This document is part of an archive of postings by John Ray on Dissecting Leftism, a blog hosted by Blogspot who are in turn owned by Google. The index to the archive is available here or here. Indexes to my other blogs can be located here or here. Archives do accompany my original postings but, given the animus towards conservative writing on Google and other internet institutions, their permanence is uncertain. These alternative archives help ensure a more permanent record of what I have written.
This is a backup copy of the original blog
Below is the backup of this blog for February, 2024. To access the backups in earlier years, click here
26 May, 2024
Overreporting COVID-19 as an Underlying Cause of Death Inflated Mortality Numbers During Pandemic
A new analysis suggests COVID-19 was reported more frequently than it should have been as an underlying cause of death, inflating COVID-19 mortality numbers and attributing deaths from other causes to the virus.
In a preprint paper published in Research Gate, researchers aimed to identify who truly died “from” COVID-19 versus who died “with” COVID-19 but were included in U.S. COVID-19 mortality numbers.
To determine if COVID-19 was overreported as an underlying cause of death, researchers calculated the overreporting adjustment factor and compared the ratio of reporting COVID-19 as a multiple—or contributing—cause of death versus an underlying cause of death on death certificates from 2020 to 2022. They also examined how “pneumonia and influenza” were reported on death certificates from 2010 to 2022.
An overreporting adjustment factor for mortality is a statistical correction applied to mortality data to account for the propensity of certain death counts reported more frequently or inaccurately than others. It typically involves comparing reported death counts to a more accurate independent benchmark, which helps ensure data reflect the true incidence of deaths in a population. Here, the researchers chose pneumonia and influenza because the conditions are similar in nature to COVID-19, and they could compare patterns using mortality data before and after the pandemic began in 2020.
According to the preprint, data show COVID-19 was systematically overreported as an underlying cause of death during the pandemic by an average of about three times for all ages compared to influenza and pneumonia during the same period—and was highest in those aged 15 to 54. Additionally, only about one-third of influenza and pneumonia-related deaths were reported as underlying causes, whereas almost all COVID-19-related deaths were reported as “deaths from COVID-19.”
When comparing underlying cause death rates for different age groups for COVID-19 with death rates from influenza and pneumonia, researchers observed that underlying cause COVID-19 death rates were higher than those for influenza and pneumonia in the 15 to 24 and older age groups. After adjusting to obtain the overreporting factor, they found COVID-19 death rates were still higher than they were for influenza and pneumonia for ages 25 to 34 and older and equal for those aged 15 to 24.
About 30 percent of influenza and pneumonia-related deaths were registered as an underlying cause of death on death certificates, whereas 90 percent of COVID-19 deaths were recorded as the underlying cause of death in 2020 and 2021. In 2022, 76 percent of COVID-19 deaths were registered as the underlying cause.
“There was a systematic overreporting of deaths from COVID when we analyze versus the flu and pneumonia, as almost all COVID deaths were reported as the underlying cause,” Edward Dowd, founder of Phinance Technologies, told The Epoch Times. “Basically, when one wants to understand the pandemic, only about 30 percent of the reported COVID-19 deaths were ‘from COVID-19’ as the underlying cause,” Mr. Dowd said.
How the US Counts COVID-19 Deaths
Each country has its own criteria for determining what constitutes a COVID-19-related death. The United States uses the World Health Organization’s (WHO) classification system to categorize and code mortality data from death certificates.
The WHO defines the underlying cause of death as “the disease or injury which initiated the chain of events leading directly to death, or the circumstances of the accident or violence which produced the fatal injury.” The underlying cause of death is chosen from the conditions listed by the physician on the death certificate. When the physician records multiple causes or conditions, the underlying cause is determined by the sequence of conditions that led to the death on the certificate, ICD provisions, and selection rules.
“The WHO methodology for identifying COVID-19-related deaths cast a wide net for potential classification of COVID-19 as either the underlying cause of death or a contributory cause of death, which could lead to over-reporting relative to other diseases. This led to criticisms of suspected over-counting of COVID-19-related deaths during the pandemic. As an example, a CDC mortality report indicated that COVID-19 was the sole cause of only about 5% of listed COVID-19 deaths,” the authors of the analysis wrote.
Each death certificate contains a single underlying cause of death and up to 20 additional multiple or contributing causes. According to the Centers for Disease Control and Prevention (CDC), properly classifying the death on a death certificate is important for mortality trends that inform public health risks and policy decisions.
Causes of Overreporting COVID-19 Deaths
According to the analysis, incentives for recording positive COVID-19 tests may have contributed to an overreporting bias in deaths attributed to COVID-19 compared to other diseases. Since the beginning of the pandemic, COVID-19 deaths have included those who died with COVID-19 and from COVID-19, and more recently, those who died of conditions attributed to long COVID, even if they had not tested positive for the virus in recent months or years.
The White House acknowledged early on that health officials were taking a very liberal approach to mortality regarding COVID-19.
“There are other countries that if you had a preexisting condition, and let’s say the virus caused you to go to the ICU and then have a heart or kidney problem, some countries are recording that as a heart issue or a kidney issue and not a COVID-19 death,” former White House coronavirus response coordinator, Dr. Deborah Birx told reporters during an April 2020 press briefing.
“Right now, we’re still recording it, and the great thing about having forms that come in and a form that has the ability to mark it as ‘COVID-19 infection’ the intent is right now that if someone dies with COVID-19, we are counting that as a COVID-19 death,” Dr. Birx said.
State health departments use the CDC’s standardized surveillance case definition and uniform criteria to define a disease for public health surveillance. They also report COVID-19 cases through the agency’s National Notifiable Diseases Surveillance System. At the beginning of the pandemic, the CDC’s definition of COVID-19 was “very simplistic,” and health departments recorded anyone with a positive COVID-19 diagnosis at the time of death a COVID-19 death, even if a clear alternative cause of death existed.
Likewise, medical examiners and coroners follow CDC guidelines when completing death certificates, and the agency’s National Center for Health Statistics provides standardized forms and procedures for certifying deaths, including how to determine underlying causes of death and report related causes.
CDC guidance states that in cases where a “definite diagnosis of COVID-19 cannot be made, but is suspected or likely,” it is “acceptable” to report COVID-19 on the death certificate as “probable” or “presumed” and certifiers can use their best clinical judgment in determining whether an individual likely had COVID-19. It’s this same discretion that allows long COVID to be counted as a COVID-19 death long after an individual tested positive for infection.
The CDC broadly defines long COVID as “signs, symptoms, and conditions that continue to develop after acute COVID-19 infection” that can last for “weeks, months, or years.” The term is also used to refer to post-acute sequelae of SARS-CoV-2 infection (PASC), long-haul COVID, and post-acute COVID-19.
The CDC guidance gives a physician or medical examiner discretion to classify long COVID as a COVID-19 fatality, and the CDC death certificate guidance allows for PASC to be listed as an underlying cause of death, which may affect COVID-19 mortality numbers.
A December 2022 Vital Statistics Rapid Release Report published by the CDC identified 3,544 deaths in the National Vital Statistics System that mentioned long COVID key terms and were coded as COVID-19 deaths in the United States from Jan. 1, 2020, through June 30, 2022.
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RFK Jr. Takes Aim at Trump, Biden Over Pandemic Policies in Libertarian Convention Address
Robert F. Kennedy Jr. chastised former President Donald Trump and President Joe Biden for not respecting the Constitution during the COVID-19 pandemic during his speech May 24 at the Libertarian National Convention.
“There’s always a reason why, right now, the rights are an inconvenience that we can’t afford. It was the Red Scare in the 1920s. It was Joe McCarthy in the 1950s. It was civil rights protests and the Vietnam War protests in the 1960s. It was the war on drugs in the 1970s. It was the war on terror after 2001. And most recently, it was the COVID pandemic,” Mr. Kennedy said.
“Maybe a brain worm ate that part of my memory, but I don’t recall any part of the United States Constitution where there’s an exemption for pandemics,” he added.
President Trump was reluctant to impose lockdowns early in the COVID pandemic, but he relented, and “many of our most fundamental rights disappeared practically overnight,” Mr. Kennedy noted.
Mr. Kennedy continued by criticizing the former president for “allowing his health regulators to mandate social distancing, which undermined our First Amendment right to freedom of assembly.”
“With no due process, no public hearings, and no notice,” America was locked down during the pandemic by President Trump, Mr. Kennedy added.
A total of 3.3 million small businesses were closed while Wal-Marts and liquor stores remained open, he remarked.
“President Trump said he was going to run America like a business, and he came in and gave the keys of all of our businesses to a 50-year bureaucrat (Dr. Anthony Fauci) who'd never been elected to anything and had no accountability.
Since entering the 2024 presidential race as a Democrat in April 2023 and then opting to run as an independent last October, Mr. Kennedy has been outspoken about President Trump’s role in moving forward with Operation Warp Speed, a program that rushed the COVID-19 vaccine to market.
When President Biden took office, “the assault on the Constitution intensified,” Mr. Kennedy continued, citing multiple censorship cases.
During his address, Mr. Kennedy also hailed journalist Julian Assange as a hero and reiterated that he would pardon him and Edward Snowden on his first day in office.
“We shouldn’t be putting [Julian Assange] in prison; we should have a monument to him here in Washington D.C.,” Mr. Kennedy said.
President Trump is scheduled to address Libertarian National Convention attendees on May 25.
The former president has escalated verbal attacks on Mr. Kennedy in recent weeks as multiple national polls have shown the independent candidate has support from conservatives and independents. National Republicans have expressed concern that will cut into President Trump’s support on Election Day.
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23 May, 2024
HHS Proposes Formal Debarment Of EcoHealth Alliance
Written by John Leake
To my pleasant surprise, the Department of Health and Human Services (HHS) actually accepted the House Select Subcommittee’s recommendation to formally debar EcoHealth Alliance, Inc
As stated in the official press release:
“HHS will immediately commence official debarment proceedings and implement a government-wide suspension of U.S. taxpayer funds to EcoHealth — including a hold on all active grants.”
It seems to me that this marks a major shift in U.S. federal agency policy with respect to EcoHealth Alliance.
The decision also opens up a fraught can of worms for the HHS and the NIH (a division of HHS).
Brad Wenstrup and his Congressional Committee have acknowledged and articulated the evidence that EcoHealth and its collaborators in the US and China are responsible for creating the Covid virus.
HHS’s acknowledgement that this evidence is sufficient to warrant debarring EcoHealth Alliance implies that the U.S. government is now formally recognizing the true, manmade cause of the COVID-19 Pandemic instead of trying to sweep it under the rug.
https://principia-scientific.com/hhs-proposes-formal-debarment-of-ecohealth-alliance/
**********************************************Australia: More Than 3,600 Children ‘Targeted’ With COVID-19 Fines in NSW
Legal advocacy groups are calling for reform of the New South Wales (NSW) fines system after 3,628 children received COVID-19 fines during the pandemic in the Australian state.
A 2024 report looking into children and COVID-19 fines in NSW found that the “penalty notice regime” implemented in NSW was “unsuitable” for achieving public health outcomes for children.
However, NSW Police have defended their response amid the rapidly evolving public health orders at the time, which required compliance and enforcement to limit movement regardless of people’s age.
The report, authored by academics at the University of NSW, University of Wollongong, and University of Technology Sydney, noted more than half of the fines issued to children were fixed at $1,000 (US$665).
The Redfern Legal Centre, Public Interest Advocacy Centre, and Aboriginal Legal Service commissioned the research, which considered statistical data and interview responses from lawyers and youth workers.
Meanwhile, some of the fines were as high as $5,000, despite the authors noting the maximum fine a child can get when found guilty of an offence in the NSW Children’s Court is $1,100.
“Children were liable to the same penalty notice fine as adults for almost all PHO offences, with the exception of two general age-based offences that concerned the failure to wear a face covering,” the report said.
The report noted the public health orders were changed and repealed frantically during the pandemic, with 266 public health orders put out between March 15, 2020, and Jan. 31, 2022.
In addition, a new public health order was brought in or modified every one and a half days during the Delta wave of COVID-19.
“The frequent changes made it especially hard for children to understand the rules, and contributed to errors in police decisions that a person had breached a PHO,” the report said.
One interviewee who spoke to the report authors said there were kids working off COVID fines who “probably shouldn’t have been issued with one in the first place.”
Analysis by the authors found that children in socioeconomically disadvantaged suburbs were “over policed” during the pandemic.
Authors said more than half of the top 30 suburbs where children received the largest number of penalty notices between March 2020 and June 2022 were in the bottom 25 percent of the social economic index.
Discussing the findings, Redfern Legal Centre chief executive officer Camilla Pandolfini said children cannot pay heavy fines and the deterrent effect is low.
“Fines are oppressive, discriminatory, and ineffective when used against children. We call for changes to policy, practice, and procedure to ensure that fines do not compound existing disadvantage and criminalise children,” she said.
Police Note Serious Nature of COVID-19 Led to Rapid Orders
A spokesperson for NSW Police explained public health order compliance was required for the safety of the community. Police could respond to breaches of the orders no matter what the age.
“The virulent nature and serious illness from the Delta variant of COVID-19 resulted in rapidly evolving Public Health Orders, including Local Government Areas of Concern being nominated by NSW Health,” the spokesperson told The Epoch Times.
“A compliance and enforcement response was required to limit movement and ensure compliance with Public Health Orders in these areas to reduce the transmission of COVID-19 and protect the community.
“Outside of these identified areas of concern, police still had the ability to respond to breaches of relevant Public Health Orders by issuing infringement notices—regardless of the age of the person involved.”
Meanwhile, report author Julia Quilter called for police to “stop issuing fines to kids” and engage in diversionary and creative problem-solving policing.
“Policing kids by issuing heavy fines during the COVID-19 pandemic highlighted, in extreme form, the problems with our fines system more generally. Kids have no or little capacity to pay fines and saddling them with crippling debts only sets them up for future failure,” she said.
“This is especially troubling given that fines are disproportionately issued by police to vulnerable kids already experiencing socio-economic and other forms of disadvantage.”
The CEO of Aboriginal Legal Service Karly Warner called for a reform of the “archaic” and “unjust” fines system.
“Aboriginal communities set the gold standard for caring for one another during the COVID-19 pandemic, yet our children paid a higher price because of the government’s punitive approach to enforcing public health orders,” she stated.
Public Interest Advocacy Centre CEO Jonathon Hunyor added, “Creating massive debts for children and families simply amplifies disadvantage and builds distrust in the system.”
Police Faced Challenges During the COVID-19 Response: Inquiry
Meanwhile, the Police Federation of Australia (PFA), which represents 65,000 police officers, including more than 17,000 in NSW, have raised a number of issues in response to the federal government’s COVID-19 Response Inquiry.
In its submission (pdf), PFA noted access to appropriate personal protective equipment for a police “became an issue of concern” during COVID-19 restrictions and lockdowns.
“Whilst it is accepted that in normal circumstances it would be the responsibility of the employer, in our case, the respective police forces, to provide such equipment, no provision appears to have been made for a national response to such a crisis,” the association noted.
In addition, the submission noted the pandemic impacted police resources and community attitudes towards police in a range of high profile incidents.
Meanwhile, the Australian Federal Police (AFP) noted extra law enforcement duties during COVID-19 took its toll on frontline police (pdf).
“The burden of the extra workload over the COVID-19 period was felt by the AFP, in particular the frontline officers, who were required to enforce mandated COVID-19 restrictions,” the AFP said.
“On an individual level, policing during the pandemic increased the risk of members contracting the COVID-19 virus through interactions with the public, as well as spreading the virus to family and friends.”
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22 May, 2024
Pfizer’s Paxlovid Reduces Risk of Post-Acute Death and Sequelae Among Hospitalised COVID-19 patients
This is a pretty good result. Anecdotally, I have heard good reports of Paxlovid
The Chinese University of Hong Kong (CUHK)’s Faculty of Medicine (CU Medicine) conducted a retrospective investigation using real-world data to examine the association of Paxlovid (also known as nirmatrelvir-ritonavir) with post-acute sequelae in hospitalised COVID-19 patients, as well as mortality.
The results showed that the risk of post-acute inpatient death (i.e. death occurring 21 days after a positive test result) in COVID-19 patients who were hospitalized and prescribed oral Paxlovid within five days after symptom onset was significantly reduced by 38% compared to those who were hospitalised and didn’t use the drug during the acute phase.
Similar effects were observed on the post-acute sequelae of cardiovascular and respiratory complications. Study results have been published in the journal The Lancet Infectious Diseases.
Importantly, while some compelling data is generated, this study was not a randomized controlled study and several limitations in the study suggest results should be interpreted with caution.
According to the CUHK team, a review of the literature suggested that the prevalence of post-COVID-19 conditions among individuals infected with SARS-CoV-2 may range from 10% to 30%. Despite authorized use of Paxlovid for treating COVID-19 in late 2021, few investigations have evaluated the association of the drug with post-acute sequelae and mortality, especially in hospitalized patients.
The Study
The current study used the real-world COVID-19 surveillance data obtained from Hong Kong Hospital Authority and Department of Health. The research team analyzed more than 50,000 hospitalized COVID-19 patients records aged 18 and over in Hong Kong between March 2022, and October 2023. Of this large group, approximately 15,000 were prescribed Paxlovid within five days of symptom onset, while those who did not take the oral drug during the acute phase were grouped as the control.
Findings
The outcomes point to the conclusion that the risk of post-acute death of hospitalized COVID-19 patients who were prescribed oral Paxlovid was 6.9%, considerably lower than the 13.5% risk of those hospitalised who did not use the drug.
This represents a 38% rate after adjusting for their demographics, clinical background, and vaccination status. Similar effects were observed on the post-acute sequelae of cardiovascular and respiratory complications.
Professor Marc Chong Ka-chun, a corresponding author of the research paper and Assistant Professor at The Jockey Club School of Public Health and Primary Care of CU Medicine, said, “Public health agencies should adequately prepare effective antivirals to manage both acute and post-acute conditions of COVID-19, particularly considering the ongoing emergence of new variants of concern of the SARS-CoV-2 virus.”
Professor Yeoh Eng-kiong, also a corresponding author of the research paper and Director at the Centre for Health Systems and Policy Research at CU Medicine’s The Jockey Club School of Public Health and Primary Care, stated, “To our knowledge, our study is the first to highlight the extended benefits of Paxlovid in patients admitted to hospital with COVID-19. This study showcases the long-term benefits of the antiviral serving as a valuable complement to COVID-19 vaccines in mitigating the global clinical burden of COVID-19 in the years ahead.”
The research team member included Ms Wang Hu-wen, a doctoral student from The Jockey Club School of Public Health and Primary Care at CU Medicine. Ms Wang was one of the awardees of the Research Grants Council’s Hong Kong PhD Fellowship Scheme 2021/22 and is the first author of the published paper.
Limitations
Numerous limitations are cited by the authors, which means that these results should be understood with caution. TrialSite summarizes key limitations which raise concern about generalization to broader populations:
The grouping of cohorts (nirmatrelvir–ritonavir group vscontrol group) relied on prescription records, which might not guarantee actual usage and could potentially lead to misgrouping.
The Hong Kong-based investigators focused on a predefined set of 13 sequelae previously identified to have an elevated risk among hospitalized patients with COVID-19 in Hong Kong. The study focused on sequelae that are typically recorded in a standardized manner using ICD codes within the electronic health system.
Here the authors focused specifically on nirmatrelvir–ritonavir rather than assessing multiple targeted antivirals for COVID-19, particularly another widely used antiviral drug, molnupiravir.
In the study, the post-acute period as starting at 21 days after the positive PCR date, following a previous local study. The authors acknowledge that other studies might use different durations, such as 28 days for post-acute or 3 months for post-COVID-19 condition, which might affect direct comparability of results.
The participants included in this study were primarily infected with omicron sublineages BA.2 and BA.5. Although the dominant sublineages in Hong Kong became XBB after April 20, 2023, case-based surveillance of COVID-19 was discontinued from Jan 30, 2023, onwards. As a result, the proportion of patients infected with XBB was relatively small compared with BA.2 and BA.5. The authors suggest caution is advised when generalizing the current findings to other variants and sublineages.
With insufficient number of events, especially in subgroup analyses, this could introduce sparse data bias.
With data availability limitations, some unmeasured confounders, such as clinical characteristics recorded during hospitalization (e.g., dyspnoea and fever), were not included in the analysis.
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21 May, 2024
Bombshell messages reveal Anthony Fauci's top advisor bragging about making emails 'disappear'
A top advisor to Anthony Fauci bragged about 'how to make emails disappear' and deleting 'smoking guns' to avoid scrutiny, lawmakers investigating the origins of COVID-19 revealed Thursday.
The shocking comments were from government health official Dr. David Morens, a senior advisor to Fauci from 1998 until 2022.
Some of Morens' emails have been obtained by congressional subpoena and were read out by House Oversight Chairman James Comer in a hearing Thursday, part of lawmakers' probe into the theory that covid came from a leak in a Chinese lab.
Morens, who works at the National Institute of Allergy and Infectious Diseases (NIAID), wrote about deleting his communications to avoid turning them over to the public under the Freedom of Information Act (FOIA).
