FDA chief says Biden administration withheld data on heart risk from Covid vaccines

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, FDA Commissioner Marty Makary claimed Thursday.

The Biden administration withheld data from the public on the risks of myocarditis from the Covid vaccine, Food and Drug Administration Commissioner Marty Makary claimed Thursday — a bold accusation that clashes with years of public statements from federal health officials.

“We have done more to study myocarditis and to go back and look at deaths of people, of children from the Covid vaccine,” Makary told NBC News in an interview. “Internal data submitted on myocarditis, we found that the Biden administration was sitting on data on myocarditis in young people, and it was not made public.”

Makary’s claim comes less than a week after Vinay Prasad, the FDA’s top vaccine regulator, told agency staff in a memo that an internal review found that at least 10 children died “after and because of receiving” the Covid shot. Prasad suggested — without evidence to support his claim — that the child deaths were tied to myocarditis.

Myocarditis, an inflammation of the heart muscle, is a known — but small — risk of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.

The FDA has not released its new findings publicly, nor has the agency published them in a peer-reviewed journal. On Wednesday, a dozen former FDA leaders issued a scathing denunciation of the new assertions.