With no efficacy or safety data, the agency is enthusiastically promoting a fifth COVID shot

BY ALEX GUTENTAG

The Tablet headline says it loud and clear. 

Michael Lerner

n Aug. 31, 2022, the Food and Drug Administration authorized bivalent boosters reformulated to target the BA.4 and BA.5 omicron subvariants. At the authorization meeting, FDA officials announced the approval of these new boosters for emergency use based on data from eight mice in a Pfizer study. At the same time, the FDA revoked authorization for the original monovalent boosters—meaning anyone subject to a booster or “up-to-date” mandate will have to take the bivalent booster, which has no proven safety or efficacy data in human beings.

While the flu vaccine is also approved on a yearly basis without full trials, the mRNA COVID vaccines do not share the flu shot’s decadeslong track record of observed safety. The population most likely to be mandated to take a bivalent booster consists largely of college students. The young men in this population are the exact demographic that face heightened safety concerns, specifically around myocarditis, as documented in multiple peer-reviewed studies. In fact, during a meeting of the Centers for Disease Control and Prevention to recommend the bivalent boosters, the agency presented updated myocarditis data that confirmed the rates of myocarditis in young men were about 2-to-3.5 times higher (slide 35) than the agency had claimed last year (slide 13). Nevertheless, the FDA and CDC moved to recommend the bivalent boosters for anyone over the age of 12 without human clinical trials.

This is just the latest episode in the FDA’s less-than-thorough approach to new COVID vaccine approvals. For example, in May 2022, the FDA authorized monovalent Pfizer boosters for children ages 5-11 based on laboratory data that showed heightened antibody response levels in just 67 children.

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