Twelve ex-Commissioners of the US FDA express grave concerns over agency's vaccine policy shift, according to NEJM

NEW YORK, Dec 3 (Reuters) - A group of twelve former U.S. Food and Drug Administration commissioners expressed serious concern on Wednesday regarding proposed modifications to vaccine regulations by the agencys chief scientific officer. Their worry also extends to his claim that COVID-19 vaccines were linked to the deaths of ten children.

The commissioners were responding to a recent email from Vinay Prasad, FDA chief medical and scientific officer, sent to agency staff last week. In it, Prasad suggested that COVID-19 vaccinations may have contributed to the deaths of at least ten children from heart inflammation but provided minimal information about the methodology behind these conclusions. Additionally, he outlined plans to revise vaccine regulations, including those for annual flu shots, emphasizing that companies should demonstrate vaccine effectiveness through randomized trials rather than studies showing immune response alone.

"These proposed guidelines would fundamentally alter vaccine oversight based on selective interpretation of evidence and through a process that sharply departs from the standards that have underpinned the FDAs internationally respected scientific credibility," wrote the former commissioners in the New England Journal of Medicine. The authors include Scott Gottlieb and Brett Giroir, who served as FDA commissioners during the final term of President Donald Trump.

According to the former leaders, Prasads memo "did not clarify the methods or analyses used to reach these retrospective conclusions, nor explain why they justify a comprehensive rewrite of vaccine regulations."

Prasad was appointed by Health Secretary Robert F. Kennedy Jr., a long-standing critic of vaccines who has previously advocated for placebo-controlled trials. Many experts note that such trials are generally considered ethically unfeasible.

Author: Grace Ellison