm nor deny” the existence of ongoing investigations.
Johnson nonetheless renewed his request that Grimm investigate Morens’ use of Gmail to conduct agency business, the alleged NIH destruction of official agency records, and any effort by Morens or and others to evade the Freedom of Information Act. But she denied the request once again.
In a Nov. 15, 2023, letter to Becerra, recounting the foregoing facts, Johnson tried again:
I request you immediately provide complete responses to my June 2021 and March 2023 letters on the origins of Covid-19—including responsive records contained in Dr. Morens’ Gmail account—produce all text messages or communications contained in Dr. Morens’ HHS-issued cell phones(s) dated from June 1, 2019 – present, and provide a detailed explanation for how HHS will hold Dr. Morens accountable for his apparent mishandling of federal records and potential violations of federal record keeping laws. I also request that HHS make Dr. Morens available for an interview with my Subcommittee staff. Please provide this information and interview by no later than December 6, 2023.
Thus far, no response.
Closing In. Johnson and his colleagues do not have subpoena power. As he told this writer, “I am attempting to convince Chairman Blumenthal to issue subpoenas to the non-responsive agencies. If that proves unsuccessful, you can rest assured that, if I become Chairman of the Permanent Subcommittee on Investigations, subpoenas will be issued and enforced.”
House Republicans do, however, have subpoena power. When Fauci testifies early next year before the House Select Subcommittee on the Coronavirus Pandemic, congressional investigators should probe his recollections concerning Chen’s report and Morens’ intriguing communications.
During his November 2022 deposition in the federal case of Missouri vs Biden, Fauci said he could not recall 174 times in response to questions related to the COVID-19 pandemic. House investigators will thus have an excellent opportunity to refresh his memory on what he learned about the origins of the deadly disease, when he learned it, and how he responded.
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The Omicron Family Gets Bigger: Characteristics of New Dominant Subvariant HV.1
According to the Centers for Disease Control and Prevention (CDC), the second half of the November 2023 data demonstrates that the HV.1 subvariant of the SARS-CoV-2 virus comprises 31.7% of all cases in the U.S. This makes it the new dominant subvariant circulating since mid-August. TrialSite previously discussed characteristics of the Eris (EG.5) subvariant which was dominant during the 2023 summer period. The Omicron family in general is highly transmissible, and HV.1 is no exception which makes it a concern for public health. In this article, we will discuss the characteristics of HV.1.
Since the advent of the COVID-19 pandemic, virologists have been on the lookout for new variants of SARS-CoV-2 that might cause concern because of their transmissibility and severity. In this lookout, Omicron was one of the difficult opponents since it spreads so fast. Luckily, the symptoms of Omicron variants tended to be mild including runny nose, sore throat and other cold-like symptoms.
Omicron emerged in November 2021 and took over the Delta variant which was previously dominant. The initial version of the Omicron variant is called BA.1. This was followed by other subvariants – BQ.1, BQ.1.1 and XBB. All of these mutations make it more difficult for our immune systems to recognize and fight the virus. However, this does not mean that these mutations will always cause a more severe disease.
Characteristics of HV.1
HV.1 is a lineage of the Omicron variant of SARS-CoV-2. It evolved from EG.5 (and previously XBB.1.5) and its characteristics are very similar to other Omicron strains. This means that it spreads fast but does not cause severe illness.
Infectious disease professor at Vanderbilt University Medical Center, William Schaffner, M.D. stated that while HV.1 may be more transmissible, it does not appear to cause more severe disease or hospitalizations. “I don’t think people should be very concerned about this,” he said. On the other hand, Schaffner also warns about the possible increase of cases in winter, as was the case for the past three years.
The symptoms of the HV.1 are not different from classical COVID-19 symptoms, including fever, cough, fatigue and sore throat. No new or alarming symptoms have been observed with the emergence of HV.1. The severity of these symptoms can vary depending on an individual's immunity and vaccination status. Additionally, while these symptoms are mostly mild, they can be dangerous for immunocompromised individuals.
Unlike its family members, HV.1 still does not have a catchy nickname, so all the sources still use the scientific Pango name. Healthcare professionals continue to investigate this new variant, and fortunately, most diagnostic tests currently in use can still reliably diagnose the various strains of the SARS-CoV-2 virus.
Will vaccines work for these new variants?
Mutations that cause HV.1 allow it to infect people with previous immunity to the SARS-CoV-2 virus more easily. Therefore, it is an important concern if the vaccines and other preventive and therapeutic measures can keep up with these new subvariants.
Moderna announced in August 2023 that its updated COVID-19 vaccine will target the expected circulating variants of COVID-19. The president of Moderna, Stephen Hoge, M.D., specifically claimed that the new results from the clinical trial data of the updated COVID-19 vaccine illustrated a robust immune response against the XBB strains including the EG.5 subvariant.
Pfizer also created a version of its shots to target the XBB strain, and Reuters mentioned that it showed effectiveness against EG.5 in a mice study.
Although they did not specifically state HV.1, since it is from the same family as XBB, one can assume that updated vaccines are expected to be effective against this new dominant subvariant.
Matthew J. Binnicker, Ph.D., who studies viral infections and is a Director of Clinical Virology at Mayo Clinic, emphasized that along with the updated vaccines, antiviral treatments such as Paxlovid can still work for the HV.1.
A new omicron sub-variant to look out for JN.1 has some concerning attributes. According to the Centers for Disease Control and Prevention (CDC) this variant is the second most predominant one in the United States.
What to expect from future variants
According to a Euronews Next article, Dr. Maria Van Kerkhove, an infectious disease epidemiologist and COVID-19 Technical Lead at the World Health Organization (WHO), emphasized that people have moved on from COVID-19 but the virus is still circulating. She stated that it continues to cause deaths and we need to keep up with it.
To understand and anticipate the future variants of SARS-CoV-2, researchers used molecular dynamics simulations. Investigating the molecular dynamics of mutations helps scientists understand how the virus creates advantages for itself to evolve.
A Think Global Health article envisioned that it is almost impossible to predict the behavior of a new variant before it comes up. But the worst-case scenario is the possibility of a “deltacron” variant which is a combination of the Delta variant’s severity and the Omicron variant’s transmissibility. This might be the scenario in which a greater death rate occurs but luckily, it seems unlikely to evolve. For now, the dominant variant HV.1 does not seem harmful in terms of creating a deadly disease but is still contagious enough to not be ignored.
TrialSite will continue to investigate newly appeared variants and their characteristics.
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19 December, 2023
FDA Inspects Moderna Main COVID-19 Vax Manufacturing Facility—Finds Numerous Quality Breaches—Issues 483 Warning Letter, Yet Not Disclosed Publicly
A recent Reuters-sponsored Freedom of Information Act (FOIA) request turned up information about Moderna production problems. Specifically, the Food and Drug Administration (FDA) in an inspection discovered serious quality control lapses at the mRNA biotech company’s main production site, including issues associated with the manufacturing of the COVID-19 vaccine known as mRNA-1273 or Spikevax. Interestingly, the inspection occurred back in September, yet to date, the FDA still has not shared the warning letter publicly. See the database. Could this finding in any way tie into DNA fragments found in samples?
Apparently, the FDA inspection was conducted between Sept. 11-21 at the Norwood, Massachusetts production site, used to manufacture both the Spikevax COVID-19 vaccine plus the investigational mRNA cancer regimen currently under development, part of a partnership with Merck, reports Patrick Wingrove.
But Moderna shared that this particular FDA inspection was routine, ensuring that any observations were not implications for product quality or safety concerns.
They said all products released by the company were tested and met product specifications and international regulatory requirements.
What did the FDA find in the inspection?
According to the Reuters entry, the FDA inspectors cited five distinct observations including the company’s failure to verify cleaning tests concerning production equipment used to make the COVID-19 vaccine.
Additionally, the regulatory agency, according to Reuters found that Moderna lacked the appropriate quality control (policies, procedures, processes and systems) at the Norwood site to offer assurance that expired materials would not be used to make vaccines, nor that airborne contaminants did not make it into any products.
According to the report by Patrick Wingrove, the FDA report found 2,000 expired items in the company’s warehouse, plus cold storage not contained in a separate or defined location from other materials.
Another indicator of slipping quality were materials put to use beyond the appropriate expiration date.
No disclosure as to risk to the public
Not known at this point is whether the batches under scrutiny made their way to the public. The agency declined to comment to Reuters. Why did Reuters have to issue a FOIA? Why hasn’t the FDA shared the 483 letters with the public as typically done?
Moderna in a statement said: "Upon receipt of the FDA’s findings, Moderna immediately and comprehensively updated the specific procedures identified and is confident that the actions taken will be satisfactory to regulators."
No Evidence of Harm, But No Evidence of Not Harm Either
Reuters reported no evidence that the quality lapses leading to the FDA observations (writer up in Form 483 letter) led to any consumer harm associated with the COVID-19 mRNA vaccines. On the other hand, they didn’t provide evidence that they have not caused problems.
Favoring a Moderna interpretation is the fact that at least thus far, there have been no FDA-issued recalls of Moderna vaccines.
Expert Commentary
Wingrove spoke with Steven Lynn, a former head of the FDA's Office of Manufacturing and Product Quality who is now a regulatory compliance consultant. He reported that the use of the drug substance in question represented a serious matter but again, it hasn’t been disclosed by the regulatory if any of the output made its way to the market.
“At face value, it appears multiple controls designed to prevent contamination were deficient,” said Lynn.
Japanese Problems
The Reuters piece reminded the reader of problems with Moderna’s quality in Japan in 2021. In that Asian nation, regulators suspended the use of 1.63 million doses of the mRNA vaccine after contaminates were found in some vials produced by a Spanish contract manufacturer called Rovi.
TrialSite has reported on anomalies with Moderna involving its communications around their key vaccine. See TrialSite’s “Moderna--Questions Regarding the Company’s Next Generation mRNA Vaccine.” This media has also questioned the true value, at least in the short to intermediate run, of the company’s pipeline. Other potential issues may present soon, concerning the dependence on one commercial product (the vaccine). The government primed the pump of demand during the pandemic. But COVID-19 national emergency status is over.
In financial disclosures as recently as 2020, the company acknowledged it had no commercial manufacturing experience, and in many ways, like Pfizer, was building the airplane while flying.
Not surprisingly, Moderna went on the record: the COVID-19 vaccines are safe and effective. Yet given the enormous cash infusion into the company thanks to the COVID-19 mandates and government support why have the quality conditions become lax enough for several observations? This finding and the lack of transparency could be indicative of more challenges ahead.
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New Study Confirms CDC and Other ‘Experts’ Hurt Children for Nothing
There have clearly been many, MANY aspects of our COVID response that were and remain inexcusable.
Vaccine passports and mandates, the nonsensical curfews and capacity limits, general mask mandates, and of course, closing beaches, should never been forgotten.
But few, if any of our pointless, ineffective COVID-era restrictions were as indefensible as child masking. And thanks to the awe-inspiring incompetence of the CDC and Dr. Anthony Fauci, the United States was a global outlier; obsessively dedicated to forcing toddlers as young as 2-years-old to wear masks.
Schools, youth programs, camps, on airplanes... anywhere children gathered, they were forcibly masked. Horrifying videos emerged of teachers or flight attendants putting masks on crying children.
Calls to mask children in schools have disturbingly continued into late 2023 in certain parts of the country.
But new research has confirmed what was obvious to anyone who studied the data and evidence over the past few years: it was all for nothing.
Child Masking Is Ineffective, New Study Finds
“Trust the science,” “Follow the data,” “Listen to the experts.”
Starting in 2020, those phrases became a relentless mantra of an oppressive government/pharma/media playbook. Instead of examining the actual evidence, data, and pre-COVID consensus, politicians, administrators, and huge swaths of the public put their faith and trust in a few unreliable, self-interested individuals. And with disastrous results.
Following the actual evidence would, in theory, have meant using evidence-based methods as espoused by experts in that field, such as Carl Heneghan from Oxford University. Primarily, that means using a hierarchy of studies, based on quality, to create systematic reviews of well-conducted research.
Instead, we were fed the CDC’s reporting of non-statistically significant results based on phone surveys, and we watched as those results were included in pro-masking reviews designed to promote an ineffective policy.
But a new systematic review from Tracy Beth Høeg and a number of other researchers has just been released on mask mandates for children. And unlike the pro-mask propaganda, it actually attempts to use high-quality evidence to come to its conclusion.
“Background Mask mandates for children during the Covid-19 pandemic varied in different locations. A risk-benefit analysis of this intervention has not yet been performed. In this study, we performed a systematic review to assess research on the effectiveness of mask wearing in children.”
They even used independent reviewers to ensure that there was no bias involved in the study selection criteria.
“Methods We performed database searches up to February 2023. The studies were screened by title and abstract, and included studies were further screened as full-text references. A risk-of-bias analysis was performed by two independent reviewers and adjudicated by a third reviewer.”
That meant that out of 597 studies screened, just 22 were included after meeting the criteria. And in a sign of how the CDC abdicated their responsibility, none were randomized controlled trials (RCT). Sure enough, when filtering out information at a risk of serious bias or confounding, there was no association between forcing kids to wear masks and infection or transmission.
“Results There were no randomised controlled trials in children assessing the benefits of mask wearing to reduce SARS-CoV-2 infection or transmission. The six observational studies reporting an association between child masking and lower infection rate or antibody seropositivity had critical (n=5) or serious (n=1) risk of bias; all six were potentially confounded by important differences between masked and unmasked groups and two were shown to have non-significant results when reanalysed. Sixteen other observational studies found no association between mask wearing and infection or transmission.”
As every intellectually honest scientist, researcher, or expert would admit, their inescapable conclusion is that the “current body of scientific data does not support masking children for protection against COVID-19.”
“Conclusions Real-world effectiveness of child mask mandates against SARS-CoV-2 transmission or infection has not been demonstrated with high-quality evidence. The current body of scientific data does not support masking children for protection against Covid-19.”
Who would have guessed?
Low-Quality Research Used to Create Low-Efficacy Policy
The details of the studies involved in this systematic review are even more damning.
Of the six observational studies that supposedly showed a benefit to masking kids, all were fatally flawed in important ways. Specifically, there were significant confounding differences between unmasked and masked children that undermine any of the reported results.
Differences included the “number of instructional school days, differences in school size, systematic baseline differences in case rates in all phases of the pandemic, testing policies, contact-tracing policy differences and teacher vaccination rates.” With differences that substantial, it’s impossible to determine whether or not the claimed reduction in infection or transmission is due to masks or one or many of those other factors.
This is why randomized controlled trials are so important. And why the CDC should have conducted them during the pandemic years. Yet at the same time, considering the results of masking RCT’s conducted on adults, it’s pretty obvious why they didn’t. Because they knew it would show that masks didn’t work.
The researchers also touched on the fact that some of the studies promoted by the CDC saw their effects vanish upon re-analysis. Specifically, one of the “observational CDC funded study” in the United States claimed to show an association between county-wide mask mandates and pediatric case counts.
Yet when subjected to “expanded reanalysis,” that association disappeared.
That initial result though is how you use low-quality studies to launder low-quality information. The CDC funds a study with what it expects are pre-determined results, the media reports the results of that study—despite being misleading, expert researchers reassess using conventional methods, and the supposed benefit disappears.
But the correction receives none of the attention of the original, because it shows a result the CDC deems unacceptable.
Even observational reporting has shown masks don’t matter at a population level for younger aged individuals. Virginia faced massive criticism for ending school mask mandates early in 2022, only to see cases collapse after a massive surge with mask mandates in place.
Similarly, cases in Philadelphia schools dropped two weeks after the mask mandate was lifted in 2022, and rose substantially for two weeks after the mask mandate in January 2023 came into effect.
As often discussed, in a sane world, this systematic review would permanently shut the door on further discussions of forced child masking. Higher quality research has confirmed that there is no evidence masks are effective and eliminating bias and confounders unsurprisingly shows the same result with children.
But sanity is dead. Therefore the current CDC director defiantly refuses to admit that masking toddlers was a mistake.
She doesn’t have to. Høeg and the other researchers who conducted this review said it for her.
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Also see my other blogs. Main ones below:
18 December, 2023
Chinese Scientists Make Inhalable Dry Powder COVID-19 Vaccine
Scientists from China have made an aerosol-based inhalable vaccine against COVID-19, which they claim provides “effective protection” against infection based on animal trials.
The study, published in the Nature journal on Dec. 13, involved researchers testing “an inhalable, single-dose, dry powder aerosol SARS-CoV-2 vaccine” that they developed. The vaccine uses nanoparticles and contains SARS-CoV-2 antigens, or substances that trigger the immune system to generate antibodies against it. Researchers designed the vaccine to target multiple COVID-19 lineages. The particles were one to four micrometers in size, optimized to be deposited in the deep lung region.
The vaccine was found to induce “strong production of IgG and IgA,” two types of antibodies. It also triggered a response from local T cells, a type of white blood cell that helps fight germs. Collectively, this conferred “effective protection” against COVID-19 among mice, hamsters, and nonhuman primates.
The study noted that while several intranasal immunization products are developing, many are largely limited to the nasal passage. In contrast, aerosol-inhaled vaccines, like the one developed by the researchers, “can penetrate deeper and wider (to major and small airways).” This can confer the vaccine's benefits even to the lower respiratory tract.
