Contamination, myocarditis, seizures: COVID vax revelations put regulators worldwide on defense
Researcher who caught dozens of CDC errors calls agency's talking points "really irresponsible." Possible roadmap for challenging mRNA vaccines after Gilead denied legal immunity for tainted remdesivir.
The Centers for Disease Control and Prevention is going to greater lengths than Pfizer to minimize the risk of heart inflammation in teenagers after COVID-19 vaccination.
The FDA authorized the latest mRNA boosters for children as young as 6 months in September despite its own researchers finding a "safety signal" for post-vaccination seizures and convulsions in 2- to 5-year-old children, a demographic at near-zero risk from SARS-CoV-2 itself.
The disconnect between agency brass and their own researchers and regulated entities is becoming more stark as other problems with COVID therapeutics emerge worldwide, especially batch contamination.
That's why critics of mRNA products are seizing on a Michigan court ruling that denied legal immunity to a drugmaker under the Public Readiness and Emergency Preparedness (PREP) Act, seeing it as an opening to challenge their authorization.
The CDC recently invoked a limited study in its own in-house journal to promote the latest boosters, which have prompted a yawn from the vast majority of Americans and sent Pfizer's guidance and share price tumbling.
By analyzing electronic health record data from January 2021 through January 2022, CDC and external researchers determined myocarditis and pericarditis risks were "significantly higher" after COVID infection than vaccination in 12-17 year-olds, according to the study in Morbidity and Mortality Weekly Report, which is not peer-reviewed.
(Myocarditis is inflammation of the heart muscle, and pericarditis is the swelling and irritation of a thin membrane surrounding the heart.)
EHR data exclude COVID cases that aren't severe, Georgia COVID analyst Kelley Krohnert wrote on X, calling the CDC's talking points "really irresponsible."
Krohnert coauthored a study that found dozens of basic statistical and numerical errors in the agency's COVID research, particularly for children, most of which the CDC acknowledged.
Pfizer didn't try to wave away vaccine adverse events in its Oct. 13 press release on updates to its 2023 guidance. It said explicitly that mRNA vaccines increase the risk of myocarditis and pericarditis, which is highest in 12-17 year-old males for its fully licensed Comirnaty.
Krohnert told Just the News she didn't think Pfizer was being "more honest than the CDC," just that the former's language has "a more matter-of-fact tone instead of a persuasive one" because it's on a package insert, which still characterizes the risk as "very low."
The CDC did not respond to queries about the rigor of its evidence for higher risk from natural infection or even the relevance of the comparison, given the vaccination cannot fully prevent infection.
Food and Drug Administration researchers also reiterated the heart inflammation risk in mRNA-vaccinated teenagers through "active monitoring" of children up to age 17 who received the original monovalent vaccines, which the agency de-authorized when bivalents were approved last year.
But the review of more than 4 million minors "from three commercial [insurance] claims databases" also found a new risk of seizure and convulsions in young children, according to their Oct. 15 preprint awaiting peer review.
They nailed down 72 cases, most of them caused by a fever, with "dose-specific signals" in two of three databases, meaning more cases associated with Moderna due to its higher mRNA dose.
About a third happened within a day of vaccination, with a median of two days, but no observable difference by sex. The risk did not reach statistical significance in an earlier peer-reviewed study of 5-17 year-olds.
The researchers emphasized, however, that a "post-hoc sensitivity analysis" showed the signal was "not observed when 2022 background rates were selected instead of 2020 rates."
They called for a "robust epidemiological study with better confounding adjustment" to nail down the risk.
Health Canada told The Epoch Times that Pfizer violated its obligation to tell the regulator about a "Simian Virus 40 DNA sequence" in its mRNA vaccine that a genomics researcher stumbled across and the Canadian regulator has since independently confirmed.
SV40 was removed from polio vaccines due to cancer fears, though the National Academy of Sciences said in 2003 "it has not been conclusively established whether it might have caused cancer in humans."
