Biden Admin Buried Covid Myocarditis Data: Makary

FDA commissioner Marty Makary has alleged that the Biden administration failed to disclose internal data on myocarditis risks in young people following Covid-19 vaccination — a charge that federal health officials and former FDA leaders swiftly rejected as unfounded.

In an interview with NBC News, Makary said an agency review he ordered uncovered information showing “the Biden administration was sitting on data on myocarditis in young people, and it was not made public.” The accusation stands in stark contrast to four years of public briefings, advisory committee meetings, and published analyses in which federal agencies have acknowledged — and repeatedly discussed — myocarditis as a known but rare side effect of mRNA vaccines from Pfizer and Moderna.

Makary maintained that the FDA’s new findings stem from an investigation involving autopsy reviews and family interviews. “These were kids who died immediately after getting the Covid shot,” he said, arguing such deaths should be considered “causal until proven otherwise.” But he did not provide details on the children’s ages, medical histories, or infection status — nor when the FDA plans to release the data. “Our scientists are working on this,” Makary said.

Makary’s comments come days after CBER director Vinay Prasad told staff in a memo that an internal review had identified at least 10 children who died “after and because of receiving” a Covid shot — a claim Prasad linked to myocarditis without presenting evidence.

The FDA has not released the underlying data, nor submitted its findings to a peer-reviewed journal. On Wednesday (12/3), 12 former FDA leaders issued a forceful public rebuke, warning that the new assertions risk damaging the credibility of the agency’s scientific processes.

A senior Biden administration health official called Makary’s claim “absurd,” adding that no one in the White House had ever pressured staff to hide adverse events or influence vaccine approvals. “There was no pressure coming from the White House,” the official said. “No one told us not to report adverse events. No one told us to approve products.”

Ofer Levy, a former member of FDA’s advisory committee that was convened during the height of myocarditis discussions, said all relevant safety data and briefing documents were posted publicly. “I certainly didn’t see any secret information or cover-up,” Levy said. “We were broadcast live in real time, with public commentary.”