The vaccine also showed promise for “readily responding” to future co-circulation of multiple COVID-19 strains and preventing the transmission of the Omicron variant, the dominant variant under circulation in the United States.
The study noted that the current crop of COVID-19 vaccines was delivered via intramuscular injections to alleviate the infection. However, “vaccines delivered intramuscularly do not provide a first line of protection at the respiratory tract owing to deficiencies of secretory IgA and IgG.”
Several intranasal vaccines are being developed or approved to overcome this. But such vaccines “are in liquid form, necessitating cold chain transportation and storage, and generally require two or three inhaled immunizations or the use of a heterologous booster vaccination.”
These limitations “motivated” the researchers to develop “a dry powder vaccine suitable for single-dose inhalation.”
“The inhalable vaccination addresses a known public health issue, in that there is more enthusiasm for this type of administration than for traditional injection, and a single-dose regimen is favorable for substantially increasing the proportion of total completed vaccination recipients,” the study said.
“Furthermore, the dry powder form of the vaccine can provide savings in storage and transportation costs, potentially supporting increased immunization coverage to remote areas,” it stated.
Moreover, the dry powder vaccine uses a microcapsule that is based on a material already approved by the U.S. Food and Drug Administration (FDA), thus boosting the prospects of the vaccine’s “clinical translation.”
“We envision that our inhaled vaccine could serve as a promising multivalent platform for fighting COVID-19 and other respiratory infectious diseases.”
The study received funding from the National Natural Science Foundation of China, Beijing Natural Science Foundation, the CAS Project for Young Scientists in Basic Research, the National Key Research and Development Program of China, the Strategic Priority Research Program of the Chinese Academy of Sciences, CAMS Innovation Fund for Medical Science, and the Major Science and Technology Special Projects of Yunnan Province.
Some “competing interests” were reported. Authors Hengliang Wang and Li Zhu have patent applications related to cholera toxin B subunit (CTB) nanoparticles submitted by the Beijing Institute of Biotechnology. The dry powder vaccine uses CTB with SARS-CoV-2 antigens.
Author Guanghui Ma is an inventor in a patent application related to porous microcapsules submitted by the Institute of Processing and Engineering.
‘Scandal of Epic Proportions’
A Dec. 13 article in Nature, which commented on the study, calls the dry powder vaccine a “unique approach” to dealing with COVID-19. However, it notes that the vaccine’s “safety and immune potency remain to be tested by clinical trials in humans.”
The researchers “have shown that the dry-powder shot remains stable at room temperature for at least one month, but it will be essential to determine how long this stability lasts at room temperature and above, and how degradation of the vaccine affects immune potency.”
“The question remains whether this 1?4-µm (micrometer) dry powder vaccine will be safe and drive an immune response when inhaled by people,” it said while raising concerns about potential “undesired inflammation.”
Regarding the dry powder vaccine’s effectiveness against emerging COVID-19 variants, the article noted that the study demonstrated the feasibility of including the spike antigens of multiple COVID-19 variant viruses into the vaccine. However, the vaccine’s protective efficacy “was not assessed,” it stated.
In addition, “frequently updating the spike antigen in vaccines might not be a viable solution to the emergence of new strains because SARS-CoV-2 evolves rapidly and thereby evades targeting by antibodies.”
The article has stoked controversy due to a statement that “intramuscularly injected vaccines cannot induce immunity in the mucosal tissues of the airways, which is the site of SARS-CoV-2 entry.”
“There's a scandal of epic proportions brewing here. A new study in Nature now asserts that mRNA ‘vaccines’ were, by their very nature, never able to stop the spread. Impossible in theory and practice. Yet that was the excuse used to force everyone to get injected with this stuff,” legal author Hans Mahncke said in a Dec. 14 X post.
“I reported this years ago. The mechanism by which the spike proteins work does not innoculate the epithelial lining from infection. Thus, it can still be spread by sneezing and coughing. Nature is a little late to the party,” podcast host Kyle Becker said in a Dec. 15 post on X.
“Intramuscular vaccines cannot induce mucosal immunity in airways (the site of SARS2 entry). This is why they did not stop the spread of Covid. Nor do much to prevent Longcovid. So let’s put that fable to rest & focus on blocking infection already,” author Dana Parish said in an X post.
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Australian Scholar Picks Apart Study Justifying Risk-Benefit of mRNA COVID Vax--Points to Mistakes & Errors
Recently, a University of Sydney professor issued a refutation to an American Journal of Epidemiology (AJE) article declaring the COVID-19 vaccines being worth the risk in the omicron era. Why is this topic relevant? Because as the science unfolds it becomes clearer that the risks associated with the Omicron version of SARS-CoV-2 become less severe (although still quite transmissible) while more safety information becomes available about the COVID-19 vaccines. Not to mention the significant benefits of preexisting and hybrid immunity against Omicron. Will someone lose their job over this one as the author Down Under implies?
Recently Raphael Lataster, Ph.D. wrote “Revisiting a Risk Benefit Analysis of mRNA COVID-19 Vaccines during the Omicron Era” declaring in his blog as well that “Someone may well lose their job over this one.”
The Challenged Piece
Published by Oxford University Press, the AJE is one of the top epidemiology-focused journals. A Johns Hopkins study (Kitano et al.) pointed out that COVID-19 vaccines are still worth the risk in the Omicron era, across all groups. Source.
Ironically, or perhaps not so, Professor Lataster reports that much of the study’s funding came from industry—grants from Merck and Johnson & Johnson. Of course, this doesn’t mean bias on its face but it most certainly should be noted.
Professor Lataster, a supporter of TrialSite, pointed to our attention that the AJE published a follow-up article by Lataster, who informs the world he has zero funding industry. In his rebuttal the Australian academic points to numerous issues and errors with the study.
What’s wrong with Kitano et al.?
As Lataster delineates in this study and corresponding blog:
The study employs peculiar timeframes, such as “Less than 5 months (days 14–149) after the primary 2 doses versus no doses.” No explanation is given. Recall a recent series of journal articles on counting window issues, likely leading to exaggerated efficacy and safety estimates in clinical trials and observational studies, that I was involved with.
"I note that there can be no valid reason why adverse effects caused by the vaccine, in the several months between the 1st injection and 14 days after the 2nd injection, should be ignored”, pointing to an anaphylaxis death occurring very soon after vaccination.
“The authors themselves made reference in their article to a Japanese study, Suzuki et al., which concerns deaths “within seven days after COVID-19 vaccination”, including myocarditis deaths, and found that several of these deaths did “show a causal relationship to vaccination”. Not only are the authors inexplicably omitting relevant data from their analysis, but they knowingly do also so.”
It’s not just when the counting windows begin that is the problem, but their length as well. “The authors only consider vaccine effectiveness and safety up to around 5 months after the last injection. This is problematic with regards to effectiveness as the vaccine is known to rapidly decline in effectiveness around that time and can even become negatively effective. This is also problematic with regards to safety as the vaccine’s long-term safety profile is still, by definition, unknown. We do know that the vaccines can cause myocarditis, however, a potentially long-term and deadly issue. While the authors effectively assume no myocarditis deaths due to a lack of data, there are recent studies that do provide some data on myocarditis deaths caused by the mRNA vaccines, meriting a reanalysis.”
Even with the data as limited and selected as it is, “the stated net benefits of the vaccines are minute”, as “the smallest gain was found to be 18.7 QALY “per 100,000 vaccinees in the 4–5 months after vaccination” (5–11-year-old males with no comorbidities, third dose vs. no third dose, Pfizer vaccine), or less than 2 hours per person”. “And even these are subject to the uncertainties and estimations admitted to by Kitano et al, to say nothing of the aforementioned criticisms, all of which may well reduce these QALY gains to effectively zero, or even negative figures.” Read that again. By having very limited data, and by being very selective with that data (just ignoring highly relevant data, because why not…), their stated net benefits are almost nothing. The actual net benefit could be zero, or even less than zero. Worth potentially risking your life for?
Lataster comments, “While attempting to argue that COVID-19 vaccination is still worthwhile, the authors inadvertently demonstrate that in the omicron era, COVID-19 is now extremely benign and that the potential benefits to the vaccines are minimal at best, at least in the young and healthy.”
TrialSite emphasizes the importance of critical review of journal material during the COVID-19 period, and frankly all the time. Industry bias, ever so subtle, is real and must be identified, called out, and countered.
While it's up to the reader to determine the merits of (Kitano et al.) and the Lataster refutation, it’s unfortunate that more media channels don’t encourage this kind of unbiased, objective presentation for critical review.
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17 December, 2023
FDA Fails to Address DNA Adulteration Concerns
The failure of government regulatory authorities to identify and disclose DNA fragment contamination of the Moderna and Pfizer/BioNTech COVID vaccine products prior to independent laboratories disclosing their contamination study findings has raised serious questions about quality control oversight of the manufacturing processes used to produce these products, as well as their overall safety. Rather than rigorously addressing specific safety questions concerning the previously undisclosed contamination or adulteration of both modified-mRNA vaccines, in a written Dec. 14 reply to a prior Dec. 6 inquiry, Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research has resorted to redirecting, gaslighting, and stonewalling the Surgeon General of the State of Florida.
Experts from around the world have raised concerns about the safety implications of DNA fragment contamination in COVID gene therapy-based “vaccine” products. Leading regulatory authorities have conceded that these rushed novel and complex biological products are contaminated, and deliver both synthetic modified messenger ribonucleic acid (mod-mRNA) and a wide variety of uncharacterized shorter DNA fragments into the cells and tissues of those who have accepted these product. The Biden administration has previously mandated and currently markets these products in the United States for Americans of all ages including during pregnancy, fraudulently claiming that they prevent SARS-CoV-2 infection and spread as well as COVID-19 disease and death.
These DNA fragments are left over contaminants from manufacturing the mod-mRNA “payload.” The contamination was first detected and reported by experienced U.S. and Canadian genomic researchers, and their findings have been replicated by many other laboratories.
To manufacture the COVID shots, both the DNA contaminants and the mod-mRNA are assembled into the most highly active lipid nanoparticle genetic delivery system ever developed, and this final drug product has been injected into over a billion human arms. After injection, the material distributes throughout the body and delivers both DNA and mod-mRNA to a wide variety of cells and tissues including ovaries.
Both mRNA and DNA can control a wide variety of cell functions. The mod-mRNA directs cells and tissues of the recipient to produce genetically engineered SARS-CoV-2 spike protein (as well as other uncharacterized “frameshifted” proteins and peptides). The DNA fragments come from the circular bacterial DNA (“plasmids”) used to manufacture the mod-mRNA. These plasmids include DNA sequences which can produce a variety of functions inside both bacterial and human cells; proteins which confer antibiotic resistance, sequences which guide DNA into the nucleus of cells, and highly active genetic switches for turning on adjacent genes in either bacterial or animal cells.
In a Dec. 6 letter from Dr. Joe Ladapo M.D., Ph.D. sent to FDA director Robert Califf, the following questions concerning DNA contamination of these mod-mRNA products were posed:
“1. Have drug manufacturers evaluated the risk of human genome integration or mutagenesis of residual DNA contaminants from the mRNA COVID-19 vaccines alongside the additional risk of DNA integration from the lipid nanoparticle delivery system and SV40 promoter/enhancer? Has FDA inquired any information from the drug manufacturers to investigate such risk?
“2. Do current FDA standards for acceptable and safe quantity of residual DNA (present as known contaminants in biological therapies) consider the lipid nanoparticle delivery system for the mRNA COVID-19 vaccines?
“3. Considering the potentially wide biodistribution of mRNA COVID-19 vaccines and DNA contaminants beyond the local injection site, have you evaluated the risk of DNA integration in reproductive cells with respect to the lipid nanoparticle delivery system?”
Earlier today, Dec. 15, the Florida Department of Health publicly posted the FDA response authored by CBER director Dr. Peter Marks to Surgeon General Dr. Ladapo dated Dec. 14, 2023. The response failed to address the questions posed by the Surgeon General, instead offering unsubstantiated platitudes such as “safe and effective” combined with redirection to irrelevant and poorly documented information.
Dr. Peter Marks (a hematologist and oncologist), together with the U.S. Government biowarfare specialist Dr. Robert Kadlec, was responsible for initial creation and regulatory management oversight of Operation Warp Speed, is very invested in the success of this program and has proposed that it be expanded to include cancer treatments. Operation Warp Speed exploited the special U.S. Emergency Use Authorization regulatory pathway to bypass many of the regulatory steps and procedures normally required to insure the safety and effectiveness of vaccine products, which typically require up to a decade of development before widespread deployment.
Worldwide administration of the resulting injectable products has been associated with over seventeen million excess deaths (globally), as well as large numbers of cases of heart damage (myocarditis) with a perverse predilection for young people, contradicting the repeated propaganda statement that these products are safe. U.S. Government officials have colluded in a widespread campaign to cover up data concerning myocarditis side effects. There are over 700 peer reviewed academic publications documenting these and many other types of damages and illnesses caused by these products.
In one of the most intensive global propaganda and marketing campaigns ever deployed, it has been widely asserted that these products will enable herd immunity, will prevent infection, replication, and spread of SARS-CoV-2, and will also prevent COVID-19 disease and death. However, it is now widely recognized that these mod-mRNA provide none of these benefits and are therefore not effective. The messaging used in this propaganda campaign has been supported by over 1,200 peer reviewed academic publications providing propagandists and marketing specialists advice how to overcome “vaccine hesitancy.”
Despite the proven and documented lack of safety and effectiveness, overlapping layers of legal protection (indemnification) prevent both deceived public and damaged individuals from obtaining compensation for this fraud.
In his response to the Surgeon General’s questions, Dr. Marks has provided a series of unsupported or misleading statements, combined with circuitous and not scientifically rigorous responses to the specific questions posed. These responses appear to suggest that the FDA has failed to require DNA integration studies to determine the dose limiting toxicity of bacterial plasmid DNA fragments when delivered into animal models using the specific formulations now injected into over a billion human beings. Dr. Marks failed to cite any studies which specifically address DNA fragment integration risks to those receiving these products, instead referring only to studies which can only detect other types of genotoxicity. DNA fragment integration is one of multiple types of genetic damage which such lipid nanoparticle formulations may cause.
In his response to Dr. Ladapo’s inquiry, Dr. Marks cites an FDA guidance document which addresses general requirements for assessing DNA contamination of vaccines (such as influenza) which are manufactured using cultured cell lines. This type of manufacturing process often yields vaccine material which is contaminated with large fragments of chromosomal DNA from the animal cells used to grow the vaccine. This contamination is substantially different from that involving the mod-mRNA products, in that we now know that those products are contaminated with small DNA fragments which are more likely to cross into the region of cells which contain the genome, and in contrast to traditional vaccines these mod-mRNA products and their DNA contaminants are assembled into highly active lipid nanoparticle delivery formulations, greatly increasing the risk that such DNA will enter both the cells and the part of the cells which house the genome (the nucleus).
Despite the fact that the risks of DNA contamination with traditional cell-based vaccines are much lower than for the novel mod-mRNA lipid nanoparticle-based products, the cited FDA guidance documents include the following specific warnings concerning DNA contamination:
“Residual DNA might be a risk to your final product because of oncogenic and/or infectivity potential. There are several potential mechanisms by which residual DNA could be oncogenic, including the integration and expression of encoded oncogenes or insertional mutagenesis following DNA integration.”
In his response to the Surgeon General, Dr. Marks refers to a specific clause in this guidance to support safety of the levels of DNA fragment contamination, which in turn refers back to a WHO document. What he fails to acknowledge is that this guidance refers to DNA contamination in a directly injected (parenteral) vaccine, not one employing the most highly active DNA and RNA lipid nanoparticle delivery system ever devised by man. This oversight either reveals Dr. Marks’ profound ignorance of this significant difference (despite the Surgeon General having pointed this out in his initial letter), or a fraudulent attempt to gaslight and obfuscate the truth of the matter. Either ignorance or intentional cover up, hard to differentiate. Here is the cited clause:
“You should limit residual DNA for continuous non-tumorigenic cells, such as low-passage Vero cells, to less than 10 ng/dose for parenteral inoculation as recommended by WHO (Ref. 31) ...”
Reference 31 refers to a WHO document developed and published in 1998, less than a decade after my initial discoveries relating to large scale mRNA manufacture and delivery and about the same time as Kariko and Weissman’s first report of their work with pseudouridine. This outdated WHO statement predates the development of the current generation of mod-mRNA delivery technology by approximately 20 years, and is completely irrelevant.
In additional efforts to cover up the apparent failure of the FDA to require the specific DNA integration toxicology studies both logically needed to rigorously assess patient risk and required for all previous DNA vaccine products prior to human experimental use, Dr. Marks cites the Summary approval document for the Pfizer/BioNTech mod-mRNA product “COMIRNATY” as well as the Summary approval document for the Moderna “SPIKEVAX” product. Specifically, Dr. Marks makes the following assertion:
“[S]tudies have been conducted in animals using the modified mRNA and lipid nanoparticle together that constitute the vaccine, including the minute quantities of residual DNA fragments left over after DNAse treatment during manufacturing, and demonstrate no evidence for genotoxicity from the vaccine ...”
