FDA's vaccine memo reckless, dangerous to public health

By Lisa Jarvis / Bloomberg Opinion

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 U.S.; and could have profound implications for both access to and the development of vaccines.

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 10 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 claim, an irresponsible and dangerous approach to regulatory oversight.

https://www.heraldnet.com/opinion/comment-fdas-vaccine-memo-reckless-dangerous-to-public-health/