He was writing to Peter Daszak, whose organization EcoHealth Alliance had its federal funding suspended this week for its role in contracting controversial coronavirus research to the Wuhan Institute of Virology.
'I learned from our FOIA lady here how to make emails disappear after I am FOIA'd but before the search starts,' Morens wrote to Daszak. 'So I think we are all safe. Plus I deleted most of those earlier emails after sending them to Gmail.'
'We are all smart enough to know to never have smoking guns,' Morens wrote in a later message. 'And if we did we wouldn't put them in emails. And if we found them we would delete them.'
Fauci and his advisors at NIAID came into the spotlight after it emerged the agency funded EcoHealth Alliance to conduct research including experiments that altered coronaviruses to make them more dangerous.
EcoHealth subcontracted the work to the Chinese lab in Wuhan and, according to the Department of Health and Human Services which pulled their funding on Wednesday, failed to adequately oversee it – potentially leading to an accident causing a global pandemic in 2020.
Congressman Brad Wenstrup, chairman of the Select Subcommittee on the Coronavirus Pandemic, is now concerned that Morens and Daszak may have tried to cover their tracks following the scandal by deleting federal records.
His committee released emails last year showing Morens discussed using his personal rather than government email and deleting communications to avoid scrutiny.
The top official for NIAID, a part of the National Institutes of Health (NIH), wrote in an email to Daszak in 2021 that he communicates on Gmail 'because my NIH email is FOIA'd constantly.'
'Just send to any of my addresses and I will delete anything I don't want to see in the New York Times,' Morens wrote, according to lawmakers.
Wenstrup has now issued two subpoenas to Morens: one for all his gmail correspondence about the origins of COVID-19, and another forcing him to testify to the committee on May 22.
DailyMail.com understands that Morens turned over about 30,000 emails to the committee on April 30.
Congressman Brad Wenstrup has now issued two subpoenas to Morens: one for all his gmail correspondence about the origins of COVID-19, and another forcing him to testify to the committee on May 22
Two shocking emails were revealed in a Thursday committee hearing where former NIH acting director Lawrence Tabak was testifying.
After reading out Morens' messages about deleting communications, Comer asked Tabak: 'Is that consistent with NIH document retention policies?'
'It is not,' he replied.
Nonprofit health research group US Right to Know has been fighting NIH in court to release officials' emails about the origins of COVID-19.
'During the last 31 years of public interest work, I have never seen a federal agency stonewall public records requests as much as NIH,' Right to Know executive director Gary Ruskin told DailyMail.com.
He said NIH is a key culprit in the US government of trying to 'hide or bury key information about COVID origins'.
'NIH's conduct has been abysmal and reprehensible. And now the Select Subcommittee is just starting to get to the bottom of how this stonewalling really happened,' he added.
'[Morens] was forced to turn over thousands of emails to the Select Subcommittee. He will soon testify about his deleting of emails and his use of a Gmail account to do official business.
'Once that testimony is complete, Congress and the public will have a better sense of what consequences are appropriate for his offenses against our democracy.'
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Increased Reports of Rare Autoimmune Disease, COVID-19 and Its Vaccine Contributed: Study
Cases of a rare autoimmune disease surged between 2020 and 2022 in Yorkshire, England, peaking in 2021. COVID-19 infection and its vaccines possibly contributed to the rise, a recent study in The Lancet’s eBioMedicine found.
The disease—melanoma differentiation-associated protein-5 (anti-MDA5) positive dermatomyositis, or anti-MDA5 dermatomyositis—is an inflammatory disease characterized by muscle weakness, skin rashes, and rapidly progressive lung disease.
Anti-MDA5 dermatomyositis is very rare.
In 2019, Yorkshire, which has a population of 3.6 million, reported two people testing positive for the disease. In 2020, there were eight. Cases peaked in 2021 with 35 new cases. The number then dropped to 16 new cases in 2022.
The new autoimmune cases may have arisen from the COVID-19 virus and vaccine RNA interactions, the study’s senior author, Dr. Dennis McGonagle, clinical professor of medicine at the University of Leeds, told The Epoch Times.
Besides the Lancet study, several case studies have documented new anti-MDA5 cases following COVID-19 infection or vaccination.
Dermatomyositis tends to affect the skin, muscles, and lungs. Anti-MDA5 dermatomyositis involves rapidly progressive lung disease, which lends the condition a poor prognosis.
MDA5 is a protein present outside of muscles and tissues, especially prominent in the lungs. Therefore, when the body forms anti-MDA5 antibodies to attack MDA5, it can deteriorate related organs and tissues.
MDA5 can detect and bind to foreign RNA, including COVID-19 RNA. Upon detection, it signals other immune cells to fight the foreign invader or vaccination.
“We think that ... [this happens] because MDA5 is the receptor or docking site for viral RNA, and that this in some way triggers the antibody against it,” Dr. McGonagle said.
In a COVID-19 infection, MDA5’s binding to RNA can result in too much MDA5 activity as a response, Dr. Pradipta Ghosh, director of the Institute for Network Medicine at the University of California–San Diego and another corresponding author of the study, told The Epoch Times.
COVID-19 patients were shown to have high MDA5 gene activity in their lung fluids, further suggesting that the virus might have triggered new MDA5 cases.
Apart from anti-MDA5, 15 other autoantibodies can contribute to similar dermatomyositis diseases. The role of MDA5 in COVID-19 infection and vaccination may explain why, during the pandemic, only anti-MDA5 dermatomyositis cases increased while other autoantibodies involved in dermatomyositis did not.
Between 2020 and 2022, all 60 new anti-MDA5 dermatomyositis patients in Yorkshire were evaluated. All developed symptoms.
Over 40 percent developed interstitial lung disease and had a worse prognosis. Half died by the time the study was published.
The authors noted that anti-MDA5 cases during the pandemic presented slightly differently than pre-pandemic cases.
Compared to pre-pandemic, anti-MDA5 cases reported during the pandemic had a lower rate of lung disease and a lower death rate, said Dr. Ghosh. The disease also affected white people as opposed to Asians, who were the more predominant demographic previously.
Pandemic-era patients tend to report skin-related conditions such as rashes, decreased blood flow to fingers, muscle aches, and so on.
Coincidental Rise
The peak of anti-MDA5 cases between April and July 2021 coincided closely with Yorkshire’s uptake of COVID-19 vaccines and occurred during a time of “higher community SARS-CoV-2 positivity during 2021,” the authors reported. Vaccinations started in Yorkshire in January 2021 and dropped off in October.
Around 90 percent of the Yorkshire population was vaccinated, and 49 of the 60 cases had documented COVID-19 vaccination.
Contrastingly, only 15 out of 60 had had a confirmed COVID-19 infection.
While many people tested positive for COVID-19 at the time, the authors noted that anti-MDA5 cases did not rise immediately after a rise in COVID-19 cases.
Other Reports
In addition to the reports in Yorkshire, other studies have shown a link between anti-MDA5 dermatomyositis and COVID-19 and its vaccine.
An Italian case study published in Frontiers in Immunology reported the case of an older, unvaccinated woman who developed anti-MDA5 dermatomyositis a month after her COVID-19 infection. She had joint pain and developed rashes and lesions on her chest, face, and hands.
The authors argued that MDA5, which is involved in the activation of various cytokines, may precipitate inflammatory reactions when exposed to SARS-CoV-2.
Another paper published in SN Comprehensive Clinical Medicine reported an anti-MDA5 dermatomyositis case that occurred a week after COVID-19 vaccination. The researchers hypothesized that antibodies to spike proteins on the SARS-CoV-2 virus may cross-react with human proteins like MDA5.
However, Dr. Ghosh said that while spike protein has been implicated in other autoimmune diseases, anti-MDA5 disease is caused by antibodies against MDA5, not spike.
“I believe that we have a lot of work to do before we can begin to understand why or how our body responds to this virus, its particles, its RNA/protein—even the RNA encoding its key components we use as vaccine in the plethora of ways that it does,” she explaine
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20 May, 2024
Another Doctor Fined for Prescribing Ivermectin
Another physician was recently punished for prescribing ivermectin during the COVID-19 pandemic. A multi-faceted drug with Nobel Prize—honored distinction, not to mention approved by the U.S. Food and Drug Administration (FDA) with billions of doses consumed involving major public health efforts such as Mectizan in the tropics—which has saved many lives, became deeply politicized during the pandemic.
In fact, TrialSite chronicled how a confluence of interests drove an information war against the drug, as well as targeting providers using the drug off-label as an early-stage antiviral regimen.
The latter practice is typically not a problem with consenting doctor and patient, however, in the national emergency an unprecedented set of forces led to far more national/federal oversight of the practice of medicine. In some cases, the courts have pushed back on the federal government, such as the FDA’s involvement in the information war against ivermectin. Now in Washington State Wei-Hsung Lin received a $5,000 fine by the Washington Medical Commission for prescribing the drug.
The state’s medical board reported on the incident, noting that Wei-Hsung Lin, M.D. (Lic. #60207016) failed to meet the “standard of care in his treatment of five patients.”
Deemed an Agreed Order, Dr. Lin prescribed ivermectin to five patients related to treatment of COVID-19 infection or symptoms characterized as similar to long-term effects of COVID-19.
According to the medical board’s order, Lin is now restricted from prescribing ivermectin for non-FDA-approved indications. Moreover, the physician who practices at Kadlec Regional Medical Center in Richland, Washington cannot provide care to patients without first establishing a physician-patient relationship.
Finally, Lin must complete continuing medical education on COVID-19 and the physician-patient relationship, prepare written papers summarizing his learning, undergo compliance audits, make personal appearances before the WMC, and pay the $5,000 fine.
MedPage Today, a media owned by Everyday Health, a subsidiary of Ziff-Davis during the pandemic reported a narrative that aligned perfectly with the FDA and other agencies and industry. Kristine Fiore, Kristina Fiore, Director of Enterprise & Investigative Reporting delved into the case further which merits a summary.
In one case, a 69-year-old male with a number of serious conditions, such as congestive heart failure, atrial fibrillation and coronary heart disease as well as hypertension and type 2 diabetes—all serious comorbidities for COVID-19—was already prescribed a coagulant and the board’s point was that the prescribing of ivermectin raised the risk for drug-drug interactions reports Ms. Fiore.
But Lin crossed another boundary with this particular patient by also doubling the dose so that the patient’s wife could access ivermectin. It turned out she was experiencing COVID-19-like symptoms and likely, given the diminishing access to the drug during the pandemic due to said politicization the Washington physician attempted to work around the system. Not a good idea.
The MedPage Today report noted that neither of the patients ended up taking the drug after discussing it with their son. Ms. Fiore provides other examples involving Lin’s prescribing practices at the time that appear questionable.
Importantly, TrialSite reported during the pandemic that physicians should not be marketing ivermectin via online as many were doing at the time. TrialSite’s founder Daniel O’Connor, who spent over two decades developing clinical trials and regulatory systems to help pharmaceutical companies adhere to FDA and other regulatory standards shared, “A big mistake ivermectin proponents made was to use social media to promote the drug as a cure or proven regimen for COVID-19.
Even though we reported on studies from around the world—in fact, many, if not most doctors prescribing ivermectin during that time learned about the drug from TrialSite News, no studies were conducted in the U.S. that led to FDA approval. This meant that the drug was not approved for that purpose and hence would need to be used off-label. In those circumstances physicians must operate with incredible care, consulting with patients face-to-face, citing the possible risks, assuring consent and documenting for purposes of future reference.”
However, we were in a pandemic and information was being suppressed and censored as TrialSite reported. This meant that pro-ivermectin physicians were in a bind. On the one hand, they felt it was a matter of life and death to get the word out, any way possible. Yet on the other hand, medicine in America is fundamentally a local affair, regulated at the state level, while drugs and the communication about such compounds are regulated at the federal level.
O’Connor continued that “once doctors start going to Twitter (now X), and other social media to make any claims, they are crossing state lines, and the minute the language even inadvertently or innocently slips into a promotional tone, there can and will be trouble for that doctor. This is just the reality of the American medical system, including the regulations and laws governing the land."
For doctors that do prescribe ivermectin off-label responsibly, they will ensure it’s done on a patient-by-patient basis, with full disclosures, consents and comprehensive documentation.
TrialSite has tracked dozens of ivermectin clinical trials and public health initiatives around the world. The reporting of TrialSite even predated the website known for tracking all ivermectin/COVID-19 studies called https://c19ivm.org/ .
There is certainly a substantial body of evidence with earlier SARS-CoV-2 variants that the drug can help at early stages of acute infection, especially when combined with doxycycline and zinc. Dr. Thomas Borody in Australia, a famous gastroenterologist who in the 1980s contributed to the development of a treatment for Helicobacter pylori even has developed a combination Ivermectin/Doxycycline/zinc regimen under development for mass use should regulatory authorities give his concern the green light. During the pandemic in Bangladesh, Dr. Tarek Alam and others reported notably positive results in decently sized randomized studies.
But to date, the medical establishment as discussed above and below deems the drug unproven. In fact, a handful of large, heavily watched clinical trials including COVID-OUT, Together, Activ6 and Principal all ostensibly led to negative outcomes for the Nobel Prize drug.
Importantly, however, a critique not heard in mainstream media suggests at least some of these studies were deeply flawed. Dr. Michael Goodkin, a retired cardiologist in Pennsylvania and TrialSite advisory committee member has uncovered what he believes to be serious problems with some of these studies; evidence of underdosing and potentially even design-for-failure elements. See “Why Ivermectin Clinical Trials Need to be Questioned—Investigated.” On the other hand, unless such analyses are peer-reviewed and accepted the findings will not impact the health system and to date, the medical establishment has closed the door on ivermectin and COVID-19.
Physicians prescribing ivermectin for COVID-19 reported far more success with earlier variants. However, with Delta and then Omicron, achieving benefits with ivermectin by itself became trickier according to a network of physicians TrialSite consults with regularly. Concerning long COVID, while some doctors are using ivermectin there is no real data publicly available that this drug helps with this condition.
TrialSite discussions with leadership in the COVID-19 vaccine injury group React19 reaffirm the questionable use of ivermectin by itself targeting long COVID or long Vax (another word for long COVID). While some doctors and patients claim some relief, many do not.
Some doctors report off-label that ivermectin combined with other drugs and supplements can possibly help alleviate some symptoms. Again, the aforementioned Dr. Borody, physicians from the Front Line COVID-19 Care Critical Care (FLCCC) Alliance and others continue to consider its use selectively.
In fact, recently, even ex-CNN news figure Chris Cuomo, now at News Nation, disclosed on the PBD Podcast that he is taking ivermectin as part of a regimen for long COVID, as was reported by MSN.
While TrialSite notes that the National Institutes of Health (NIH) COVID-19 Treatment Guidelines continues to declare the drug should only be used in research (e.g. clinical trials), the post-pandemic world seems to loosen up about the ivermectin topic, its use with less politicization as compared to pandemic times.
The drug was unfairly targeted and attacked by a confluence of government, academia and industry interests, likely following a higher-up directive during the pandemic heavily focused on a top-down pharmaceutical-centric model of countermeasure response: vaccination and then pharmaceutical products from antivirals such as Paxlovid (mixed success with its use); Molnupiravir (far less success and safety issues) and Remdesivir (controversial but lots of evidence it has saved lives, but safety issues are a factor) to monoclonal antibodies while early evidence for use of corticosteroids as a potential lifesaver was largely ignored by the mainstream media.
Obviously, physicians have a right to prescribe ivermectin to present (either face to face or potentially telehealth if done correctly) consenting patients with full disclosure of the current authorizations. An information war was launched on physicians in America; however this never directly represented an attempt to ban its use off-label (like what happened with Australia’s Therapeutic Goods Administration), but indirectly in many cases in America, the government’s effort had such an impact as the drug became exceedingly difficult to access for off-label use. TrialSite documents exactly how that occurred, and how the doctors always had a right to prescribe the drug under certain conditions.
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Major win for Aussie workers who refuse to get the Covid vaccine as 'unreasonable' mandate is scrapped
Mandates requiring health workers in NSW to receive two doses of a Covid vaccine will be scrapped this week.
In March, NSW Health said it was reviewing the rule and it has now been revealed that it will be removed for existing personnel and for new recruits from Thursday.
The rule was put in place in August 2021 and about six months later NSW Health said that 995 staff members had either resigned or been sacked over the policy.
Former paramedic and campaigner against the mandate John Larter received a letter from lawyers for NSW Health who had written to his legal team informing him of the change.
'This symbolises NSW Health have acknowledged they can no longer continue to maintain their position due to overwhelming evidence that mandatory vaccination was a misuse of power,' Mr Larter told 2GB's Ben Fordham Live.
'It was completely disproportionate and unreasonable to sack frontline workers which negatively impacted health workers, patient care and outcomes,' he said.
'Lets hope all of those sacked workers are reinstated and compensated.'
Queensland and Western Australia removed their Covid vaccine requirements for health workers in 2023.
Mr Larter had previously launched legal action against the mandates and taken NSW Health Minister Brad Hazzard to the Supreme Court in 2021.
The devout Catholic argued the laws were invalid and that they stopped residents from conscientously objecting to the vaccine based on religious grounds.
Mr Larter said he didn't receive the AstraZeneca vaccine because he believed it was sourced from the cells of aborted fetuses.
He lost his court battle after Justice Christine Adamson dismissed his case.
https://www.dailymail.co.uk/health/article-13419117/Covid-mandate-NSW-health-scrapped.html
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AstraZeneca Covid vaccine victim: Athletic marathon-running father, 50, left disabled, unable to work and struggling to breathe after suffering ultra-rare complication from the jab
He must have had some underlying condition. I had two shots of Astra-Zeneca and they might as well have injected me with saline for all the reaction I had
A taxi driver has been left unable to drive or even walk more than 20 metres after getting the AstraZeneca Covid vaccine.
Self-employed Adrian Walker, from Grantham, Lincolnshire, had the jab in February 2021 to 'protect others', including vulnerable children he helped take to school.
But just two weeks later the previously healthy marathon runner was fighting for his life, admitted to hospital with multiple blood clots in his lungs and bowel.
The ordeal left him struggling with short-term memory, breathlessness and fatigue.
Mr Walker was diagnosed with vaccine-induced immune thrombotic thrombocytopenia (VITT) in late March 2021, with medics confirming it was a result of the AstraZeneca vaccine.
Three years on from getting the jab, he told MailOnline how VITT had laid him low despite his good health.
'I was an extremely healthy and fit 47-year-old, a non-smoker who rarely drank, a sub four-hour marathon runner and a former semi-professional football referee,' he said.
Mr Walker claimed his life 'has flipped on its head' and he is no longer able to drive or run.
Like many others who signed up for the historic Covid jab rollout, Mr Walker, a grandfather, said he was motived to do so for altruistic reasons.
He explained that during the pandemic he often ferried vulnerable children back and forth to school, some of whom were disabled and at a high risk of the virus if they were to be infected.
'I was never worried about catching Covid myself as I was fit and healthy. It was more to protect others,' he said.
Soon after getting jabbed, Mr Walker began to feel unwell. However, he brushed it off, assuming they were the flu-like symptoms he had been warned of as a potential vaccine side effect.
Even when he started to feel worse, he wasn't that concerned, theorising that because it was February he might have caught a cold, or a feeling of lightheaded-ness was due to not having had his dinner.
But 10 days after getting the vaccine, he recalled 'feeling really rough' and even called in sick to work, something Mr Walker had rarely done.
He even decided to get a Covid test, but it came back negative.
However, the seriousness of his condition became apparent when he started experiencing chest pains and was told to go to hospital. He packed an overnight bag and was given steroids and blood tests.
Mr Walker's blood tests came back with worrying results. His platelet levels were just seven, vastly below the normal range for person of between 150,000 to 350,000 per microliter of blood.
Platelets typically help the blood to clot. Other blood tests conducted on Mr Walker were also extremely worrying.
His D-dimer levels, a test doctors use to check for blood clots, was 56,000 — drastically above the 500 score considered normal.
Mr Walker was then taken via an ambulance to another hospital. He would remain there for over a month.
Scans revealed he had multiple clots in his lungs and in the portal vein from his bowel.
So dire was his condition that a week after Mr Walker's was admitted to hospital his wife CJ, 47, was called in and told to prepare for his death.
Mr Walker said that, at the time, he had no idea how serious his condition was.
'I knew I was really ill, but with how fit and healthy I normally am, I wasn't concerned as such,' he said.
'To be honest to a degree I probably never really knew what was going on. Although I was always conscious I probably wasn't coherent all the time.
'My wife would tell me that I would ring her up and tell her something and call her again five minutes later and I could not recall having a conversation with them five minutes previously.'
VITT is thought to be linked to at least 81 deaths in the UK, according to figures collated by UK drug watchdog, the MHRA.
The complication – now listed as a potential side-effect of the jab – causes blood clots along with a low platelet count.
It is exceedingly rare, given the millions of doses dished out during the roll-out. The risk is thought to be in the region of one in 50,000, with the risk dying from it lower.
But at the time Mr Walker's was jabbed no one had yet linked the AstraZeneca vaccine to VITT, also called thrombosis with thrombocytopenia syndrome (TTS).
