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.

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