FDA’s Top Vaccine Official Opposed Broad Covid-19 Shot Use, Override Memos Reveal
FDA Covid-19 vaccine override: Dr. Vinay Prasad overruled internal advice to limit broad use of updated Covid-19 vaccines. Documents released this week reveal that Prasad cited concerns over safety. He also noted a reduced threat from the virus, especially for younger, healthy populations.
Overrides Spark Backlash
Prasad’s override memos, issued in May, go against the recommendations of roughly 30 FDA scientists. These scientists had supported approval for Novavax’s Nuvaxovid and Moderna’s updated mRNA vaccine, mNexspike, for individuals aged 12 and older.
Citing insufficient safety data and concerns about the risk of myocarditis—particularly in teen boys and young men—Prasad concluded that broader use of the vaccines was not justified. These decisions align with Health and Human Services Secretary Robert F. Kennedy Jr.’s position to limit Covid-19 vaccinations to high-risk groups.
Disregarding Agency Norms
According to experts, Prasad’s override marks a substantial shift from the FDA’s customary responsibilities. In the past, advisory groups and the Centers for Disease Control and Prevention (CDC) have issued recommendations about vaccine eligibility rather than the FDA. Dr. Daniel Griffin of Columbia University called it “a major overreach.” He noted that restricting access increases, not decreases, the risk of myocarditis in unvaccinated individuals.
Dr. Peter Lurie, former FDA associate commissioner, said it’s highly unusual for an override to limit access to products deemed safe and effective by internal reviewers. “This is not how the FDA has typically operated,” he added.
A New Era of FDA Leadership
Prasad, known for challenging medical orthodoxy and groupthink, assumed his FDA post in May following the controversial ousting of former CBER chief Dr. Peter Marks. Biotech markets reacted sharply to his appointment, with analysts calling it a signal of more skeptical oversight of the vaccine sector.
Speaking to staff shortly after assuming his role, Prasad emphasized caution about repeat Covid-19 boosters:
“The efficacy of repeat doses … is uncertain, and there are important safety considerations whose long-term impact is not fully known.”
As this leadership shift plays out, public health experts warn of the potential consequences: a politicized FDA, shaken public trust, and reduced vaccine access in the face of ongoing viral risk.
Source: CNN
