Former FDA Officials Warn of “Deep Concern” After Leak Suggests Vaccine Policy Shift

A dozen former US Food and Drug Administration (FDA) officials on Wednesday voiced alarm over potential changes to national vaccine policy after the leak of an internal document that linked Covid-19 vaccines to children’s deaths.

Their warning, published in the New England Journal of Medicine, comes just days after the disclosure of an FDA memo that questioned Covid-19 vaccine safety and proposed revising long-standing regulatory procedures.

“We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe, effective, and available when the public needs them most,” wrote the 12 physicians, all of whom previously held senior FDA roles under both Democratic and Republican administrations.

The controversy erupts as President Donald Trump has placed US health policy under Health Secretary Robert F. Kennedy Jr., a prominent vaccine skeptic known for promoting widely debunked conspiracy theories about immunization.

The leaked memo — signed by senior FDA official Vinay Prasad — reportedly claims that Covid-19 vaccines were linked to the deaths of at least 10 children, citing an unpublished internal analysis. It also proposes a review of approval procedures for several vaccines, including influenza shots.

Global health authorities continue to affirm that Covid-19 vaccines are safe and effective, especially in preventing severe disease.

In their criticism, the former FDA officials said the memo “offered no explanation of the process and analyses used to reach the new retrospective judgment, nor did it indicate why that assessment should justify wholesale rewriting of vaccine regulation.”

Kennedy has dramatically restructured federal health agencies since taking office, overseeing mass dismissals and installing controversial figures in senior positions. He has long championed unfounded vaccine claims that have become central to his “Make America Healthy Again” (MAHA) movement — a key faction within Trump’s divided Make America Great Again (MAGA) base.

The Department of Health and Human Services and the FDA declined to comment on the leaked memo despite multiple inquiries.