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Editorial

FDA’s leaked COVID memo is reckless and dangerous

By Lisa Jarvis
The Philadelphia Tribune
https://www.phillytrib.com/

On Nov. 28, Vinay Prasad, who is head of the FDA’s Center for Biologics Evaluation and Research, which oversees vaccines, blood products and gene therapies, sent a memo to the center’s staff saying that agency scientists had identified 10 cases in which the deaths of children were tied to the COVID vaccines made by Pfizer and Moderna. —AP PHOTO/MANUEL BALCE CENETA

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.

Lisa Jarvis is a Bloomberg Opinion columnist covering biotech, health care and the pharmaceutical industry. Previously, she was executive editor of Chemical & Engineering News.

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