The Food and Drug Administration’s top vaccine regulator is pushing new limits on how vaccines win approval. The tougher standards could cloud prospects for vaccine makers and rattle investors in major healthcare and biotech names.
Center for Biologics Evaluation and Research Director Vinay Prasad has reportedly unveiled a sweeping plan to tighten how vaccines win federal approval after an internal safety review raised new alarms about COVID-19 shots, Washington Post reports, citing an internal email.
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The memo, circulated Friday inside the FDA, outlines tougher standards for vaccine makers and asserts that at least 10 child deaths followed COVID-19 vaccinations.
Regulator Cites Child Deaths In Justifying Shift
Prasad wrote that his staff spent months examining safety data before concluding some deaths were vaccine related.
“This is a profound revelation,” Prasad wrote in the memo. He added, “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” The Washington Post adds.
New Rules Target Flu Shots, Pregnancy, Combined Vaccines
Under the proposed framework, manufacturers would need larger trials that prove real-world protection, not only antibody responses.
Prasad said companies seeking approval for pneumonia vaccines must show reductions in pneumonia itself, not just immune markers.
He also promised far tighter standards for vaccines given during pregnancy and for multiple shots administered simultaneously, the report adds.
Plan Could Slow Vaccine Development
Current and former FDA staffers warned the overhaul could dramatically lengthen timelines and discourage new vaccine projects.
They said larger, longer trials for each indication may delay additions to existing vaccines’ eligible populations. Some also cautioned that guidance on routine childhood schedules and annual flu strategies could face sweeping revisions.
Kennedy’s Influence And Anti-Vaccine History
Prasad’s direction aligns with Health Secretary Robert F. Kennedy Jr., a longtime critic of modern immunization programs.
Kennedy, who founded a prominent anti-vaccine group, once called the coronavirus shot “the deadliest ever made.” He and senior aides have revisited discredited claims linking childhood vaccines with autism, drawing rebukes from medical organizations.
Experts Say Evidence For New Claims Is Thin
Former FDA vaccine chief Peter Marks said earlier reviews found no deaths definitively attributed to COVID-19 shots.
Jesse Goodman, another past vaccines director, said existing approval rules are already “quite strict.”
Review Of Child Death Reports
Prasad said his team analyzed 96 reported deaths from 2021 through 2024 in federal surveillance data. He concluded that “no fewer” than 10 were vaccine related and promised “swift action regarding this new safety concern.”
Those cases came from the Vaccine Adverse Event Reporting System, which contains unverified submissions from clinicians, families and others. The Centers for Disease Control and Prevention stresses that VAERS alone cannot establish whether a vaccine caused a death.
Separately, CDC staff reported at least 25 pediatric COVID-associated deaths since July 2023 among hospitalized children. None of the 16 children eligible for vaccination in that group were fully up to date.
Related Market Angle
Stricter approval standards could weigh on vaccine makers such as Pfizer Inc. (NYSE:PFE) and Moderna Inc. (NASDAQ:MRNA).
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