The very limited studies performed are incapable of detecting DNA fragment integration. Once again, this statement reflects either intentional gaslighting or incompetence. The COMIRNATY document provides no specific references to genotoxicity or integration studies having been performed prior to human authorization. In contrast, the SPIKEVAX document (SPIKEVAX is not the same product as COMIRNATY) lists the following assays performed:
“Other Supportive Toxicology Studies
“The safety of SPIKEVAX is further supported by the aggregate rat repeat-dose toxicity profiles observed in six GLP toxicity studies of five vaccines formulated in SM-102 lipid particles containing mRNAs encoding various viral glycoprotein antigens, demonstrating tolerance of repeat doses of these vaccines without any detrimental effects. Three other toxicology studies were also reviewed in support of safety of SPIKEVAX. A study report from an in vitro rat micronucleus assay evaluating the genotoxic potential of (b) (4) mRNA in SM-102 LNP revealed no genotoxic effects of SM-102 LNP. In addition, study reports from a bacterial reverse mutation test and an in vitro mammalian cell micronucleus test of PEG2000-DMG were also reviewed. No genotoxic effects of PEG2000-DMG were observed in these studies.”
Under the heading “Other Supportive Toxicology Studies,” this regulatory submission demonstrates the gross inadequacy of the testing performed for SPIKEVAX, which despite this inadequacy apparently still exceeds the testing performed for COMIRNATY. The SPIKEVAX documentation refers to an in vitro (ergo in a test tube) rat micronucleus assay of the formulated mRNA. No mention is made of any level of DNA fragment contamination in the tested preparation. The in vitro rat micronucleus assay is a method for rapidly testing the activity of a pharmaceutical or radiologic treatment in grossly disrupting chromosomes. It is completely inappropriate and incapable of detecting insertional mutagenesis. PEG2000-DMG is one of many components of the lipid nanoparticle, and these test results are irrelevant to the questions raised by the Surgeon General, as neither mod-mRNA nor DNA fragments were tested, and once again the tests performed would fail to detect any integration events.
The appropriate testing for DNA fragment integration is covered in the FDA guidance document “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications,” which Dr. Marks has failed to cite in his response. Dr. Marks’ makes the following assertion in his response to the Surgeon General:
“On first principle, it is quite implausible that the residual small DNA fragments located in the cytosol could find their way into the nucleus through the nuclear membrane present in intact cells and then be incorporated into chromosomal DNA.”
This statement is directly contradicted by the guidance cited above, which states the following:
“Theoretical concerns regarding DNA integration include the risk of tumorigenisis if insertion reduces the activity of a tumor suppressor or increases the activity of an oncogene. In addition, DNA integration may result in chromosomal instability through the induction of chromosomal breaks or rearrangements.”
In direct contradiction to the poorly cited assertion made by Dr. Marks, Moderna acknowledges these risks in its own patent filings. In the issued U.S. Patent #US2019/0240317 A1 (see image above) titled “HPIV3 Vaccines,” Moderna provides the following text:
“[0012] Deoxyribonucleic acid (DNA) vaccination is one technique used to stimulate humoral and cellular immune responses to foreign antigens, such as hMPV antigens and/or PIV antigens and/or RSV antigens. The direct injection of genetically engineered DNA (e.g., naked plasmid DNA) into a living host results in a small number of its cells directly producing an antigen, resulting in a protective immunological response. With this technique, however, comes potential problems, including the possibility of insertional mutagenesis, which could lead to the activation of oncogenes or the inhibition of tumor suppressor genes.”
The FDA’s own “Guidance for Industry Considerations for Plasmid DNA Vaccines for Infectious Disease Indications” provides clear guidance concerning how the risks of DNA integration risk should be addressed:
“A typical integration study will assess all tissue(s) containing persisting DNA plasmid. We recommend that at least four independent DNA samples be analyzed. Each sample may include DNA pooled from several different donors. Q-PCR is generally used to detect and quantify the amount of plasmid DNA present in each genomic DNA preparation. Unintegrated plasmid DNA may be separated from high molecular weight genomic DNA by gel purification. Concatamer may be eliminated by restriction endonuclease digestion targeting a rare motif present in the DNA plasmid. Specifically designed PCR primers may be used to confirm integration and identify genomic integration sites.”
Based on these and many other examples of existing FDA guidance and prior regulatory submissions, there are both well-developed protocols and well-established precedent for performing DNA fragment integration studies. The failure of Dr. Marks to correctly cite FDA guidance, past precedent, or reference any relevant studies performed to assess these risks in the context of either the COMIRNATY or SPIKEVAX regulatory dossiers clearly demonstrates a tragic failure of proper regulatory oversight and diligence.
Conclusion
In its response to an appropriate and well-documented inquiry from the Florida Surgeon General, the U.S. FDA has clearly failed to establish that it was aware of the contamination or adulteration of COMIRNATY or SPIKEVAX final drug products with plasmid DNA fragments, and has completely failed to insist on the testing necessary to both establish dose limiting toxicity of DNA fragments when delivered to animals or humans using these highly active lipid nanoparticle formulations. Furthermore, in the written FDA response to the Dec. 6, 2023 inquiry from Dr. Ladapo concerning the risks of this contamination, the FDA has demonstrated a lack of rigor in addressing the questions posed which is combined with a series of statements which can only be interpreted as either ignorant, incompetent, or intentionally misleading.
The Surgeon General and citizens of the State of Florida, the U.S. public, and the citizens of the world deserve better than to be mislead and gaslight about the risks of the widely acknowledged DNA fragment contamination present in virtually all batches and lots of COMIRNATY and SPIKEVAX. Based on FDA’s the abject failure to address these risks in a serious manner, and its willingness to substitute platitudes, half truths, and outright falsehoods for actual data, the FDA, CBER, and Dr. Marks have once again damaged the credibility of the U.S. HHS in the eyes of both the U.S. public and the world. We all deserve better, but in the interim it must be concluded that the risks associated with DNA plasmid fragment adulteration when delivered with the highly active lipid nanoparticle formulations of COMIRNATY and SPIKEVAX are both real and uncharacterized, and consistent with U.S. Federal statute CFR Title 21, CHAPTER 9, SUBCHAPTER V § 351, the products must be withdrawn from the market until the necessary tests have been performed and safety demonstrated.
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14 December, 2023
Long COVID & Chronic Conditions Impacting Workplace --Study
Recently, Integrated Benefits Institute (IBI), a health and productivity research non-profit, analyzed the impact of long-term COVID and certain chronic conditions on productivity, disability, and disability claims, finding that US employees with long-term COVID, along with certain comorbid conditions, have a two-fold increase in missed workdays. The chronic conditions highlighted in the analysis include cancer, cardiovascular disease, diabetes, obesity, musculoskeletal, respiratory, and mental health conditions.
A Real Problem Impacting the Workplace
The prevalence of long COVID has had a profound impact on disability claims, work absences, and healthcare expenses. According to a recent analysis of workforce absences in the Journal of Public Economics, around 500,000 individuals in the US were removed from the workforce due to COVID-related illnesses between March 2020 and June 2022. The study did not delve into the problem of long Vax, or COVID-19 vaccine-related injury.
Nearly one in five US adults who have had COVID-19 are still experiencing persistent symptoms three or more months after their initial COVID-19 diagnosis. The likelihood of developing long COVID was found to be more than five -times higher in those with severe COVID-19 symptoms, compared to those with mild or no symptoms. Those with moderate symptoms are more than two times more likely.
This recently published study used data from the National Health Interview Survey (NHIS) and the IBI Benchmarking Portal, the largest collection of claims for employer-sponsored short-term disability (STD), long-term disability (LTD), family and medical leave (FML), and workers' compensation (WC) in the US. The study's findings shed light on the complex relationship that exists between long COVID, chronic conditions, and work-related outcomes.
Chronic Conditions & Impact
Almost half (47%) of individuals with long COVID report obesity as a comorbid condition. More than one third (38.5%) of individuals with long COVID also report having a mental health condition – specifically, anxiety or depression, followed by musculoskeletal conditions (22.7%). Approximately 5.9% of long COVID cases are also affected by heart disease or stroke, 6.1% with cancer, and 9.1% with diabetes.
Certain chronic conditions are more strongly associated with developing long COVID. Those with asthma or chronic obstructive pulmonary disease (COPD) have 94% increased odds of developing long COVID. Those with musculoskeletal disorders have a 49% increase, obesity a 52% increase, and those with anxiety and depression have 38% increased odds of experiencing long COVID.
Long COVID in individuals without any chronic conditions results in an average of 10.2 missed workdays. Combining chronic illnesses with long COVID leads to a two-fold increase (102%) in missed workdays, from 8.9 to 17.9 missed days. For example, those with cardiovascular disease and long COVID results in an average of 26.2 workdays missed, a stunning 122.1% increase above 11.8 workdays missed for cardiovascular disease alone.
52.5% of NHIS working-age respondents with obesity and comorbid long COVID have a work disability, underscoring the significant obstacles they must overcome. The comorbid long COVID and mental health disorders group has an even higher work disability rate (61.1%). And 37.1% of people with MSK conditions and comorbid long COVID report a work disability.
Disability claims
Long COVID has had a significant impact on disability claims, duration, and costs.
The study data derived from IBI's Benchmarking Portal data reveals long COVID had 4,442 STD claims in 2021. The industries that report the highest STD claims are manufacturing (13,671 claims) and services (11,860 claims), followed by the finance, insurance, & real estate sector with 5,534 claims.
For COVID-19, the average payment per closed STD claim stands at $2,739. Long COVID, however, has a notably higher average STD payment of $5,417, reflecting the more substantial financial burden associated with managing long COVID-related STD claims. The construction sector has the highest average payment for long COVID-related STD claims, at $11,744, followed by the services sector with a significantly higher than average payment of $8,779 per closed long COVID claim.
Long COVID has a much higher number of calendar days lost per STD claim at 90 days, compared with COVID-19 claims (22 days). Notably, 16% of these STD claims transitioned into LTD claims, resulting in 5,427 cases of long COVID LTD claims. These LTD claims had significantly higher payments, averaging $9,307 per closed claim. Importantly, 35% of individuals with LTD claims successfully returned to work within two years.
What does this mean for employers?
Employers face the challenge of navigating reduced productivity, disability claim costs, and the prolonged symptoms experienced by individuals with long COVID.
IBI spoke with HR and benefits managers on how they are approaching the challenges this diagnosis presents.
Recognize long COVID's varied and extended symptoms, encompassing physical, cognitive, and emotional issues.
Promote a gradual transition back to work and consider the challenges employees face.
Be proactive in establishing policies to accommodate employees with long COVID.
Consider implementing a trial period and reevaluation process for accommodation requests.
Be prepared for the possibility of relapse after an employee returns to work.
Acknowledge long COVID's potential classification as a disability under the ADA.
Collaborate with affected employees to determine effective accommodation solutions.
Maintain open lines of communication to tailor accommodations based on specific symptoms and limitations.
Provide flexible scheduling to accommodate variations in energy levels and symptom severity.
Prioritize employees' mental well-being by encouraging behavioral therapy or counseling.
https://www.trialsitenews.com/a/long-covid-chronic-conditions-impacting-workplace-study-0be8a9b6
**********************************************Recent Vaccine Injury Settlement the Exception More than the Rule
The family of an 8-year-old paraplegic girl who was afflicted with transverse myelitis after receiving childhood vaccines as an infant has settled a personal injury claim with the federal government for $4 million, according to reports in the Missouri Lawyers Media. Such settlements are quite rare given the large number of vaccines administered, according to data from the U.S. Department of Health and Human Services, Health Resources and Services Administration (HRSA). But also making compensation is an onerous legal process involving complex science and several other factors.
In the most recent HRSA report citing CDC data, from 2006 to 2022, over 5 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 11,358 petitions were adjudicated by the Court, and of those, 8,131 were compensated via the Vaccine Injury Compensation Program (VICP).
The report cites that for every 1 million doses of vaccine that were distributed, about 1 individual ends up compensated.
Further, the report states that since 1988, over 26,862 petitions have been filed with the VICP. During this three-decade-plus period, 22,983 petitions were adjudicated, with 10,371 of those determined to be compensable, while 12,612 were dismissed. Total compensation paid over the life of the program is approximately $5 billion.
Of course, what the government doesn’t share is that it’s quite difficult to secure compensation from VICP. An onerous process with lots of disqualifying twists and turns
Determining whether a particular health condition is a result of a vaccine can be complex. Some injuries may have multiple potential causes and proving a direct link to a vaccine can be challenging.
Scientific Uncertainty
The science of vaccine-related injuries is not always clear-cut. Medical and scientific evidence may not definitively establish a causal relationship between a vaccine and a specific injury, leading to uncertainty in some cases.
Legal Complexity
The VICP operates within a legal framework with specific rules and procedures. Navigating this legal process can be challenging for claimants who may not be familiar with legal proceedings.
Statute of Limitations
There are strict deadlines for filing claims with the VICP. Some claimants may miss the filing window due to lack of awareness, delayed diagnosis, or other reasons.
Causation Burden
Claimants must demonstrate a plausible connection between the vaccine and the alleged injury. This burden of proof can be difficult to meet, particularly when dealing with rare or poorly understood medical conditions.
Limited Compensation
The compensation awarded by the VICP may not fully cover all the costs associated with a vaccine injury. Claimants may still face financial challenges despite receiving compensation.
Adverse Public Perception
Some individuals may view the VICP as a barrier to pursuing justice through the traditional legal system. There can be a perception that the program protects vaccine manufacturers more than it supports injured individuals.
Lengthy Process
The VICP process can be time-consuming. It may take months or even years for a case to be resolved, which can be stressful for individuals dealing with the aftermath of a vaccine injury.
As hard as it may be to secure compensation with VICP, the situation remains far worse for individuals injured by COVID-19 vaccines who are subject to the Countermeasures Injury Compensation Program (CICP). This is the program in the United States that provides compensation to individuals who suffer serious injuries or death as a result of certain medical countermeasures. These countermeasures are often used in response to public health emergencies, such as pandemics or bioterrorism events (e.g., COVID-19). The CICP is a part of the Public Readiness and Emergency Preparedness (PREP) Act.
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13 December, 2023
New Zealand Government Data Suggests Alarming Pfizer Death Rate
A statistician has come forward with disturbing information that, if correct, will promote doubt on the safety of mRNA vaccination for decades into the future. The whistleblower was involved with building and implementing the New Zealand government database vaccine payment system, a “pay per dose system” that would remit payments to vaccination providers.
In an interview with New Zealand journalist and lawyer Liz Gunn, and using a false name of Winston Smith, the statistician states that “science is all about being sceptical and curious at the same time. We shouldn’t be criticised for being sceptical, we shouldn’t be vilified for having a different opinion. We should be allowed to have that.”
Smith explained by way of introduction “I’m not anti-vax. I helped build the vaccination system. But I am pro-choice and I do believe in [the] fundamental freedoms of humans, and that we should not have a procedure forced onto us because of a mandate just to keep our jobs. That is against everything I stand for. It is a huge overreach by the government.”
Smith’s work also involved data analysis. Smith had noticed discrepancies almost immediately the system went live with people dying within a week of being injected.
Looking at the government data, he ran a query to identify days when more than one hundred and twenty people died in New Zealand. Historic peaks above this level, as Smith demonstrates, are rare. This normal distribution of deaths at this level is only rarely exceeded on the occasional day, or for disaster events, such as the 2011 Christchurch earthquake, mosque shooting in 2019, or an unusually bad influenza season.
In the small country of New Zealand, daily mortality levels that exceed one hundred and twenty could plausibly be considered to be a signal of a disaster event that should trigger public discussion and controversy.
New Zealand had a highly unusual winter flu season in June-July 2019, and no days exceeded the harm-signal level in 2020.
However, in June and July 2021 Smith observed 10 days where mortality exceeded the signal-level. This could be attributed to either COVID-19 or to the injections. Yet not more than a few deaths due to COVID-19 were registered in this time period.
This uptick in deaths coincided with expansion of the vaccine rollout. The mRNA gene therapy was offered to the general public, two million people from July 2021 onwards.
However, by April 2022, as Smith states “now the vaccine rollout comes into full effect.” Booster-injections had peaked in the first quarter of 2022, in the New Zealand summer.
In June 2022, 50 percent of all days exceeded the signal-level with excessive mortality rates rolling into 2023.
Smith bases his claim that the 2022 data is not muddied by COVID-19 deaths, as SARS-CoV-2 deaths were relatively stable in 2022, rarely exceeding 30 deaths per day and only once exceeding 50 deaths per day, and COVID-19 related deaths dropping steeply off after this date.
Smith claims that there are spikes in unexpected mortality rates in less populated regions outside the capital cities, far in excess of normal background rates.
Of the twenty worst sites, seven of them appear in Christchurch city, a university town with a population of 380,000.
Smith drew attention to one site in Invercargill, a city of 50,000 that he alleges had a vaccine-related death count of 253, following a total vaccine rate on that site, a medical centre, of 837. He claims that “one in three people who were vaccinated at this site are now dead.”
I note that in April 2022 media were reporting a spike in COVID-19 infections in Invercargill, but no corresponding death rate. People may have been compelled to get vaccinated in this period knowing the virus was circulating; however, it is plausible that they may have also been exposed to a “triple whammy” of the heart-damaging and inflammatory spike protein following injections, then boosters, and the circulating virus.
