FDA Vaccine Review Signals Regulatory Shift in US Health Policy
A significant development in US pharmaceutical regulation has emerged as Food and Drug Administration official Vinay Prasad, director of the Center for Biologics Evaluation and Research, outlined substantial changes to vaccine oversight protocols in an internal memo dated Friday.
The document, published by The Washington Post, reveals that Prasad has linked the deaths of at least 10 children to COVID-19 vaccination following an analysis of 96 reported deaths between 2021 and 2024. The review was conducted using data from the federal Vaccine Adverse Event Reporting System (VAERS).
Regulatory Framework Under Review
Prasad's memo indicates a comprehensive reassessment of vaccine authorization processes, describing current protocols as requiring evidence-based recalibration. The proposed changes include heightened scrutiny of simultaneous vaccine administration and revision of annual influenza vaccine frameworks.
"For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children," Prasad stated in the memo, characterizing the findings as "a profound revelation."
The regulatory shift extends to pneumonia vaccines, which will now require manufacturers to demonstrate actual disease reduction rather than antibody generation. Additionally, more stringent requirements for vaccine authorization during pregnancy are under consideration.
Data Quality and Verification Challenges
The VAERS system, which forms the basis of this analysis, operates as an open reporting platform where "anyone" can submit adverse event reports, according to CDC documentation. This methodology raises questions about data verification and causal attribution that will likely influence regulatory discourse.
Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia, has requested comprehensive evidence review, stating that "all this will do is scare people unnecessarily" without proper data substantiation.
Regional Implications for ASEAN Markets
This regulatory pivot in the US market may influence pharmaceutical oversight frameworks across Southeast Asian jurisdictions, particularly as regional health authorities evaluate their own vaccine approval processes. Singapore's Health Sciences Authority and similar regulatory bodies across ASEAN have maintained robust evidence-based assessment protocols that could serve as benchmarks during this transitional period.
The memo also addresses information governance, with Prasad criticizing unauthorized media communications from FDA staff, describing such practices as "unethical, illegal, and factually incorrect."
The Department of Health and Human Services has not yet responded to requests for comment regarding the proposed regulatory changes.