One quote stood out to me during the Advisory Committee hearing on booster shots for Pfizer in September 2021. When Doran Fink, M.D., deputy director of the clinical side of the FDA’s Division of Vaccines and Related Products Applications, was asked if he could identify the age where the risk of myocarditis following vaccination dropped off, he answered:
“If you look at the healthcare claims data, you see that there is evidence of some attributable risk at all age groups, although, the older you get, the higher the risk of complications from COVID that offset the risk of myocarditis,” he said. “So, when you look at the balances of risk versus benefit, what we really start to see is risk of myocarditis being higher [than COVID-19] in males under age 40.”
Then, Fink said the claims data showed a risk of 1 in 5,000 that young men would suffer from myocarditis, pericarditis, or myopericarditis, usually following the second dose of the mRNA vaccines. At the time, there was no data on third doses. A new preprint study by Kaiser Permanente Northwest shows the FDA data is a significant underestimate. Using the insurer’s cohort of 12- to 39-year-old patients, they followed the participants for 30 days after the second dose of mRNA.
The study found cases of the cardiac side effects that the claims data collected in the Vaccine Safety Database (VSD) used by the vaccine advisory committees for the CDC and FDA would have missed. The more detailed analysis found a risk for the three cardiac complications of 1 in 1860 for males 18-24 and 1 in 2650 for boys 12-17. The researchers did no investigation about side effects for boys 5-11 in this study.
Physicians do not give patients treatments where the risk of the treatment is higher than the risk of the illness it is supposed to cure or prevent. According to Fink’s assessment, the age where the risk/benefit calculation changed was 40. By any standard of care that existed before the pandemic, no healthy male under 40 would receive an mRNA vaccine. According to Kaiser’s study, there is almost no circumstance where a male between 12 and 24 should receive an mRNA vaccine. A society that was not intent on burdening its children to make adults feel safer would not subject any child under 12 to an mRNA vaccine out of an abundance of caution.
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Clearly, that is not where we are. Colleges and universities require students to receive initial vaccines and boosters to attend classes in person. President Biden is insisting that members of the military receive the vaccines despite waning protection and the evasion by Omicron. Without convening the expert advisory committee, the FDA just approved boosters for children 12-15. California, New York City, and Chicago have mandates that require all children over the age of five to receive vaccines to access restaurants, entertainment venues, and even school.
According to Dr. Marty Makary of Johns Hopkins University, Kaiser’s findings could explain the astonishing number of soccer players and other athletes collapsing on the field and suffering sudden death. A sane FDA would halt the vaccine program for young, healthy people until further research determined these risks with certainty.
A corporate media interested in protecting the public would challenge the White House and Dr. Fauci and FDA personnel on Kaiser’s findings. In the last two years, we have learned that CNN and the New York Times are probably not even aware of this study. Not a single corporate media outlet reported on Fink’s comments from September. It is up to informed citizens to protect our nation’s sons and fight for their right to participate in education, athletics, the workforce, and recreation without the burden of potential damage to their hearts. When our healthy young men are weakened, our entire nation is weaker.
The FDA has failed in its fundamental mission. The agency is supposed to protect Americans’ health by assuring the safety of the medications, medical devices, and cosmetics we use and assuring that the manufacturers don’t make false claims. There is no way to justify the second dose of an mRNA vaccine for males between 12 and 24, let alone a third dose where the risk may well be cumulative. Every Republican running in 2022 must get asked how they propose to reform the FDA, CDC, and NIH to get them out of the business of Big Pharma and back to the business of protecting the health and safety of Americans.