Smith’s data suggests that some vaccination sites, including medical centres, pharmacies, and rest homes for the elderly, had extremely high death counts above 20 percent and at times more than 30 percent for as many as 800 or 900 vaccinations onsite.
Smith is unclear about the time between injection and death, surmising that it could be up to two months, but adamant that even in the rest homes, the death rate exceeded the normal distribution for the very elderly.
Smith suspects that there could be an issue with batch numbers and irregularities in the vaccine. As a biologic drug, the mRNA gene therapy was always vulnerable to irregularities and contamination.
Smith toggled batch ID numbers with the associated death rate to arrive at a death count and a ratio of deaths by batch. The top ten batches were all Pfizer. (Note: global batch IDs can be sourced from “Find My Batch.”)
Registered deaths by vaccinator also suggests that vaccinators (or the batch numbers used by the vaccinators) increased risk, with death by vaccinator up to 25 percent of people vaccinated.
Deaths would also cluster on particular days, for example in Invercargill, discussed above there were ten clusters of 3–10 deaths per day, and four clusters of 21–30 deaths per day.
Smith maintains “this is not natural, this is man-made.” His IT system has 2.2 million New Zealanders registered, and the natural background mortality rate is 0.75, and all ages are registered. Smith insists that his data suggests not chance, or bad luck, but causality.
“There’s so much pain and tears.”
Smith had not come forward earlier, because as a scientist, he was aware he required a strong consistent signal in order for his findings to be accepted.
Interviewer Gunn stated, “I’d like to remind people. We were sold the jab to protect the old people.”
Smith approached former mainstream journalist and lawyer Liz Gunn to help disclose this information, and the two have worked with a global group of academics and experts to ensure the release of this information was suitably handled.
Smith was in an unusual position as the database administrator for the payment system. “Because New Zealand is a small country, you can get away with one database administrator. I am in a unique position, and because New Zealand is a Tier 1 country with really good IT, I was able to manage and build this system.”
“Death is the ultimate adverse event ... statistically it’s very difficult to disprove this.”
If it was settled science we’d be living on a flat earth and we’d be the centre of the universe.
Smith and Gunn are encouraging experts in data analysis to come forward and look at his data.
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United Kingdom Excess Deaths Surge 100% Between 2019 & 2023
The UK government reports on the latest excess death data, evidencing an ongoing disturbing increase in mortality. With a focus on England and Wales, provisional counts of the number of deaths registered by age, sex, and region in the latest weeks for which data are available. This data set includes the most up-to-date figures available for deaths involving coronavirus (COVID-19).
The latest data compares 2019, the year before the COVID-19 pandemic, and 2023, a year that represented the transition out of the global public health emergency.
What are excess deaths?
Referring to the number of deaths observed in a specific time period that exceeds the expected number of deaths based on historical data, excess deaths represent a metric often used to better understand the impact of events such as pandemics, natural disasters or other crises impacting mortality rates.
How are excess deaths calculated?
Excess deaths are calculated by comparing the actual number of deaths during a particular period to the expected number of deaths based on previous trends. The expected number of deaths is usually determined by looking at data from previous years, considering factors like population growth and age distribution.
Helps with broader understanding of scale of impact
During an event such as COVID-19, excess deaths can be a more comprehensive measure of the overall impact than just looking at the reported deaths directly tied to the specific cause (e.g., COVID-19 deaths). This is because some deaths related to the event may not be directly attributed to the cause, and other indirect effects, such as disruptions to healthcare systems, economic downturns, or stress-related health issues, can contribute to increased mortality.
What’s the true impact of a crisis on mortality? Calculating and analyzing excess deaths helps offer a more comprehensive picture of true impacts from events such as the COVID-19 pandemic, and associated tends, from disrupted health access to possibly, although it’s not dared mentioned in most mainstream media, impacts of pharmaceutical interventions (e.g., vaccines) to other intertwined factors and forces. We cannot be certain in the UK unless the government allocates the funding for academic medical centers to study the matter in detail.
https://www.trialsitenews.com/a/united-kingdom-excess-deaths-surge-100-between-2019-2023-74807ace
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Supreme Court endorses end of Federal COVID-19 Vaccine Mandates
In unsigned rulings, the justices said that rulings against mandates imposed by President Biden and the U.S. military have been vacated.
They also remanded the cases back to lower courts with instructions for the courts to vacate preliminary injunctions that had been in place against the administration as moot.
The decisions mean that the rulings won't act as precedent in future vaccine mandate cases.
“We believe the United States Constitution clearly does not permit the federal government to force federal workers—or any law abiding citizen—to inject their bodies with something against their will. In fact, the freedom to control your own body and your own medical information is so basic that, without those liberties, it is impossible to truly be ‘free’ at all," Marcus Thornton, president of Feds for Freedom, said in a statement. "We are disappointed that the Supreme Court dodged these important Constitutional arguments and instead chose to vacate our case on technicalities."
One case was brought by Feds for Freedom and involved President Biden's mandate for federal employees. The mandate was imposed in 2021, with the president claiming that vaccination was the "best way to slow the spread of COVID-19" and that requiring vaccination would "promote the health and safety of the federal workforce and the efficiency of the civil service.”
U.S. District Judge Jeffrey Brown had ruled previously that the president lacked the authority to impose the vaccine mandate.
Another case was brought by a federal worker who recovered from COVID-19 and thus enjoyed some protection against the illness but was still being forced to receive a vaccination under President Biden's mandate because the government refused to formally recognize the post-infection protection. Jason Payne, the worker, said the mandate exceeded President Biden's authority.
In the third case, federal judges ruled that the U.S. Air Force's handling of its mandate was illegal, and prevented the branch from taking disciplinary action against members who had requested religious exemptions.
Government lawyers urged the Supreme Court to rule the decisions in these cases as moot, given that the vaccine mandates were ended.
"Consistent with this court’s ordinary practice under such circumstances, the court should grant the petition for a writ of certiorari, vacate the judgment below, and remand with instructions to direct the district court to dismiss its order granting a preliminary injunction as moot," the lawyers wrote in one petition to the court.
Mr. Payne's lawyers also asked for the decisions to be ruled as moot, after two courts ruled against him and following the rescinding of the mandate that affected him.
Lawyers for the other federal workers and for the military members opposed the request.
The government was asking the Supreme Court to endorse a "heads we win, tails you get vacated" version of a previous court decision, United States v. Munsingwear, lawyers for the federal workers wrote in one brief. If granted, the government would be able to "litigate to the hilt in both district and circuit court and—only if they lose—then decline to seek substantive review from this court and instead moot the case and ask this court to erase the circuit court loss from the books," according to the brief.
Lawyers for the military members noted that Congress forced the military to rescind its mandate, but that the legislation didn't prevent the Department of Defense from issuing another mandate.
Government lawyers said the mandates were rescinded because the pandemic situation had changed, not because they were challenged. They also argued that the mandates "cannot be reasonably expected to recur."
Lawyers for the military members said that the claim was "in serious tension" with the demand to vacate the rulings under the Munsingwear precedent, given that the purpose of such a move "is to clear the path for future re-litigation without res judicata concerns."
None of the Supreme Court justices except for Justice Ketanji Brown Jackson, who was appointed by President Biden, explained their decisions on the cases.
"Although I would require that the party seeking vacatur establish equitable entitlement to that remedy, I accede to vacatur here based on the court’s established practice when the mootness occurs through the unilateral action of the party that prevailed in the lower court," she said in regard to Mr. Payne's case.
In the two other cases, Justice Jackson said that the government hadn't "established equitable entitlement" to vacatur, but that she concurred with the overall judgment from her colleagues.
She cited a Dec. 5 decision in which the court ruled against a civil rights activist who sought a ruling that would force hotels to make information for disabled people publicly available.
Justice Jackson sided with the majority in that ruling but contested the majority's decision to vacate a lower court ruling, arguing that vacatur—or the setting aside of the judgment—shouldn't be granted automatically.
"Automatic vacatur plainly flouts the requirement of an individualized, circumstance-driven fairness evaluation, which, as I have explained, is the hallmark of an equitable remedy," she wrote.
It's also "flatly inconsistent with our common-law tradition of case-by-case adjudication, which 'assumes that judicial decisions are valuable and should not be cast aside lightly,'" Justice Jackson said, quoting from yet another ruling.
"As a general matter, I believe that a party who claims equitable entitlement to vacatur must explain what harm—other than having to accept the law as the lower court stated it—flows from the inability to appeal the lower court decision."
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Covid has much more severe post vaccination symptoms than influenza
Many of my Op-eds have examined symptoms/diseases in VAERS (Vaccine Adverse Events Reporting System) following COVID-19 vaccinations. Each Op-ed has focused on a different organ (e.g., renal, skin) or system (e.g., cardiovascular, neurological, musculoskeletal). These Op-eds have also included a section comparing frequency of symptoms that occurred following COVID-19 vaccinations and Influenza vaccinations. For some symptoms, the difference between COVID-19 symptom frequencies and Influenza symptom frequencies was quite large, COVID-19 always being larger. For other symptoms, COVID-19 relative frequency was noticeable, but not nearly as large.
Are there any patterns to those symptoms showing either 1) massive differences in their frequencies following these vaccinations or 2) modest differences following these vaccinations? To answer this question, it was decided to examine ALL the symptoms listed in VAERS following COVID-19 vaccinations and following Influenza vaccinations. The focus would be on the two extremes: massive differences between the symptom frequencies of each vaccine, and extremely small differences, including the ~1/3% of cases where Influenza post-vaccination symptom frequencies were larger than those of COVID-19.
METHODOLOGY
In late November 2023, the VAERS database was accessed, and all the symptoms following COVID-19 vaccinations and following Influenza vaccinations were downloaded, including those symptoms with zero entries. For each case, a total of 17716 symptoms was downloaded. The two sets of symptoms were combined, and the ratios of 1) symptom frequencies following COVID-19 vaccinations to 2) symptom frequencies following Influenza vaccinations were computed.
RESULTS AND DISCUSSION
The ratios were divided into five groups, and the extreme ratios from each group are shown in Appendices 1-5. The five groups are: 1) Symptom frequency post-Influenza vaccination zero (total of 12771 symptoms - see Appendix 1); 2), Symptom frequency post-Influenza vaccination one (total of 1809 symptoms - see Appendix 2); 3) Symptom frequency post-Influenza vaccination two (total of 720 symptoms - see Appendix 3); 4) Symptom frequency post-Influenza vaccination greater than two, and the COVID-19/Influenza symptom frequency ratio is one or greater (total of 2346 symptoms - see Appendix 4); 5) Symptom frequency post-Influenza vaccination greater than two, and the COVID-19/Influenza symptom frequency ratio is less than one (total of 66 symptoms - see Appendix 5). The symptom frequencies for all symptoms following COVID-19 vaccinations total 4,186,684 events, and symptom frequencies for all symptoms following Influenza vaccinations total 178,284 events. This yields an overall aggregate COVID-19/Influenza post-vaccination symptom ratio of 23.48........
Overall, the number of symptoms post-COVID-19 vaccinations that have massively higher frequencies than their influenza vaccination counterparts are over a thousand even when limited to the very high threshold ratios of thirty or more that were used as cutoff. It is difficult to see how any credible scientist or regulator can consider differences on the order of those shown in this study as anything other than signals of an extremely unsafe substance.
SUMMARY AND CONCLUSIONS
All the symptoms listed in VAERS following COVID-19 vaccinations and following Influenza vaccinations were compared for numbers of events associated with each symptom. The analysis focused on the two extremes: massive differences between the two vaccines, and extremely small differences, including cases where Influenza post-vaccination symptom frequencies were larger than those of COVID-19.
The symptom frequencies for all symptoms following COVID-19 vaccinations totaled 4,186,684 events, and symptom frequencies for all symptoms following Influenza vaccinations totaled 178,284 events. Since the VAERS numbers strongly under-represent the real-world numbers, they need to be multiplied by an under-reporting factor (URF) to translate into numbers of real-world symptoms. Using my most recent URF value of 66, the real-world symptom frequencies for all symptoms following COVID-19 vaccinations totaled 276,321,144 events, and real-world symptom frequencies for all symptoms following Influenza vaccinations totaled 11,766,744 events. The ratio of these two event totals yields an overall aggregate COVID-19/Influenza post-vaccination ratio of 23.48.
Cardiovascular issues, blood issues, and cancer issues were some of the more noticeable sub-themes that displayed extreme differences between 1) post-COVID-19 vaccination symptoms and 2) post-influenza vaccination symptoms. However, neurological, immune/autoimmune, respiratory, renal, gastrointestinal, infection, endocrine, auditory, vision, skin, musculoskeletal, and myriad other disorders had significant representation at the extremes as well. One disturbing feature of the results is the large number of “breakthrough COVID-19” cases that occurred post-COVID-19 vaccinations. What kind of vaccine increases vulnerability to the infection that the vaccine is supposed to prevent?
While all these disorders are concerning, perhaps the disorders of highest concern are the Cancer issues. Cancers are appearing within (sometimes well within) the three years since COVID-19 vaccinations started, far sooner than would be expected from their typical latency periods. This does not bode well for the future. Given the destructive nature of the mRNA platform on the surveillance and attack/destroy functions of the immune system, all the vaccines projected to operate on this platform for the future (e.g., RSV (respiratory syncytial virus), HIV, Zika, Epstein-Barr virus, tuberculosis, malaria, shingles, and flu) will only increase the likelihood of Cancers cumulatively with each injection.
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11 December, 2023
CDC Reveals New 'Fastest-Growing' COVID-19 Variant in US
The U.S. Centers for Disease Control and Prevention (CDC) indicated that the JN.1 COVID-19 subvariant is increasingly across the United States, comprising potentially a third of all cases.
The variant comprised about 0.1 percent of all COVID-19 cases in the United States as of late October, according to the federal health agency in a Dec. 8 update. But as of Dec. 8, it now makes up about 15 to 29 percent of cases, it said.
"CDC projects that JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences," the CDC said. "It is currently the fastest-growing variant in the United States."
The CDC said in another update that the JN.1 level jumped from 8.1 percent to 21.4 percent in the past two weeks. JN.1 is now the second-most common variant in the U.S., behind only the HV.1 variant, according to the CDC.
Despite the fast growth of JN.1, there is "no evidence" at this time that it "presents an increased risk to public health relative to other currently circulating variants," said the CDC. There is also no signs of "increased severity" from the variant, the agency added.
Current COVID-19 treatments and tests are believed to be effective against JN.1, it said, adding that "the continued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems."
The CDC also said it's unclear to what extent JN.1 is contributing to hospitalizations in the U.S. but said that COVID-19 activity is likely going to increase during the winter months.
Researchers and the CDC say that JN.1 is a COVID-19 variant that descended from the BA.2.86 lineage, which is another Omicron sub-variant.
“BA.2.86 has more than 20 mutations on the spike protein and there was a concern when it was first detected a while back that, wow, this might be a real problem,” Thomas Russo, professor and chief of infectious diseases at the University at Buffalo in New York, told Prevention.
Symptoms
There is no data to indicate if JN.1 causes any new symptoms, said William Schaffner, a professor at the Vanderbilt University School of Medicine.
“It’s an Omicron variant and looks to be similar,” he told the outlet.
The CDC says that symptoms include cough, shortness of breath, fever or chills, fatigue, muscle aches, loss of taste or smell, sore throat, runny nose, headache, vomiting, diarrhea, or nausea.
"It is not currently known whether JN.1 infection produces different symptoms from other variants," said the CDC update. "In general, symptoms of COVID-19 tend to be similar across variants. The types of symptoms and how severe they are usually depend more on a person’s immunity and overall health rather than which variant causes the infection."
Other Respiratory Illnesses
Separate data provided by the CDC show that while COVID-19 hospitalizations have been on the rise in recent weeks, weekly COVID-19 hospitalizations have not reached the same levels as previous "surges" earlier on in the pandemic. As of the week ending Dec. 2, there were 22,513 recorded hospitalizations, which is significantly lower than the same weekly period in December 2022.
Flu hospitalizations are on the rise although the number of new admissions appears to be low with 5,753 admitted to the week ending on Dec. 2, which is an increase from 4,268 during the prior week, according to the most recent CDC data. The also data suggests that there have been 2.6 million influenza cases, 26,000 hospital cases, and 1,600 deaths during the flu season so far.
Earlier this month, the CDC said that despite reported spikes of pneumonia cases among children in several states, the CDC's director, Mandy Cohen, said earlier this month that transmission rates are considered "typical."
"As of today, we are not seeing anything that is atypical in terms of pneumonia-related emergency department visits," she told reporters.
It came amid concerns that a spate of pediatric pneumonia cases in mainland China could spread to the U.S., which drew an alert from the ProMed global surveillance system in late November.
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UK: Airforce intelligence officers joined Whitehall and Army in 'spying' on Covid lockdown critics - including David Davis and Peter Hitchens
RAF intelligence officers joined a shadowy Whitehall operation accused of spying on members of the public who criticised Covid lockdown policies, The Mail on Sunday can reveal.
Official military documents obtained by this newspaper show that analysts from RAF Wyton in Cambridgeshire helped to scour social media posts by the public.
The MoS revealed in January how the Army's secretive 'information warfare brigade' was tasked with scrutinising online posts – an activity the Ministry of Defence, in public, repeatedly denied doing.
