The FDA says it will soon outline proposed regulatory changes after unverified claims that Covid vaccination was linked to deaths, including an allegation of child deaths that has not been backed by published evidence. Officials report re‑examining roughly 25 VAERS reports and studying deaths across age groups, while signaling a broader revision of vaccine safety monitoring. Lawmakers, former FDA leaders and public‑health experts demand data—such as medical‑examiner reports and independent review—and warn that unexplained changes could slow approvals and erode public confidence.
FDA Promises Regulatory Revisions After Unverified Claims Of Covid Vaccine‑Linked Deaths — Calls For Data Grow
‘All 12 former heads of the FDA blasted the moves as a threat.’Photograph: Marysia Kaminska/Alamy
The U.S. Food and Drug Administration (FDA) said it will soon publish details of proposed regulatory changes after unverified claims that deaths followed Covid vaccination. The announcement, communicated in internal messages and public briefings, has prompted demands from lawmakers, former agency leaders and public‑health experts for transparent evidence and independent review.
What Officials Say
In internal communications, an FDA official asserted that Covid vaccination had been linked to multiple child deaths, a claim that so far has not been supported by published evidence. A Health and Human Services (HHS) spokesperson confirmed that the agency is re‑examining reports of deaths across age groups and said the FDA is conducting a "thorough investigation" and will release more information "soon." The spokesperson also criticized prior leadership for allegedly not fully investigating the reports.
Scope Of The Review
Earlier reporting indicated the FDA had been reviewing roughly 25 deaths drawn from the Vaccine Adverse Event Reporting System (VAERS), a public database that accepts reports from anyone. HHS said the review includes adult deaths as well as those involving children. Officials who discussed the matter in advisory meetings said they are "widening the net" to look for additional potential safety signals and are adopting new analytical approaches.
Responses From Experts And Lawmakers
Public‑health experts called for transparency and rigorous evidence. Former CDC official Debra Houry said she would expect underlying data and independent verification, including forensic findings such as medical‑examiner autopsy reports, before accepting conclusions about causation. Yale health policy professor Jason L. Schwartz described the absence of published evidence as "striking," given how safety signals have typically been shared and examined by advisory groups.
Democratic members of the House Committee on Energy and Commerce sent a letter expressing concern that the FDA's handling of the matter could undermine public trust in the vaccine system. All 12 former FDA commissioners published commentary criticizing internal moves they said threatened evidence‑based vaccine policy. A Republican senator also requested a full Senate briefing, warning that withholding data could increase confusion and fear among patients and parents.
Proposed Changes To Monitoring And Approval Standards
FDA officials briefed advisers that the agency is revising its vaccine safety‑monitoring framework and may change evidentiary standards for expanding vaccine indications to groups such as pregnant people and young children. Among the options discussed were wider surveillance definitions, different analytic methods, and a greater reliance on randomized controlled trials before expanding indications.
Officials also indicated renewed oversight of seasonal influenza vaccines, though public statements did not fully explain why concerns tied to Covid vaccine reports would prompt changes for flu vaccines, which follow distinct development and update processes.
Unanswered Questions And Potential Implications
Critics say the delay in publishing data raises questions about the basis for dramatic claims and about what new information triggered the renewed reviews. Experts emphasized that serious adverse events and deaths are routinely investigated, but noted it is unusual for senior officials to make specific public claims without releasing the underlying evidence or convening external scientific review.
Bottom line: The FDA has signaled changes to vaccine regulatory practices while investigators re‑examine reports of deaths following Covid vaccination. Until the agency publishes the data and methods underpinning the review, policymakers, clinicians and the public will likely press for transparent, verifiable evidence to support any policy shifts.