The connection would only be made after a series of cases in Europe in March, around the time Mr Walker was hospitalised.
UK regulators would only start restricting the use of the jab in April that year.
Mr Walker recalls mentioning feeling unwell after the AstraZeneca jab to the medics treating him, but at the time he didn't think much of it.
'I remember saying to the consultant that I hadn't been well since I had the vaccine. I wasn't saying it was that, but I thought it was strange,' Mr Walker said.
Mr Walker said VITT had affected both his everyday life and his ability to work since 2021.
'I struggle to walk 20 metres, I am constantly short of breath, I suffer with really bad short term memory loss and I am not allowed to drive because of the fatigue,' he said.
He added another impact had been on his personal life and ability to spend time with his loved ones.
'I've not been able to work, I can't be the father, the husband or the grandfather I wanted to be,' he said.
'I can't play football with my grandson, he loves to go to junior park run, I can't go running with him.
'It just feels like life has just literally flipped on its head and you know. I depended on my wife, I could not live independently.
'I dream of just being able to walk to a pup, go in the pub, have a pint, stand at the bar and walk home just something that everybody takes for granted.'
While medics were suspicious his illness was caused by the vaccine, it wasn't until researchers linked the AstraZeneca vaccine and rare cases of blood clotting with a low platelet count.
Four weeks after he was admitted to hospital he got the diagnosis in writing, in late March 2021.
'I left hospital on April 4, so I'd been in there for 34 days, and I breathed a huge sigh of relief when I got wheeled out of those doors and my wife met me at the door of a car. I was still very ill then,' Mr Walker recalled.
But even though he had been injured as a result of the vaccine, he was still unaware of the Government's little-known vaccine damage payment scheme.
He only learnt about it until 'by chance' when another person who was injured from the vaccine told him about the scheme on social media.
But even then, he had to wait almost two years to receive the £120,000 pay-out, which he now calls 'not fit for purpose'.
'I applied to the government's vaccine damage scheme and was eventually paid in April 2023, some 21 months after I applied,' Mr Walker said.
The Vaccine Damage Payment Scheme, originally set up in the 70s, offers those who have been injured, or their families in cases of death, a £120,000 tax-free sum.
This policy covers an array of vaccines recommended by the Government, such as the measles, mumps and rubella vaccine, and was extended to include Covid jabs during the pandemic.
In principle, the scheme is meant to reassure people that, in the unlikely event something goes wrong due to a vaccine they get, the state will provide them support and encourage people to get vaccinated in interests of public health.
But Mr Walker said he doesn't think the scheme is 'fit for purpose', given it took two years for him to receive any money.
During that time, he was forced to live off savings, a fact he said compounded the stress he was under during his recovery.
'The stress of it all on top of when you are ill, when you are struggling to live day to day as it is, to then have that heaped on top was horrible,' he said.
He added: 'I've got a friend who, who suffered a broken hip and leg in a in a car accident and in much less time his case and compensation was settled and now he's fully recovered.'
Freedom of information (FOI) requests to NHS Business Services Authority (NHSBSA), the body managing the UK's Vaccine Damage Payment Scheme, show £3.7m was paid out to 31 Brits injured or bereaved from AstraZeneca's Covid jab between November 2021 and April 2023.
When Mr Walker received his money in April 2023, 4,178 similar claims had been made to the Vaccine Damage Payment Scheme but only 63 claimants had been notified they were entitled to any money.
Now, one year on another FOI shows the scheme has received more than 11,000 Covid vaccine claims as of April 2.
Of these, 168 claims for state-funded financial support have now been approved.
Fewer than five were for fellow Covid jab makers Pfizer and Moderna, the remaining claims are all for AstraZeneca.
Successful claims to the scheme not only cover those affected by VITT but also other jab-related side effects such as the nerve condition Guillain-Barre syndrome, anaphylaxis or other blood clot reactions.
Time to resolution isn't the only criticism of the Vaccine Damage Payment Scheme.
Those injured by a vaccine have either be killed or be at least 60 per cent disabled by their injury, as assessed by a medic, to get any money.
Data shows more than 4,800 claims have been rejected by the scheme, including 324 because they failed to meet this 60 per cent threshold.
'Although the claims met the criteria for causation, the independent medical assessor recommended that the vaccine has not caused severe disablement,' the NHSBSA said.
In practice the scheme's rule means people who are assessed as only 59 per cent disabled by a jab don't get a penny, a policy described as cruel by its critics.
Mr Walker argues it shows the scheme is vastly out of date and needs an overhaul.
To make it fairer, he believes there should be a tiered system to help the people who are cut off from getting any compensation.
Another criticism of the current scheme the maximum £120,000 cap.
This means, for example, someone who is completely paralysed by a vaccine would receive the same £120,000 as someone who had lost a leg.
Many alleged victims of the AstraZeneca jab, facing financial ruin from ongoing care costs and being unable to work, have turned to other means for compensation.
Fifty-one families, including Mr Walker, are currently pursuing legal action against AstraZeneca arguing its 'defective' jab was to blame for their injuries and deaths of loved ones.
Some of these people have already received a payment from Vaccine Damage Payment Scheme.
Others are in the process of applying for a payment. Some have been told they are ineligible.
Should the action prove successful, compensation could reach seven-figure sums.
AstraZeneca, however, will not foot the bill.
Under a legal indemnity that the Government gave the company early in the pandemic — given the need to roll out the vaccine fast — the UK taxpayer will have to pay any compensation awarded.
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16 May, 2024
National University Singapore Scientists Develop mRNA-based Mucosal Nasal Vaccine
Scientist, academic researcher and entrepreneur Ayça Altay Benetti, Ph.D., of National University of Singapore (NUS) along with Kevin P. White and Giorgia Pastorin—both professors also at NUS and colleagues present design and characterization attributes of a novel formulation for delivery of COVID-19 mRNA vaccine targeting the nasal mucosal pathway. They are exploring alternative substances to use as a vehicle to not only efficiently deliver mRNA payloads to the nasal mucosa, but also with the ability to promote uptake by target cells such as epithelial and immune cells.
Identifying chitosan, a natural polysaccharide derived from chitin for this purpose—given its biocompatibility, biodegradability and mucoadhesive characteristics, the Singapore-based team reports on formulations achieving a mRNA encapsulation efficiency of ~80.2% with chitosan-lipid nanoparticles, as measured by the RiboGreen assay.
Reporting on transfection levels in select human cells as part of the evaluation of SARS-CoV-2 Spike (S) receptor-binding domain (RBD) expression via ELISA for the group’s vaccine formulations, the most promising vaccine formulation was also responsive to lyophilization (freeze drying or cryodesiccation)with minimal degradation of loaded mRNA, demonstrating a pathway towards a more accessible and stable vaccine.
Studying the highly experimental vaccine in in vivo mice studies, the team evaluated the systemic and local immune responses. The authors report that a nasal bronchoalveolar lavage fluid (BALF) wash evidenced sufficient levels of antibody concentrations less any problematic systemic antibody response. The academic center scientists in Singapore suggest they have developed a potential candidate for clinical development and commercialization.
Why Researchers Look into Nasal Mucosal Vaccines against COVID-19?
Nasal mucosal vaccines targeting COVID-19 are desirable for several reasons.
First, they can potentially enhance immune response at the SARS-CoV-2 pathogen entry point. COVID-19 primarily enters the body via the respiratory tract. Nasal vaccines can induce strong mucosal immune response in nasal passages and upper respiratory tract, and this happens to be the initial site of the infection.
The premise here is that such localized immunity can potentially prevent the virus from establishing an infection, thereby providing an effective first line of defense. Furthermore, this class of vaccine can potentially reduce aid reduction in transmission, meaning that when nasal mucosal vaccines generate immunity directly in the respiratory mucosa, nasal vaccines possibly can reduce viral shedding and transmission. Put another way, if SARS-CoV-2 is neutralized in the nasal passages, it is less likely to be spread to others through respiratory droplets.
Also, this vaccine method could be administered without needles, meaning it’s easier to administer. This results in a more user-friendly form of vaccine, reducing any discomfort and anxiety associated with injections. But there is more. A nasal mucosal vaccine may stimulate broader immune response, including the production of IgA antibodies, which play a key role in mucosal immunity. This can complement the systemic immunity (IgG antibodies generated by traditional intramuscular vaccines, potentially offering more comprehensive protection.
Other potential benefits of a nasal type of vaccine targeting COVID-19 include the potential for rapid deployment, improved acceptance (given its non-invasive delivery) and cross-protection against variants. On this latter point, preliminary research suggests that mucosal immunity might offer better cross-protection against various variants of the virus. Why? Well, since the nasal passages are the primary entry point for respiratory viruses, a robust mucosal immune response could help in neutralizing diverse viral strains before they cause systemic infection.
The Singapore-based team points out in their paper published in MDPI’s Vaccines, that a chitosan-based formulation represents a good possibility for an mRNA nasal vaccine. With a mucoadhesive nature and ability to transiently open tight junctions between epithelial cells, chitosan facilitates the transport of macromolecules across the nasal mucosa. In their paper, the authors note, “One of the few natural polymers with a positive charge at a slightly acidic pH, chitosan is expected to prolong the local delivery of actives at the mucosa through electrostatic interactions with negatively charged mucin.”
Based on some evidence, the authors suggest this could enable the efficient delivery of mRNA to target cells within the nasal epithelium, ultimately offering opportunity to develop COVID-19 vaccines through the intranasal route.
The authors point to the promise of using the unique mucoadhesive properties of chitosan, potentially in combination with the delivery capabilities of LNPs or liposomal vehicles. This could lead to new avenues for the development of mRNA-based nasal therapeutics. And establish in the future ways to treat COVID-19 via local immunization, along with other benefits including improved bioavailability, reduced systemic degradation, and enhanced uptake by target cells within the nasal mucosa.
But can mucosal formulations overcome some of the current limitations or challenges associated with the current COVID-19 vaccines?
Threats to cargo (mRNA) stability mainly include RNAse enzymes, which easily degrade mRNA (which is hydrolyzed at pH > 6). Even through the existing COVID-19 vaccines use LNPs to encapsulate the nucleic acid therapeutic, regardless instability still occurs in the LNP system when cationic lipids lower the pKa of ribose 2′ hydroxyl group in mRNA, which can increase RNA hydrolysis.
Need for ultra cold chain
mRNA vaccines need to be stored at far lower temperatures. If compromised by external factors resulting from storage conditions, these dosage forms will cause the premature release and degradation of the mRNA by RNase
So, to improve mRNA formulation stability requires one of two directions: either modify the mRNA itself (the cargo) or improve the drug delivery system. The study team assumes that the current methodology is safe and effective, not concerned with a growing, yet not frequently cited literature expressing concern around stability and there are safety issues linked to the instructions to produce the spike protein, although the majority medical research establishment has yet to acknowledge or accept such concerns.
The Study Background
In this study, the team evaluated the stability and efficacy of liposomal formulations, in the presence or absence of chitosan or PEG lipids loaded with linear or circular mRNA. By comparing circular RNA (cRNA) to traditional linear poly-adenylated RNA, the team studied whether the cRNA could display greater stability due to its resistance to exonucleases.
Importantly, what they refer to as optimized formulations in the investigation depend on “self-assembling systems” involving lipids complexed with mRNA, an adjustable process allowing differing ratios of cationic lipid to cholesterol or the ratios of lipid to cholesterol to PEG lipid to chitosan.
Discussion
Achieving an mRNA encapsulation efficiency of ~80.2% using chitosan-lipid nanoparticles, the team employed use of RiboGreen assay for measuring results.
Using ELISA to evaluate the team’s vaccine formulations and corresponding spike protein receptor-binding domain (RBD) expression, the team reports transfection levels “in human embryonic kidney cells (HEK 293), lung carcinoma cells (A549), and dendritic cells (DC 2.4) equal to 9.9 ± 0.1 ng/mL (174.7 ± 1.1 fold change from untreated cells (UT)), 7.0 ± 0.2 ng/mL (128.1 ± 4.9 fold change from UT), and 0.9 ± 0.0 ng/mL (18.0 ± 0.1 fold change from UT), respectively.”
With their top investigational vaccine prospect amenable to lyophilization with minimal degradation of loaded mRNA, the Singapore-based team expresses enthusiasm for the prospect of a more accessible and stable vaccine.
Summarizing at least initial in vivo studies in mice with a nasal bronchoalveolar lavage fluid (BALF) wash highlighting an optimized formulation, which led to local antibody concentrations less any systemic antibody response.
They suggest, “If further improved and developed, it could potentially contribute to the management of COVID-19 through nasopharyngeal immunization strategies.”
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Ear nose and throat illness was slightly elevated among Covid vaccine users
Do COVID-19 vaccines lead to otolaryngology-based adverse events, and ultimately injuries? A medical specialty which is focused on the ears, nose, and throat as well as otolaryngology-head and neck surgeries, these specialists are trained in both medicine and surgery. An otolaryngologist is often called an ear, nose, and throat doctor, or an ENT for short, and recently, specialists from the Tri-State Area published a report on “Otolaryngologic side Effects After COVID-19 Vaccination.” Led by Christina Fang, M.D., Department of Otorhinolaryngology – Head and Neck Surgery, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York, the team designed a r1etrospective analysis of national registry the team investigated the frequency of otolaryngologic adverse events (AEs) after COVID-19 vaccination as compared to other vaccines in a national database.
Tapping into the Food and Drug Administration's (FDA) Vaccine Adverse Event Reporting System (VAERS) database from December 2020 to May 2021, for all COVID-19 vaccination AEs, the team represented by Dr. Fang and colleagues categorized complaints as otolaryngologic and sub stratified into different anatomic components. The study authors determine reporting odds ratios (ROR) and proportional reporting ratios (PRR) were determined for AEs of clinical significance.
While the investigators identified numerous otolaryngologic symptoms, few were found to be clinically significant. Fang and team report facial paralysis, Bell's palsy, and anaphylaxis did not meet signal thresholds to be determined significant. However, signal ratios were detected for a range of issues including dysgeusia, ageusia Tinnitus and Vertigo.
The recent outcomes were reported in the journal The Laryngoscope.
Findings
The authors reported 1,280,950 AEs from vaccination potentially linked to Moderna, Pfizer-BioNTech, and Janssen. 4.9% of the total or 62,660 fell in the otolaryngologic category.
32.6% of the incidents were associated with oropharynx/larynx, 18.3% with the nasal cavity/sinuses, 17.1% with the ears/vestibular system, 10.0% with the oral cavity, and 21.9% miscellaneous.
According to Fang and colleagues, “Signal ratios reached significance levels for dysgeusia (n = 2124, PRR: 17.33, ROR: 16.36), ageusia (n = 1376, PRR: 2.81, ROR: 2.81), anosmia (n = 983, PRR: 4.01, ROR: 4.01), rhinorrhea (n = 2203, PRR: 2.99, ROR: 3.00), throat tightness (n = 3666, PRR: 4.99, ROR: 5.00), throat irritation (n = 3313, PRR: 4.51, ROR: 4.52), dysphagia (n = 2538, PRR: 2.07, ROR: 2.07), tinnitus (n = 4377, PRR: 3.97, ROR: 3.98), and vertigo (n = 2887, PRR: 3.93, ROR: 3.93).”
However, no significant signal ratios were identified for facial paralysis, Bell's palsy, anaphylaxis, sinusitis, hearing disability, and ear pain.
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15 May, 2024
Thousands of Children Prescribed Ivermectin or Hydroxychloroquine for COVID: Study
Doctors prescribed ivermectin or hydroxychloroquine more than 4,400 times to children with COVID-19 during periods of time when the drugs were not recommended against the illness by authorities, according to a new study.
Doctors issued 813 prescriptions of hydroxychloroquine to minors with COVID-19 after the Pediatric Infectious Diseases Society on Sept. 12, 2020, advised against using hydroxychloroquine outside of a clinical trial, researchers found. The recommendation came after the U.S. Food and Drug Administration (FDA) revoked emergency use authorization for hydroxychloroquine against COVID-19.
Another 3,602 prescriptions of ivermectin for children with COVID-19 were issued after Feb. 5, 2021, when the Infectious Diseases Society of America released guidelines advising not to use ivermectin outside of a trial. The FDA later in 2021 urged people not to take ivermectin against COVID-19, although it has since been forced to rescind those warnings.
Dr. Julianne Burns, a clinical assistant professor of pediatric infectious diseases at Stanford Medicine Children’s Health, and other researchers examined records from Komodo Healthcare Map, a health care claims database that Komodo Health says covers 330 million patients. They looked for children who had acute COVID-19 from March 7, 2020, to Dec. 31, 2022.
After excluding some children, including those who did not have continuous insurance coverage for at least one year prior to diagnosis, the researchers found approximately 4,480 prescriptions of “nonrecommended medications.”
All but a few dozen of the prescriptions were for ivermectin or hydroxychloroquine.
Both drugs are approved by the FDA, but not against COVID-19. Some agencies, groups, and doctors say the drugs should not be used against the illness, pointing in part to clinical trials that have found little or no evidence that they’re effective. Other organizations and doctors, though, say the drugs work against COVID-19, citing their own experience and other trials that found the drugs were beneficial. Off-label prescriptions are common in the United States.
Dr. Burns and the other researchers who conducted the new study, which was published by the American Academy of Pediatrics’ journal, said their findings showed “children were prescribed ineffective and potentially harmful medications for acute COVID-19 despite national clinical guidelines.”
The only data on effectiveness or lack thereof they cited was the FDA’s authorization revocation for hydroxychloroquine and the guidance from the Pediatric Infectious Diseases Society and Infectious Diseases Society of America. As for their safety description, they pointed to a federal advisory that found a 24-fold increase in ivermectin prescriptions and a five-fold increase during the same time of ivermectin-related calls to poison control centers.
Dr. Robert Apter, who was not involved in the study, highlighted how the study referred to potential issues but cited no evidence of actual issues from usage of the drugs against COVID-19.
“The fact that there was a report of increased calls to poison control centers about ivermectin doesn’t mean a thing. When something gets in the news and people are curious about it, they may call the poison control center,” Dr. Apter told The Epoch Times.
He said that the drugs “have a long history of safe use in children.”
Dr. Apter has prescribed treatments for thousands of COVID-19 patients and was one of the doctors who sued the FDA over its anti-ivermectin statements. He said he’s prescribed ivermectin or hydroxychloroquine for several teenagers who became so sick that their families became concerned. Those children improved quickly and there were no side effects, according to the doctor.
Dr. Burns did not respond to a request for comment.
The researchers said limitations to their study stemmed from their reliance on health care records, which can’t account for COVID-19 infections that were not reported to a health care provider and might contain mislabeled codes. Funding came from the Stanford Maternal and Child Health Research Institute. No conflicts of interest were listed.
A previous study, examining claims data from Dec. 1, 2020, through March 31, 2021, identified 128 prescriptions of ivermectin for children for non-parasitic infections, with researchers assuming the prescriptions were for COVID-19. That paper drew from IQVIA’s health claims database. The researchers also examined data from patients with Medicare Advantage insurance and found some ivermectin prescriptions, though none for children.
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UPenn Led Researchers Find Political Bias in Who Reports COVID-19 Vaccine Adverse Events
True, the COVID-19 pandemic became ultra-politicized but was this something that manifested in the reporting of injuries linked to the COVID-19 vaccines? Researchers affiliated with University of Pennsylvania (UPenn) and Washington University School of Medicine in St. Louis sought to investigate.
Designing a cross-sectional study involving 620,456 adverse event reports, David A. Asch, M.D., MBA, Senior Vice President for Strategic Initiatives, and the John Morgan Professor at the Perelman School of Medicine and at The Wharton School, and colleagues at UPenn uncovered aw10% increase in state Republican voting was associated with a 5% increase in the odds that a COVID-19 vaccine adverse events would be reported, a 25% increase in the odds that a severe adverse event would be reported, and a 21% increase in the odds that any reported adverse event would be severe.
Interesting Data Points
With 620,456 adverse events (435,797 from women [70.2%]; mean [SD] age, 51.8 [17.7] years) linked to COVID-19 vaccination, the UPenn-based team found a 10% increase in state-level Republican voting associated with increased odds of adverse event reports (odds ratio [OR], 1.05; 95% CI, 1.05-1.05; P < .001). Looking at severe adverse event reports (OR, 1.25; 95% CI, 1.24-1.26; P < .001), plus the proportion of such adverse events reported as severe (OR, 1.21; 95% CI, 1.20-1.22; P < .001) such positive associations between political inclination and reports of COVID-19 vaccination adverse events are revealed in the table above against no associations between political inclination and reports of influenza AEs.
The authors also report the same pattern across all age strata in stratified analyses and in analyses less the District of Columbia, all sustained in the previously cited sensitivity analysis.
Summary
Does the association between observation and belief run both ways? Does the saying “seeing is believing” recognize that humanity’s individual experiences inform our sense of truth? Does “believing is seeing” recognize that human preconceptions control what we experience in the first place? Asch and his colleagues write, “In finding that Republican-inclined states show higher COVID-19 adverse event reporting than Democrat-inclined states, this study suggests that Republicans are more likely to perceive or report those adverse events and that Democrats are less likely to.”
