A group of 12 former senior officials from the US Food and Drug Administration (FDA) voiced strong concern on Wednesday over potential shifts in federal vaccine policy following the leak of a document alleging a link between Covid-19 vaccines and the deaths of several children.
Their warning, published in the New England Journal of Medicine, comes days after an internal FDA memo surfaced, questioning the safety of Covid-19 vaccines and urging changes to current approval 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,” the former officials wrote. The signatories served under both Democratic and Republican administrations.
The leaked document, authored by senior FDA official Vinay Prasad, claimed that an internal analysis linked Covid-19 vaccines to the deaths of at least 10 children. It also proposed reviewing approval processes for several vaccines, including flu shots.
Global health authorities continue to affirm that Covid-19 vaccines are safe, effective, and crucial in preventing severe illness.
The former officials criticised the memo, saying it did not explain how its conclusions were reached, nor why the findings should justify a major overhaul of vaccine regulations.
The controversy unfolds as US President Donald Trump has placed national health policy under Health Secretary Robert F. Kennedy Jr, a long-time vaccine skeptic known for promoting widely debunked conspiracy theories. Since taking office, Kennedy has overhauled federal health agencies through sweeping layoffs and the appointment of divisive figures to senior roles.
Kennedy’s “Make America Healthy Again (MAHA)” movement has become a key pillar within Trump’s broader MAGA coalition.
The US Department of Health and Human Services and the FDA have not commented on the leaked memo.