Now this newspaper can show that the military's assistance to Government cells, such as the Counter Disinformation Unit, based in the Department for Digital, Culture, Media and Sport, and Rapid Response Unit in the Cabinet Office was far more extensive than previously thought.
These Whitehall outfits were tasked with tackling 'disinformation' and 'harmful narratives' during the pandemic. Their activities have faced fierce criticism after it emerged they also collected legitimate social media posts questioning Government lockdown policies.
Dossiers were compiled on public figures including Tory ex-Minister David Davis, who questioned the modelling behind alarming Covid death toll predictions, and The MoS's Peter Hitchens.
The documents reveal defence chiefs privately conceded the military's work for the Government could pose a 'potential presentational risk of Defence 'spying' or conducting 'Psyops' on the UK'. But the MoD feared that if the Armed Forces did not help the Government's online monitoring, then 'harmful misinformation and disinformation' could spread.
Jake Hurfurt, of the campaign group Big Brother Watch, last night branded Whitehall's use of military personnel as 'an attack on freedom of speech' and 'behaviour befitting an authoritarian state'. He added: 'The revelations that the RAF as well as the Army spied on the British people during the pandemic is yet more evidence that the MoD misled the public about the role of its psyops troops in 2020.'
'These documents prove that Whitehall officials knew deploying the military to monitor social media posts from politicians, journalists and the press would look like spying – but they carried on anyway.'
The RAF and Army's assistance to Whitehall is detailed in documents outlining official requests known as 'Military Aid to the Civil Authorities' (MACA). These are normally used by the Government when military help is needed to respond to natural disasters.
The papers also show how in 2020 the Government was considering a dramatic expansion of the Counter Disinformation Unit by ordering monitoring of online chatter about Brexit and the NHS.
Mr Hurfurt last night demanded that the Covid Inquiry also investigate how the Government 'monitored the British people'.
Peter Hitchens was monitored after sharing an article, based on leaked NHS papers, which claimed data used to publicly justify the lockdown was incomplete.
An internal Rapid Response Unit email said Mr Hitchens wanted to 'further [an] anti-lockdown agenda and influence the Commons vote'.
The Government said: 'Online disinformation is a serious threat, which is why in the pandemic we brought together expertise from across government to monitor disinformation about Covid.
'The units used publicly available data, including material on social media. They did not target individuals or take action that could impact the ability to discuss issues freely.'
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Descriptive Analysis of Japanese Deaths Associated with Pfizer-BioNTech mRNA COVID-19 Vax: Troubling Data
A physician-researcher based at YASP Medical Information Laboratory for Dermatology in Aichi, Japan, 188 miles south of Tokyo, recently published in peer-reviewed Cureus the study “An analysis of the Association Between BNT162b2 mRNA COVID-19 Vaccination and Deaths within 10 Days After Vaccination Using the Sex Ratio in Japan.” The study finding “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
An important study as mass vaccination necessitates a higher level of safety than pharmaceuticals used for treatment, and consequently, should have an exceptionally low vaccination mortality rate. It’s important to analyze vaccine safety using statistical methods able to detect significant differences even when the vaccination mortality rate is exceptionally low.
Background
The author reports that “the association between coronavirus disease 2019 (COVID-19) vaccinations and deaths after vaccination has been investigated primarily through cohort and self-controlled case series studies. In the present study, the sex ratios of reported deaths were compared by period.”
The Study
In this descriptive analysis-based study, Dr. Yasusi Suzumura tapped into and extracted data on deaths reported after vaccination with the Pfizer-BioNTech COVID-19 mRNA vaccine called BNT162b2. The data used were published by the Ministry of Health, Labour and Welfare in Japan.
For the study’s risk period, Dr. Suzumura’s study defined this parameter as within 10 days of vaccination, with the control period defined as 11 to 180 days post-administration of the COVID-19 jab.
Using sex ratios to calculate all-cause deaths, for each outcome the researcher divided the number of males by females all by 100. Then, the study author performed Fisher’s exact test (categorical data that results from classifying objects in two different ways; it is used to examine the significance of the association) for outcomes analysis. Thereafter, the author used graphs to present the data, including the number of days from vaccination to death, plus the reported death outcomes.
Study Findings
During the risk period (0-10 days) all-cause deaths among elderly persons (aged ?65 years), Dr. Yasusi Suzumura reports a sex ratio of 92, which turns out to be “significantly lower than that during the control period (130) (p=0.0050).”
When analyzing the data for all-cause deaths of persons aged ?64 years, the authors report the sex ratio during the risk period was 204, significantly higher than that during the control period (111) (p=0.044).
“Reported deaths were concentrated during the risk period in both groups. Sex ratios by period for each outcome were also examined. However, the differences were not significant across any of the outcomes.”
Takeaway
According to the Japanese study author the Pfizer-BioNTech mRNA vaccination for all-cause deaths among those aged ?64 years, “vaccination may influence the occurrence of death during the risk period.”
The study finding here “indicates that the vaccination may influence the occurrence of death during the risk period and might be associated with death.”
TrialSite Breakdown
While a Japanese cohort study previously conducted led to no significant increase in all-cause mortality involving COVID-19 vaccination, the author points out, “This does not contradict the results of the present study.” While the previous cohort study points to support for COVID-19 vaccine safety, Dr. Suzumura points out that “This does not indicate that vaccine-related deaths are nonexistent; it only indicates that their number is not large enough to make a significant difference.”
On this occasion, it is difficult to determine whether a post-vaccination death is incidental or vaccine-related. A self-controlled risk interval design and a comparison of sex ratios by period may be useful in examining the association between vaccination and deaths after vaccination when a cohort study does not detect a significant difference due to a low mortality rate. The latter approach may be particularly useful for analyzing data with reporting bias. The author believes that this approach may not provide conclusive evidence, but it can offer valuable insights into assessing vaccine safety.
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10 December, 2023
Now BIDEN'S ex-Covid advisor admits pandemic may have been caused by a Wuhan lab leak - and warns there's a 50% chance of another pandemic by 2050
President Joe Biden's former Covid advisor has admitted the pandemic may have been borne out of a laboratory leak in Wuhan.
Speaking at a New York City health conference this week, Dr Raj Panjabi, former Special Assistant to the President, described the lab leak theory as 'plausible' and called on Governments around the world to 'do more to keep labs safe.’
Biden called former President Donald Trump 'nakedly xenophobic’ in May 2020, for suggesting Covid was the result of Chinese experiments gone wrong.
But now the FBI, Department of Energy and many scientists and US government officials believe it is the most likely origin of the pandemic.
However, the official line from Biden's White House is that the origin of Covid remains uncertain — a view echoed by National Security Advisor Jake Sullivan, who said there is 'no definitive answer' to the question.
But ex-Covid adviser Dr Panjabi appeared to veer away from the party line this week saying: ‘It is plausible that Covid originated in a lab accident in Wuhan...we have got to do more to keep labs safe.’
He also issued a chilling prediction: There's a 50/50 chance of another pandemic happening by 2050.
'The risk of a pandemic is only growing in the modern world,' Dr Punjabi said in a speech at the Forbes Healthcare Summit 2023 earlier this week.
'There is a 50 percent risk one will happen in the next 25 years. This is because of globalization, or what I call the three Ps.
‘These are: Pathogen spillover [when diseases jump from animals to humans]... planes [global travel], and poor public health systems that are shattered and lack investment.’
Dr Panjabi is a physician specializing in infectious disease and epidemiology. He has also been named as one of the 100 most influential people in the world by TIME magazine.
Panjabi worked for the Biden administration from 2021 to late 2023, playing a key role in two public health crises: the Covid-19 pandemic and the monkeypox outbreak that began in the Spring of 2022.
He also led the White House strategy for boosting Covid vaccine uptake in the US and abroad — a program that saw 1.1billion shots distributed to third-world countries.
Safety practices in US scientific laboratories are gaining increasing attention from Government officials, in a bid to prevent future pandemics.
Congress is currently considering tighter regulation of labs, with the House Energy and Commerce Committee currently holding hearings on the subject.
In September, Republicans escalated their Covid origins investigation, demanding the Biden administration and other politicians comply with their requests — or face being subpoenaed.
In a letter sent to HHS Sec. Xavier Becerra first obtained by DailyMail.com, the Republicans wrote they 'expect full and timely compliance' with their requests, which have gone unanswered since they launched the probe in February.
And Dr Anthony Fauci has finally agreed to testify to Congress on his involvement in the public cover up of Covid's origins.
The onetime White House doctor will be grilled on his former department's funding of dangerous experiments in Wuhan, as well as the stark difference between his public and private comments about the lab leak theory.
He is due to speak in front of the House in January, which will be the first time he has testified under oath since his infamous showdown in front of the Senate in July 2021.
The lab leak theory of Covid was dismissed as a conspiracy in the early days of the pandemic by leading figures including Dr Fauci.
Dr Panjabi is just the latest high ranking official to give credence to the lab leak theory, after Secretary of State Mike Pompeo, former top health official Dr Robert Kadlec and former national security director John Ratcliffe all came out in support of it.
Speaking to Sky News last month, Dr Ratcliffe said: ‘It’s more than just a possibility, it’s certainly a probability and it’s probably a certainty.’
Dr Rober Kadlec, who initially worked with Dr Fauci to hush the lab leak theory, has suggested in a report that Covid likely escaped during the work of scientist Dr Zhou Yusen at the Wuhan Institute of Virology (WIV).
He filed a patent for a Covid vaccine in February 2020, which suggested he had been working on it for months.
Countless reports have revealed lax practices at US labs - including a military research facility Fort Detrik, in Maryland.
The lab is accused of leaking Ebola and Anthrax into local water supplies in May 2018 after a tank holding wastewater from labs became over-pressurized and sprayed infectious waste for three hours.
There are also suggestions that pandemics have been caused by lab leaks before, including the 2004 and 2005 influenza outbreak.
Researchers said the strain that caused it bore a remarkable resemblance to one that had been spreading decades earlier.
https://www.dailymail.co.uk/health/article-12828911/biden-covid-advisor-lab-leak-Dr-panjabi.html
*******************************************Children With Respiratory Illnesses at Pediatric Centers More Likely to Be Hospitalized if Vaccinated: CDC Study
Children who reported to pediatric center emergency departments with respiratory illness and were hospitalized were more likely to have taken COVID-19 vaccines, according to a new study from the U.S. Centers for Disease Control and Prevention (CDC).
More than half of vaccinated children included in the study were admitted to hospitals as inpatients, compared to less than half of unvaccinated children.
The study examined children aged 6 months to 4 years who went to emergency departments at one of seven pediatric medical centers, including Children's Hospital of Pittsburgh and Seattle Children's Hospital. Some of the children were admitted to hospitals. The encounters happened as early as July 1, 2022, and as late as Sept. 30, 2023.
The children needed to have one or more symptoms indicating acute respiratory illness, such as fever, cough, or shortness of breath.
The overwhelming majority of the young children in the study never received a dose of a vaccine. That group of 6,377 far outnumbered the 281 children who received one dose and the 776 children who received at least two doses. Across the United States, most young children are unvaccinated.
Of the unvaccinated children in the study, 44 percent were hospitalized. Of the vaccinated, 55 percent were hospitalized.
"This means that upon visiting hospital emergency departments, compared to unvaccinated children, vaccinated children had *increased* risks of inpatient hospitalization, very statistically significantly so," Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, who was not involved with the study, told The Epoch Times in an email.
Vaccinated children were also more likely to receive intensive care, need supplemental oxygen, and die, according to the paper, though just three deaths were recorded among the study population and some of the differences were not statistically significant.
The CDC's media office, which promoted the study, told The Epoch Times in an email: "Although proportionally more hospitalized children had received a COVID-19 vaccine than children enrolled in the emergency department (ED), this does not mean that vaccinated children were more likely to be hospitalized."
The CDC also said the paper showed that vaccination was "effective at reducing emergency department visits and hospitalizations in children."
Dr. Eyal Shahar, an epidemiologist at the University of Arizona who reviewed the study, noted that the vaccinated children had worse underlying health. "That largely explains worse outcomes," Dr. Shahar told The Epoch Times via email. "We cannot attribute the outcomes to vaccination."
The CDC published the paper in its quasi-journal. Papers published by the journal are typically not peer-reviewed but are shaped to align with CDC policy. The CDC currently recommends COVID-19 vaccination for nearly all Americans, regardless of prior infection or underlying health.
The study's authors, some of whom work for the CDC, said the study showed that "receipt of ?2 COVID-19 mRNA vaccine doses was 40% effective ... in preventing emergency department visits and hospitalization," referring to the Pfizer and Moderna modified messenger RNA (mRNA) vaccines.
The authors reached that conclusion after separating out patients who tested positive for COVID-19. There were 387, with 94 percent unvaccinated. The unvaccinated were only 85 percent of the study population, indicating they were at higher risk of visiting an emergency department with respiratory illness and then testing positive for COVID-19.
"No one cares whether the vaccines reduce COVID-associated hospitalization if at the same time they increase non-COVID-associated hospitalization," Dr. Risch said.
The researchers estimated that the effectiveness of one vaccine dose against emergency department presentation or hospitalization was 31 percent, increasing to 40 percent for at least two doses.
Dr. Tracy Beth Hoeg, an epidemiologist in California who reviewed the paper, said that the authors inappropriately inferred causality despite the study being observational.
"They should have said 'was associated with lower rate of...' rather than 'was effective in preventing,'" Dr. Hoeg told The Epoch Times via email.
The researchers did not present separate estimates for protection against hospitalization and emergency department visits, nor did they track how the effectiveness estimates changed over time. Vaccine effectiveness has been shown to drop over time in other studies.
Regarding effectiveness, the authors referred to an earlier CDC-published study that estimated vaccination provided from 7 percent to 80 percent protection against COVID-19-associated urgent care counters and emergency department visits. A third CDC-published study estimated protection against symptomatic COVID-19 infection among young children was typically under 50 percent.
Vaccines are supposed to provide at least 50 percent protection, according to U.S. Food and Drug Administration (FDA) and World Health Organization guidance.
Dr. Heidi Klein, who works for the CDC, and Dr. Eileen Klein, an emergency medicine doctor at Seattle Children's Hospital, did not respond to requests for comment. They were listed as the new study's senior authors.
The conflicts of interest described were lengthy, with three authors reporting funding from Pfizer.
Limitations of the paper, the authors said, included the low number of vaccinated children.
"This appears to be another substandard observational study of vaccine efficacy in children published without peer review by the CDC. The list of limitations is a mile long and understates the study's methodological limitations," Dr. Jay Bhattacharya, a professor of health policy at Stanford University who reviewed the study, told The Epoch Times via email. "If the CDC wants to answer the question of COVID vaccine benefits and harms to children, it should commission a large, rigorous, randomized trial with meaningful clinical endpoints like prevention of hospitalization and death."
More on Methods
Researchers collected data for the study through interviews with parents, chart reviews, and immunization records.
All children included had signs of acute respiratory illness.
Children who tested positive for COVID-19 were considered case patients while controls were children who tested negative for COVID-19.
Exclusions included children whose illness lasted more than 10 days, children without verified vaccination status, and children with inconclusive COVID-19 test results.
Ninety-five percent of the children tested negative for COVID-19. Many tested positive for other viruses, such as rhinovirus. Out of 7,434 children, just 387 tested positive for COVID-19.
Those children fared worse by many measures than those who did not, including having a higher probability of needing supplemental oxygen.
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7 December, 2023
Next Generation mRNA COVID-19 Vax Shows Promise in Preclinical Studies
A novel mRNA vaccine developed by GreenLight Biosciences demonstrates significant potential in preclinical animal studies. Does the market need more COVID-19 vaccines? Well, while the market for the existing COVID-19 vaccines have collapsed for now, COVID-19 will likely be around ongoing. As surges may worsen in the future, next generation vaccines will be needed, ones that are more effective, including ones more durable and safer.
This experimental mRNA vaccine encodes for the full-length SARS-CoV-2 Wuhan wild-type spike protein.
What’s the candidate?
GLB-COV2-043, positioned to be a low-cost mRNA vaccine targeting COVID-19.
So how does this early-stage, investigational vaccine differ from say Pfizer-BioNTech’s BNT162b2 or Moderna’s mRNA-1273?
For starters, TrialSite has referred to the above vaccines as version “1.0” or first-generation mRNA vaccines. The current authors concur, however, and not surprisingly, are very careful with their language in the journal entry. Referring to those first mRNA vaccines as “the first-generation mRNA vaccines, encoding for a prefusion stabilized version of the spike (S) protein of SARS-CoV-2 wild-type (Wuhan-Hu-1) strain,” they insert the customary (and likely mandatory) reminder that these current vaccines are considered “safe and highly effective in preventing severe COVID-19 disease, hospitalization, and death in clinical trials,” and therefore authorized for emergency use in humans.
But the authors go on to discuss in pre-clinical research the promise for GLB-COV2-043-driven durability. That is the ability for the vaccine to induce long-term memory responses and durability of binding and neutralizing antibodies against homologous strain and several heterologous variants of SARS-CoV-2.
Also investigating a third booster jab, the data at least thus far suggests GLB-COV2-043 elicits short and long-term potent humoral and cellular immune responses in C57BL/6 mice.
They also point out the success of GLB-COV2-043 in protecting Golden Syrian hamsters in a challenge model against Omicron BA.1 virus.