Limitations
While vaccine reporting and political voting happen at an individual level, they are measured at the level of states, and the authors ponder the likelihood of their assumptions as not high.
Yet what’s interesting is that clearly, highly intelligent authors don’t educate the reader on the true limitations of a study such as this one. For example, such cross-sectional studies are unable to establish causality. While this class of study can certainly provide a snapshot of a population as a specific point in time, establishing cause-and-effect relationships between variables is very difficult.
Moreover, such studies are generally fixed in time, meaning they cannot capture changes in variables over time—in this latter case, longitudinal data is superior. What about any bias in sample selection? And then there is the reality that such studies can provide prevalence data but lack the ability to determine incidence. And there is the potential for confounding variables, and other limitations.
Despite these limitations, cross-sectional studies can help generate hypotheses, estimating prevalence, identifying associations between variables, and providing a snapshot of a population's characteristics at a specific point in time.
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Australia: Three years on from Covid lockdown protests Judge Liz Gaynor of the County Court slams police for responding with 'unjustified violence'
In a shock decision, a judge has ruled that Victoria Police used 'unlawful' and 'unjustified violence' on anti-lockdown protesters during the Covid-19 pandemic.
Judge Liz Gaynor of the County Court ruled the police were the 'aggressors' at a protest in Melbourne on May 29, 2021 which left a man with a dislocated arm.
Victoria had some of the world's strictest lockdown conditions at the time, including that people could only move within a 5kilometre area of their home for shopping or exercise, and the banning of public and private gatherings.
The May 29 gathering at Flagstaff Gardens saw police officers vastly outnumbering the 150 protesters who turned up, more than a dozen of whom were arrested for offences such as assault and breaching the chief health officer's directions.
Jason Reeves, Nicholas Patterson and Adam Roob were each thrown to the ground and arrested at the protest after being asked to leave, the Herald Sun reported.
Judge Gaynor said the men's arrests were unlawful and that they had done nothing to warrant the violent response captured on the police's body-worn cameras.
Mr Reeves was punched in the face by police and thrown to the ground, which the judge said was an 'immediate and violent' response.
Mr Patterson and Mr Roob said they tried to defend Mr Reeves and in doing so were pepper sprayed and thrown to the ground, with Mr Paterson's arm dislocated in the scuffle.
Mr Roob and Mr Patterson were in court for charges such as common law assault and assaulting an emergency worker on duty.
But the judge ruled that the police evidence was inadmissible because 'by their unlawful violence police instigated the response by the accused which underlies the charges they now face'.
Judge Gaynor said the police had several options to deal with the pair, such as issuing infringement notices or telling them they breaching restrictions and were to be placed under arrest.
'However, the police chose not to respond that way. I am satisfied that in arresting Mr Reeves, police used unnecessary and unwarranted force and violence.'
She said video of the group in the 30 minutes before the arrest did not indicate they would be violent and that she was 'satisfied that (police) were the aggressors in the situation and that they employed unjustified violence on Mr Reeves'.
The judge said the police did not speak to him and tell him he was under arrest or why he was arrested, but instead 'confronted, pushed, and attacked him before bringing him to the ground'.
She also found that Mr Paterson and Mr Roob 'were met with physical intervention'.
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14 May, 2024
Technofascist Acts Against Health Freedom
I am not quite sure what to make of the article below by Maryam Henein. She seems to be an "alternative" person rather than a person with a science background but there is no doubt that censorship of Covid matters has been extreme. I am the most mainstream scientist you would meet. I even talk about such things as "an experiment-wise error-rate approach to significance testing". Yet Google have censored even me on occasions. So the advocacy of free speech by Maryam Henein is welcome.
How many of us in this Post-Truth world have been silenced? It hurts a bit more when your profession is to be a messenger, report, and alert.
I have been banned for life from PayPal, Amazon, Venmo, and Vimeo. I was scrubbed off Kiva and GoFundMe. My COVID-19 Vaccine Detox Guide to help injured people was removed from SmashWords and my entire profile.
Google buried my company, HoneyColony.com, and our Facebook ads were temporarily shut down while our data was wiped out. Chase debanked me. Media Matters and NBC Peacock smeared me in a horrendous series like Shadowland, where they assured me they’d feature my story but only discovered my person. You can watch my reaction to the series here.
In truth, I can write a whole series about technofascist acts in the health and wellness space.
In 2018, Care2, a site that “connects people with causes,” closed down its “Healthy Living and Causes” sections. They claimed this was to ‘sharpen its focus on advocacy work and nonprofit partners.” They could have archived the stories but deleted THOUSANDS of informative articles about alternative health instead. Poof. Gone. Vaporized.
While putting together my presentation for Anarchapulco Reborn X 2024, titled Health Censorship In An Age of Technofascism & How To Navigate for Truth, it occurred to me that they knew the Rona Regime was coming, and they scrubbed the articles because they did NOT want those locked down at home to educate themselves.
“I know it’s super frustrating to see content that you’ve written disappear,” one of their old editors wrote. Super frustrating? I’d never had my content deleted. Now five years later, i am a seasoned censored pro.
As Mercola wrote:
“It’s a frightening future. Big Tech has joined the movement, bringing in a global concentration of wealth to eliminate competition and critical voices—voices that bring awareness . . . .as our rights, freedoms, and competition erode into a fascist sunset, all disguised as a means to protect you from ‘misinformation.’”
Chet Bowers, who first used the word ‘technofascist’ asks:
“Will enough of the public recognize the dangers that lie ahead, and will they be able to articulate the importance of what is being lost, including how what is being lost undermines the diversity of common cultural experiences that are more ecologically sustainable?
The most critical question is whether there will be resistance to how everyday lives are being increasingly monitored, motivated to pursue the increasingly narrow economic agenda of the emerging techno-fascist culture and stripped of historical values and identity?”
In “1984,” the torture is too much. Winston, the main character, betrays his lover, Julia, in exchange for his own life. She does the same.
“Power is in tearing human minds to pieces and putting them together again in new shapes of your own choosing,” Orwell writes.
In 2019, I asked If we would stand up for rights for health, freedom, and sovereignty. Or sit back and play with our phones while we lose our rights and are forcefully stuck with needles?
Unfortunately, we know the answer by now. Maybe next time, it will be different???
“Anytime you are truly free, there is a cost to pay,” Dr. Cornel West told Joe Rogan.
I agree, but the alternative is ghastly. I don’t believe we have to be slaves to Big Brother. Speak out and share. Tend to your gut and your brain with micronutrients and access the cleanest food. De-Google your life and use other search engines like QWANT.
As Orwell says, “Until they become conscious, they will never rebel, and until after they have rebelled, they cannot become conscious.”
https://principia-scientific.com/part-3-terrifying-technofascist-acts-against-health-freedom/
****************************************************The Tide Turns: Research on COVID Vaccine Harms, Once a Taboo Subject, Now Appearing in Some Medical Journals
By Joe Wang
When COVID-19 took the world by storm in early 2020, I mostly relied on reading Nature Medicine, The Lancet, and a few other medical journals to learn the latest on this new disease.
In March 2020, I read an article published in Nature Medicine titled “The proximal origin of SARS-CoV-2” with great interest. Written by California-based Scripps Institute’s Kristian Andersen and four other well-known professors, it said SARS-CoV-2 binds to human cells much better than any computer programs predicted, and concluded that “SARS-CoV-2 is not the product of purposeful manipulation.”
Having been a scientist with the world’s largest vaccine company for more than 10 years, I took issue with this claim.
In a May 2022 commentary titled “Pandemic Lessons Learned: Scientific Debate Silenced, With Deadly Consequences” I wrote: “If SARS-CoV-2 infects people better than your computer predicts, then the only conclusion you can draw is that your computer sucks. How did these world-renowned scientists get the basic logic so wrong? And how did the prestigious publication Nature Medicine not catch that? Did anyone even read the paper before publishing it, not to mention peer review it?”
The Andersen article’s conclusion, as it turned out, was a complete flip-flop on Andersen’s Jan. 31, 2020, email to Dr. Anthony Fauci, then the director of the National Institute of Allergy and Infectious Diseases (NIAID), in which he wrote that “some of the features (potentially) look engineered,” referring to the coronavirus.
The Fauci emails were made public in June 2021 via Freedom of Information Act requests.
Nevertheless, the Nature Medicine paper became the authority on the origin of COVID. It essentially excluded the Chinese Communist Party (CCP) and Dr. Fauci from any responsibility for the emergence of the virus. Any attempts to investigate or explore other possibilities were labelled conspiracy theories.
Andersen, and the article itself, were the subject of a U.S. Congressional Hearing by the Select Subcommittee on the Coronavirus Pandemic in June 2023. The debate on how COVID originated is still ongoing today.
The Lancet and the Daszak Statement
Andersen and Nature Medicine weren’t the only ones trying to please the CCP and Fauci.
On Feb. 18, 2020, The Lancet, another top medical journal, published a political statement with no science in it. It was organized by Peter Daszak from EcoHealth Alliance, which was the middleman for channeling Fauci’s National Institutes of Health (NIH) funds to the Wuhan Institute of Virology, according to a U.S. Congress report released on May 1 of this year.
The Daszak et al. statement dismissed as a conspiracy theory any suggestion that COVID was not of natural origin.
“We stand together to strongly condemn conspiracy theories suggesting that COVID-19 does not have a natural origin,” they wrote. “Conspiracy theories do nothing but create fear, rumours, and prejudice that jeopardize our global collaboration in the fight against this virus.”
The Tune Is Set
The Daszak statement, along with the Andersen article, set the tune for the officially accepted narrative. The narrative then expanded from “a natural origin of the virus” to “a COVID vaccine will flatten the curve and save the world.” Scientists, doctors, and journal editors who dared to challenge the narrative were cancelled and/or labelled conspiracy theorists and anti-vaxxers.
It has been four years and six months since the world first encountered SARS-CoV-2. Despite the claims by famous scientists like Fauci and Andersen, and despite the countless efforts by top virologists and public health professionals, evidence that the virus originated naturally has not been found.
More and more people now believe that the virus was leaked or escaped from a laboratory at the Wuhan Institute of Virology, which has been doing gain-of-function research on coronaviruses, and published such research in Nature Medicine in 2015, with NIH funding acknowledged.
The lab origin is no longer a conspiracy theory. The U.S. Energy Department and the FBI both now believe that the virus was more likely leaked from a lab than having developed naturally.
Encouraging Developments
Since the pandemic, The Epoch Times and NTD have been publishing documentary films on COVID origin and vaccine injuries. The first such documentary, Joshua Philipp’s “Tracking Down the Origin of the Wuhan Coronavirus,” was viewed over 100 million times on different platforms combined. However, such reports are rarely seen in other legacy media.
It has also been a taboo subject for scientific research and publication, but that may be starting to change.
Recently, I wrote a commentary about a new paper by five Japanese scientists that was published on Cureus, a peer-reviewed medical journal owned by the Springer Nature Group, the same company that owns Nature and Nature Medicine.
The scientists analyzed data collected from the entire 123 million Japanese population and concluded that the majority of the 115,799 excess deaths in 2022 was not due to COVID infection but rather vaccination, in particular the third COVID shot.
I was pleasantly surprised that a once-taboo subject was now published in a peer-reviewed medical journal, especially a member journal of the Springer Nature Group.
In another positive development, this month the International Journal of Biological Macromolecules (IJBM) published a paper titled “Review: N1-methyl-pseudouridine: Friend or foe of cancer?” linking a key ingredient in the COVID-19 mRNA vaccine with cancer development.
IJBM is owned by the Dutch academic publishing company Elsevier, which also owns renowned publications like The Lancet, Cell, and ScienceDirect.
May the Force Be With the Editors-in-Chief
In the spring of 2022, when more scientists started to challenge the accepted narratives and seek the truth, I co-wrote the commentary “May the Force Be With Them: Scientists Fight Back.”
At that time, these brave scientists needed all the help they could get. For example, when a journal published a well-researched, well-written, and fact-based scientific paper on the safety concerns of the mRNA vaccines, the editor-in-chief of that journal was ousted.
The journal was Food and Chemical Toxicology, another Elsevier publication, and the editor-in-chief was Dr. José Luis Domingo.
Two years later, I’m optimistic that the IJBM editors-in-chief won’t face the same treatment as Dr. Domingo.
Why? I believe the tide has turned.
A recent New York Times article on COVID vaccine injuries is also an encouraging sign. It cites the Food and Drug Administration’s former acting commissioner Dr. Janet Woodcock as saying the injuries are “serious” and “life-changing,” and “should be taken seriously.”
“I’m disappointed in myself,” she added. “I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.”
Among the reported injured is the editor-in-chief of the journal Vaccine, Dr. Gregory Poland. He has been suffering from tinnitus since his first shot. The Centers for Disease Control didn’t take his report on his personal experience seriously. He told the NY Times that he did not “get any sense of movement (from the CDC).”
“If they have done studies (on vaccine injury), those studies should be published,” Dr. Poland added.
The journal Vaccine is also an Elsevier publication, and as the editor-in-chief, Dr. Poland is well positioned to offer his encouragement on vaccine injury studies.
Yes, I believe the tide has turned.
However, as of today, the Daszak statement is still on The Lancet website and the Andersen paper is still on Nature Medicine.
I wonder when the Lancet and Nature Medicine will have the courage to retract them? And when will these two eminent journals start publishing research on COVID vaccine injuries?
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13 May, 2024
COVID-19 Medical Freedom Warriors Seek to Use the Courts to Take on Vaccines
The undoubted bad behavior of governments during the pandemic has undermined their authority and tends to hand authority to the courts, which may not always be very friendly to personal liberty
While numerous bills were introduced in state legislatures prior to the pandemic challenging state vaccine requirements, politicization of vaccines has intensified since the COVID-19 pandemic. As politicians and in some cases, state health officials make moves to cater to angry, at times conservative or medical freedom-focused populations reacting to what many felt were overreaching COVID-19 pandemic programs, the health crisis led to a notable surge in vaccine-related litigation across America. To some extent, the vaccine policy area has moved from lawmaking and legislators into the courts, but TrialSite notes legislation continues to play a key role in vaccination policy. However, could litigation increasingly constrain what public health-minded legislatures can do to protect the public with vaccination schemes statewide?
SCOTUS shoots down some federal mandates
Since COVID-19 TrialSite reports on a growing presence of the courts as a source of power and vaccine policy---for example, profound issues related to vaccine science and public health powers may now be settled more by judges than by legislatures or public health experts via administrative actions.
An area with precedent, over a century of settled law confirms the constitutionality of state vaccine mandates—however, these increasingly may fall into question as dissenting justices of the US Supreme Court could lean toward undoing such legal tenets.
The highest court in America heard cases pertaining to federal and employer powers to compel vaccination, and in some cases shot down presidential edict during the pandemic on grounds of constitutionality, or lack thereof. More on that below.
CICP backlogged
A major thrust involving a confluence of forces, from traditional anti-vaxxers to newbies in the health freedom movement, to groups with claims such as the COVID-19 vaccine injured, targets the lower courts. In these forums, could some conservative-minded appellate judges possibly make moves to grind down liability protections for vaccine manufacturers? Meanwhile, political pressure against vaccine liability protection may grow, given the huge backlogs linked to the U.S Countermeasure Injury Compensation Program (CICP), established to compensate persons injured by COVID-19 countermeasures (vaccines).
How many are injured from COVID-19 vaccines?
TrialSite has reported on the appalling state of those programs, an utter failure leaving possibly tens of thousands of people with nowhere to turn. Some medical freedom movement figures claim the figure of COVID-19 vaccine injured to be in the many millions. TrialSite has estimated the number to be between a quarter-of-a-million to about two million people nationwide grappling with some set of challenges impacting quality of life. To put these figures in context, about 230 million people in the U.S. were deemed fully vaccinated during the pandemic.
With no end in sight, litigation could represent profound challenges for what government health agencies refer to as vaccine confidence or the lack thereof. Even public health itself during the pandemic, due in part to politicization from all sides, but also a range of behavior from over-reach to incompetence on the part of the government, has led to even questions about the legitimacy of public health agencies such as the Centers for Disease Control and Prevention (CDCP itself).
Does Jacobson v. Massachusetts stand the test of time?
Could the result of all of this be seismic changes in law around the country?
For example, states’ traditional rights to mandate vaccination could be under fire given the backlash against vaccination since COVID-19. For example, with the intense array of rules, mandates and the like emerging during the pandemic, now numerous lawsuits play out, reaching the highest levels including the Supreme Court.
In fact, on that topic, several cases have made their way to the high court, and the justices, conservatively leaning, have demonstrated a proclivity for revisiting past policies promulgated at the state level. Laws under the gun include Jacobson v. Massachusetts (1906) and Zucht v. King (1922)—both cases affirming a state’s ability to use its police powers to compel vaccination.
While Jacobson didn't touch on religion exemption cases working their way up, the highest courts are looking at these issues. Known as the COVID-19 Bar, the milieu of lawyers involved with challenging what’s known as the COVID regime, they suggest that Jacobson was decided in an era when the Supreme Court was upholding forced sterilization laws, and the eugenics movement sought to perfect the human race with unbridled and faith in science as an example of a different point of view.
Is Gorsuch a Justice to watch?
Justice Neil Gorsuch, a conservative-minded judge nominated by former President Donald Trump has expressed particularly more radical views when considering the mainstream medical and health policy establishment’s paradigm.
For example, Gorsuch has voiced agreement with expanding religious exemptions to immunization requirements, plus went on the record about COVID-19 public health actions stating they were, “the greatest intrusions on civil liberties in the peacetime history of this country.”
Moreover, in another case, Gorsuch suggested that public health actions need a material check on powers, lacking any imminent disease threat.
However, if such a ruling were ever to become reality the public health establishment would argue that this would undermine the ability of states’ public health agencies to strive for and maintain herd immunity against vaccine-preventable diseases, not to mention stopping outbreaks.
Importantly, in Zucht v. King (1922), the Supreme Court ruled that public schools can constitutionally exclude unvaccinated students, even when there isn't an outbreak of a particular illness. The 9–0 decision was made on November 13, 1922, after the case was argued on October 20, 1922.
But what if Gorsuch and others became a majority on this matter? Could they eventually overturn Zucht? That would dramatically change the face of public health in the United States. Will Gorsuch find the opportunity, based on mounting litigation working its way up the lower courts and above thanks to conflicting decisions—to apply his thinking which could literally eliminate modern public health powers?
What’s the status of religious exemption cases?
In Mississippi last year, a judge at the federal court level ordered the state to allow religious exemptions to immunization requirements. The result? What essentially is the upending of a 44-year-old state law established at the Supreme Court level, ruling that a lack of those exemptions does not violate religious freedom? How? By placing such religious freedom beliefs of a minority over more far-reaching public health interests.
In the above case, it was reported in the Mississippi Free Press on September 29, 2023, that the state’s attorney general would not oppose the ultimate decision favoring the anti-vaccine—or some might say pro-freedom litigants.
While such decisions may lead to less vaccination with traditional childhood scheduled immunizations, meaning diseases such as the measles could rise, public health agencies are also concerned about more systematic efforts of religious-focused anti-vaccine groups use of the topic as a front to systematically attack tried and true vaccination programs more broadly.
Ongoing litigations threaten federal powers
To many persons in what is broadly referred to as the medical freedom movement, President Joe Biden’s proclamations in August 2021 were an affront on freedom. A milieu of actions, from mandates to policies to bolster COVID-19 immunization rates, Biden’s administration took this approach despite the fact that the federal government traditionally wields little power involving healthcare laws. Rather, these laws fall under the state and local jurisdiction.
Biden’s actions generated resistance across a range of interests, including TrialSite. While this media is not “anti-vaxx” or even part of a “medical freedom movement,” we simply reported on the contradictions in the series of mandates and requirements Biden announced. One challenge was that by that point in time, the unfolding science was evident, that the COVID-19 vaccines did not stop viral transmission. Since they were not sterilizing vaccines and the durability of the vaccines was mediocre to say the least (e.g. waning in protection as quickly as in 90 days) the impetus to compel vaccination seemed a real stretch. After all these “vaccines” behaved more like temporary therapeutics.
Biden tapped into and exploited a collection of laws, powers and policies, from the Center for Medicare and Medicaid Service (CMS) contingencies for accepting federal health-related money to the Occupational Safety and Health Act involving government contractors to military personnel. The White House’s moves were challenged, with the Supreme Court ultimately diverging on the Biden mandates. While the Medicare requirement was kept, the Supreme Court shot down the other Biden mandates.
But even the CMS ruling, that contractors or organizations funded with CMS monies needed to mandate the COVID-19 vaccine, was ultimately terminated by the Biden administration itself. Was this move by Biden further evidence of a strengthening of the medical freedom movement?
Other upending of the public health system?
Attorneys favoring universal vaccination and robust public health authority express concern about recent court decisions. In one case, a New York judge rejected standard government vaccination policy because the COVID-19 vaccine failed to stop all viral transmission. Public health advocates fret that such decisions inhibit the exercise of public health authority on what they would argue were based on faulty premises. While not all vaccines fully stop transmission, they tend to certainly slow the spread, along with contributing to substantially lower morbidity and mortality rates. With courts intervening, inhibiting the public health authority to achieve its aims not only threatens the public health but also the balance of powers in the United States.
