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.”

“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.

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