FDA Official Proposes Overhaul of Vaccine Approval Process After Memo Says 10 Child Deaths Linked to COVID-19 Shots

A senior Food and Drug Administration official announced plans to change the agency's vaccine approval framework after an internal memo claimed an initial review linked 10 child deaths to COVID-19 vaccination. The memo, circulated internally, said those findings came from an "initial analysis" of 96 reported deaths but did not provide case-level details or explain the methods used to reach those conclusions.

Who spoke and what was claimed

Dr. Vinay Prasad, the FDA's chief medical and scientific officer and director of the Center for Biologics Evaluation and Research, wrote that "healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death." He did not attach detailed evidence or case reports to the memo.

"I have no doubt that many vaccines have saved millions of lives globally, and many have benefits that far exceed risks, but vaccines are like any other medical product," Prasad wrote. "The right drug given to the right patient at the right time is great, but the same drug can be inappropriately given, causing harm."

Proposed regulatory changes

According to the memo, the FDA will adopt a more rigorous approval pathway for vaccines, emphasizing stronger evidence of safety and clinical benefit before marketing authorization. Proposed directions include:

• Stricter authorization standards for vaccines intended for pregnant people.
• Pneumonia vaccine trials that must show actual disease reduction rather than relying solely on antibody responses as a surrogate endpoint.
• A reappraisal of the framework for annual influenza vaccines, with more transparent safety labeling.

Prasad warned that these changes could require larger, longer clinical studies and therefore lengthen approval timelines.

Internal debate and staffing

The memo invited internal discussion but urged that debates remain within the agency. It also stated that staff who do not agree with the agency's stated "core principles and operating principles" should consider resigning.

Context and broader policy shifts

The memo aligns with policy positions associated with the current Department of Health and Human Services leadership. It also follows a series of controversial changes to federal vaccine policy that critics say have reduced long-standing institutional safeguards. These policy moves include reductions to certain vaccine-development programs and reorganization of advisory panels. Public-health authorities emphasize that long-established vaccine safety conclusions are based on extensive evidence, and they dispute claims that vaccines cause autism or other conditions for which there is no scientifically supported link.

Requests for comment were sent to the FDA and the Department of Health and Human Services; no detailed public response to the memo had been released at the time of reporting.

Upcoming advisory review

A federal vaccine advisory committee is scheduled to review the childhood immunization schedule, including the timing of the first hepatitis B dose given shortly after birth. For more than three decades, that early-dose strategy has been part of U.S. public-health guidance and has contributed to a dramatic reduction in childhood hepatitis B cases. The advisory panel is reportedly considering whether to change the timing of the birth dose despite no newly disclosed evidence challenging its safety or effectiveness.

Notes on the memo’s claims

Because the memo did not include case-level data or a methodological appendix, independent reviewers cannot evaluate its conclusions. The assertion that 10 child deaths are linked to vaccination remains an internal allegation until the FDA publishes detailed findings or peer-reviewed analyses. Transparency about data and methods will be essential for assessing the validity and implications of the memo's claims.