Supreme Court ruling tosses out “de minimus” standard
Has the medical freedom movement’s backlash to COVID-19 impacted what’s been an accepted authority on behalf of an employer to mandate vaccination on the job? Absolutely! See SCOTUS’ Groff v. DeJoy in 2022. In this case, the court clarified the undue hardship legal standard by addressing various lower court tests developed over the last 50 years that evaluated undue hardship in terms of whether an accommodation imposed “more than de minimis costs” or “substantial costs or expenditures” to the employer.
Based on this decision, employers must now prove “substantial increased costs” rather than the de minimis cost standard. We see a mounting number of cases driven by the Equal Employment Opportunity Commission (EEOC) involving numerous cases targeting employers due to the denial of religious exemptions to the COVID-19 vaccines. Will employers face more aggressive EEOC enforcements involving refusal to grant mandate exemptions? Some experts believe so.
What about the PREP ACT?
Importantly, manufacturers who marketed countermeasures during the pandemic (and after) benefit from broad liability waivers granted to vaccine makers such as Pfizer and Moderna, thanks to the Public Readiness and Emergency Preparedness Act (PREP Act). The presumption here is that any and all vendors involved with the development and administration of COVID-19 countermeasures benefit from universal liability protection by the government, again thanks to this legislation. But the emergence of some lawsuits has spooked government, industry, and other attorneys representing the countermeasure value chain. For example, in a handful of cases, the courts of appeal ruled that the PREP Act was not meant to preempt state tort claims, given that the emergency act fails to offer adequate judicial alternatives for injured plaintiffs.
Courts suggest ways around PREP Act
For example, ruling that the PREP Act wasn’t meant to fully supersede state law claims, the Third, Fifth, Seventh, and Ninth federal circuit courts have suggested that the PREP Act cannot completely preempt state law claims, thus allowing these claims at the state level to proceed. So, for example, negligence/willful negligence, or wrongful death, or perhaps some form of fraud could trigger state-based actions, meaning a federal action might be avoided in association with the case. TrialSite is currently tracking this topic. In one major case, M.T. v. Walmart Stores, Inc. invoking the PREP Act led to the ruling that this Act fails to afford an acceptable judicial alternative for injured parties.
In another major test, however, the Court of Appeals of Kansas found that the PREP Act does in fact preempt vaccine-related tort claims. As mentioned above, TrialSite has reported on emerging judicial conflict at the level of the federal appeals court, meaning the high likelihood of litigation over the PREP act.
Could Pfizer, Moderna, or even health systems that administered the mRNA COVID-19 vaccines confront hostile courts in the future? Any litigation that makes it through the seemingly impenetrable wall of PREP Act could open up discovery and a process not conducive to pharmaceutical industry innovation, especially if product liability claims breached such a legislatively constructed fortress.
Do we have the right to refuse?
With a marked rise in vaccine litigation post the COVID-19 pandemic and a fledgling medical freedom movement—which generally refers to a range of beliefs and activities advocating for individuals to have autonomy and choice regarding their own medical decisions, a host of issues, such as the right to refuse certain medical treatments or interventions; or for that matter, the right to choose alternative or complementary therapies, will increasingly confront courts at all levels.
Medical Freedom Movement’s future
Over a century of case law and precedent, involving an incrementally evolving, empowered public health reality could be under assault, or at least under fire, from a growing cadre of interests interested in the right to make informed decisions about one's own health care without undue interference or coercion. Ironically at least some stakeholders within the medical freedom movement take a staunchly anti-abortion stance, which has been embraced as part of the women’s freedom movement over the past decades. Will the medical freedom movement, often intersecting with debates around vaccine mandates, medical privacy, informed consent, and governmental or institutional policies that affect individual health choices, accelerate post-COVID-19, or on the other hand, slow down as the populace tires of anything and everything COVID-19?
Personal autonomy versus public health
Proponents argue that individuals should have the freedom to make decisions about their own bodies and health care without interference from external authorities, while critics may raise concerns about public health implications and the potential for misinformation to influence decision-making. This latter point of view raises serious concern about some of the court decisions made during the COVID-19 pandemic period. They view such decisions as a step backward from modernity. The medical freedom movement reflects broader discussions about personal autonomy, individual rights, and the balance between personal choice and public health considerations in the realm of medicine and healthcare, and no doubt the courts will continue to be where the parties clash.
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12 May, 2024
Why Major Ivermectin Clinical Trials Need to be Questioned--Investigated
There were four large randomized, ivermectin trials I have exhaustively analyzed, likely more than any human--TOGETHER from McMaster University in Canada, COVID-OUT in University of Minnesota, ACTIV-6 sponsored by NIH and run by Duke and PRINCIPLE run by Oxford.
Note that my findings are in the context of a clear information war that unfolded during the COVID-19 pandemic against ivermectin. In fact, the Food and Drug Administration (FDA) recently lost a lawsuit, as front-line doctors challenged the agency’s unethical, illicit behavior during the pandemic.
In the aggregate, tens of billions of dollars of potential profits were within reach of pharmaceutical companies during the pandemic. A system with biases and importantly, pecuniary interests heavily influence paradigms and strategies for combating pandemics. During the unprecedented federal takeover of medicine during the pandemic, government actors clearly favored branded and expensive drugs over economically accessible generic combinations, as the latter would not drive exorbitant profits. This is the context for which a handful of key ivermectin studies were designed and executed.
After an exhaustive review of these studies, what follows are key points of concern, discrepancies and other issues that I have found, and thus raise substantial doubt about the outcomes announced. While my findings are not published nor peer-reviewed, I invite anyone interested to review and verify for themselves. My findings reveal a disturbing set of patterns that suggest that these clinical trials were designed with failure in mind. But importantly, review and come to your own conclusions.
1. All these clinical trials as if synchronized gave patients within 23% of the same dose. The dose was 42% of the average recommended cumulative dose of the front-line physicians who were arguably the top front-line physicians prescribing the drug off-label during the pandemic. Known as the Front Line COVID-19 Critical Care (FLCCC) Alliance, these physicians aligned with providers from Australia and Eastern Europe to Bangladesh and India; from Nigeria and Latin America to Zimbabwe and Peru, forming a community-centric, bottom-up, patient-centric approach to rapid, early treatment often in combination with doxycycline and zinc during the worst pandemic in a century.
The world’s top ivermectin experts, at least during the pandemic, ironically first learned about ivermectin’s use around the world via TrialSite News The FLCCC is of course, not an acknowledged evidentiary reference body, nonetheless the group kept the spirit of the local community physician, seeking what’s right for the patient alive and well during the unprecedented pandemic, with its federally-driven, top-down, truly unorthodox approach to medicine.
The FLCCC physicians were so influential that the ACTIV-6 investigators consulted with them via online communication, but the latter failed to heed their advice. An investigator from one of these studies claimed on Twitter (now X) that the FLCCC said that their dosing was perfectly reasonable. This is not a factual statement, as proven by the FLCCC website and Dr. Pierre Kory’s Twitter page.
The point here is to emphasize the influence of the FLCCC and its ivermectin-based protocols, irrespective of whether its’ recommendations were included by federal authorities or medical bodies during the pandemic—which they were not.
2. All the trials gave ivermectin on an empty stomach when the blood level is 157% higher when the typical dose that they used, 30 mg, is given with a fatty meal. This regimen markedly differed from what the physician experts in the field recommended at the time.
3. TOGETHER, ACTIV-6 and PRINCIPLE all limited the dose by weight for no medical reason. Overweight patients who were at higher risk, had their dose limited the most, which made no sense.
4.All the trials gave ivermectin late, at an average of 4.9 days of symptoms. Paxlovid is usually given in one to two days. What we found is that there was a regular and systematic pattern of not only underdosing the drug but having the drug taken when it was frankly, too late.
5. The NIH-sponsored ACTIV-6 ivermectin trial gave 37% of the FLCCC recommended cumulative dose on an empty stomach and got it to patients at an extremely late six days on average. 75% of the patients would not have been candidates for Paxlovid, meaning the trial looked at from this lens was all but designed to fail. 75% of the patients would not have been candidates for Paxlovid, meaning the study wasn’t enrolled with the right participants.
6. Ivermectin would be declared effective if it showed at least a 95% chance of benefit in the entire 1591 patients or in any of the analyses every 300 patients. Yet as will be shown, when the data demonstrated a positive impact, nothing was done.
7. Despite the undertreatment and late treatment, ivermectin evidenced a 98% chance of benefit, so the investigators changed the primary endpoint from 14 days to 28 days, which is unethical. It showed a 91% chance of benefit, which was not statistically significant. The investigators said that ivermectin could not be recommended. Any normal person would have been happy to take a cheap, safe drug if it had a 91% chance to help them.
8. The investigators never reported any of the interim analyses because that would have revealed significant benefit at 900 patients. Ivermectin was effective for the first 900 patients who had over 90% Delta. It is highly likely that ivermectin would also have shown benefit at 600 patients. The actual data from the trial is needed to prove this. It could be obtained by a subpoena from the House Select Subcommittee on the COVID-19 pandemic or in discovery in targeted litigation.
9.Ivermectin should have been declared effective in the initial ACTIV-6 trial, later called ACTIV-6 400. As suggested above, at certain points the data suggested efficacy.
10. Early intervention with combinations such as ivermectin with doxycycline and zinc could have helped alleviate some of the suffering during the pandemic. I am a retired physician, and it is my opinion that had ivermectin been declared effective as it should have been by December 2021, hundreds of millions to billions of people around the world could have received and benefited from the drug. In the U.S., about 200 million people fell ill to COVID-19 since Dec 2021, and in my opinion, the information war launched against ivermectin by the U.S. FDA and to some extent, NIH caused tremendous unnecessary harm to Americans and others worldwide.
TrialSite chronicled extensively public health initiatives involving the combination of ivermectin, doxycycline and zinc in the Indian state of Uttar Pradesh for example, where the battle against Delta was so successful that even the World Health Organization issued a press release to celebrate the turning around of the COVID-19 [Delta] surge during the spring to summer of 2021.
Read “Uttar Pradesh going the last mile to stop COVID-19” by the WHO---they report on the entire public health initiative, only omitting the medicines used in the local home medical kit---which of course included ivermectin. See the link.
Let's do a proper comparison. In my opinion, a large, randomized trial of ivermectin at an appropriate dose versus Paxlovid or molnupiravir in patients with COVID-19 for five days or less would settle the issue once and for all. A recent study revealed Paxlovid isn’t even effective against placebo in healthy people, and molnupiravir is avoided by most doctors now.
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AstraZeneca Covid vaccine withdrawn over side effects but ‘fear more deadly’
I have doubts about whether ANY of the Covid vaccines was of net benefit but if we accept that AstraZeneca was of net benefit, the observations below are reasonable
A leading infectious diseases physician says overblown fears about the AstraZeneca Covid-19 vaccine probably caused more deaths than the vaccine’s rare adverse side effects.
The response comes as the vaccine was withdrawn globally after the manufacturer admitted it can cause rare blood clots.
The Anglo-Swedish pharmaceutical producer withdrew the vaccine globally on Tuesday.
It comes after Australia’s Therapeutic Goods Authority discontinued use of the AstraZeneca vaccine in April last year.
On April 30 this year, AstraZeneca conceded the vaccine, sold under the name Vaxzevria, can cause fatal blood clots.
The admission came through court documents in a British class action lawsuit that sought £100m ($190m) for almost 50 victims of AstraZeneca vaccine side effects.
The application to withdraw the vaccine was made on March 5 and came into effect on May 7.
“I can see why it’s recalled because it does have probably a death rate of about 1 in 100,000 people from this clotting disorder,” the ANU’s Professor Peter Collignon said.
“But having said that, there are deaths associated with every drug and every vaccine we have – even aspirin, if you take it regularly, about 1 in 100,000 people per year die from that.
“One of the things that this side effect induced back in 2021, in my view, was the fear and the publicity about the adverse effect caused more deaths than the actual vaccine did. If you were an 80-year-old and got Covid, you had a 1 in 10 chance of dying. Yet, if you had this vaccine, you had a 1 in 100,000 chance of dying from the effect of a complication. Yet, there were a lot of people, because we had zero Covid at the time, who said, ‘oh no, I’ll wait because the Pfizer vaccine’s better’.”
The TGA provisionally approved the AstraZeneca vaccine for use for people aged 18 and over as a primary course from February 15, 2021 and as a booster from February 8, 2022. In the same period, Pfizer and Moderna vaccines were recommended over the AstraZeneca vaccine.
In June 2021, the Australian Technical Advisory Group on Immunisation recommended that Australians over the age of 60 avoid taking Vaxzevria.
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May 10, 2024
My article on this blog: "Key Ingredient in Pfizer and Moderna COVID Shots Aids Cancer Development, New Study Shows" has been deleted by Google. As host of Blogspot, they can do that. It appeared on May 1st and reported a study by an international group of authors that appeared in an academic journal. So it is a surprising bit of censorship. The article is still online at the site I got it from:
https://www.theepochtimes.com/opinion/key-ingredient-in-pfizer-and-moderna-covid-shot-aids-cancer-development-new-study-shows-5638998
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9 May, 2024
New Study From Czech Republic Confirms Covid Vaccines Have Around Zero Efficacy Against Death
Dr. Eyal Shahar
In 2021, we were flooded with visuals showing us how effective the mRNA vaccines were against death from Covid.
We saw, for example, that the Covid mortality graph of those who completed the two-dose protocol was substantially lower than that of the unvaccinated. To strengthen the point, we were shown a consistent pattern across age groups or after age adjustment.
Much of this was an illusion. Back then, they did not display comparable graphs for non-Covid deaths. If they did, we would have seen that the vaccinated also fared better on non-Covid mortality. Of course, no one expects these vaccines to prevent death from cancer, heart disease, stroke and so on.
The pseudo-effectiveness of Covid vaccines against death from unrelated causes is not a new observation. The same kind of pseudo-effectiveness was discovered long ago for the flu vaccines. It is called the ‘healthy vaccinee effect’.
For various reasons unrelated to the vaccines, people who are vaccinated have better background health on average than people who are not, and therefore they are less likely to die from ‘anything’, including flu and Covid. Vaccinated or not, they would have had lower Covid mortality than their unvaccinated counterparts.
When we try to estimate the effect of Covid (or flu) vaccines, the healthy vaccinee effect becomes the healthy vaccinee bias, a source of distortion that must be removed. (Conversely, we may call it the ‘unhealthy unvaccinated’ bias.) Research on this topic has been sparse, however.
Neither the pharmaceutical industry nor public health officials have had an interest in discovering that common vaccines were not as effective as they claimed them to be, or perhaps not effective at all.
A recent study from the Czech Republic has made significant contributions to the scientific literature on Covid vaccines and the healthy vaccinee effect. First, the authors observe the phenomenon in an additional country, lending support to its universal nature. Second, they provide clear evidence that those who chose (or were coerced) to be vaccinated were indeed healthier.
Third, they show that the phenomenon is consistent along the sequence of doses, as was evident in U.K. data for booster doses: those who continued to the next dose were healthier than those who did not. Lastly, they demonstrate that the observed pattern in their data can be reproduced by simulated data when a vaccine has no effect and only the healthy vaccinee effect is operating. It is worth reading the paper in full, whether or not you are a science specialist.
What was done in the study?
The authors computed rates of all-cause death in periods of Covid waves and in periods of low (almost no) Covid deaths. The latter are essentially rates of non-Covid death, which means that any ‘effect’ of the Covid vaccines during these periods is a pseudo-effect: it is the healthy vaccinee phenomenon alone. In each period, they compared the mortality rate between the unvaccinated and various groups of vaccinated people.
I will discuss one key topic: the pseudo-effect of the two-dose protocol, starting four weeks after the second dose when people are considered fully protected. To focus on that group versus the unvaccinated, I added oblique arrows to Figure 2. Notice that these bars show rates, not counts, of deaths in a period with low Covid deaths (green panel). Again, although these are deaths from any cause, 99.7% were not related to Covid. Therefore, they may be considered rates of non-Covid death, and that’s what I will call them.
In each age group, the rate of non-Covid death in the effectively vaccinated (yellow) is much lower than the rate in the unvaccinated (black). Of course, that’s a pseudo-effect of the vaccines. That’s the healthy vaccinee effect, or bias when trying to estimate the true effectiveness against Covid death.
The authors kindly provided their data, which are summarised in my table for the low-Covid period.
As you can see from the computation, the ‘bias factor’ (last row) is simply the inverse of the pseudo-effect of vaccination. It tells us how much more likely the unvaccinated are to die ‘in general’, as compared with those who completed the two-dose protocol at least four weeks earlier. Formally, it should be called the bias correction factor, but we’ll keep it short.
My next table compares the results from the Czech Republic to data from the U.K. and the U.S. in similar age groups (my computation from the available data).
Notably, the bias factor in data from different countries and cultures varies in a narrow range: between 2 and 3.5. It is lower in the oldest age group but is still at least 2. Overall, the unvaccinated are two to three times more likely to die from various causes than the fully vaccinated.
Other data indicate that the gap narrowed over time (because unvaccinated survivors were ‘healthier’ as time went on and some of the less healthy died), but it lasted months, not a few weeks. When a third dose was introduced, the healthier moved to the three-dose group, leaving behind a sicker group of ‘only two doses’.
As a result, the two-dose group now appeared to have higher mortality than the unvaccinated. This observation was mistakenly interpreted as evidence of vaccine-related deaths (which unquestionably happened).
To remove the healthy vaccinee bias, we multiply the biased rate ratio of Covid death by the bias factor, as explained elsewhere. For example, if the biased rate ratio of Covid death is 0.4 (60% ‘vaccine effectiveness’) and the bias factor is 2.5, the correct effect on Covid death is 0.4 × 2.5 = 1, which is 0% vaccine effectiveness.
I will conclude with another example of the healthy vaccinee bias and the true effectiveness after correction.
A study of U.S. veterans presented survival graphs of fully vaccinated and unvaccinated elderly people following a PCR test (figure below). I will consider a death following a positive PCR as ‘Covid death’ and a death following a negative PCR as ‘non-Covid death’.
It is just an approximation, of course, but that’s all we can get from the paper to distinguish between the two types of death. Studies of Covid vaccines rarely report data on non-Covid death by vaccination status, so we often have to derive such data from whatever is provided.
I visually estimated the risk of death at three time points, where the survival probabilities for a pairwise comparison were close to the marks on the Y-axis (2% intervals). My rough estimates are summarised in the busy table below.
As you can see, correcting for the healthy vaccinee bias has changed estimates of effectiveness from around 70% to around 10%. And that’s not the only bias in observational studies of Covid vaccines. Differential misclassification of the cause of death is another strong bias. Would any effectiveness have remained if all the biases could have been removed? Were lives indeed saved by these vaccines?
Let me end with a comment not on Covid vaccines, but on flu vaccines.
If you look at the U.S. CDC website, you will find data on the effectiveness of the flu shot each year. Usually, it does not exceed 50% in the elderly (a risk ratio of 0.5). By now, you should be able to compute the correct effectiveness, say, with a bias factor of 2.
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The Predictable Wastes of COVID Relief
If you ever had the vague sense that COVID relief funding worked in a manner akin to U.S. aid packages in failed Middle Eastern dictatorships, your instincts weren’t wrong.
First off, there were cases of just outright fraud nearing the $200 billion mark with drug gangs and racketeers collecting COVID unemployment benefits from the U.S. government, with some recipient fraudsters not even having the common decency of being honest American fraudsters.
Even worse, though, were some legitimate uses of COVID funds that actually counted as legitimate despite being laughably frivolous or clearly unrelated to nominal goals connected to public health or helping communities deal with the economic impact of the virus—or, more accurately, the lockdowns.
One of the most should-be-satirical-but-actually-real examples of a legitimate use of COVID cash was a researcher at North Dakota State University being awarded $300,000 by the National Science Foundation through a grant funded at least in part through the American Rescue Plan Act of 2021 to aid her in her 2023 efforts to reimagine grading in the name of equity. (If none of that makes sense, please don’t hurt yourself with mental pirouettes.)
Other more mundane projects pertained to prisons and law enforcement using COVID relief money for purposes that extended well-beyond simply paying salaries or keeping the lights on. In 2022 The Appeal and The Marshall Project reported on how large sums of COVID money went to prison construction and expansion projects and to outfit police departments with new weaponry, vehicles, and canines. Regardless of how you feel about law enforcement or our prison system, these probably did little to stop the spread of COVID or keep out-of-work bartenders afloat while public health bureaucrats consulted horoscopes or goat entrails or their equally useful models to divine the proper time to let businesses reopen safely at half-capacity to diners willing to wear a mask between bites but too afraid to leave their homes.
Yet, of course, that didn’t stop people from trying to make the case that these expenditures absolutely were essential to slowing the spread. Often coming off like precocious children explaining to their parents how a new puppy would help teach them responsibility or an overpriced pair of sneakers would facilitate their social-emotional development by ensuring the cool kids would like them, local sheriffs and city managers were reported as claiming prison expansions could help prisoners social distance from each other, new tasers would help officers social distance from suspects, and new vehicles would allow officers to take their cars home with them rather than share one with another officer who might end up contaminating it with their COVID cooties.
