Three senior Democratic members of the House Energy and Commerce Committee sent a detailed oversight letter to FDA Commissioner Martin Makary expressing concern about recent internal FDA communications on vaccine regulation. The lawmakers argue that statements made by Vinay Prasad, MD, MPH, director of the Center for Biologics Evaluation and Research (CBER), and subsequently echoed by Makary, include unsupported claims linking COVID-19 vaccination to pediatric deaths and outline significant regulatory changes without adequate scientific evidence or public transparency.1
Concerns About Claims of Vaccine-Associated Pediatric Deaths
The letter focuses on an internal email in which Prasad asserted that “at least 10 children have died after and because of receiving COVID-19 vaccination.”
Key issues raised by the lawmakers include:
- The alleged findings have not been published in a peer-reviewed journal or made publicly available.
- Prasad’s own memo describes the deaths as merely “possible,” contradicting the earlier statement of causality.
- The FDA did not provide the underlying data, despite describing these findings as a “profound revelation.”
- The claims rely on VAERS reports, which HHS explicitly notes may contain incomplete, inaccurate, or unverifiable information, and which are intended only for signal detection, not for determining causality.
- FDA career staff reportedly described the analysis as “a huge exaggeration.”
The lawmakers also emphasize that 183 children died of COVID-19 in the United States from 2020–2022, citing data, and argue that FDA leadership appeared to dismiss the disease burden when discussing vaccine risks.
Concerns About Withholding Data and Deviating From Standard Processes
The representatives state that:
- FDA leadership did not release data or epidemiologic analyses supporting the claim of vaccine-linked deaths, including whether cases were medically verified, whether autopsy or death certificate findings were reviewed, or whether alternative causes of death were ruled out.
- FDA has not responded to a prior July 2025 congressional inquiry about similar policy changes.
Proposed Changes to Vaccine Regulatory Standards
Prasad’s internal memo reportedly proposed multiple changes that would substantially alter FDA’s vaccine evaluation framework, including:
- More stringent requirements for vaccines used in pregnancy
- Unspecified revisions to the seasonal influenza vaccine approval process
- Mandatory studies for vaccine co-administration (already standard practice)
- Requiring large randomized trials for pneumococcal vaccines to show clinical disease reduction, not just immunogenicity
The lawmakers note that:
- 12 former FDA Commissioners from both parties publicly warned that such changes could undermine established, evidence-based vaccine policy.
- Experts have said the proposed standards would be “impossible” or “unethical” to meet and could delay access to safe and effective vaccines.
- Issuing regulatory policy via internal email is legally questionable and bypasses required rulemaking procedures, including public comment and VRBPAC review.
What You Need to Know
Lawmakers are seeking transparency after FDA officials cited pediatric deaths allegedly linked to COVID-19 vaccination without providing peer-reviewed evidence or verified case data.
Experts warn that proposed FDA requirements, including large randomized trials for routine vaccines, would be infeasible, unethical, and could delay access to influenza, pneumococcal, and maternal vaccines.
The oversight letter reflects growing bipartisan concern that internal FDA policy shifts may bypass established regulatory processes and threaten evidence-based national immunization programs.
Integration of Additional Context From Infectious Disease Experts and Regulatory Stakeholders
These congressional concerns mirror those raised by clinicians and regulatory experts who reviewed a separate internal memo circulating within the agency in late October. In that memo, Prasad proposed broadly similar requirements: pre-market RCTs for most vaccines, including annual influenza vaccines, pneumococcal vaccines, and vaccines used in pregnancy. Infectious disease specialists, including Paul Offit, MD, emphasized that Prasad presented no evidence for his claims linking COVID-19 vaccination to pediatric deaths and that such assertions require rigorous documentation, including autopsy findings and exclusion of alternative causes.2
Clinical and epidemiologic experts across multiple institutions warned that demanding annual RCTs for influenza vaccines or large post-licensure trials for updated pneumococcal formulations would be infeasible, delay seasonal vaccine availability, and expose patients to preventable disease. Former FDA officials also noted that it would be unethical to conduct placebo-controlled pneumococcal vaccine trials when effective vaccines already exist.2
Legal scholars further underscored that implementing major regulatory shifts without public rulemaking could render the policies “arbitrary and capricious,” exposing the FDA to litigation and undermining manufacturers’ ability to rely on predictable regulatory standards. Experts warned that even if vaccines technically remain authorized, losing ACIP recommendations due to unworkable FDA requirements would function as a “de facto ban” by eliminating insurance coverage and reducing provider uptake.2
Requests for Information
To restore transparency, the committee members request detailed documentation from FDA by December 19, 2025, including:
- Deidentified data for the 10 alleged pediatric cases, including age, underlying conditions, vaccine product/dose, timing, cause of death, and verification methods
- Slides from a meeting at which Tracy Beth Høeg, MD, PhD reportedly presented pediatric death data
- Documentation on how FDA weighed vaccine benefits (hospitalization prevention, Long COVID, cardiac outcomes) against alleged risks
- Evidence supporting proposed changes to vaccine approval and safety standards
- Legal justification for issuing regulatory policy via internal email
- Citations for a 2022 study Prasad referenced as evidence of booster-related harm in young men
- Clarification regarding VRBPAC involvement and any planned policy shifts related to aluminum adjuvants
The letter reflects growing bipartisan scrutiny of recent vaccine regulatory communications coming from within the FDA. Lawmakers say the agency must provide transparent, peer-reviewed evidence to justify claims about pediatric vaccine safety and must follow established regulatory procedures when proposing changes with wide-reaching public health implications. Experts warn that implementing unfeasible clinical trial requirements could weaken national immunization programs at a time when maintaining trust, access, and evidence-based oversight remains critical.
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