FDA to tighten vaccine approvals; internal review links 10 child deaths to COVID shots
An internal FDA memo from vaccine chief Dr. Vinay Prasad — reported by NPR and CBS — urges tighter vaccine approval standards (revising the annual flu framework, stricter labeling and authorizations including for pregnant women, requiring disease‑reduction endpoints for pneumonia vaccines, and questioning simultaneous administration) and cites an internal review of 96 pediatric death reports that it says shows at least 10 children died “after and because of” COVID‑19 vaccination, with myocarditis suggested as a likely cause; the findings have not been peer‑reviewed and omit detailed case data. Twelve former FDA commissioners and other public‑health experts denounced the claims in a NEJM letter, arguing surveillance reports cannot prove causation and that the proposals could harm high‑risk patients, while HHS defended the effort and some professional societies (AAP, IDSA) continue broader pediatric recommendations amid the shift in ACIP guidance.
📌 Key Facts
- Dr. Vinay Prasad, the FDA's vaccine chief, circulated an internal email outlining major policy changes — revising the annual flu‑vaccine framework, updating labels to be more 'honest,' tightening authorization standards for use in pregnant women, requiring pneumonia vaccines to show disease‑reduction (not just antibody responses), and questioning simultaneous administration of multiple vaccines.
- Prasad directed FDA biostatistics and pharmacovigilance teams to review 96 pediatric death reports from 2021–2024 and concluded that 10 deaths occurred 'after and because of' COVID‑19 vaccination; he suggested myocarditis as the likely cause but did not provide ages, comorbidity details, or underlying data, and the findings have not been peer‑reviewed or publicly disclosed.
- The memo and Prasad's assertions prompted internal and external controversy, including a letter in NEJM from 12 former FDA commissioners condemning the vaccine‑safety claims and proposed policy changes as based on surveillance reports insufficient to establish causation and warning the proposals could disadvantage high‑risk Americans, slow replacement of older vaccines, and reduce transparency.
- Outside experts and professional societies reacted sharply: Dr. Paul Offit criticized the absence of presented evidence for the 10‑death claim; Dr. Jesse Goodman defended the use of immunologic endpoints for accelerated approvals with post‑approval confirmation; and IDSA president Dr. Ronald Nahass said the FDA was creating confusion and mistrust while calling vaccines 'lifesaving.'
- FDA Commissioner Marty Makary said the agency will stop 'rubber‑stamping' vaccines and called prior practices a 'mockery of science.' An HHS spokesperson later framed criticism from former officials who opposed 'raising the bar' as confirmation that the administration is on the right track.
- CBS reported the internal memo told staff who disagreed with the planned changes that they should resign.
- For context, CBS noted that in April 2025 the FDA expanded myocarditis/pericarditis warnings to males 16–25 and cited an estimated rate of about 8 myocarditis/pericarditis cases per million doses for people under 65 after the 2025 season; CDC's ACIP — now entirely appointed by HHS Secretary Robert F. Kennedy Jr. — has shifted toward individualized vaccine decisions while the AAP and IDSA continue to recommend broader vaccination for children.
- The story is evolving: HHS/FDA did not immediately respond to NPR's requests for comment about the analysis and proposed standards changes, and the memo's conclusions have not been independently peer‑reviewed or fully disclosed for external evaluation.
📰 Sources (4)
12 ex-FDA leaders criticize claims made by agency's current vaccine chief
New information:
- Twelve former FDA commissioners and acting commissioners published a NEJM letter denouncing the internal memo’s vaccine-safety assertions and proposed policy changes.
- They argue the claim of at least 10 child deaths 'after and because of' COVID-19 vaccination relies on surveillance reports insufficient to prove causation and contradicts prior government analyses.
- The NEJM letter says the proposals would disadvantage high‑risk Americans, slow replacement of older vaccines, and reduce transparency.
- HHS spokesperson responded that criticism from former officials who opposed 'raising the bar' confirms the administration is on the right track.
- IDSA president Dr. Ronald Nahass said FDA is creating confusion and mistrust without supplying evidence, calling vaccines 'lifesaving.'
- CBS reports the internal Prasad memo told staff who disagreed with the planned changes should resign.
FDA to raise hurdles for vaccines, faulting COVID shots for 10 kids' deaths
New information:
- FDA Commissioner Marty Makary said on Fox News the agency will stop 'rubber-stamping' vaccines and called prior practices a 'mockery of science.'
- An internal email from FDA vaccine chief Dr. Vinay Prasad outlines policy changes: revising the annual flu vaccine framework, updating labels to be 'honest,' tightening authorization standards for use in pregnant women, requiring pneumonia vaccines to show disease reduction (not just antibody response), and questioning simultaneous administration of multiple vaccines.
- Prasad directed FDA biostatistics/pharmacovigilance teams to analyze 96 pediatric death reports (2021–2024) and concluded 10 deaths occurred 'after and because of' COVID vaccination; he suggested the true number may be higher.
- HHS/FDA did not immediately respond to NPR’s requests for comment on the analysis or standards changes.
- External experts reacted: Dr. Paul Offit criticized lack of presented evidence supporting the 10-death claim; Dr. Jesse Goodman defended immunologic endpoints for accelerated approvals and post-approval confirmation.
FDA official claims link between COVID-19 vaccines and pediatric deaths
New information:
- CBS reports the memo stated 'at least 10 children have died after and because of receiving COVID-19 vaccination,' according to multiple sources familiar with the email.
- The memo suggested myocarditis as the likely cause of those deaths; Prasad did not provide ages, comorbidities, or underlying data, and the findings were not peer-reviewed.
- CBS notes FDA’s prior expansion (April 2025) of myocarditis/pericarditis warnings to males 16–25 and cites the ~8 cases per million doses rate for sub‑65 after the 2025 season.
- Context: CDC’s ACIP—now entirely appointed by HHS Secretary Robert F. Kennedy Jr.—shifted guidance to individualized decisions rather than general recommendation, with AAP and IDSA maintaining broader recommendations for children.