But even worse than the funds that were outright plundered or just snatched up as part of a cash grab were those that were used on projects that helped further erode the freedoms of American citizens.
As documented in a 2023 report from the Electronic Privacy Information Center, more than seventy local governments used ARPA funds to expand surveillance programs in their communities, purchasing or licensing gunshot detection systems, automatic license plate readers, drones, social media monitoring tools, and equipment to hack smartphones and other connected devices.
Sometimes EPIC reported that this was done with little, if any, public debate over the civil liberties and privacy concerns inherent to these tools. In one case from a town in Ohio, approval for ARPA-funded ALPRs—cameras that can create a searchable, time-stamped history for the movements of passing vehicles—came after only a 12-minute presentation by their police chief.
Similarly, schools also likely used money from ARPA, as well as the 2020 Coronavirus Aid, Relief, and Economic Security Act, for their own surveillance purposes, although documentation of how schools used their COVID money is said to be somewhat spotty at best.
Vice News in 2021 reported how Ed Tech and surveillance vendors such as Motorola Solutions, Verkada, and SchoolPass marketed their products as tools to help reduce the spread of COVID and allow schools to reopen safely.
Some attempts such as Vice’s description of SchoolPass presenting ALPRs as a means to assist with social distancing come off like police departments explaining the social distancing benefits of tasers.
Others, however, such as Motorola plying schools with lists of behavioral analysis programs that “monitor social distancing violations” and room occupancy while “automat[ing] the detection of students who are not wearing face masks,” seem to offer a glimpse of the dystopian future into which we are heading—as do the other surveillance tools bought with COVID cash.
Maybe at some point Disease X, about which our ruling class has been warning us, will hit and the additional drones, ALPRs, and social media monitoring tools bought by the law enforcement agencies reported on by EPIC will be used to monitor adults for social distancing violations and automatically detect who isn’t wearing a mask. Maybe those tools will just be used to keep a digital notebook of the daily activities of everyone while police reassure us that they promise only to look at it when they really really need to.
In either case, though, if you currently have the vague sense that post-COVID America is a little more like a Chinese surveillance state than in the Before Times, your instincts are dead-on.
https://brownstone.org/articles/the-predictable-wastes-of-covid-relief/
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Large 4.1m FDA Study Confirms small but significant Myocarditis/Pericarditis and Seizure Safety Signals in Young People
The results depend heavily on diagnostic accuracy, which can certainly not be assumed
Researchers from the Food and Drug Administration (FDA) as well as major pharmacy retail chains, payers and data-based companies investigated whether statistical signals detected health outcomes post-vaccination with ancestral COVID-19 vaccine in children aged 6 months to 17 years. Part of an active safety monitoring program involving COVID-19 vaccination, a bid to detect rare outcomes not identified in clinical trials involved researchers from the FDA, CVS Health/Aetna Blue Bell, Optum Epidemiology (part of UnitedHealthcare), IQVIA, Acumen LLC and Carelon Research led by Patricia C. Lloyd, Ph.D., ScM of the FDA.
An FDA-sponsored clinical trial with results published in the journal JAMA Network, the cohort study evaluated 21 prespecified health outcomes post-exposure before early 2023 to Pfizer (BNT162b2), Moderna (mRNA-1273), or Novavax (NVX-CoV2373) ancestral monovalent COVID-19 vaccines in children aged 6 months to 17 years by applying a near-real-time monitoring framework using healthcare data from three commercial claims databases in the US (Optum [through April 2023], Carelon Research [through March 2023], and CVS Health [through February 2023]).
Lloyd and colleagues analyzed and reported on increased rates of each outcome after vaccinations were compared with annual historical rates from January 1 to December 31, 2019, and January 1 to December 31, 2020, as well as between April 1 and December 31, 2020. The study involved 4,102,016 vaccinated enrollees aged 6 months to 17 years. 2,058,142 (50.2%) of the total were male, and 3,901,370 (95.1%) lived in an urban area.
Thirteen of 15 sequentially tested outcomes failed to meet the threshold for a statistical signal. However, as was reported on with the group’s preprint, statistical signals were detected for myocarditis or pericarditis after BNT162b2 vaccination in children aged 12 to 17 years plus seizure after vaccination with BNT162b2 and mRNA-1273 in children aged 2 to 4 or 5 years.
Conducting a post hoc sensitivity analysis, the study team reported that the statistical signal for seizure was observed only after exposure to the Moderna vaccine (mRNA-1273) when 2019 background rates were selected; no statistical signal was observed when 2022 rates were selected.
Real-Word Data
This study team tapped into what is known as a form of real-world data, from commercial administrative health claims including Optum (UnitedHealth and affiliated health plans), Carelon Research (Elevance Health, formerly Anthem, and affiliated health plans), and CVS Health (Aetna and affiliated health plans).
These databases contain longitudinal medical and pharmacy claims data supplemented with vaccination data from participating local and state Immunization Information Systems. Such sources are nationally representative of the commercially insured population aged 0 to 64 years and provide comprehensive capture of medical services submitted for insurance reimbursement.
Other factors make this a robust study. Broad geographical coverage across 3 commercial health insurance databases with vast representation across America. The commercial data (claims) were supplemented with immunization information systems data plus medical records reviews.
Findings
An FDA statistician since 2021, corresponding author Patricia C. Lloyd, and colleagues report on the study involving 4,102,016 vaccinated individuals aged 6 months to 17 years, with 3,920,563 (95.6%) receiving BNT162b2 vaccination, 174,427 (4.3%) receiving mRNA-1273, and 53 (<0.1%) receiving NVX-CoV2373.
As depicted above, a total of 8,444,?355 ancestral monovalent COVID-19 vaccine doses were administered to young people, including 8,121,591 BNT162b2 doses (dose 1: 3,843,778; dose 2: 3,235,442, dose 3 or monovalent booster: 1,033,036, and unknown or unclear: 9335), 322,628 mRNA-1273 doses (dose 1: 173,857; dose 2: 140,734; dose 3 or monovalent booster: 5284; and unknown or unclear: 2753) administered to children aged 6 months to 17 years, as well as 136 NVX-CoV2373 doses (dose 1: 63; dose 2: 43; dose 3 or monovalent booster and unknown or unclear: 30) administered to children aged 12 to 17 years.
Sequential Testing
Of the established 15 outcomes that the study team sequentially tested, two (2) outcomes met the statistical threshold for a signal, including myocarditis or pericarditis in children aged 12 to 15 years and 16 to 17 years, and seizure in children aged 2 to 4 or 5 years.
The study team found statistical signals for myocarditis or pericarditis during the primary analysis after Pfizer-BioNTech (BNT162b2) COVID-19 vaccination among children aged 12 to 15 years and 16 to 17 years in all three commercial databases.
The authors report dose-specific statistical signals for 1 or more definitions of the outcomes detected in children aged 12 to 17 years after dose 1, dose 2, and dose 3 of BNT162b2 vaccine in at least 1 of the 3 databases. See eTable 8 in Supplement 1.
According to Lloyd and colleagues:
“In the primary analysis, seizure met the statistical threshold for a signal in children aged 2 to 4 years after BNT162b2 vaccination in all 3 databases and in children aged 2 to 5 years after mRNA-1273 vaccination in 2 of the 3 databases. Dose-specific statistical signals for seizure were detected in 2 of the 3 databases after dose 1 and dose 2 BNT162b2 vaccination in children aged 2 to 4 years and after dose 2 of mRNA-1273 vaccination in children aged 2 to 5 years.” Again, see eTable 8.
Signal Characterization
The authors report 72 observed seizure cases among children aged 2 to 4 or 5 years; 51 (70.8%) of these cases met the definition of febrile seizures. Lloyd and the team found no differences in rates of seizure by sex. Based on the timing of cases, the team reports no indication of substantial clustering with cases distributed across the 0- to 7-day risk window; 23 (31.9%) of the seizure cases occurred within the 0- to 1-day period after COVID-19 vaccination. The median (IQR) time between vaccination and diagnosis of seizure was 2 (1-5) days.
Selection of comparator rates impacted statistical signals for seizure. For instance, when evaluating annual background rates of seizure demonstrates rates used in the primary analyses (2020) were lower than rates in 2022 and 2019.
“Background rates in 2022 and 2019 ranged from approximately 2.2 to 2.4 times and 1.7 to 1.9 times the 2020 rates, respectively, across 3 databases.”
As mentioned at the onset, “the post hoc sensitivity analysis, using 2022 background rates as the comparator in sequential testing, did not identify any statistical signals for seizure in any databases. Using 2019 background rates as the comparator resulted in a statistical signal for seizure after primary series vaccination with mRNA-1273 in 2 of the 3 databases and after dose 2 vaccination with mRNA-1273 in 1 of the 3 databases.”
Is the incidence of myocarditis considered rare?
Yes. The authors report a rate of reported mean incidence of 39.3 cases per 1 million vaccine doses administered in children aged 5 to 17 years within 7 days after BNT162b2 vaccination according to two CDC separate studies. However, TrialSite notes that some studies suggest the rates are higher.
What about the rate of myocarditis and pericarditis outcome measured in the inpatient and emergency department settings?
In the 1 to 7 days window post the COVID-19 jab, the team reports an observed rate of 27.0 inpatient or emergency department cases per million doses in days 1 to 7 after the primary series in children aged 12 to 15 years and 38.2 cases per million doses after the primary series in children aged 16 to 17 years. There was a lack of any myocarditis/pericarditis signal in children aged 12 and under.
A new seizure signal was reported.
Lloyd and co-authors report that such a seizure signal in children aged 2 to 4 or 5 years has not been previously reported for this age group in active surveillance studies of mRNA COVID-19 vaccines.
The authors point to reports in the Vaccine Adverse Events Reporting System (VAERS), which is a “passive reporting system” with “limitations,” hence the data there was all but ignored. TrialSite suggests there very well may be more signals buried in VAERS, but this must be proven in rigorous study.
But the authors point to only 8 identified seizures in VAERS after approximately 1 million mRNA vaccinations through August 2022, in children aged 6 months to 5 years. They note that out of all those, 8 of the seizures were afebrile.
Do the FDA-sponsored authors suggest interpreting the seizure data with caution?
Yes. They call for more robust epidemiologic study. We at TrialSite concur. How can the CDC relentlessly push for young people to continuously get the latest booster with such data available? Especially so, given the risk-benefit analyses continuously change given pre-existing infection, milder Omicron variants, etc.
Study Limitations
Like all such observational studies, the limitations must be understood. TrialSite bulletizes for summary.
Near-real-time surveillance method, which may be sensitive to comparator rate selection and does not include controlling for bias and confounding
The study only includes data from a commercially insured pediatric population and may not be nationally representative—meaning the generalizability could be quested despite the broad coverage
Here, small counts of NVX-CoV2373 prevented evaluation of most demographic factors due to privacy concerns
The authors report that they could not conduct medical record review for all outcomes included in the study due to resource, time, and legal constraints. For the myocarditis or pericarditis outcome, they reviewed medical records of a subset of identified cases of myocarditis or pericarditis that were obtained from the medical professionals.
2020 background rates as the historical comparator for the seizure analysis because this period was marked by behavioral shifts during the early pandemic that may have caused a sustained decrease in the underlying outcome rates. Hence the study team compared both prepandemic and peripandemic periods across data partners when selecting historical rates and generally selected the lower rate as the historical comparator.
For the Novavax vaccine, only 53 children aged 12 to 17 years who received at least 1 dose of NVX-CoV2373 and 4266 children aged 5 to 17 years who received at least 1 dose of mRNA-1273.
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7 May, 2024
The British government downplayed 'gobsmacking' Covid lab leak information amid resistance from scientific advisers, sources claim
The UK Government downplayed the 'high likelihood' that Covid-19 emerged from a lab leak in China because of resistance from scientific advisers, it was claimed yesterday.
US officials shared their views on the origin of the virus in a call with other members of the Five Eyes intelligence alliance – the UK, Canada, Australia and New Zealand.
But the 'lab leak' theory was downplayed in Britain because of resistance from government scientists who favoured the idea that Covid 'jumped the species barrier' from animals to humans, according to US sources.
Taking part in the January 2021 phone call were Mike Pompeo, Donald Trump's secretary of state, and the UK's then foreign secretary Dominic Raab and their counterparts.
The call – previously reported by The Mail on Sunday – was 'open', meaning unencrypted, in the hope the Chinese government would intercept the call, it is claimed.
The allegations, made by unnamed officials speaking in The Sunday Telegraph yesterday, are likely to increase calls to open the Covid Inquiry to the question of where the virus originated.
One US source who worked on the intelligence said: 'We saw several pieces of information and thought they were gobsmacking.
'They obviously pointed to the high likelihood that this was indeed a lab leak.'
An intelligence dossier revealed the Chinese military worked with the Wuhan Institute of Virology in the years leading up to the pandemic, and some lab researchers fell sick shortly before the virus was first recorded nearby.
Other revelations showed Chinese scientists carried out 'gain of function' research, whereby a virus is genetically manipulated to show different behaviour, such as becoming more infectious, or to become infectious against different species.
The UK Government, including Boris Johnson, initially rejected the claim that Covid had been created by scientists, saying in June 2021: 'The advice that we have had is that it doesn't look as though this disease of zoonotic origin came from a lab.'
Two former officials said the evidence was not taken seriously because ministers saw lab leak claims as a 'radioactive American political issue' that was discredited by public disagreement between government scientists and Mr Trump.
One official said: 'Once the thing became fundamentally political, the ability to pursue it internationally really just collapsed because no one else was interested in touching it.
'I think [Five Eyes] were kind of annoyed by the way the issue had become treated in US politics.'
The two sources cited by The Sunday Telegraph both separately named Sir Jeremy Farrar, then a member of the Scientific Advisory Group for Emergencies, as a key opponent of the lab leak theory in the UK Government.
Sir Jeremy and 26 other scientists rejected the lab leak theory in February 2020, signing a statement which said: 'We stand together to condemn conspiracy theories suggesting that Covid-19 does not have a natural origin.'
While many scientific experts say an animal-to-human interaction is the most likely cause of the first infection, some figures, most notably Michael Gove, say the virus was 'man-made'.
Mr Gove told the Covid Inquiry in November there was a 'significant body of judgement that believes that the virus itself was man-made – and that presents its own set of challenges'.
Both the FBI and US Department of Energy have said they believe a lab leak is the most likely cause of the disease. UK ministers are facing calls to widen the Covid Inquiry to include an investigation into the origins.
A UK Government spokesman said: 'There are questions that need to be answered about the origin of Covid-19, not least so we can ensure we are better prepared for future pandemics.
'The UK supports the World Health Organisation in its study of the origins. It is important China and other countries co-operate fully.'
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Thousands Demonstrate Against the WHO’s Pandemic Treaty in Japan
While dozens of U.S. senators representing the entire Senate Republican Conference called on the Biden administration to reject the World Health Organization (WHO) International Health Regulations (IHR) treaty, few Americans actually went to the level of protest. That was different in Japan last month, when protestors took to the streets. On April 13, 2024, thousands of demonstrators assembled across Japan to voice their opposition to the proposed pandemic treaty by the WHO’s IHR.
The protest which spanned the streets of Ikebukuro, Tokyo, to the Higashi-Ikebukuro Central Park, reflected growing concern that infectious diseases and public health are becoming tools used to justify the adaptation of an overly controlling surveillance system for governments. The demonstrators in Japan also expressed concerns over health officials overstepping their boundaries, plus their ties to multinational pharmaceutical companies. This reflects a growing sense of disenfranchisement.
TrialSite previously reported on the 7th meeting of the WHO Intergovernmental Negotiating Body (INB) that took place between November 6 and December 6, 2023, in a bid to fine-tune the proposed pandemic treaty.
The INB recently held its 8th and 9th INB meetings between February and March 2024. The final result of this treaty is yet to be decided as the INB plans to converge one last time from April 29 to May 10, 2024, to resume its negotiations on finalizing the pandemic treaty. However, some individuals supporting the demonstration in Japan have claimed that Japanese lawmakers are uninformed about the details of their country's proposal to the WHO regarding the pandemic treaty and revisions to the IHR. They emphasize the perceived lack of transparency in the process and have voiced these concerns.
How it began
The protests began on the streets of Tokyo, Japan, and were fueled by concerns raised by civil vaccine critic groups. As details of the treaty emerged, these groups sounded alarms over potential threats to Japanese sovereignty. Some individuals who addressed the crowd during the pre-demonstration include Toshie Ikeda, a member of the Hino City Council. Speakers including Professor Masayasu Inoue, a Professor Emeritus of Osaka City University Medical School and Chikatsu Hayashi, a modern history researcher, addressed the crowd before the demonstration. Their talks explored the relationship between global health organizations and the pharmaceutical industry. Inoue expressed concern about weaponizing health information in a way he likened to “a third world war.”
Professor Inoue called for public resistance to the introduction of genetic vaccines. He also alleged that the WHO receives funding from pharmaceutical companies and private foundations, like the Bill and Melinda Gates Foundation. Hayashi, in his address, emphasized the importance of taking a proactive stance against what he perceived as potential threats to individual freedoms, using the metaphorical term “stopping the third atomic bomb with our hands.”
What were the protesters calling for?
Some demonstrators demanded that the government inform the public about the pandemic treaty and IHR, stating that they wouldn’t agree to the WHO holding people as what they perceived to be “health hostages.” They added that they won’t tolerate all policies that ignore vaccine damage. These protesters alleged that the Health Minister, Keizo Takemi, was guiding the medical association to a “history of vaccines.”
Aside from the transparency concerns by the Japanese people, these demonstrators also raised concerns about two key issues: a reported rise in excess mortality and the need for more transparency regarding the side effects of vaccines. The organizers aimed to have about 100,000 protesters present for this rally. They rallied against the use of genetic vaccines for influenza and also the development of what they termed “dangerous replicon vaccines.”
Effects of the vaccines in Japan
As in many other countries, there are conflicting views on the effects of the vaccines in Japan. Did the COVID-19 vaccines fulfill their intended purpose of safeguarding public health or cause more harmful effects than beneficial ones? A 2023 study published in Nature evaluated the effect of the COVID-19 vaccines in Japan in 2021. It asserts that the COVID-19 vaccination program was effective, reducing the death rates by 97%, compared to what they could have been without the vaccines. The study also revealed that the timing of opening up vaccination to a wider population and those who received it played a significant role in reducing the disease burden.
However, some studies have shown that COVID-19 vaccines increased the risks for myocarditis and pericarditis in adolescent and young adult males. In October 2022, TrialSite reported a study on vaccine safety that showed that the COVID-19 vaccines increased myocarditis risks by four times. An opinion piece on TrialSite also reported a study on the death of a 14-year-old Japanese girl post-vaccination. The researchers attributed her death to myocarditis and pericarditis.
A cause for alarm?
The protests in Japan against the WHO's proposed pandemic treaty and the IHR reveal a growing concern and distrust among certain groups regarding the influence of global health organizations and their perceived ties with the pharma industries. The demonstrators' demands for transparency raise questions about the decision-making processes involved in the treaty negotiations.
The recent move by the entire Senate Republican Conference called for the Biden administration to withdraw its support for the two international agreements on the table at World Health Assembly seeking greater authority for what is perceived as a dysfunctional and even captured WHO.
While the intentions behind the pandemic treaty and IHR may be rooted in a desire to improve global preparedness and response to future health emergencies, the government cannot easily dismiss the concerns expressed by street level protests in Japan either. The perception that these health regulations can threaten individual freedoms and national sovereignty needs to be addressed.
Regarding the effects of vaccines, studies have shown high efficacy of COVID-19 vaccines in reducing mortality rates. However, reports of increased risks of myocarditis and pericarditis among certain age groups cannot be ignored.
As the negotiations for the pandemic treaty and IHR revisions continue, the officials involved may need to consider the voices of all stakeholders and concerned citizens.
