FDA head accuses Biden administration of withholding data on heart risk in Covid vaccines

FDA Commissioner Marty Makary accused the Biden administration of concealing information about myocarditis risks linked to Covid vaccines, asserting that internal data on heart inflammation in young people was not shared with the public. Makary made the statement during an interview with NBC News on Thursday.

We have conducted extensive studies on myocarditis and reviewed deaths of children following Covid vaccination, Makary said. Our investigation revealed that data on myocarditis among young people was withheld by the administration.

This allegation follows a memo from FDA vaccine regulator Vinay Prasad, who indicated that an internal review identified at least 10 child deaths following Covid vaccination. Prasad suggested a connection to myocarditis, though no definitive evidence has been presented.

Myocarditis, an inflammation of the heart muscle, is a known but rare side effect of the mRNA vaccines from Pfizer and Moderna, a risk that federal agencies have publicly discussed since 2021. However, the FDA has not yet released the new findings publicly or in any peer-reviewed publication.

Former FDA officials have strongly criticized Makarys claims. Reports of myocarditis following Covid vaccination first appeared in March 2021 from the U.S. and Israel, with symptoms including chest pain, shortness of breath, and rapid heartbeats. By May 2021, the CDC began reviewing heart inflammation cases in adolescents, around the time Pfizers vaccine was authorized for young teens. In June, the CDC advisory panel publicly discussed the potential link and concluded that vaccine benefits outweighed the risks. The FDA subsequently updated fact sheets to include a warning about rare myocarditis cases.

A senior federal health official described Makarys statements as absurd and warned they could undermine public trust in the FDA, emphasizing that no pressure from the White House influenced reporting or vaccine approvals. The government has held multiple public meetings and published research on myocarditis since vaccines were first authorized in late 2020.

Dr. Ofer Levy, who served on the FDA advisory group, noted that data and briefing documents were publicly accessible, with live-streamed discussions allowing real-time public input. I did not see any hidden information or cover-up during my time at the FDA, Levy said.

Makary stated that the new findings regarding child deaths come from investigations including family interviews and autopsy reviews. He suggested a causal link between vaccination and severe complications leading to fatalities, though details on age, medical history, or Covid infection status were not provided, nor was a timeline for public release of the data.

Available evidence shows that myocarditis risk is highest in teenage and young adult males, usually after the second mRNA dose. CDC data from 2021 indicated 40.6 cases per million second doses in males aged 1229 and 2.4 cases per million in males aged 30 and older. Most cases are mild and resolve quickly. Covid infection itself can also cause myocarditis, often more severe than post-vaccine cases, and no confirmed deaths have been linked to vaccination-induced myocarditis.

Analysis: Evaluating Claims on Myocarditis and Covid Vaccines

The recent statements by FDA Commissioner Marty Makary allege that the Biden administration withheld data on myocarditis in young people following Covid vaccination. While these claims are serious, current publicly available evidence shows that myocarditis is a known but rare side effect of mRNA vaccines, primarily affecting teenage and young adult males after the second dose.

Federal agencies, including the CDC and FDA, have documented myocarditis cases since 2021 and updated vaccine fact sheets accordingly. Public meetings and research have been published, and advisory panels have consistently concluded that vaccine benefits outweigh myocarditis risks. No confirmed deaths have been linked to vaccination-induced myocarditis.

Makary's report cites investigations of child deaths using family interviews and autopsies, but details regarding age, medical history, or Covid infection status remain unclear, and the data has not been peer-reviewed or released publicly. Former FDA officials have criticized his claims, noting that all relevant information was accessible and discussions were transparent.

Given the lack of peer-reviewed evidence and the context of longstanding public reporting on myocarditis, these allegations should be approached cautiously. Ongoing surveillance and transparent communication remain crucial for maintaining public trust while monitoring rare vaccine side effects.

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