The FDA's leaked COVID memo is reckless and dangerous

An internal memo written by the Food and Drug Administration's top vaccine regulator offers a concerning glimpse into the future of vaccine regulation in the US - and could have profound implications for both access to and the development of vaccines.

- Lisa Jarvis, Tribune News Service

Robert F. Kennedy Jr.

Vinay Prasad's memo, which was leaked to the news media, makes alarming claims about the COVID-19 vaccine - including the assertion, made without any supporting evidence, that it has caused the death of "at least IO children." It also suggests that the FDA will make significant changes to the way vaccines are regulated. The memo comes at a time of great turmoil at the agency, which intensified this week with the news of yet another leader's potential exit, and amid increasingly aggressive efforts by Health Secretary Robert F. Kennedy Jr. to both undermine confidence in and limit access to vaccines.

Prasad made the extraordinary claim about the safety of COVID vaccines in the email to his staff at the FDA's Center for Biologics Evaluation and Research (CBER). He said an internal investigation found the children died due to myocarditis, a form of heart inflammation. Yet he provided no data or research to support the claiman irresponsible and dangerous approach to regulatory oversight.

It is also wildly out of step with the agency's typically careful process of reviewing safety data. Proving that a vaccine caused a death is a complex endeavor that requires significant evidence, explains Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, who previously served on the FDA's vaccine advisory committee.