WASHINGTON (AP) — A coalition of twelve former leaders of the U.S. Food and Drug Administration (FDA), from both Republican and Democratic administrations, has sharply criticized recent proposals from the agency undermining vaccine safety protocols.
The concerned officials have stated that the agency's ongoing reassessment of vaccine management—highlighted in a confidential FDA memo last week—could significantly endanger public health, especially among millions of Americans at heightened risk from infections.
“The proposed new directives are not minor updates but represent a drastic overhaul of the FDA’s essential role,” warned the officials in an article published on Wednesday in the New England Journal of Medicine.
The memo, attributed to FDA vaccine chief Dr. Vinay Prasad, asserts—without providing scientific backing—that COVID-19 vaccines have led to the death of ten children, while pushing for a structural change in how vaccines are regulated. Those working within the agency who disagree with these new guidelines are encouraged to resign.
Among the proposed changes are alterations to the management of annual flu vaccinations and an increased focus on the risk and benefits of administering multiple vaccines at once. This aligns with a narrative often cited by vaccine skeptics but contradicted by substantial scientific research indicating that combined vaccinations do not overwhelm children's immune systems.
These recommendations arise during a politically sensitive time, with Health Secretary Robert F. Kennedy Jr.—a long-time figure in the anti-vaccine movement—attempting to reshape federal health policies concerning vaccines. Kennedy has already removed a previous advisory committee that informed the Centers for Disease Control and Prevention (CDC) on vaccine recommendations, substituting it with his appointees. Additionally, he dismissed CDC Chief Susan Monarez after just 29 days due to disagreements over vaccination policies.
In light of the FDA's assertions about vaccine safety, former FDA leaders note that claims regarding child deaths have been investigated by government scientists before, yielding different findings. They reaffirm that significant evidence supports the effectiveness of COVID-19 vaccines in reducing severe illness and hospitalization among children.
The overarching concern expressed by the FDA's past leaders is that these new recommendations not only reject established scientific assessment methods for vaccines but also threaten to stall innovation and transparency in vaccine development.
