FDA chief accuses Biden administration of withholding data on heart risk from Covid vaccines

Food and Drug Administration (FDA) Commissioner Marty Makary alleged on Thursday that the Biden administration did not disclose information regarding myocarditis risks from Covid-19 vaccines to the public. This statement contrasts sharply with prior public communications from federal health authorities.

In an interview with NBC News, Makary stated, We have done extensive research on myocarditis, including reviewing deaths of children following Covid vaccination. Internal FDA data indicated that the Biden administration possessed information on myocarditis cases in young individuals but chose not to make it public.

Makarys comments follow a memo from Vinay Prasad, the FDAs leading vaccine regulator, who recently informed agency staff that an internal review identified at least 10 children who died after and because of receiving a Covid vaccine. Prasad suggested a connection to myocarditis, though no conclusive evidence was provided.

Myocarditis, an inflammation of the heart muscle, is a known but rare side effect of mRNA vaccines like Pfizer and Moderna. Federal agencies have acknowledged this risk since 2021. However, the FDA has not yet publicly shared the recent findings or submitted them to peer-reviewed journals.

Former FDA officials have strongly criticized these new claims. Initial reports of myocarditis cases after Covid vaccination appeared in March 2021 from both the U.S. and Israel. Symptoms include chest pain, shortness of breath, and irregular heartbeat.

By May 2021, as Pfizers vaccine became authorized for adolescents, the Centers for Disease Control and Prevention (CDC) began reviewing cases of heart inflammation in young people. In June, the CDCs advisory panel publicly discussed a probable link between the vaccines and myocarditis but concluded that vaccination benefits outweighed risks. The FDA later updated vaccine fact sheets to include a warning about rare myocarditis cases.

A senior federal health official described Makarys statements as absurd and warned they could damage public trust in the FDA. The official confirmed no pressure came from the White House regarding vaccine approvals or reporting of adverse events.

Since late 2020, the government has held multiple public meetings and published data on Covid vaccine safety, including myocarditis risks. Dr. Ofer Levy, who participated in the FDAs advisory discussions, emphasized that relevant information was publicly available and there was no hidden data or cover-up.

Makary noted that the FDAs recent findings involve direct investigation, including family interviews and autopsy reviews. He claimed, These were children who developed myocarditis or other severe complications shortly after vaccination, which in my view suggests causation until proven otherwise.

He did not provide specifics on the childrens ages, medical history, Covid status, or when the data would be released. Our scientists are compiling the information, he said.

Current evidence on vaccine-associated myocarditis shows the highest risk among teen and young adult males, particularly within days of the second dose of mRNA vaccines. A CDC report from 2021 recorded 40.6 cases per million second doses in males aged 1229, versus 2.4 cases per million in males over 30. Most cases have been mild and resolved quickly. Covid infection itself carries a higher risk of myocarditis than vaccination. To date, no confirmed deaths have been directly linked to Covid vaccines.

Author: Lucas Grant