FDA moves to tighten vaccine rules after internal review links COVID-19 vaccines to child deaths

By HPN staff

The Food and Drug Administration plans to impose stricter approval standards for vaccines — including those for pregnant women, the seasonal flu and other new shots — following an internal review controversially linking COVID-19 vaccines to the deaths of 10 children.

In an internal memo, top vaccine regulator Vinay Prasad described the findings as “a profound revelation,” asserting that the FDA would formally acknowledge that COVID-19 vaccines “have killed American children.” He called for future vaccine approvals to rely on randomized pre-market trials that measure real clinical outcomes, rather than just antibody responses, and indicated stricter rules for immunizations given to pregnant women.

The proposed changes extend beyond COVID vaccines. Pneumonia shots would need to show reductions in actual disease incidence rather than triggering an immune response, the annual flu vaccine could face new clinical testing requirements and the practice of administering multiple vaccines at once would be scrutinized.

Additionally, the Centers for Disease Control and Prevention vaccine committee has voted to make changes to its recommendation of the Hepatitis B vaccination for infants.

Why it matters

The memo reviewed 96 pediatric deaths reported to the federal Vaccine Adverse Event Reporting System between 2021 and 2024, concluding that “no fewer than 10” were linked to COVID-19 vaccination, often citing myocarditis or heart inflammation.

But the findings have not been published in any peer-reviewed journal, and public documentation is limited. The memo reportedly omitted key details, including children’s ages, medical histories and the methods used to reach its conclusions. Many public-health experts and former FDA officials have disputed the claims, cautioning that both the analysis and the proposed rule changes lack transparency and sufficient scientific support.

Experts also warn that implementing these stricter standards could slow vaccine development, raise costs and make routine vaccines less accessible — potentially delaying flu shots and standard childhood immunizations.

The big picture

What’s happening at the FDA is part of a broader shakeup in federal vaccine policy. Vinay Prasad returned this year to lead the agency’s Center for Biologics Evaluation and Research after a controversial resignation, raising concerns among experts about political influence over scientific decisions.

The Advisory Committee on Immunization Practices (ACIP) has also seen major personnel changes under Health and Human Services Secretary Robert F. Kennedy Jr., signaling a potential shift in U.S. immunization strategy.

Put together, these moves suggest regulators are moving away from historically established vaccine-approval pathways. Even long-accepted vaccines, like the seasonal flu or routine childhood shots, could face tougher evidence requirements.