FDA Chief Claims Biden Admin Withheld Covid Vaccine Heart Risk Data

A recent statement from Food and Drug Administration (FDA) Commissioner Marty Makary alleges that the Biden administration withheld critical data regarding the myocarditis risks associated with the Covid vaccine. This claim challenges long-standing communications from federal health officials on the subject.

Claims of Withheld Data on Covid Vaccine Heart Risks

In an interview with NBC News, Makary asserted that internal data concerning myocarditis was not publicly disclosed by the Biden administration. He claimed that significant findings about myocarditis in young individuals were suppressed.

Allegations of Child Deaths Linked to Covid Vaccination

Makary’s statements follow a recent internal memo from Vinay Prasad, the FDA’s top vaccine regulator. The memo noted that an internal review indicated at least ten children died following Covid vaccination, with some of these deaths possibly linked to myocarditis.

• Myocarditis is an inflammation of the heart muscle, recognized as a rare side effect of mRNA Covid vaccines from Pfizer and Moderna.
• Federal agencies have acknowledged this risk since 2021.
• The FDA has yet to publish its findings regarding the claimed child deaths.

Timeline of Myocarditis Awareness

Initial reports of a possible connection between Covid vaccines and myocarditis emerged in March 2021, observed in both the U.S. and Israel. The CDC began investigating these reports around the same time.

• In May 2021, the CDC’s vaccine safety group started reviewing heart inflammation reports in youths.
• By June 2021, the CDC acknowledged a “likely association” between myocarditis and Covid vaccines but deemed the benefits of vaccination to outweigh the risks.
• A warning regarding myocarditis was added to the fact sheets for Covid vaccines on June 25, 2021.

Responses from Health Officials

Several former FDA leaders criticized Makary’s comments, calling them unfounded and damaging to public trust. A senior official from the Biden administration described his allegations as “absurd” and emphasized transparency in the reporting of adverse events during the vaccine approval process.

Expert Opinions on Data Availability

Dr. Ofer Levy, who served on the FDA’s advisory group concerning myocarditis, stated that data and documents were accessible to the public. He refuted any notion of a cover-up, asserting that the vaccine review processes were transparent and conducted openly.

Current Understanding of Myocarditis Risks

The claim regarding the vaccine-related myocarditis risks appears to contradict existing evidence. Research indicates that the highest incidence of myocarditis related to mRNA vaccines is in adolescent and young adult males, particularly after the second dose.

• A 2021 CDC report documented 40.6 myocarditis cases per million doses in males aged 12 to 29.
• Conversely, older males showed a rate of only 2.4 cases per million.

Despite the identified risk, Covid infection itself can lead to myocarditis and is often more severe than vaccine-related cases. Thus far, no fatalities have been formally connected to myocarditis caused by the Covid vaccines.