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6 May, 2024
Australia: Hundreds of patients died after catching COVID in Victorian hospitals, new data shows When Dean's* father was rushed to hospital with a bad case of gastro in February, he assumed he'd be back on his feet in a few days. Instead, he caught COVID, probably in the emergency department at the Monash Medical Centre, a major hospital in Melbourne's south-east. His 79-year-old dad became so unwell, so quickly, that Dean — who visited him in the infectious diseases ward wearing an N95 mask — was terrified he wouldn't survive. "He was as sick as I'd ever seen him," said Dean, who was shocked that his father's COVID infection seemed to trigger symptoms of Huntington's Disease, a neurodegenerative condition he'd been diagnosed with many years earlier. "I'd say it was very touch-and-go. I've seen people with cancer a few days before they've died, and there was a look in his eye and he was completely emaciated. He couldn't speak, couldn't communicate — he was just croaking." Dean was also shocked that most of the hospital staff were wearing surgical masks, some on their chin. It bothered him, he said, because surgical masks are much less effective at preventing COVID transmission than N95 respirators. "No one seemed to give a hoot about protecting themselves or the patients," he said. "From what I know about COVID, I believe all the staff in an infectious diseases ward should be wearing respirators … the fact that it is not standard is just bamboozling." But perhaps he shouldn't have been so surprised. For months doctors and public health experts have been warning that too many patients are catching COVID in Australian hospitals with sometimes devastating consequences — though timely statistics are difficult to access because health departments do not publish them. Now, new data shows thousands of patients caught COVID in Victorian public hospitals in the past two years — and hundreds died — fuelling concerns that hospitals are not taking strong enough precautions against airborne viruses, and calls for stronger leadership from the Department of Health. Almost one in 10 patients who caught COVID in hospital died Documents obtained by ABC News under Freedom of Information laws reveal at least 6,212 patients caught COVID in hospital in 24 months — 3,890 in 2022 and 2,322 in 2023. Of those, 586 died — almost six per week, on average — with men dying at a higher rate than women (11 per cent vs 8 per cent). Though hospital-acquired infections and deaths declined in 2023 — in line with COVID mortality trends in the broader community — the proportion of patients who died after catching the virus in hospital hardly budged, dropping from about 10 per cent in 2022 to about 9 per cent in 2023. It comes following the release of new research that shows screening hospital patients for COVID and staff wearing N95 masks can substantially reduce infections and deaths, saving the health system potentially hundreds of millions of dollars in the long term. Experts say the findings should spark a paradigm shift in the way hospitals approach COVID infection prevention — that's if the latest indicators of illness and death don't. Too many patients are catching COVID in hospitals, doctors say Hospitals have become a strange new battleground in the fight against COVID, with doctors and public health experts concerned that too many patients are catching the virus — and an alarming number are dying — as a result of inadequate infection control. "The numbers indicate that there is a big problem here — these infections and deaths are potentially preventable," said Associate Professor Suman Majumdar, chief health officer for COVID and health emergencies at the Burnet Institute. "We're talking about a specific setting where people are sicker, more vulnerable and more at risk. We need to drastically reduce the risk of people catching COVID in hospital when they don't come in with it. I think we can all agree we can do better — that should be the starting point." Alarmingly, the proportion of hospitalised COVID patients who caught the virus in public hospitals was much higher last year than in 2022 — up from 13 per cent to 20 per cent, on average — coinciding with a reduction in COVID screening and healthcare worker mask use across the state. Most Victorian hospitals began scaling back infection prevention measures in late 2022, when pandemic public health orders were revoked. Now, because hospitals determine their own COVID policies, there is wide variation in how they approach the issue. For instance, in the past fortnight several health services — including St Vincent's in Melbourne and Barwon Health — announced they were no longer requiring staff to wear masks in clinical areas because community transmission had fallen (the latest available data shows it's increasing). Others dropped masking and scaled back testing months ago, while some still insist on routine testing and surgical mask use in particular wards. With golden staph, 'we aim for zero' "There's no consistency between health services," said Stéphane Bouchoucha, president of the Australasian College for Infection Prevention and Control and associate professor in nursing at Deakin University. "And there doesn't seem to be leadership from the Department of Health, saying, 'We want to reduce COVID infections in healthcare, therefore … we need to do universal testing, we need to mandate N95 masks for healthcare workers'." As for the number of people catching COVID in hospital, Dr Bouchoucha said: "I think any hospital acquired infection is concerning". There isn't an "acceptable" number of golden staph or tuberculosis infections — "we aim for zero", he said. "So why don't we do that with COVID?" He's not the only one asking that question. Staphylococcus aureus or golden staph bloodstream infections can be life-threatening, which is why hospitals track and report them and aim to prevent them using hand hygiene strategies — it's part of hospital accreditation standards and there are targets in every state. But there are no targets or reporting requirements for COVID, Dr Majumdar said. As a point of comparison, he said, there are about 600 staph aureus bacteraemia infections in Victoria each year, with a similar death rate to COVID hospital-acquired infections. "So why aren't we applying the same mindset and measures for airborne infections such as COVID and influenza?" At the hospital level, there are several possible answers. Many health services, under huge financial pressure, have rolled back COVID mitigations to try and save money — sometimes against the advice of their own infection prevention leads. Many hospital executives also subscribe to the myth that COVID is "just a cold" and does not warrant taking serious action against, while others have acted on complaints that staff are "sick of wearing" masks. "Many people are telling me they're tired of wearing masks and some patients are saying they're tired of seeing their carers in masks, as well," Professor Rhonda Stuart, director of public health and infection prevention at Monash Health, told staff at an employee forum in February. Professor Stuart pointed to a UK study that found removing a surgical mask wearing policy in some hospital wards did not significantly affect the rate of nosocomial COVID infections, or those caught in hospital. "I think we're starting to see that possibly happening across Monash at the moment," she said — "that maybe masks aren't making the difference in hospital-acquired infections". Testing and N95s save lives and money But the findings of a new preprint study pose a serious challenge to that claim. For the study, researchers from the Burnet Institute and the Victorian Department of Health, which funded it, used a mathematical model to simulate outbreaks in a hospital with various combinations of interventions in place: different kinds of masks worn or admission testing performed. They also calculated the statewide financial costs of each intervention — N95 vs surgical masks, PCR vs rapid antigen testing (RAT), and patient bed costs and staff absenteeism — as well as the health outcomes for infected patients. How scientists are protecting themselves from COVID Three of Australia's leading COVID-19 experts share their personal safety strategies and reflect on what must happen if we're to blunt the growing health crisis the pandemic is causing — and prepare for the next one. The results were striking: compared to staff wearing surgical masks and not screening patients on admission, the combination of wearing N95 masks and testing patients using RATs was the cheapest, saving an estimated $78.4 million and preventing 1,543 deaths statewide per year. Staff wearing N95s and screening patients with PCR tests was the most effective option, saving $62.6 million and preventing 1,684 deaths per year. In other words, testing and wearing N95s to detect and prevent COVID can save lives and money because it reduces the costs of keeping patients in hospital for longer and replacing furloughed staff. "I think it provides a very persuasive rationale that doing small things to reduce infections can add up to big positive impacts and cost benefits," said Dr Majumdar, a co-author of the study. "It then becomes an issue of how practical it is for hospitals to implement these interventions and change behaviours. We know improving ventilation, testing and wearing masks has been effective during the pandemic, so I don't think there's an argument to say it's not feasible or not worth figuring out how to do." The Victorian Department of Health did not respond directly to questions about whether it would be acting on the study's findings, or if it was comfortable with current rates of illness and death in hospitals. "Since the pandemic began we have assisted health services to respond to increased impacts of COVID-19 — a roadmap to guide hospital responses was introduced and has remained in place since June 2022," a Department spokesperson said. "Modelling is one of many tools used when developing and evaluating healthcare policy." Managing 'masking fatigue' But hospitals don't always follow that "roadmap". Associate Professor Caroline Marshall, head of the Royal Melbourne Hospital's Infection Prevention and Surveillance Service, said her hospital uses a "hierarchy of controls" to prevent COVID transmission — strategies honed in the grim early years of the pandemic when patients and staff were infected in dizzying numbers. Today, every patient is screened for COVID on admission with a PCR test — which few hospitals still do. COVID patients are generally cared for in single-bed negative pressure rooms by staff in N95 masks. Air purifiers are stationed around the hospital, an old building with not-so-great ventilation. "To me … any sort of nosocomial infection is a disaster," Dr Marshall said. "So we do our utmost and we're not always successful, but we do as much as we reasonably can [to prevent them] based on the evidence we have and the factors we have to take into account." One of those factors is the impact of masking on healthcare workers, who Dr Marshall said are "sick of wearing" N95 respirators because they're uncomfortable. At the moment Royal Melbourne Hospital staff must wear surgical masks in clinical areas unless they're caring for COVID, transplant or haematology patients, when N95s are required. The decision to use surgical masks is influenced by a few things, Dr Marshall said, including the prevalence of COVID in the community, the severity of circulating variants, population levels of immunity and a new tolerance for risk among staff. "If a staff member wants to wear one for whatever reason, they can," she said. "But I think the reality is, at a practical level, you cannot continue to get staff to wear N95 masks forever." Other infection prevention control experts disagree. For Dr Bouchoucha, masking fatigue is a challenge to be "managed", not succumbed to — including because addressing healthcare workers' concerns about respirator use improves compliance and patient safety. "It's definitely something to take into account," he said. "But we can mitigate it." Catching COVID made Ruby sick and derailed her care Many patients feel similarly. When Ruby* caught COVID in hospital earlier this year, she was fully prepared to feel terrible for a few days — but she didn't expect it to completely derail the care she was there to receive. Ruby was admitted to Upton House, the adult psychiatric unit at Box Hill Hospital, in late January after experiencing family violence and a decline in her mental health. When she tested positive to COVID a few days later, she wasn't surprised: other patients with COVID were allowed to roam freely through the ward without masks, she said, and staff were either in surgical masks — many "below their nose" — or no masks at all. "It made me really sick," said Ruby, who suffered mostly from gastrointestinal symptoms, brain fog and low mood. "I was pissed off that I'd caught COVID but I didn't realise it would affect my care as much as it did, and I was really shocked at the drop-off in psychiatric support as soon as I had it." The exterior sign of the Box Hill Hospital, underneath which a bush of white flowers blooms next to a concrete staircase. Ruby wasn't surprised when she tested positive to COVID during her admission at Box Hill Hospital.(ABC News: Patrick Rocca) A doctor who prescribed Ruby antivirals dramatically reduced her dose of psychiatric medication without consulting her, she said, which triggered unpleasant side effects. Having COVID also meant her psychiatrist visited her less frequently than he was supposed to, she said, and if she went to the nursing station to ask for paracetamol, she was instructed just to go back to her room. "I also wasn't allowed to go to the kitchen for meals and my food was generally brought to me an hour late, cold, without cutlery," she said. "So most of the time I didn't eat." Ruby was relieved to be discharged even though she was "in limbo" psychiatrically — feeling much worse than when she arrived — and still testing positive to COVID. "I can't imagine how hard it is to work in a psychiatric unit," she said, adding that the nursing staff were clearly very busy. "But there was a total lack of empathy and then as soon as I had a medical problem [COVID], absolutely no attention or compassion. Something as simple as not being able to get any Panadol was almost traumatic — even though I was in there for more severe trauma issues." Long COVID will take your health, your wealth — then it will come for your marriage Long COVID is not just destroying people's health. Behind closed doors, in homes across Australia and abroad, it is irreversibly changing relationships — sometimes for the better, too often for worse. A spokesperson for Eastern Health told ABC News they were unable to comment on Ruby's case but said if a COVID outbreak occurs, "additional measures are put in place including requirements to wear N95 masks, reduced movement and access to certain wards and clinical areas, increased hand hygiene, taking breaks outside and meeting virtually where possible." Monash Health also would not address specific questions about Dean's father's admission. "Monash Health provides N95 and surgical masks as part of its infection prevention precautions to protect its patients, visitors and staff," a spokesperson said. "Monash Health cares for COVID-positive patients … in single rooms with negative pressure or negative flow, in addition to requiring staff and visitors to wear appropriate PPE including N95 masks." At least that's not what Dean observed. He's still upset that the hospital didn't alert him when his father tested positive to COVID, and that his dad blamed himself for catching it in the emergency department in the first place. "In the whole time of his admission I only saw one staff member … wearing a respirator — I felt overdressed," Dean said. "I'm just horrified that vulnerable people go into a place where they expect to be safe and cared for but are given something that, in this case, potentially nearly kills them and there's no apology — not even acknowledgement." ABC News requested interviews with infection prevention and control experts at Western Health, Barwon Health and Alfred Health — all declined. https://www.abc.net.au/news/2024-05-06/hundreds-died-catching-covid-victoria-hospitals-testing-masking/103784896 ************************************************* 5 May, 2024
Neurosurgeon, 37, and nurse, 54, claim they were left brain damaged and paralyzed from Covid vaccines - as they say they've been 'dismissed and gaslighted' as anti-vaxxers
Americans who claim they were badly injured by the Covid vaccines feel they are being ignored and gaslighted by the government.
Over 13,000 formal complaints about adverse reactions to the shots have been filed since 2021 - but only 19 percent have been reviewed.
And just 12 patients have been compensated at an average of about $3,600, a figure which some have called insultingly low given the debilitating health issues they have been left with.
Experts say that researchers who've tried to investigate the little-understood side effect profile of Covid vaccines have been blocked by government officials and scientists who fear that even entertaining the possibility that vaccines can cause harm would fuel the anti-vax, which become bigger and louder during the pandemic.
Still, people are suffering from a range of conditions that came on soon after getting their first shot, including brain damage, tinnitus, neurological syndromes, facial paralysis, heart trouble, and shingles.
Unlike several countries like Australia, Canada, and Denmark, which have centralized health records compiled on a single database, the US has no such thing, leaving scientists to sift through reports of mild to severe side effects, of which there are more than four million lodged to the CDC’s voluntary adverse reporting website.
Before Michelle Zimmerman, 37, had to say goodbye to her career as a neuroscientist, her regular 20-mile bike rides, and her lectures on the latest in AI, she had received the Johnson & Johnson vaccine in 2021.
No longer able to stand up on her own for long periods of time, and eventually diagnosed with brain damage, Dr Zimmerman had to move back in with her parents. She is convinced the vaccine she got came from a contaminated batch.
She told the New York Times: ‘When I let myself think about the devastation of what this has done to my life, and how much I’ve lost, sometimes it feels even too hard to comprehend.’
Dr Zimmerman submitted her application for the Covid vaccine compensation program in October 2021, but it took two years for that claim to be acknowledged by the federal government. She has yet to receive any help from government officials.
She is far from the only one who has submitted such a claim. The Health Resources and Services Administration’s Countermeasures Injury Compensation Program (CICP), 13,116 claims have been filed, of which more than 10,000 are still in review.
Twelve claims have been compensated at an average of about $3,600. This is because the office recognizes so few side effects as stemming from the Covid vaccine.
Shaun Barcavage, a 54-year-old nurse practitioner in New York, said that merely standing up would make his heart race ever since he got his first Covid shot.
His symptoms suggested postural orthostatic tachycardia syndrome (POTS), a condition in which the body cannot regulate the flow of blood properly, causing lightheadedness, fainting, and rapid heartbeat.
POTS has been tenuously linked to the vaccines, but more often with Covid infection itself.
Mr Barcavage, who in his career has worked on clinical trials for both HIV and Covid, said: ‘I can’t get the government to help me. I am told I’m not real. I’m told I’m rare. I’m told I’m coincidence.’
And Dr Gregory Poland, 68, who edits the journal Vaccine, has had a loud whoosing sound in his ears accompany every single second since he got his shot, and now fears never having a silent moment again.
His colleagues at the CDC did not take on his pleas for further research into the post-vaccine phenomenon.
Covid vaccines from Pfizer and BioNTech as well as Johnson and Johnson – which is no longer available – have been credited with averted at least three million deaths in the US and around 20 million globally due to the virus.
But even the best vaccines are not perfect, and when given to more than 270 million Americans in nearly 677 million doses, adverse reactions are bound to crop up.
Scientists fear the minority of vaccine recipients who have experienced severe reactions that have upended their lives are being ignored by federal officials with the power to initiate and fund more research into the matter.
Dr Akiko Iwasaki, an immunologist and vaccine expert at Yale University, said: 'At least long Covid has been somewhat recognized', added people complaining of post-vaccine injuries are 'just completely ignored and dismissed and gaslighted.'
Dr Janet Woodcock, who headed the FDA from January 2021 through February 2022 during a crucial time which which early vaccines and treatments were being reviewed, told the New York Times that she wished government officials would hear those people out.
She said: ‘I feel bad for those people. I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously.
‘I’m disappointed in myself. I did a lot of things I feel very good about, but this is one of the few things I feel I just didn’t bring it home.’
The understaffed office heading the complaints database has left suffering Americans feeling let down by what was meant to be a highly specific, high efficient means of recourse for Covid shot recipients.
Renee France, 49 of Seattle, developed a form of facial paralysis called Bell’s palsy causing one side of her face to droop, which can be a reaction to a viral infection as well as the flu vaccine. She also developed shingles that caused a severe rash that crossed her face and debilitated her for weeks.
She submitted her claim to the database two times but heard nothing back. Like many other patients, her doctor dismissed her fears that the symptoms were side effects of her Covid shot. People have complained of being brushed off and labeled anti-vax by family and friends, despite their support for vaccines.
Dr. Buddy Creech, 50, who led several Covid vaccine trials at Vanderbilt University and suffered tinnitus and racing heartbeat for about a week after each shot, said: ‘When our patients experience a side effect that may or may not be related to the vaccine, we owe it to them to investigate that as completely as we can.’
Countries that store patient data in a single place have conducted more extensive research into side effects simply because they can spot them easier.
The CDC’s adverse events reporting system is voluntary, so anyone can file a report, and the reports are not verified by the agency as being true or unbiased.
In addition to poring over the CDC system, researchers have to sift through insurance claims, and even then there are gaps.
Shots given at mass vaccination sites that cropped up in parking lots across the country did not file vaccine claims with insurers.
Rebecca Chandler, a vaccine safety expert at the Coalition for Epidemic Preparedness Innovations, said: ‘It’s harder to see signals when you have so many people, and things are happening in different parts of the country, and they’re not all collected in the same system.’
But in China, Europe, and Israel, scientists have actively sought out instances of adverse reactions, even mild ones, in order to study them further.
Harvard and Yale scientists probing new condition linked to Covid shot
Patients with the condition appear to suffer from symptoms similar to 'Long Covid' - including persistent headaches, intense tiredness and abnormal heart rate and blood pressure.
The European Medicines Agency has uncovered and linked facial paralysis and numbness to the Pfizer and Moderna shots, which the US has not, despite there being nearly 3,000 reports of facial paralysis on the CDC’s voluntary database.
And Israeli authorities were first to spot an unusual side effect in April 2021 primarily among young men after a second dose of a Pfizer or Moderna shot – inflammation of the heart muscle, also known as myocarditis.
Meanwhile, the CDC maintained there was no strong link between heart inflammation and Covid vaccines. That continued until the agency decided the following May to investigate a smattering of reports of heart inflammation in teenagers that occurred just a few days after they got a dose of the Pfizer or Moderna vaccines.
But despite the 16,700 reports of tinnitus, the 9,000 reports of vertigo, the 7,000 reports of irregularly fast heart beat, the 3,800 reports of Bell’s palsy, or any of the other millions of adverse event reports submitted to the CDC’s system, the NIH is not conducting thorough research into the matter.
Dr William Murphy, a cancer researcher of 12 years at the NIH who has been pushing for these investigations, said that officials told him the same hackneyed phrase he had been hearing for years: the virus is worse.
He said: ‘Yes, the virus is worse, but that doesn’t obviate doing research to make sure that there may be other options.’
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2 May, 2024
CDC Found Evidence COVID-19 Vaccines Caused Deaths
U.S. Centers for Disease Control and Prevention (CDC) officials found evidence that the Pfizer-BioNTech and Moderna COVID-19 vaccines caused multiple deaths before claiming that there was no evidence linking the vaccines to any deaths, The Epoch Times has learned.
CDC employees worked to track down information on reported post-vaccination deaths and learned that myocarditis—or heart inflammation, a confirmed side effect of the vaccines—was listed on death certificates and in autopsies for some of the deaths, according to an internal file obtained by The Epoch Times.
Myocarditis was also described as being caused by vaccination in a subset of the deaths.
In other cases, the CDC workers found that deaths met the agency’s definition for myocarditis, that the patients started showing symptoms within 42 days of a vaccine dose, and that the deceased displayed no virus-related symptoms. Officials say that after 42 days, a possible link between the vaccine and symptoms becomes tenuous, and they list post-vaccination deaths as unrelated if they can find any possible alternative causes.
In cases with those three features, it’s “absolutely” safe to say that the vaccines caused the deaths, Dr. Clare Craig, a British pathologist and co-chair of the Health Advisory and Recovery Team Group, told The Epoch Times in an email.
Despite the findings, most of which were made by the end of 2021, the CDC claimed that it had seen no signs linking the Moderna and Pfizer messenger RNA (mRNA) vaccines to any deaths reported to the Vaccine Adverse Event Reporting System (VAERS).
CDC officials in a letter to The Epoch Times dated June 13, 2023, said that there were no deaths reported to the VAERS for which the agency determined “the available evidence” indicated Moderna or Pfizer vaccination “caused or contributed to the deaths.”
The agency also said that evidence from seven deaths from thrombosis with thrombocytopenia syndrome following the Johnson & Johnson vaccination suggested that the vaccine led to people dying.
“That’s a scandal, where you have information like this and you continue to put out this dishonest line that there’s only seven deaths and they’re all unrelated to the mRNA vaccines,” Dr. Andrew Bostom, a heart expert based in the United States, told The Epoch Times.
The CDC is “concealing these deaths,” he said.
A CDC spokeswoman, presented with the file and dozens of questions about it, said that “determining a person’s cause of death is done by the certifying official, physician, medical examiner, or coroner, who completes the death certificate.”
The spokeswoman declined to explain why the CDC doesn’t consider autopsies or death certificates as evidence of causality, the criteria that would establish vaccine-caused deaths, or whether the numbers have been updated since 2023. She also declined to answer questions about specific deaths outlined in the file, citing “privacy and confidentiality.”
