The U.S. Food and Drug Administration (FDA) announced on December 9, 2025, that it is expanding its ongoing safety review of COVID-19 vaccines to explicitly investigate potential links between the shots and deaths in adults, in addition to the pediatric cases it has already been examining.
This development has sparked significant debate, with supporters viewing it as a necessary reckoning on vaccine safety and critics labeling it as politically motivated doubt-mongering that could undermine public health efforts.
The probe originated from an internal FDA memo leaked in late November 2025, where Dr. Vinay Prasad, the agency’s top vaccine regulator, claimed a review of 96 reported child deaths post-vaccination had identified at least 10 as “likely, probable, or possible” vaccine-related, primarily due to myocarditis (heart inflammation).
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These findings were not peer-reviewed or publicly detailed at the time, prompting calls for transparency from experts. On December 9, HHS spokesperson Andrew Nixon confirmed the investigation now covers “multiple age groups,” including adults, with a focus on deaths “potentially related to coronavirus vaccines.”
The FDA is coordinating across divisions to analyze data from systems like VAERS (Vaccine Adverse Event Reporting System), which has logged over 19,000 U.S. death reports post-vaccination since 2020—though VAERS reports are unverified and do not prove causation.
The review aligns with shifts under Health Secretary Robert F. Kennedy Jr., a longtime vaccine skeptic who has limited COVID-19 vaccine recommendations to those over 65 or with underlying conditions. FDA Commissioner Marty Makary has echoed concerns, stating the agency will release supporting data later in December 2025.
This comes amid broader FDA proposals to tighten vaccine approval processes, potentially requiring larger trials and delaying new shots. The 10 child deaths were attributed to myocarditis, a known rare side effect of mRNA vaccines, occurring at rates of about 27 cases per million doses in young males.
Autopsy-confirmed cases from 2021-2022 (e.g., two adolescents) have been published, but experts note these are exceedingly rare and often involve confounding factors like pre-existing conditions. No specific adult death counts have been released yet, but the probe draws on VAERS data showing temporal associations.
Broader studies, including post-mortem analyses of 325 cases, suggest a “high likelihood” of vaccine links in some multi-organ failures, though causation remains debated. Over 450 peer-reviewed studies have flagged potential harms like immune dysregulation, spike protein persistence up to 3+ years, and increased cancer risks.
However, global surveillance (e.g., CDC data from 2021-2025) found no excess cardiac deaths or transplants in myocarditis cases post-vaccination. Probe uncovers “cover-ups” from prior administrations; vaccines risky for low-risk groups; calls for market suspension or black-box warnings.
If links are confirmed, it could lead to revised guidelines, lawsuits, or halted boosters—exacerbating hesitancy already at 23% adult uptake for 2024-2025 season. Conversely, unsubstantiated claims risk more COVID deaths from unvaccinated individuals.
FDA promises data release soon; parallel reviews of RSV vaccines for infants are underway. Independent experts urge peer-reviewed publication before policy changes.
This investigation reflects deeper tensions in U.S. vaccine policy under the current administration, but the scientific consensus—bolstered by billions of global doses—still holds that COVID-19 vaccines saved far more lives than they harmed.