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January 6, 2023 COVID News

COVID

New Analysis Shows Studies of COVID Vaccine-Induced Myocarditis Hid Critical Safety Signal

A new peer-reviewed analysis of studies on COVID-19 vaccine-induced myocarditis in young males shows many studies hid an important safety signal by not providing “adequate stratification,” according to Vinay Prasad, M.D., M.P.H., co-author of the review.

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A new peer-reviewed analysis of studies on COVID-19 vaccine-induced myocarditis in young males shows many studies hid an important safety signal by not providing “adequate stratification.”

“Many studies lump everyone together to hide a legitimate safety signal,” said Vinay Prasad, M.D., M.P.H., co-author of the analysis published last month in the European Journal of Clinical Investigation.

Stratification means isolating the people in a study into groups based on pertinent factors, such as age and sex, according to Prasad, a hematologist-oncologist and professor at the University of California, San Francisco.

By lumping all ages, sexes, dosages and COVID-19 vaccine manufacturers together, researchers “have been hiding and obscuring very necessary dialogue — which is that our vaccine policies don’t have to be the same for a 16-year-old man and an 87-year-old woman,” Prasad said.

Stratification is a basic skill for developing meaningful medical statistics, Prasad said. But the systematic review he conducted found that only a quarter of the studies used the four “elementary stratifying variables” (i.e. sex, age, dose number and manufacturer) when reporting the highest risk of myocarditis.

Prasad wrote this week that the net benefit of vaccination for a woman in her eighties was different from the net benefit of vaccination for a man in his late teens.

“As early as July 2021, with colleagues from mathematics, cardiology, and pediatrics, we worried that dose 2 [of the COVID-19 vaccine] was unfavorable in adolescent boys,” Prasad said. “With emerging data from the UK it was clear that for some products and some doses, myocarditis post vax exceeded myocarditis post illness.”

It turns out that when you look at myocarditis just in the highest-risk demographics — young men who get a second Moderna shot — the risk is substantially higher than when you lump “16-year-old boys with their great grandma.”

“This should be obvious,” Prasad added.

Why the one-size-fits-all COVID vaccine policy?

In a video discussion of his analysis, Prasad told viewers he sometimes feels pessimistic when he thinks about how “the only reason smart people would have a one-size-fits-all policy is it benefits the manufacturer because they can sell more dose of their product.”

“But that would be such a silly reason,” he added, “because credibility in public health is much more important than the meager short-term market share of a company like Pfizer. I can’t understand it.”

Prasad said he wonders if officials at the Centers for Disease Control and Prevention (CDC) and members of its Advisory Committee on Immunization Practices (ACIP) could be “so bad at their job that they can’t understand that boosters and young people might have a different risk-benefit calculation than in older people” — even after “they literally had it told to them” by Marion Gruber and Phil Krause, two senior U.S. Food and Drug Administration vaccine leaders, who resigned over the issue.

“So they [CDC officials and ACIP members] are so dense that even when the people who’ve done it for decades are telling you, ‘I will resign over this issue,’ they still don’t understand,” Prasad said.

Prasad said he believes COVID-19 vaccine mandates were “always unjustified” and that he strongly supports the repeal of any such law — especially college vaccine mandates that were created by “some mid-level bureaucrat” who had no scientific expertise.

College students who were required for attendance to get the COVID-19 vaccine and now have myocarditis or pericarditis should be able to sue that college, he said.

Prasad added:

“Colleges need to be litigated. They need to lose the litigation so they learn some humility — which is that if you’re running random garbage liberal arts school you’re not qualified to be creating mandates.”

Watch the video here:

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