People who die in the United States with confirmed or suspected COVID-19 are counted as COVID-19 deaths. That count has included a number of deaths from unrelated causes. The CDC also in 2023 advised death certifiers to include COVID-19 on certificates even if the deaths happened years after COVID-19 infection.
“They are taking the exact opposite approach to COVID deaths! Every death after a test was a COVID death. No death after a vaccine is a vaccine death!” Dr. Craig said. She questioned what it would take for the CDC to admit that the vaccines have caused some myocarditis-related deaths.
More People Died
The file, acquired by The Epoch Times through a Freedom of Information Act request, has never before been reported. The file was obtained after U.S. authorities rejected another Freedom of Information Act request for the autopsies themselves. The file outlines the agency’s investigation into reports submitted to VAERS of suspected cases of myocarditis or a related condition, pericarditis, following COVID-19 vaccination.
CDC employees, starting in April 2021, contacted health care providers and other agencies to obtain medical records, death certificates, and autopsies as they sought to confirm whether each report was legitimate.
The file shows the CDC examined 3,780 reports through April 13, 2023, a small number of which were duplicates. Among the reported cases, 101 resulted in death.
In one instance, a 37-year-old man started suffering symptoms that can be caused by myocarditis, such as shortness of breath, shortly after receiving a Moderna COVID-19 shot. The man collapsed three days after vaccination and was soon pronounced dead.
Dr. Darinka Mileusnic, the medical examiner who examined the man, said in an autopsy report that the patient died of “post vaccination systemic inflammation response” which caused, among other problems, acute myocarditis, according to the CDC file.
The CDC worker who was assigned to look into the death wrote that it was “evident of a sudden death post second dose of Moderna vaccine.”
“One of the factor[s] to death [sic] is acute myocarditis. There are other findings related to VAE [vaccine adverse event] and non vaccine related. Thus, it can’t be distinguished that only vaccine may have caused the death,” the CDC employee wrote.
Dr. Mileusnic declined a request for comment through her employer, the Knox County Regional Forensic Center in Tennessee. The center said it would only provide an autopsy report if the decedent’s name and date of death were provided. The CDC file did not include names.
After another man, 24, died on Oct. 27, 2021, about two months after receiving a second Pfizer injection, his health care provider diagnosed him with myocarditis. An autopsy listed “complications of COVID-19 vaccine-related myocarditis” as the cause of death, according to the file.
A post-mortem test for COVID-19 returned negative, there were no viral organisms found in post-mortem testing of the heart, and there were no other signs of viruses causing the myocarditis, the notes show.
Another vaccine recipient, a 77-year-old man, was found dead at home on Nov. 14, 2021. The autopsy confirmed the man had pericarditis and listed the cause of death as “complications from the COV-19 booster,” according to the file.
The CDC worker who looked at that case said it met the CDC’s definition of pericarditis based on the autopsy and death certificate but noted there were comorbidities such as coronary artery disease that were listed as contributing to the death. The patient also received shots against influenza and shingles about two months before death, so “it is difficult to say that COV-19 vaccine alone caused pericarditis,” the worker wrote.
A voicemail left for the man’s doctor was not returned.
Among other deaths in the CDC file are:
A male, whose age was redacted, suffered sudden cardiac death in April 2021 following a Johnson & Johnson vaccination. He was diagnosed with myocarditis, which was confirmed by the medical examiner. A CDC worker stated that the case did not technically meet the agency’s case definition, but they would “consider probable subclinical myocarditis, given the histopathological findings.”
A 21-year-old woman who died in 2021 after seizures and cardiac arrhythmias following Pfizer vaccination was found on autopsy to have lymphocytic myocarditis. The CDC listed her case as confirmed myocarditis with no evidence of viral causes.
A 45-year-old man was found dead in his bed in 2021 after Moderna vaccination but testing for myocarditis and pericarditis was not performed.
A 55-year-old woman who was “found unresponsive in [a] field” in 2021 after Johnson & Johnson vaccination was confirmed on autopsy to have myocarditis and to have suffered a cardiac arrest. The death met the CDC’s case definition but concurrent upper respiratory infection “makes viral myocarditis a potential alternative cause,” a CDC worker stated. The medical examiner declined to comment.
Pfizer, Moderna, and Johnson & Johnson did not return requests for comment.
Lot numbers for the vaccines injected into people who died were among the information in the file redacted by the CDC. Some vaccine lots have caused significantly more problems than others, according to CDC data obtained by the nonprofit Informed Consent Action Network.
Deaths in other countries from vaccine-induced myocarditis have been reported in journals, including deaths among young people. More deaths from vaccines in cases that didn’t include myocarditis have been confirmed by international authorities. Death certificates obtained by The Epoch Times from several U.S. states have also listed the COVID-19 vaccines as causing or contributing to dozens of deaths.
Overruling
The file and a tranche of emails also obtained by The Epoch Times shows the agency started intervening shortly after the vaccines were introduced in post-vaccination cases that led to death and sometimes overruled the certifier.
Take the case of a 23-year-old man who left home on April 13, 2021, to go for a jog and was found dead on the side of the road. His death occurred four days after receiving Johnson & Johnson’s COVID-19 vaccine.
An autopsy found myocarditis and the case met the CDC’s case definition for myocarditis. But the CDC’s Infectious Diseases Pathology Branch (IDPB) then weighed in. “Per IDPB evaluation, not myocarditis,” the notes for the case say.
The evaluation is one of the documents the CDC has refused to disclose. It also refused to answer questions about the man’s death or other specific cases, referring vaguely to privacy.
Dr. Bostom, after reviewing the notes on the case, said it was a “clear-cut” example of vaccine-caused myocarditis.
The CDC doesn’t conduct autopsies itself but gathers the files as part of the investigation. Autopsies aren’t perfect but are considered the gold standard in figuring out the cause of death, Dr. Bostom said.
“It’s about the strongest evidence we can get,” he said.
Two of the cases in the file were reported by Dr. James Gill, the chief medical examiner of Connecticut, and several other doctors in a February 2022 peer-reviewed paper. The doctors revealed findings of atypical myocarditis in two teenagers after Pfizer vaccination, describing it as a “post-vaccine reaction” that might have developed due to “an excessive inflammatory response.”
CDC officials issued a public response saying IDPB’s evaluation of the cases pointed to non-vaccine causes: a parvovirus in one case, and sepsis from a bacterial infection in the other.
“These omissions could lead incorrectly to the assumption that COVID-19 vaccines were directly responsible for the deaths of these 2 patients. We believe that providing these important pathologic findings will allow readers a fuller perspective of the causes of death in these cases,” the CDC said at the time.
Dr. Christopher Paddock, one of the officials, said in an email obtained by The Epoch Times that the CDC response detailed “the work we did to identify the actual cause of death in this young man.”
In a blunt reply, the doctors said the CDC “overstepped its role” with the response and explained why the CDC’s claims didn’t hold up. The parvovirus, they said, wouldn’t cause the type of heart injury seen in the boy who died. The presence of bacteria is “not the cause of death but a consequence of death,” they said.
The certificate for the boy who died in Connecticut mentioned vaccination, Dr. Gill has told The Epoch Times. The autopsy report of the other boy notes he died of “myocarditis of uncertain etiology.”
Another death of a minor was examined by CDC workers after being reported to VAERS. A 7-year-old in Washington state died on Feb. 26, 2022, about two weeks after receiving a Pfizer shot. The medical examiner identified myocarditis as a cause of death, but, “per IDPB, infectious causes [were] identified,” according to the file.
“CDC followed-up to assist in [the] investigation of the case. From the investigation, the cause of the myocarditis could not be clearly determined,” a spokesperson for Public Health – Seattle & King County told The Epoch Times via email.
Other emails obtained by The Epoch Times show that in addition to Washington state officials, authorities in multiple states asked the CDC to test tissue samples from people who died after vaccination. They also reveal that the CDC knew of several additional post-vaccination deaths in which myocarditis was found on autopsy—and at least some other possible causes were ruled out—before issuing its 2023 statement on zero deaths.
Details From Emails
A man on active duty in the Army, for example, “collapsed after a short run” and was unable to be resuscitated, Dr. John Su, the lead official for vaccine safety for the CDC’s COVID-19 vaccine task force, wrote on March 30, 2022. “On autopsy, the pathologist observed evidence of myocarditis.”
Testing for COVID-19 came back negative, and “toxicology and other analyses were unremarkable,” according to the email, although there were indications that an “anatomic variant in the vasculature of the heart” could have caused the sudden cardiac arrest.
The CDC around the same time received a request to analyze tissue from a 42-year-old New Hampshire resident who died in early 2022 after a Pfizer vaccine dose. The autopsy found “extensive acute and subacute myocarditis,” Dr. Jennie Duval, the chief medical examiner at the New Hampshire Department of Justice, told the CDC. Postmortem testing for COVID-19 returned negative.
A spokesperson for the department told The Epoch Times in an email that its Office of the Chief Medical Examiner “will not release cause and manner of death or any other information because autopsy reports, investigative reports and supporting documentation are confidential medical records.”
The CDC also in 2022 received autopsy reports for George Watts Jr., a 24-year-old from New York state who collapsed at home after receiving a Pfizer vaccine, died from “COVID-19 vaccine-related myocarditis,” and tested negative for COVID-19; and Joseph Keating, a 26-year-old man from South Dakota who, per an autopsy and death certificate, died from vaccine-induced myocarditis.
It’s not clear why the CDC doesn’t count the death certificates or autopsies as evidence that vaccines contributed to or caused the deaths.
The CDC’s position is not surprising since it was among agencies that “were the leaders of the disinformation campaign to convince the American public, including George Watts, Jr., that experimental vaccines were safe and effective even before they were licensed,” Ray Flores, an attorney representing the Watts family in a lawsuit filed against the government, told The Epoch Times via email.
“Now everyone knows they’ve unequivocally been shown to kill,” he said.
A CDC official said in one missive in early 2022 that the CDC’s IDPB had recently become “heavily involved in coordination, consultation, and laboratory evaluation of autopsy tissues from deaths occurring after COVID-19 vaccination, including cases of suspected myocarditis.”
The effort involved closely coordinating with the CDC’s Immunization Safety Office, state health officials, and CDC officials working on policy and communications, she said.
“When requested, CDC can provide consultation for analysis of tissue specimens,” a CDC spokeswoman told The Epoch Times.
The CDC’s 2023 statement of zero deaths being linked to the Moderna or Pfizer vaccines was attributed to the Immunization Safety Office.
The office was headed at the time by Dr. Tom Shimabukuro, who offered false information about COVID-19 vaccine safety during the pandemic. The CDC also hid the finding of hundreds of safety signals for the shots, including sudden death and tinnitus, and published a paper this month that was falsely promoted as debunking an association between sudden death and the mRNA vaccines.
More than 676 million doses of the vaccines have been administered to date, the CDC noted. While the Johnson & Johnson vaccine has been pulled from the market, the agency maintains that shots from Pfizer, Moderna, and Novavax are “safe and effective.”
“The authorized and approved COVID-19 vaccines are being administered under the most comprehensive and intensive vaccine safety monitoring effort in U.S. history,” the CDC spokeswoman told The Epoch Times.
The spokesperson said the agency “has not detected any unusual or unexpected patterns for deaths following COVID-19 vaccination that have not already been thoroughly described and made public in the published biomedical literature or public presentations.”
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1 May, 2024
Key Ingredient in Pfizer and Moderna COVID Shots Aids Cancer Development, New Study Shows
Joe Wang
The role that a key ingredient in the COVID-19 mRNA vaccine plays in cancer development has been analyzed in a comprehensive review newly published in a peer-reviewed scientific journal. The conclusion: The specific form of this ingredient, pseudouridine, that Pfizer and Moderna use to make their vaccines aids cancer development.
N1-methyl-pseudouridine (I will call it pseudoU in this article) is a critical component of the mRNA vaccine. Pfizer and Moderna chemically introduce pseudoU into their vaccines to make the mRNA molecules last longer in the human body (escaping degradation by enzymes), and to avoid suppression by the innate immune system, the body’s first line of defense against foreign invaders.
The study, titled “Review: N1-methyl-pseudouridine: Friend or foe of cancer?” is authored by five scientists from Mexico, UK, Canada, United States, and Saudi Arabia and was published in the May 2024 issue of International Journal of Biological Macromolecules.
PseudoU Aids Cancer Development
Messenger RNA is a single-stranded molecule made up of four types of nucleotides: A, C, G, and U. In their vaccines, Pfizer and Moderna replace all the “U” nucleotides with pseudoU, a chemically modified version. The invention was praised by many in the field.
However, since pseudoU is not native to the human body, is it safe?
For their study, the five scientists analyzed data in an article published in the peer-reviewed journal Frontiers in Immunology in October 2022, where a group of researchers in Thailand, using a melanoma mouse model, tested cancer development with mRNA vaccines. They found that all mRNA vaccines in which pseudoU replaced “U” stimulated cancer growth and metastasis (spread of cancer cells). The higher the percentage of pseudoU, the more severe the cancer growth.
Both the Pfizer and Moderna mRNA vaccines replace “U” with pseudoU 100 percent. This greatly contributed to the effectiveness of the COVID vaccines compared to unmodified mRNA vaccines, according to a 2021study titled “The Critical Contribution of Pseudouridine to mRNA COVID-19 Vaccines.”
The body’s immune system can recognize the “U” component of foreign mRNA and trigger a cascade of immune responses. But substituting “U” with pseudoU removes that recognition and decreases innate immunogenicity, allowing cancer cells to grow uncontrollably.
Claims by Pfizer and Moderna
The review article concluded that Pfizer and Moderna emphasized only the positive aspects related to replacing “U” with pseudoU when launching their vaccines. The new design makes the mRNA more stable, leading to more S (spike) protein produced and a more desirable immune response against SARS-CoV-2. The vaccine makers did not, however, provide information on the potential harms of the S protein, which is a known toxin, or on the potential side effects of avoiding an innate immune response.
I, for one, felt misled.
When I first learned that Pfizer was developing an mRNA-based vaccine, my reaction was “Oh, at least it’s not going to do much harm, as mRNA normally lasts only a few minutes in the body.” As a messenger, mRNA’s job is to deliver the message (of making a protein) and then quickly disappear.
My assumption was reinforced when the Centers for Disease Control and Prevention claimed: “After the body produces an immune response, it discards all of the vaccine ingredients, just as it would discard any substance that cells no longer need.”
Well, it turns out the mRNA is not what I thought.
By replacing every “U” with pseudoU, Pfizer and Moderna designed their vaccines to stay in the body longer to produce the S protein to trigger immune responses. The problem is that the modification made the molecules too stable, and thus they stay in the body for far too long.
Some of the consequences of this are now beginning to emerge.
S Protein Causes Cancer
When we consider the possible harms from the COVID shot, we need to look at not only the components of the vaccine, i.e., the SARS-CoV-2 mRNA-LNP molecules that are being injected into human bodies, but also the recombinant S protein that the mRNA encodes for.
I wrote a column recently on the findings of a Japanese study on cancer development resulting from the COVID vaccine, in which I noted the additional harm caused by the S protein. A 2022 study by Oscar Solis and colleagues found that when the SARS-CoV-2 S protein is mixed with each of about 9,000 human proteins, the S protein binds well with human estrogen receptor alpha (ER-alpha).
ER-alpha is an important regulator in the body’s reproductive system. But when the cell carrying the vaccine molecules produces the S protein as encoded by the mRNA, the S protein then binds to ER-alpha, disrupting the cell’s normal function and leading to cancer development.
The mRNA vaccine is also found to weaken human cancer immunosurveillance, allowing easy growth of cancers.
As further proof, we now have the new review of N1-methyl-pseudouridine showing that pseudoU-containing mRNA vaccines foster cancer development.
Which Is Smarter, Science or Our Innate Immunity?
National Institutes of Health scientists Dr. Jordan Meier and Dr. Kellie Nance have praised the invention of the COVID-19 vaccine using pseudoU.
“The modified nucleobase helps cloak mRNA vaccines from the immune system, limiting their undesired immune stimulation, and in certain circumstances may also enhance the synthesis of antigens by the protein-producing machinery of the cell,” they concluded in a 2021 paper. “This allows these vaccines to tap into the natural process of mRNA translation without triggering harmful side effects such as anaphylaxis.”
I wonder if Drs. Meier and Nance would draw the same conclusion today, given that so much information is emerging on the harms of the mRNA vaccine, especially when it comes to replacing “U” with pseudoU in the mRNA molecules.
The human body is a near-perfect design with a comprehensive immune system that protects it from harm while keeping a balance of things within the body’s environment. Weakening the immune system for short-term gain is dangerous and almost certain to have long-term adverse effects.
Replacing “U” with pseudoU may successfully protect mRNA vaccines from the recipient’s own immune system like a trojan horse; however, this trojan horse may eventually release hostile forces that could kill the host.
The “undesired immune stimulation” (from the NIH scientists and the mRNA vaccine’s perspective) is exactly what the body needs to protect itself, but the immune system can’t attack the invader because it’s been suppressed by pseudoU.
When treating a terminally ill patient, the doctor may endeavour to achieve the “desired” immune response to ensure survival at all costs, regardless of the side effects. However, that approach should not be used when healthy people are the subject.
Modern science is not yet advanced enough to fully understand the human immune system. For scientists to make “desired” versus “undesired” immune response decisions for hundreds of millions of healthy people via the jab is irresponsible and arrogant, to say the least.
In my recent column I commended the Springer Nature Group for allowing one of its medical journals, Cureus, to publish the Japanese study on cancer deaths after the third COVID shot. Now I’d like to commend Elsevier, the Dutch academic publishing company that owns renowned journals like The Lancet and Cell, for allowing its journal, International Journal of Biological Macromolecules, to publish the review article on pseudoU and cancer.
I am hopeful that top journals such as The Lancet and Nature will soon follow their sister publications and accept research papers on the harms of the COVID shot.
It is becoming increasingly clear that the mRNA vaccine is not safe and must be stopped.
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NZ Nurse Fined $18,000 and Suspended for Criticising Mandates, Lockdowns
A tribunal has told a New Zealand nurse she brought “discredit to the profession” for comments she made during an interview at a COVID-19 freedom demonstration in 2021.
At the rally, Debra Elizabeth Green spoke with Chantelle Baker, a self-styled social media journalist and a prominent opponent of government COVID-19 policy.
The rally was attended by those who opposed vaccine mandates, lockdowns, and were sceptical about the efficacy of vaccines.
Ms. Green, at the time working as a pool staff nurse at Christchurch Hospital, wore her uniform to the demonstration and commented to Ms. Baker about the “segregation” of unvaccinated people at the hospital.
She also said “vaccine-damaged” patients had been admitted, and that staff were “blind” to jab side-effects.
“The bulk of the patients would be vaccinated. If you’re not vaccinated you get segregated, you get put in a different part of ED, put into isolation,” she said.
“I had one consultant on my last night, she stood in front of our big board with everybody, all the patients and all their symptoms and she said, ‘What’s going on? Why have we got so many patients?’
“It’s all cardiac, cardiac, cardiac, short of breath, collapses, falls, and I just can say ... this is adverse reaction, adverse reaction,” she said in reference to myocarditis, a known side-effect of the jab.
“All of our wards are full of people having cardiac problems, people with flare-ups from their cancer, like you name it. I guarantee a hospital is full of vaccine damaged, it’s just, people were blind, people just cannot see it.”
The Nursing Council received seven complaints over Ms. Green’s appearance in the video concerning the spreading of misinformation about the vaccine, with one complainant saying her comments posed a “risk of public harm.”
Christchurch Hospital terminated her employment in November 2021 after Ms. Green refused to get vaccinated which was a breach of the health worker’s mandate as set down by the government.
Tribunal Hands Down Tough Penalties
Ms. Green was not present at the hearing, but had earlier defended her comments via a letter, in which she said her concerns were “appropriate to raise.”
“What I said regarding vaccine injuries/adverse reactions and how they were being treated by health professionals at the time, was truthful.”
She did concede however her claims were hyperbolic.
“That said … I did exaggerate the concerns I had, which I did not mean to do. For this I do wish to apologise,” she said in the letter.
The tribunal found Ms. Green’s comments were “misleading” and her conduct “carried a significant likelihood of undermining the public trust and confidence in both the public health response to the COVID-19 pandemic and the nursing profession.”
“Ms. Green was not an expert as she portrayed and had no legitimate authority to purport to whistleblow about the circumstances of the ED to Christchurch.”
A defence adopted by Ms. Green was that she had the right to freedom of expression, but this was rejected by the tribunal which stated those rights were not protected in the context of a public health emergency.
She was suspended from nursing for three months, ordered to pay $18,000, and for the next 12 months, must let prospective employers know about the tribunal’s findings.
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Also see my other blogs. Main ones below:
http://edwatch.blogspot.com (EDUCATION WATCH)
http://antigreen.blogspot.com (GREENIE WATCH)
http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH)
http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com (TONGUE-TIED)
https://immigwatch.blogspot.com (IMMIGRATION WATCH)
https://awesternheart.blogspot.com (THE PSYCHOLOGIST)
http://jonjayray.com/blogall.html More blogs
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