Startling omission of safety review: VRBPACnot informed that the US early vaccine safety warning system is effectively disabled because safety signals for all vaccines are masked by COVID-19 vaccine reports in VAERS: Urgent action required.
Abstract
Vaccines and Related Biological Products Advisory Committee, May 28, 2026 Docket No. FDA-2026-N-3962 Absent from the agenda of the May 28, 2026 VRBPAC meeting, is a review of COVID-19 vaccine safety. This absence is startling given the findings of a recent Majority interim report of the Permanent Subcommittee on Investigations of the US Senate Committee on Homeland Security and Governmental Affairs. This report revealed that FDA was aware that its primary vaccine safety early warning system was effectively disabled for COVID-19 vaccines because of a phenomenon called masking. The report documents FDA’s refusal to implement available solutions and its attempts to silence those raising concerns about masking. Hundreds of safety signals were lost, representing potential risk FDA was required to consider for an EUA, without proving causality. The suppression of this largely uninvestigated potential risk by masking, including the failure to inform VRBPAC which was being asked to make recommendations on the “totality of evidence,” is both a scientific and a regulatory failure. It impugns the reliability of decisions regarding authorization, approval, and vaccine injury compensation. So serious is the problem that the ability to detect VAERS safety signals for ALL OTHER vaccines is compromised because VAERS is inundated with COVID-19 vaccine reports across a wide variety of event types. These findings challenge the core tenets of public policy on COVID-19 vaccination, and as former FDA and CDC officials Marks and Jernigan noted: “failure to detect and communicate a serious health issue related to a vaccine could impact confidence not only in COVID-19 vaccines but in all vaccines.” I recommend that VRBPAC ask HHS Secretary to provide a corrective action plan within 30 days.
https://www.researchgate.net/publication/405413063_Startling_omission_of_safety_review_VRBPAC_not_informed_that_the_US_early_vaccine_safety_warning_system_is_effectively_disabled_because_safety_signals_for_all_vaccines_are_masked_by_COVID-19_vaccine_r