What about safety?
Thus far tests (cGLP Toxicology study) in Sprague Dawley Rats suggest that GLB-COV2-043 is well-tolerated and effects attributed were consistent with the immunological and inflammatory changes associated with the intramuscular administration of an immunogenic mRNA vaccine.
What’s the delivery technology?
The delivery mechanism involves modified mRNA and lipid-nanoparticle (LNP) technology.
What are pre-clinical results to date?
Studying the vaccine in mice, the researchers from GreenLight finding that GLB-COV2-043 induces robust antigen-specific binding and virus-neutralizing antibody responses targeting both homologous and heterologous SARS-CoV-2 variants and a TH1-biased immune response, as reported by the study authors in a recent entry in the peer-reviewed journal Nature.
The authors point out:
“Boosting mice with monovalent or bivalent mRNA-LNPs provided rapid recall and long-lasting neutralizing antibody titers, an increase in antibody avidity and breadth that was held over time and generation of antigen-specific memory B- and T- cells.”
Further study in hamsters found injecting GLB-COV2-043 led to lower viral loads, reduced incidence of SARS-CoV-2-related microscopic findings in lungs, and protection against weight loss after heterologous challenge with Omicron BA.1 live virus.
What’s the takeaway?
Results show that the “GLB-COV2-043 mRNA-LNP vaccine candidate elicits robust protective humoral and cellular immune responses and establishes our mRNA-LNP platform for subsequent clinical evaluations.”
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UK Covid Inquiry Continues with New Testimony, Some Provocative Speakers Show Up
The ongoing Covid Inquiry in the United Kingdom continues this week with former prime minister Boris Johnson finally facing two days of questions about the British government’s actions during the pandemic. The Inquiry is being led by Baroness Heather Hallett in several locations in London. As TrialSite has reported the Inquiry aims to offer a review of the government pandemic response, lessons learned from mistakes with the goal of improving the next pandemic response. Some speakers considered proactive traveled across the pond to discuss problems with the COVID-19 vaccine response at the request of controversial MP Andrew Bridgen. The MP doesn’t trust the formal COVID-19 narrative.
Dealing with the Pandemic
So far, the inquiry has covered topics such as, Resilience and Preparedness, Core UK Decision Making and Political Governance, the impact of Covid-19 on the healthcare system and Vaccines and Therapeutics. On that note, one specific conference led by KC Anne Morris deals with the Vaccine Injured. The vaccine compensation system is a disaster, much like in the United States. According to Morris, the vaccine scheme doesn’t work, it’s not “fit for purpose….”
Apparently, the Inquiry has some influence and can determine if reform to the compensation scheme is necessary. According to the Daily Mail, at least 6,399 claims have been filed with over 500 individuals waiting over a year to get a decision. 166 are “stuck in limbo for more than 18 months,” lawyers told the Inquiry. And as mentioned previously, 127 claims have been approved, state-funded financial support totaling over $18.7 million.
A Different Narrative: COVID-19 Vax Critics Contribute
Yesterday, a panel of experts well known to openly question governments’ top down, rigid response to COVID-19—some even attacked and branded as “conspiracy theorists” testified in front of over twenty members of parliament.
The panel of experts included Dr David E. Martin, Dr Robert Malone, Dr Ryan Cole, Dr Pierre Kory, Professor Angus Dalgleish and Steve Kirsch, the latter being a particularly extreme anti-COVID-19 vaccine advocate. Steve Kirsch has gone on the record that far more people have been killed by the vaccines than saved. While the mainstream medical establishment evades Kirsch, the wealthy Silicon Valley entrepreneur continuously seeks to find smoking gun evidence to shut down the countermeasure program.
Dr. Robert Malone became relatively famous, or infamous, when he went on the Joe Rogan show, and is associated with at least one of the types of research workstreams involved in early mRNA laboratory work. Malone has branded himself as “the inventor of mRNA technology” and has established a substantial platform to call out and question governments’ responses to the pandemic.
Malone, who is now branded an anti-vaxxer by elements within the U.S. said about the Covid vaccine, “What we have here is a rushed product. A rushed technology. A failure to provide respect for humans in not allowing them to have informed consent. And furthermore, actively deploying the most massive propaganda campaign in the history of the modern world, to suppress the ability of the public to gain access-merely to have the knowledge- of what the adverse event risks are. I come to you with one request- open the books! Let’s see the data and let’s allow the data to be examined so we can actually get to the bottom of the most important question the world is facing: were these products actually safe and effective?”
They also mentioned the question of the origin of the Covid virus, and the cover up of early treatments for the disease. Malone also brought up the side effects of the Covid vaccine including myocarditis and the possibility of reproductive damage to women. While there is some peer -reviewed evidence for at least temporary altering of menstrual cycles, there is no direct evidence that the vaccines permanently damage the reproductive system. Malone also emphasized the importance of transparency and the need to access COVID-19 vaccine injury data.
Boris Johnson Expected
The British mainstream media acknowledges members of their Government are under examination and should be treated as severely as how Britons were treated by the Government during what is being referred to as “the Great Panic of 2020-21.” Boris Johnson, the former prime minister, is expected to appear at the inquiry and will be questioned.
The questioning will be a rare opportunity for Johnson to face close scrutiny about the decisions he made during the pandemic, a time when he breached the lockdown rules which he was urging others to follow. The ex-PM is also expected to apologize to the Covid Inquiry because he didn’t get everything right during the pandemic, but he was correct on the “big calls”. Apparently, Johnson has to do some reputation management.
Johnson’s Skill Set
According to Johnson’s former director of communications, Lee Cain, the pandemic was the wrong crisis for Johnson’s skill set, with Cain saying there was “dithering and delay”. This is not the only criticism coming from people who served in the UK government with Johnson. The former chief scientific officer, Sir Patrick Vallance claims Johnson was "bamboozled" by scientific data. Vallance has contradicted himself by also saying “we should have "Locked down harder, earlier.”
The chief scientific adviser to the government did a complete U-turn on what he said to start with! Vallance also revealed he was “reprimanded” by a couple of civil servants when calling for the lock down action by mid-March 2020. While Boris Johnson announced the Covid-19 response by March 23, Vallance shared he privately thought the lockdowns should commence on March 14 or 15. Another former advisor, Dominic Cummings, described the former prime minister as “the trolley” due to his tendency to veer around and constantly change his mind. Johnson’s sister, Sarah, claims the inquiry is just a “show trial” to scapegoat those who were in government during Covid.
Boris Johnson is expected to make an apology on behalf of the government over his early handling of the pandemic, but he’ll defend his personal behavior, obviously over the “party gate” scandal when the PM didn’t adhere to the rules he set for others. Ironically, in Sir Patrick Vallance’s diaries, he claims Johnson, when he was prime minister, pushed to “punish people who aren’t doing the right thing” and for “massive fines” when it came to lockdown rules.
Former Prime Minister to Face Tough Questions
Johnson may be asked specific questions like, “Was the UK too slow to impose lockdowns?” “Did the former PM really say, “let the bodies pile high?” and other similar statements when discussing the idea of a lockdown in 2020. It’s also claimed Johnson said, “Covid is nature’s way of dealing with old people.”
Families of Covid victims are expected to confront Johnson at the inquiry. The former prime minister will be quizzed under oath, and reportedly, Johnson is uncomfortable taking questions so much so, supposedly he once hid in a refrigerator in order not answer inquiries. However, as uncomfortable as Johnson is, the British public may finally get some answers.
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6 December, 2023
Systematic Study Finds No Good Evidence for Masking Benefit for Children Inhibiting SARS-CoV-2 Transmission & Infection
A group of physician-researchers from the San Francisco Bay Area screened 597 studies culling that number down to 22 in a systematic analysis investigating the benefits of children masking during the pandemic. Adversely impacting the weight of the evidence is the fact that no randomized controlled trials involving children were used. So, any findings one way or the other in regard to its impact on SARS-CoV-2 infection or transmission would benefit for more evidence. The six observational studies reporting an association between child masking and lower infection rate or antibody seropositivity had critical (n=5) or serious (n=1) risk of bias, according to the study’s authors.
All six of those studies are likely confounded by important differences between masked and unmasked groups. Upon reanalysis, two of the studies were shown to have non-significant results. Sixteen other observational studies found no association between mask-wearing and infection or transmission. The authors such as Dr. Tracy Hoeg, known to be critical of the government’s response to COVID-19, used this systematic review to assess the state of mask wearing in children, what are the outcomes? The authors report that based on the observation of real-world outcomes, the evidence for the benefit of child masking as a non-pharmaceutical intervention to reduce COVID-19 transmission or infection is weak.
During the pandemic, one of the most controversial interventions was the use of masking requirements to improve public health to protect against COVID-19. This research divulges that such requirements—to enforce masking in places like public schools, “appear to be entirely based on mechanistic and observational data, and a systematic review assessing the evidence has not been performed.”
This counters others meta-analysis studies showing masking actually helped. On the other hand, reviews of some of the evidence suggest dependence on “junk science.”
Here, the peer-reviewed systematic study published in The BMJ showed 16 studies point to a lack of mask efficacy, while six studies point to some associated protective outcome, but the limitations of these latter investigations cannot be ignored due to the risk of bias. had critical or serious risk of bias.
The authors point out, “Because benefits of masking for COVID-19 have not been identified, it should be recognized that mask recommendations for children are not supported by scientific evidence.”
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The Epistle of Paul to the Americans: Exposing White Coat Supremacy
“Why would a virologist, who is also the head of the CDC not be included in discussions concerning the origin of COVID-19?” wonders Sen. Rand Paul (R-Ky.), the only member of Congress to call out Dr. Anthony Fauci in a conflict thoroughly chronicled in his latest book, Deception: The Great Covid Cover-Up.
That CDC leader is Dr. Robert Redfield, a veteran of the Army Medical Corps, co-founder of the University of Maryland’s Institute of Human Virology, and vice chair of medicine at the University of Maryland. Dr. Fauci, head of the National Institute of Allergy and Infectious Diseases (NIAID) since 1984, excluded Redfield from meetings because “[he] was open to the possibility that COVID-19 could have leaked from the Wuhan lab,” Sen. Paul tells his readers. For that position, Redfield received death threats.
“COVID-19 seemed to show up in Wuhan instantly pre-adapted to transmit easily in humans,” notes Paul, a medical doctor. His account shows, in an understandable way, how this can be achieved, and how gain-of-function research can make viruses more lethal and transmissible.
As Sen. Paul pointed out, Dr. Fauci funded that kind of research at the Wuhan Institute of Virology (WIV) and then lied about it to Congress, which is a crime. Readers get full exchanges, and Dr. Fauci’s deception stands out in stark relief. Paul also exposes Fauci’s “yes-men,” who spotted the lab origin but changed their mind under pressure from the NIAID boss who controls their funding.
Sen. Paul Calls Out Fauci’s Lies
Fauci “commissioned and pre-approved” a paper titled “The proximal origin of SARS-CoV-2,” to back the position that the COVID virus arose naturally in the wild. To refute the paper, Paul taps scientists much more qualified than Fauci or Peter Daszak, the conduit for U.S. funds to the WIV. As Paul contends, “the viral backbone could simply have been one of the many unreported viruses held at the Wuhan Institute of Virology.” Many of them were in fact reported, right from the start.
In January 2020, Israeli molecular biologist Dr. Dany Shoman published China and Viruses: The Case of Dr. Xiangguo Qiu. According to Dr. Shoham, the “main culprit” in the transfer of deadly pathogens to China is Xiangguo Qiu, an “outstanding Chinese scientist” who came to Canada for graduate studies in 1996 and came to head the Special Pathogens program at Canada’s National Microbiology Laboratory (NML) in Winnipeg. Since 2006, Dr. Qiu has been “studying powerful viruses—Ebola most of all—at the NML.”
The viruses that were surreptitiously shipped from the NML to China included Machupo, Junin, Rift Valley Fever, Crimean-Congo Hemorrhagic Fever, and Hendra. In 2017 and 2018 alone, Qiu made at least five trips to the Wuhan lab. This too was ignored by the establishment media, which hurled charges of “conspiracy theory” at anything less than worshipful of Dr. Fauci. As Paul notes, in the spring of 2021, CNN was still claiming that the lab leak hypothesis was “a controversial theory without evidence.”
Fauci and his men “had a conflict of interest,” and were fully aware that “the billion-dollar ‘business of science’ could be damaged if the public becomes aware that the pandemic may have originated in a lab.” At the time of his writing “not one Democrat committee chairman has consigned the release request for COVID records from the Biden administration.” As Paul learned from experience, “[N]ot only is the intelligence community hiding documents that implicate China in the origins of the pandemic, they are now directing social media companies to restrict speech across America.”
As Paul recalls, some people had little to no symptoms with COVID infection, “but as usual, Fauci was convinced that anything that gave hope to people, anything that might lessen the arguments for lockdowns, mask mandates and universal vaccines must be dismissed out of hand.” COVID vaccine mandates, “should not be dictated by anyone who stands to gain monetarily,” but Paul finds this simple principle “still not understood or accepted.”
During the pandemic, “fear gripped the nation, and where we needed calming and reasoned voices, alarming sirens of hysteria dominated the airwaves. A free people let down their guard and the impulse to authoritarianism sprouted and multiplied.” All true, but there was more to it.
White Coat Supremacy
In the pandemic, “we had entered a frightening new era of medicine, where the training and expertise of one’s physician are secondary to the rigid rules and edicts of government bureaucrats.” Sen. Paul charts the dangers and dynamics of white coat supremacy, and he hasn’t forgotten Fauci. The NIAID boss wielded executive-level power without ever facing the voters.
“Despite his extraordinary accumulation of power over nearly four decades,” Paul observes, “the Senate never once voted to confirm Anthony Fauci.” As readers of Deception should know, the reality is much worse.
Fauci earned a medical degree in 1966 but if he ever practiced medicine it was only for a short time. In 1968, to avoid service treating American GIs, Dr. Fauci took a cushy “yellow beret” job with the National Institutes of Health. Dr. Fauci’s bio showed no advanced degrees in biochemistry or molecular biology but by 1984 he was heading the National Institute of Allergy and Infectious Disease (NIAID).
Back in the 1990s Nobel laureate Kary Mullis, inventor of the polymerase chain reaction (PCR), went on record to say that Fauci “doesn’t understand electron microscopy and he doesn’t understand medicine. He should not be in a position like he’s in.” Fauci should never had the job in the first place.
The NIAID boss predicted that AIDS would ravage vast swaths of the population, which never happened. (See Inventing the AIDS Virus by Peter Duesberg and The Myth of Heterosexual AIDS by Michael Fumento.) Despite the failure, Fauci expanded his power in devious ways.
In 1995, NIH nurse Christine Grady authored The Search for an AIDS Vaccine: Ethical Issues in the Development and Testing of a Preventative HIV Vaccine. The author justifies dangerous drug trials on children and pregnant women and touts Dr. Fauci without revealing that she had been married to him for 10 years.
The NIH failed to reveal the relationship when they named Grady chief of the Department of Bioethics of the NIH Clinical Center in 2012. It was the mother of all conflicts of interest, justifying Fauci’s drug trials with black foster children in New York, as Robert F. Kennedy noted in The Real Anthony Fauci.
During the 1980s, Fauci fast-tracked approval of AZT (azidothymidine), a DNA chain terminator forced on the foster children with tragic results. Biologist Rebecca V. Culshaw, author of The Real AIDS Epidemic, finds a parallel with the rush to approve mRNA vaccines for COVID. That was “essentially a massive clinical trial was conducted in real time on the entire population,” including children, the group least vulnerable to the disease. Children also lost valuable school time due to Fauci’s lockdown policies.
Sen. Paul was the only member of Congress to challenge Dr. Fauci, a Lysenko figure wielding extraordinary power but never held to account. Invaluable for the general reader, Deception: The Great Covid Cover-up would be a fine Christmas gift for members of Congress. At first opportunity Congress, should slash the NIAID budget, limit the director to one four-year term, and above all investigate Dr. Anthony Fauci. The struggle against white coat supremacy is the struggle of memory against forgetting.
https://www.independent.org/news/article.asp?id=14751&omhide=true&trk=rm
********************************************************5 December, 2023
CDC Study of Young Children: COVID-19 mRNA Vaccines Bomb, Fail WHO Threshold--Agency Still Promotes Universal Immunization
The Centers for Disease Control and Prevention (CDC) sponsored the latest Morbidity and Mortality Weekly Report (MMWR) focusing on the epidemiology of COVID-19 mRNA vaccine effectiveness concerning young children ranging in age from 6 months to 4 years. tracking vaccine effectiveness from July 2022, to September 2023.
Represented by epidemiologist and corresponding author Heidi Moline, M.D., Ph.D., a large study team acknowledges first and foremost, that “SARS-CoV-2 infection in young children is often mild or asymptomatic; however, some children are at risk for severe disease.” While agencies such as the CDC have promoted universal vaccination for children aged 6 months and up regardless, data as to the protective effectiveness of the mRNA vaccines developed as countermeasures by Pfizer-BioNTech and Moderna have been limited.
The results here, while touted by the authors as reinforcing the universal vaccination position of the CDC, fail a standard World Health Organization threshold for vaccine effectiveness. In fact, Moderna’s vaccine effectiveness in preventing ER or hospitalization equals 29% for two-dose mRNA primary series. This is not preventing infection, but more severe outcomes.
