Agency Broadens Probe Initiated on Pediatric Cases, Citing Ongoing Data Analysis

December 10, 2025|Washington, D.C. - The U.S. Food and Drug Administration (FDA) announced Tuesday that it is extending its ongoing safety review of COVID-19 vaccines to include an examination of potential links between the shots and deaths among adults. This expansion builds on an earlier investigation focused on pediatric cases, where agency officials reported preliminary findings suggesting a connection in a small number of instances.

The review, which began in September, was initially prompted by internal analyses of reported adverse events. In a late November memo to staff, FDA's chief medical and scientific officer, Dr. Vinay Prasad, stated that an initial review of 96 deaths among children between 2021 and 2024 had identified at least 10 cases where the vaccines may have contributed, primarily due to heart inflammation. However, the agency has not yet publicly released supporting data or peer-reviewed evidence for these assertions.

"FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines," Andrew Nixon, a spokesperson for the Department of Health and Human Services (HHS), said in a statement. The probe now encompasses adults, though specific details on the scope, data sources, or timeline for findings were not provided.

This development comes amid broader changes to U.S. vaccine policy under Health Secretary Robert F. Kennedy Jr., who has advocated for stricter oversight of immunization programs. Kennedy has publicly questioned the safety profile of COVID-19 vaccines, despite extensive studies affirming their overall benefits in preventing severe illness and death from the virus. The FDA's review is part of a larger effort to revise approval standards, potentially requiring pharmaceutical manufacturers to conduct larger studies and demonstrate disease prevention beyond antibody production.

Vaccine manufacturers, including Pfizer and Moderna, have reiterated the established safety records of their products. In statements responding to the probe, both companies emphasized that no new safety concerns have emerged from post-market surveillance. Moderna noted that its Spikevax vaccine has undergone continuous monitoring, with rare serious side effects like myocarditis occurring predominantly in young males and resolving in most cases. Pfizer, in partnership with BioNTech, similarly affirmed the vaccine's efficacy and safety based on data from over 700 million doses administered in the U.S. since late 2020.

Public health experts have welcomed the commitment to rigorous monitoring but cautioned against drawing conclusions without comprehensive evidence. "Adverse event reporting systems like VAERS are essential for signal detection, but they do not establish causation on their own," said Dr. Michael Kinch, a drug development expert at Stony Brook University. Kinch added that the expansion could help address public concerns but might also fuel unnecessary doubt if not communicated transparently.

The FDA has encouraged healthcare providers to continue submitting reports of any adverse events following vaccination through the Vaccine Adverse Event Reporting System (VAERS). Officials stressed that the investigation remains part of standard post-approval surveillance and that COVID-19 vaccines continue to be recommended for high-risk groups, including adults over 65 and those with underlying conditions.

As the review progresses, the agency plans to release additional documents outlining its framework and any supporting data. No immediate changes to vaccine availability or recommendations have been announced.