Kevin McKernan, who managed MIT's research and development for the Human Genome Project, published a preprint this spring on his finding, concluding that Pfizer and Moderna vaccines had DNA contamination in excess of European Medicines Agency and FDA limits.
DNA contamination is "something that regulatory agencies around the world have specifically said is not possible with the mRNA vaccines," Spectator Australia reported last month.
It also said McKernan is serving as expert witness in an Australian lawsuit to halt distribution of mRNA vaccines because the contamination makes them a "genetically modified organism" under Australian law, requiring a license from the Office of the Gene Technology Regulator.
The U.K.'s Medicine and Healthcare products Regulatory Agency tacitly admitted it authorized Pfizer's vaccine without data on mass-manufactured specimens as opposed to small clinical batches, according to a retired Ministry of Defence official.
Writing in The Daily Sceptic, Nick Hunt said he submitted a public records request to MHRA after Israeli academics warned in the British Medical Journal that they couldn't find a public report comparing small-batch "Process 1" and large-scale "Process 2."
MHRA responded that it didn't know whether anyone was vaccinated under Process 2 before authorization and it didn't have Pfizer's comparison report, which was a condition of authorization until September 2022. This undercuts MHRA CEO June Raine's December 2020 insistence that "no corners have been cut" in authorization, Hunt said.
Michigan's Washtenaw County Circuit Court denied PREP Act immunity to Gilead Sciences in a lawsuit by an alleged victim of its repurposed COVID antiviral remdesivir, sometimes mocked as "run, death is near" for its serious documented adverse events.
Dan Nowacki had two strokes after receiving two known doses from a batch "contaminated with glass particles," leaving him "permanently bedridden and in need of 24/7 round-the-clock care," Mid-Michigan NOW reported in August, paraphrasing his lawsuit.
St. Joseph Mercy Hospital confirmed in writing Nowacki received the bad batches, which Gilead recalled the following month. Judge Carol Kuhnke sent the case to trial because the drug "substantially deviated from FDA approval and included glass particles," the TV station paraphrased.
It's not clear why the ruling didn't attract wider attention before Vaccine Safety Research Foundation founder and former Democratic Party megadonor Steve Kirsch touted it Saturday as "breaking" news.
"I seriously doubt there’s any disclosure of SV40 contamination," Kirsch wrote on X. "That means we have an adulterated vaccine and the FDA has to remove it from the market until the adulteration is fixed."
The FDA answered Just the News queries about whether it knew of the seizure signal when it authorized the latest boosters and how it plans to respond to the increasing evidence of DNA contamination on Oct. 30.
"With over a billion doses of the mRNA vaccines administered, no safety concerns related to the sequence of, or amount of, residual DNA have been identified," an agency statement from press officer Cherie Duvall-Jones reads.
"In general, with regard to the mRNA vaccines, while concerns have been raised previously as theoretical issues, available scientific evidence supports the conclusion that the vaccines are safe and effective. The FDA stands behind its findings of quality, safety, and efficacy for the mRNA vaccines," the statement says.
The Facts Inside Our Reporter's Notebook
- FDA authorized the latest mRNA boosters
- "safety signal" for post-vaccination seizures and convulsions
- The CDC recently invoked
- sent Pfizer's guidance and share price tumbling
- Morbidity and Mortality Weekly Report
- Kelley Krohnert wrote on X
- Krohnert coauthored a study
- methodologically dubious COVID research
- peer-reviewed analysis of its mask studies
- Oct. 13 press release
- Oct. 15 preprint
- earlier peer-reviewed study of 5-17 year-olds
- The Epoch Times
- National Academy of Sciences said in 2003
- MIT's research and development
- published a preprint on his finding
- Spectator Australia
- The Daily Sceptic
- Israeli academics warned in the British Medical Journal
- MHRA responded that it didn't know
- June Raine's December 2020 insistence
- sometimes mocked as "run, death is near"
- serious documented adverse events
- Mid-Michigan NOW
- St. Joseph Mercy Hospital confirmed in writing
- Steve Kirsch touted it Saturday
- Kirsch wrote on X