To be approved, vaccines are required to have a high efficacy rate of 50% or above according to the World Health Organization (WHO). After approval, they continue to be monitored for ongoing safety and effectiveness. See link to the WHO.
In this CDC-sponsored study, the investigators use data from a prospective population-based surveillance system called the New Vaccine Surveillance Network.
Tapping into collecting, categorizing and analyzing this data led to estimates of vaccine effectiveness using a test-negative, case-control design. Including 7,434 children included, 5% received a positive SARS-CoV-2 test result, and 95% received a negative test result; 86% were unvaccinated, 4% had received 1 dose of any vaccine product, and 10% had received ?2 doses.
According to this observational class of study when comparing unvaccinated children with those children receiving ?2 COVID-19 mRNA vaccine doses the authors report a 40% effective (95% CI = 8%–60%) rate in preventing ED visits and hospitalization. The authors exclude any investigation into vaccine safety, suggesting a form of bias, as a true risk-benefit analysis would need such information.
What is the New Vaccine Surveillance Network (NVSN)?
NVSN conducts population-based, prospective surveillance for acute respiratory illness (ARI) in children at seven pediatric medical centers. The centers include Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania; Children’s Mercy Hospital, Kansas City, Missouri; Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio; Golisano Children’s Hospital, Rochester, New York; Seattle Children’s Hospital, Seattle, Washington; Texas Children’s Hospital, Houston, Texas; Vanderbilt University Medical Center, Nashville, Tennessee.
How many children received no vaccine?
86%
Were there racial and ethnicity differences in COVID-19 vaccination rates for this vulnerable cohort?
Yes. Compared with White children, Black children were about seven times less likely, and Hispanic/Latino children were approximately three times less likely to have received ?2 doses of the COVID-19 vaccine.
What was the overall incidence of COVID-19?
Low. Only 5% of children with symptoms turn out to be COVID-19 positive. Also, the authors report co-detections of other respiratory viruses were present in approximately one-third of children who received positive SARS-CoV-2 test results.
So, what was the vaccine's effectiveness in preventing ED visits and hospitalization?
40%. It ranges as low as 8%. Moderna primary series equals 29%.
Do the CDC authors acknowledge the impact of previous exposure/natural immunity in reducing severity of COVID-19 in this young cohort?
Yes.
So, is 40% vaccine effectiveness sufficient for typical standards?
No, especially not 40% against ER or hospitalization. As TrialSite suggests above, WHO recommends 50%. See the link.
What is the rationale for the ongoing recommendation?
According to the authors' own logic, we are not certain. It appears that it's just a generic stance the CDC takes without critically vetting the data. The study authors point out that “Despite low vaccination coverage and the circulation of several Omicron subvariants, COVID-19–associated ED visits and hospitalization among children with ARI enrolled in NVSN were rare, suggesting most children in this age group experience mild illness from these subvariants or have immune protection from previous SARS-CoV-2 exposure (7). These findings indicate that COVID-19 mRNA vaccines are protective and are consistent with other VE estimates for this age group, ranging from 29% for 2-dose Moderna coverage to 43% for 3-dose Pfizer-BioNTech coverage (5); however, low vaccination coverage and low incidence of medically attended COVID-19 limit precision in these VE estimates.”
What are some key limitations?
First and foremost, a vaccine’s efficacy is measured in a controlled clinical trial and is based on how many people who got vaccinated developed the ‘outcome of interest’ (usually disease) compared with how many people who got the placebo (dummy vaccine) developed the same outcome. This class of study does not indicate causation.
Other limitations provided by the authors include
1) seroprevalence of infection-induced SARS-CoV-2 antibodies in children and adolescents has increased over time, which might affect vaccine effectiveness estimates and assessment of severe outcomes, as more children have immunity from previous SARS-CoV-2 infection
2) low vaccination coverage might indicate that vaccinated children are systematically different from unvaccinated children;
3) NVSN data might be subject to enrollment biases that might vary by site, such as number of enrollment days per week and availability of interpreters for non-English speakers;
4) low vaccination coverage and disease incidence limit the precision of the point estimates and were too low to analyze data by time since dose or to stratify by setting or product and
5) Moderna vaccine is administered as a 2-dose primary series whereas Pfizer-BioNTech requires 3 doses, and receipt of ?2 doses might underestimate the protection afforded by the complete 3-dose Pfizer-BioNTech primary series.
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Skin Disorders Post-COVID-19 Vaccinations
The purpose of the present Op-ed is to identify the scope and number of occurrences of skin and subcutaneous tissue disorders (hereafter abbreviated as skin disorders) that occur following COVID-19 vaccinations.
What are skin disorders? “Skin diseases are conditions that affect your skin. These diseases may cause rashes, inflammation, itchiness or other skin changes. Some skin conditions may be genetic, while lifestyle factors may cause others”. For purposes of this Op-ed, skin disorders encompass Angioedema and urticaria, Cornification and dystrophic skin disorders, Cutaneous neoplasms benign, Epidermal and dermal conditions, Pigmentation disorders, Skin and subcutaneous tissue disorders Not Otherwise Classified, Skin and subcutaneous tissue infections and infestations Not Otherwise Classified, Skin appendage conditions, Skin neoplasms malignant and unspecified, Skin vascular abnormalities.
While cardiovascular disorders, cancers, immune system disorders, and neurological disorders post-COVID-19 vaccination have been studied to a modest extent, skin disorders following COVID-19 vaccination have not been studied to nearly the same extent. This Op-ed will examine a very broad spectrum of skin disorders following COVID-19 vaccinations as reported by VAERS (Vaccine Adverse Events Reporting System). Additionally, the COVID-19 results will be compared to similar results following influenza vaccinations.
METHODOLOGY
Because of the extensive use of the MedDRA (Medical Dictionary for Regulatory Activities) vocabulary in this study, the MedDRA vocabulary will be discussed before the specific methodology is presented. “VAERS uses the MedDRA vocabulary to represent each of the ~18,000 symptoms listed in VAERS. MedDRA consists of five hierarchical levels of symptoms/diseases: System Organ Class (SOC), High-Level Group Terms (HLGT); High-Level Terms (HLT); Preferred Terms (PT); Lower Level Terms (LLT). Only a subset of the bottom level (LLT) is used for the VAERS terminology”. There are 27 SOCS in MedDRA, one of which is Skin and Subcutaneous Tissue Disorders. In the present Op-ed, all the LLT terms that are contained within the Skin and Subcutaneous Tissue Disorders SOC in the full MedDRA database are used to query the VAERS database.
Also, as stated by Medalerts, “the full MedDRA has 87,592 LLT [lowest level terms) symptoms, but VAERS uses only 17,679 (20%).” The MedDRA terms in any category are determined by groups of experts, and are associated with subjectivities and uncertainties that accompany any group decisions.
Now, the specific methodology used to obtain the results will be described. On 23 November 2023, the VAERS database (current as of 27 October 2023), was accessed through CDC Wonder, and all the symptoms were retrieved for COVID-19 vaccines, including those with zero entries. The same type of retrieval was done for influenza vaccines. To obtain the VAERS results for post-COVID-19 vaccination skin disorders, the final list of 6033 MedDRA LLT terms (see Appendix 1 for the specific MedDRA query used to identify skin disorder-related symptoms in VAERS) was intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-COVID-19 vaccination (see Appendix 2 for the VAERS COVID-19 results).
Selected VAERS skin disorder results post-COVID-19 vaccinations were also compared to selected VAERS skin disorder results post-influenza vaccinations, using similar numbers of vaccine doses administered. To generate these similar numbers of vaccine doses administered, the influenza VAERS results were retrieved for the period 2019-2023, while the COVID-19 VAERS results were retrieved for the period 2021-2023.
To obtain the VAERS results for post-influenza vaccination skin disorders, the final list of 6033 MedDRA LLT terms was also intersected with all the ~18,000 VAERS terms to identify VAERS symptoms related to skin disorders post-influenza vaccination (see Appendix 3 for the VAERS influenza results).
RESULTS AND DISCUSSION
VAERS Symptoms Related to Skin Disorders Post-COVID-19 Vaccination
The VAERS symptoms related to skin disorders that occurred post-COVID-19 vaccinations are listed in Appendix 2, Table 1. There were 766 symptoms with a non-zero number of events, and a total of 448,517 events. The parallel numbers for post-influenza vaccination are 317 symptoms with a non-zero number of events, and a total of 29,592 events.
To translate from VAERS numbers to real-world numbers, the VAERS numbers (which are strongly under-reported) must be multiplied by an under-reporting factor (URF), to produce real-world numbers. My latest Op-eds use a URF of 66. With that assumption, the total real-world number of skin disorder symptom events post-COVID-19 vaccinations is 448,517 x 66, which equals approximately 29.6 million skin disorder-related events post-COVID-19 vaccinations.
The skin disorders post-COVID-19 vaccinations cover a wide range of symptoms, some of which can be very serious. These latter symptoms include (but are not limited to) Pemphigus vulgaris (52 events), Stevens-Johnson syndrome (43), Toxic epidermal necrolysis (8), Toxic shock syndrome (5), Necrotising fasciitis (16), DRESS syndrome (30) and myriad Skin cancers that are addressed later in this study (168) (link#1; link#2).
Comparison of Skin Disorders Post-COVID-19 Vaccinations and Post-Influenza Vaccinations
Table 1 contains a comparison of selected high/mid-frequency VAERS-related skin disorders terms post-COVID-19 vaccinations and post-Influenza vaccinations. It has been subdivided into five groups. The first group shown in the table (HIGH #COV; ZERO #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, but did not occur at all in VAERS post-influenza vaccinations.
The second group shown in the table (HIGH #COV; 1 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and once in VAERS post-influenza vaccinations. As in the first group, the most frequent symptom relates to increased skin sensitivity.
The third group shown in the table (HIGH #COV; 2 #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred twice in VAERS post-influenza vaccinations.
The fourth group shown in the table (HIGH #COV/#FLU RATIO) contains symptoms that occurred frequently in VAERS post-COVID-19 vaccinations, and occurred much less frequently in VAERS post-influenza vaccinations. As in the first three groups, many types of skin disorders are shown, and there appears to be no central theme.
The fifth group shown in the table (HIGH #COV; HIGH #FLU) contains symptoms that occurred moderately frequently in VAERS post-COVID-19 vaccinations, and occurred moderately less frequently in VAERS post-influenza vaccinations. It is a small group, with symptoms mainly related to injection site issues.
https://www.trialsitenews.com/a/skin-disorders-post-covid-19-vaccinations-23bc7188
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US Military Study on Postvaccination Myocarditis Released
A small U.S. military study on postvaccination myocarditis has been quietly released, with authors saying they found no overt or subclinical heart inflammation.
Outside experts said the study did show some concerning signs and that the military researchers failed to explore those signs further.
The U.S. military was one of the first entities in the world to detect myocarditis and a related condition, pericarditis, after COVID-19 vaccination. The military also mandated COVID-19 vaccination for the force.
With those facts in mind, "it is particularly important to understand the prevalence of subclinical myocarditis/pericarditis along with the potential for additional complications," the authors of the new paper said.
The researchers recruited people who received a Pfizer or Moderna modified messenger RNA (mRNA) shot, were between 12 and 40 years of age, and were enrolled in TRICARE, which provides health care for many service members and their family members. The people received a second or subsequent dose of a vaccine between June 2022 and June 2023.
Participants visited investigators within 24 hours of and three to seven days after vaccination. Their symptoms, troponin T levels, and C-reactive protein were measured. Researchers also used electrocardiograms on the patients.
Thirty people ended up being part of the study, with 23 being active-duty military members. Four had a jump in troponin T, an indicator of subclinical heart damage, from 1 to 16 nanograms a liter after vaccination. However, the researchers said none had subclinical myocarditis because they defined subclinical myocarditis as an increase of more than 20 nanograms a liter. A fifth participant reported chest pain and shortness of breath, two possible signs of heart inflammation, but did not have a rise in troponin T.
"This is the first study to report on signs or symptoms of myocarditis/pericarditis collected through active surveillance following administration of mRNA vaccination in a military setting," Dr. Richelle Homo, a pediatric resident at Madigan Army Medical Center and a fellow at Brooke Army Medical Center, and her co-authors wrote.
The authors acknowledged that the study was not large enough to estimate the incidence of myocarditis after vaccination "due to the unpredictable nature of the pandemic and delays in recruitment." By June 2022, many people, including military members, had stopped getting COVID-19 vaccines.
"Nonetheless, the absence of myocarditis/pericarditis in this study offers some reassurance. As mRNA technology continues to advance, a deeper understanding of the incidence and extent of these complications will be necessary to ensure populations are well informed on the risks, benefits and potential need for monitoring following administration," the authors added.
The paper was published by the British Medical Journal.
Experts Weigh In
Several experts who reviewed the paper said the study did not provide any reassurance due to its small population and the definition of subclinical myocarditis.
Rates of clinical myocarditis, or heart inflammation manifesting through symptoms, run around 1 in 3,000 to 6,000 in multiple previous studies.
Defining subclinical myocarditis as troponin raised to a certain level without cardiac MRI cannot rule out the condition, doctors said.
The levels recorded in some of the participants indicate that there was "some damage to the myocardium," according to Dr. Kirk Milhoan, a pediatric cardiologist. He said he'd have liked to see cardiac MRIs performed on those participants.
"Why don't we look further and see what that is, as opposed to saying, 'well, since nothing was over 20, it was just ignored,'" he told The Epoch Times.
Dr. Sanjay Verma, a cardiologist in California, said that elevated troponin, especially at low levels, can have non-vaccine causes and that cardiac imaging helps differentiate between the causes.
Dr. Verma said the study population was important, noting that researchers only included people who received at least their second dose of a vaccine.
"This inclusion criteria by definition would exclude those who may have already had myocarditis after dose 1. Furthermore, 70% of the study population received a fourth dose (i.e., they did not have myocarditis after the first 3). The study therefore is a self selected population of those who didn’t have myocarditis from dose 1-3," Dr. Verma told The Epoch Times in an email.
"Therefore, the study doesn’t prove or disprove anything about the true rate of myocarditis or subclinical myocarditis in all comers who receive dose 1 and 2 of mRNA COVID-10 vaccination."
It's unclear why the researchers chose the 20 nanograms per liter definition. The first study from the military used a definition of 10-fold to 400-fold the upper limits of reference ranges, which, according to the Cleveland Clinic, can be as low as 0.01 nanograms per liter. The first study did require acute chest pain as well, as it looked at clinical myocarditis.
A newer study from Switzerland examining subclinical myocarditis used a minimum of 8.9 nanograms per liter in women and 15.5 nanograms per liter in men, although other requirements were also considered for the final diagnoses.
Dr. Homo did not respond to emailed questions, nor did the Defense Health Agency, which funded the study.
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New Report Reveals Biden Admin Pressured YouTube To 'Crack Down On Vaccine Misinformation'
According to a new report, the Biden Administration pressured YouTube to target alleged misinformation relating to the draconian COVID-19 vaccines.
Documents obtained by the House Judiciary Committee show that the Biden White House forced the streaming platform to suppress any negative COVID-19 vaccine information to push more people to get the jab.
In April 2021, President Joe Biden's former Director of Digital Strategy, Robert Flaherty, emailed Google team members to "connect […] about the work you're doing to combat vaccine hesitancy, but also crack down on vaccine misinformation."
More from Fox News Digital:
Flaherty continued, asking for trends surrounding vaccine misinformation on the website while offering government assistance in the form of COVID experts at the White House to partner in product work with YouTube. Google, in an internal email, noted that after a subsequent meeting with Flaherty, the White House staffer "particularly dug in on our decision making for borderline content" — which is content that doesn't cross Community Guidelines but rather brushes up against it, according to YouTube. A week later, Google acknowledged that it sent the White House the total amount of videos removed for COVID-19 vaccine misinformation, while discussing the government's desire for even more data. The next day, YouTube's Government Affairs team emailed YouTube's Product team, flagging the interactions with the White House.
An internal email from YouTube revealed a "high degree of interest" coming from the White House regarding vaccine misinformation and hesitancy.
"Unfortunately, the role of tech in addressing vaccine hesitancy is about to come under a massive spotlight, particularly as the supply of the vaccine is soon to outpace demand," the email continued. "The White House is very interested in our work on borderline content, and more specifically vaccine-related content as well as our work to promote authoritative sources for vaccines."
House Judiciary Chairman Jim Jordan (R-OH) told FOX Business that they knew the White House was working closely with Big Tech to censor the First Amendment and that "internal documents from Google obtained by the Judiciary Committee and Select Subcommittee show that their scheme extended to YouTube."
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Big Korean Study of Post-COVID-19 Vax Inflammatory Musculoskeletal Conditions
University researchers from Ewha Womans University College of Medicine, Mokdong Hospital and University Guro Hospital, both in Seoul, Korea conducted a retrospective nationwide cohort study tapping into data at the Korean National Health Insurance Service (NHIS) database. With a total of 2,218,715 patients from January 1, 2021, to 12 weeks post the second dose of vaccine for vaccinated persons and 12 weeks after September 30, 2021, for unvaccinated persons, the study team sought to investigate the incidence rates of inflammatory musculoskeletal disorders post COVID-19 vaccination, comparing to the unvaccinated cohort.
Among the two cohorts, the vaccinations included mRNA vaccine (Moderna/Pfizer-BioNTech), viral vector (AstraZeneca, J&J) and mixing and matching. Multivariate logistic regression analysis was used to determine the risk factors of musculoskeletal disorders after adjusting for potential confounders.
The authors report in their still-to-be-reviewed study paper that individuals who received any COVID-19 vaccine were more likely to be diagnosed with inflammatory musculoskeletal disorders than those who did not. The authors believe that the information will be useful in clarifying the adverse reactions to COVID-19 vaccines and informing people about their potential for inflammatory musculoskeletal disorders after vaccination.
The authors point out that earlier research on COVID-19 vaccines points to a range of adverse reactions related to proinflammatory actions that can lead to an excessive immune response and sustained inflammation. However, they claim no study has been conducted on the association between inflammatory musculoskeletal disorders and COVID-19 vaccines.
A strong study, the 2+ million individuals randomly selected from the Korean NHIS offers a substantial national cohort. Because Korea uses comprehensive medical databases for population-level analysis, overall, the reliability and representativeness bolsters these findings. The authors report that such large population-based databases, which are available only in Taiwan, Sweden, and Korea, offer “excellent resources for answering questions that are difficult to address using single-institution or small-scale studies.”
Conditions such as adhesive capsulitis, also known as frozen shoulder, an inflammatory condition characterized by shoulder stiffness, pain, and significant loss of passive range of motion, can debilitate individuals, interfering with work and quality of life. Long-term disability has been reported at 10-20% in patients, and the persistence of symptoms at 30-60%.
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3 December, 2023
These Experts Advocated for Lockdowns; Now They Say They Were Wrong
As the dust settles from the COVID-19 pandemic and the fallout over lockdown policies becomes more pronounced, some lockdown proponents, like New York University Professor Scott Galloway, have admitted they were wrong for supporting lockdowns.
"I was on the board of my kid's school during COVID. I wanted a harsher lockdown policy. In retrospect, I was wrong," Mr. Galloway told Bill Maher.
"The damage to kids of keeping them out of school longer was greater than the risk. But here's the bottom line, myself, our great people at the CDC, I'd like to think the governor, we were all operating with imperfect information, and we were doing our best." he said, referring to the Centers for Disease Control and Prevention and then-New York Gov. Andrew Cuomo.
"Let's learn from it. Let's hold each other accountable, but let's bring a little bit of grace and forgiveness," he said.
Mr. Galloway isn't the only one to admit he was wrong for supporting lockdowns, especially for children.
However, some others aren't as quick to blame "imperfect information," and plead for forgiveness.
Dr. Ari Joffe, a clinical professor of pediatrics at the University of Alberta, Canada, and an attending physician in Pediatric Critical Care Medicine, initially supported lockdowns.
So did Kevin Bass, a seventh-year medical student and researcher at a Texas medical school.
Both now say they were wrong because of "groupthink" and "fear-mongering," rather than imperfect information.
And both push back against Mr. Galloway's notion that the powers that be were "doing [their] best."
On March 16, 2020, the Imperial College COVID-19 Response Team published modeling that showed without lockdowns enforced for more than two-thirds of the time over two years, "there would be 510,000 deaths in Great Britain and 2.2 million deaths in the United States by mid-April, surpassing ICU demand by 30 times," Dr. Joffe reported in his peer-reviewed paper, "COVID-19: Rethinking the Lockdown Groupthink."
The Imperial College estimated that there would be "7.0 billion infections and 40 million deaths" globally in the first year.
The result from that modeling was widespread fear, Dr. Joffe said, of which he was not immune.
Consequently, he fully supported government-imposed lockdown measures at the beginning of the pandemic because he believed "lockdowns would reduce viral transmission and deaths, as famously, inaccurately, and tautologically modeled at Imperial College," Dr. Joffe told The Epoch Times.
Mr. Bass, who said at the beginning of the pandemic he was a hard-core Covidian (someone who elevated COVID prevention and mitigation to an almost religious persuasion), said the Imperial College's modeling highly influenced his initial support for lockdowns, as did reports from the World Health Organization (WHO).
"They said it kills 3.4 percent of the people it infects—that was the World Health Organization's figure until early April—3.4 percent, that's way too many people! That's like one out of every 30 people is going to die," Mr. Bass told The Epoch Times.
"And then we had these Imperial College London models which modeled how many deaths there would be due to the pandemic in different scenarios, whether mitigated or unmitigated, with no lockdowns or measures taken.
"And there was essentially no other data. I think, because of the hysteria, the fear, the example of China perhaps, people had an excessive amount of confidence—scientists, social scientists—in the Imperial College of London models."
But as the pandemic unfolded, Dr. Joffe and Mr. Bass began to rethink their early lockdown support.
Recognizing Groupthink
"In the first few months of lockdown, I realized that my (and similarly trained medical colleagues) expertise was poorly suited to give advice during a pandemic," Dr. Joffe said.
He added that when he first saw the Imperial College's modeling, he failed to note that "the high-risk groups were those aged 70 years and older (especially in long-term care), and those aged 60 to 69 with severe comorbidities."
But that fact soon became apparent, and the infection fatality rate was more than 10 times lower than the reported case fatality rate.
"The modeling was flawed, and in general, modeling (forecasting) failed during the pandemic. This was because the models were based on flawed assumptions and non-transparent methods," Dr. Joffe said.
"If you put in inaccurate assumptions (e.g., the infection fatality rate was way too high; the population was modeled as homogeneous when in reality it is highly heterogeneous in terms of risk and exposure; the outbreak was modeled as never-ending exponential increase, unlike any epidemic in history; the herd immunity threshold was assumed to be far too high; and more), the model will show what you want it to show."
Dr. Joffe said that he also saw the effect of lockdowns on students at the university and came to recognize that his support of lockdowns was from a privileged position that "failed to recognize that loneliness, unemployment, and adverse childhood experiences are top risk factors for shortened lifespan, mental health problems, and chronic non-communicable diseases."
Plus, he'd "failed to recognize that missing school will affect an entire generation with reduced social development, executive function (i.e., decision-making ability), earning potential, and future lifespan, and lead to marked increases in adverse mental health outcomes."
Once he recognized those facts, Dr. Joffe began researching lockdowns and his paper was published on Feb. 26, 2021.
In his conclusion, Dr. Joffe states, "The economic recession, through austerity in government spending on the social determinants of health, can be expected to cause far more loss of life and wellbeing over the long-run than COVID-19 can.
"We must open up society to save many more lives than we can by attempting to avoid every case (or even most cases) of COVID-19. It is past time to take an effortful pause, calibrate our response to the true risk, make rational cost-benefit analyses of the trade-offs, and end the lockdown groupthink."
For Mr. Bass, the road to rethinking his lockdown support was more circuitous.
He said that in early 2022, he was trying to find new topics to discuss in health and, as a popular figure on social media, was becoming more skeptical of "things in general." Simultaneously, Mr. Bass realized his online audience was primarily peers, not the everyday person looking for health answers, so he decided to explore a "range of different issues."
"Even though I was very, very closely following the science, I was reading papers super closely, super carefully, and knew what I was talking about, I got a lot of pushback from the very same community that I had been a part of which used to cheer me on about debunking misinformation," Mr. Bass said.
"They started accusing me of misinformation! I started getting mobbed by my own team."
The pushback forced Mr. Bass to recognize the tribalism within his community and that they weren't following the facts but instead following conventional thinking and so-called experts with the most prominent online platforms.
"Once I realized that, I started to see it in many different things, and I started questioning," he said.
That questioning came to a head when, in 2022, Elon Musk bought Twitter, now X, and posted his pronouns as "Prosecute Fauci."
"I retweeted that, or maybe even heightened, quote-tweeted that, like approvingly, and I just got dogpiled," Mr. Bass said. "I was always a Covidian. I always thought that we should have lockdowns, we should have mask mandates, and vaccine mandates, and I was very authoritarian.
"Looking back on it now, it's embarrassing."
During that time, he was also listening to other luminaries who questioned the government response, and that gave rise to his own questions.
"They were saying things about COVID, and I thought, 'Well, that's very interesting. Maybe that's true. Maybe it's important for us also to keep an open mind about critical perspectives.' So, during this entire time, I was doubting and thinking about things," Mr. Bass said.
"And it became obvious that this whole zero-COVID narrative … was [expletive]. Like we weren't ever going to control COVID, and it just became obvious that lockdowns, in general, were a pipe dream, a fantasy. And to the extent that they could, you'd end up with a totalitarian nightmare."
Recognizing his error and wanting to acknowledge it, Mr. Bass posted to X on Dec. 12, 2022, "I was wrong about lockdowns and mandates. I was wrong and the reason I was wrong was my tribalism, my emotions, and my distorted understanding of human nature and of the virus. It doesn't matter much, but I wanted to apologize for being wrong."
Avoidable Mistakes
Dr. Joffe said, "governments put the wrong people in charge of advising and managing the public emergency of the pandemic.
"The public health medical officers were not trained nor experienced in managing a public emergency. The medical expert groups also were not trained nor experienced in managing a public emergency. All were susceptible to groupthink."
Dr. Joffe, along with David Redman, a retired lieutenant colonel at the Alberta Emergency Management Agency, said in a paper that emergency management agencies, with their specific procedures, should have managed the pandemic.
Instead governments controlled the response and focused only on things like "flattening the curve" and "protecting the healthcare system" and failed to calculate the impact that lockdowns would have on society against their true efficacy.
"A common mistake was to consider correlation as causation—meaning, when lockdowns were implemented, cases and hospitalizations sometimes decreased, and this was incorrectly interpreted as lockdown efficacy," Dr. Joffe said.
"The problem was, this was not due to causation … it was clear that regardless of lockdown, the trajectories of the pandemic were the same."
Mr. Bass agrees, "When the pandemic started, I was very aware of the downsides of this ideology, but still, I went along with it. My ultimate belief—and I think many people shared this—was that every human life is precious. I mean, nobody can argue with that, right?
"We thought, basically, 'Yes, we might have some economic devastation for a short period. Or yes, there might be some inconvenience,' as Fauci used to put it whenever he dealt with lockdown protesters or international leaders. But nonetheless, like these inconveniences, these slight mild economic recessions, they might not be all bad, and we'll rebound, was a thing we told ourselves. And so, we had this overwhelming focus on the positives."
More here:
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1 December, 2023
Pursuing justice’: Texas sues Pfizer for overstating COVID-19 vaccine effectiveness
Texas Attorney-General Ken Paxton has accused Pfizer of misrepresenting the effectiveness of the company’s COVID-19 vaccine in a lawsuit filed in state court.
The pharmaceutical giant used misleading statistics to promote its vaccine and sought to “intimidate and silence” those who questioned the product’s efficacy, the lawsuit, filed on Thursday Austin-time, alleges.
Paxton is seeking more than $US10 million ($15 million) in civil fines and a court order barring Pfizer from speaking publicly about the efficacy of its vaccine.
“We are pursuing justice for the people of Texas, many of whom were coerced by tyrannical vaccine mandates to take a defective product sold by lies,” Paxton said in a statement.
The lawsuit follows a probe launched by Paxton’s office in May into three major drug companies related to claims they made about the effectiveness of their vaccines. Paxton has been a vocal opponent of COVID-19 safety mandates since the onset of the pandemic.
In the complaint filed in a Lubbock County state court, Paxton said it was misleading for Pfizer to claim its vaccine was 95 per cent effective because it offered a “relative risk reduction” for people to who took it.
Paxton said the claim was based on only two months of clinical trial data, and claimed the pandemic got worse even after people started taking Pfizer’s vaccine.
“Pfizer intentionally misrepresented the efficacy of its COVID-19 vaccine and censored persons who threatened to disseminate the truth in order to facilitate fast adoption of the product and expand its commercial opportunity,” the complaint said.
Paxton’s statement included the claim: “COVID-19 cases increased after widespread vaccine administration, and some areas saw a greater percentage of deaths from COVID-19 among the vaccinated population than the unvaccinated.”
“When the failure of its product became apparent, Pfizer then pivoted to silencing truth-teller
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Study suggests pandemic lockdowns accelerated ‘significant’ memory and cognitive decline in seniors
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A new study conducted by the University of Exeter Medical School, led by Dr. Anne Corbett, has revealed that the lockdowns and societal restrictions imposed during the pandemic had a detrimental impact not only on the mental health of children and teens, but also on elderly individuals.
Using data collected from 3,142 people aged 50 years or over who were taking part in a long-term dementia study in Britain, it was observed that there was a significant worsening of executive function and working memory among the cohort (average age 67.5) in both the first and second year of lockdowns.
Despite restrictions being eased after this period, it appears that much damage had already been done.
The study revealed that reduced exercise and increased drinking were significantly associated with cognitive decline among the entire cohort. Notably, depression was a prominent factor of cognitive decline among those who contracted COVID-19.
Additionally, it was found that loneliness had especially detrimental effects on those with mild cognitive impairment.
“People aged 50 years and older in the UK had accelerated decline in executive function and working memory during the first year of the COVID-19 pandemic, during which the UK was subjected to three societal lockdowns for a total period of 6 months,” said the study, published in the Lancet journal Healthy Longevity.
The British Government, funded by the National Institute for Health and Care Research, implemented restrictions on the number of times citizens could exercise outside during the pandemic, as well as closing gyms, golf courses, sports courts, swimming pools and indoor sports facilities.
“The scale of change is also of note, with all groups—the whole cohort and the individual subgroups—showing more than a 50% greater decline in working memory and executive function and many effect sizes reaching a clinically significant threshold of greater than 0·3,” said the researchers.
Governments across the West have implemented lockdown measures on and off throughout the pandemic, despite early indications that serious cognitive decline would be a consequence, especially for elderly individuals.
For example, Italian scientists noted in an October 2020 paper in Frontiers in Psychiatry that social disconnection – which is practically guaranteed by the closure of voluntary associations, churches, parishes, gyms and other meeting places for seniors – is a risk factor for dementia and likely to increase the risk of depression and anxiety amongst elderly people.
The researchers further highlighted that these factors mirror population-wide changes in health and lifestyle seen during and after lockdowns, prompting a pertinent question regarding the impact of the pandemic on cognitive health and risk across populations.
“Lockdown could affect disproportionately the mental health of old people, whom relatives contracted COVID-19, people who live alone and whose only social contacts take place outside home, and people who do not have close relatives or friends and rely on the support of voluntary services or social assistance,” said the paper.
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Half-Dose of COVID-19 Booster Just as Effective as a Full Dose: Study
Reducing the dose of a Pfizer COVID-19 booster vaccine can elicit a comparable immune response in adults compared to a full dose with fewer side effects, new research has found.
Led by the Murdoch Institute and the National Centre for Communicable Diseases in Mongolia, the study involved 601 participants over 18 years old from Mongolia, and is the first to assess and compare widely used COVID-19 vaccines in low- and middle-income countries.
The study focused on adults who had previously received AstraZeneca or Sinopharm COVID-19 shots, finding that a half dose of the Pfizer booster produced a non-inferior immune response.
Murdoch Institute’s Professor Kim Mulholland said reduced doses would make booster programs more cost-effective.
“Fractional dosing may improve COVID-19 booster acceptability and uptake and reduce the per-dose cost of COVID-19 booster programs,” he said.
“Policymakers and immunisation advisory committees can draw upon this data to make flexible boosting schedules decisions.”
However, the study noted that half-dose boosting may be less effective in adults primed with the Russian COVID-19 vaccine, Sputnik V.
Fewer Side Effects for Half Doses
Participants receiving half doses reported fewer side effects compared to those receiving full doses, highlighting the potential benefits of this approach.
Among half-dose boosted participants, 60 percent reported local reactions including pain and tenderness, and 25 percent reported systemic reactions including fevers, vomiting, diarrhoea, and headaches.
On the other hand, 72 percent of full-dose boosted participants reported local reactions, and 32 percent reported system reactions.
The study will continue to follow up on participants at six and 12-month intervals to explore their immune response, such as waning rates and breakthrough infections.
FDA Vaccine Adviser: Most Don't Need Yet Another COVID-19 Booster
This comes amid recommendations from the Food and Drug Administration's (FDA) vaccine adviser Dr. Paul Offit that most people did not need another COVID-19 booster.
In an article in a medical journal, he said that asking young, healthy people to get boosted with a variant-specific booster was pointless.
“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” Dr. Offit wrote in the paper.
Medical researcher and immunology specialist Kevin Bass echoed his sentiment saying people were likely to take a hard pass on the new COVID-19 booster shot unless it was mandated.
“Public opinion has swung so hard against the vaccines that I can’t imagine a scenario where a significant amount of people are going to sign up for another shot,” he told The Epoch Times in a recent interview. “If people have the choice, they are going to say no.”
Global Trial Investigating Reduced COVID-19 Boosters
The new research was published in the Lancet, and is part of an international clinical trial funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
This trial, involving 3,300 healthy adults across Australia, Indonesia, and Mongolia, investigates the impact of administering a reduced dose of COVID-19 booster shots.
The efficacy, side effects, and acceptability of fractional doses explored will inform flexible booster strategies and address global vaccine supply challenges.
CEPI receives funding from the Australian government.
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