FDA Opens Investigation Into Reported Deaths Following COVID-19 Vaccination

FDA Investigation Into COVID-19 Vaccination

Internal Memorandum Sparks Tension

New Regulatory Measures Proposed

According to reporting by the EFE news agency, the FDA is investigating whether COVID-19 vaccines could be linked to reported deaths in adults, as part of a broader review conducted by U.S. health authorities.

Andrew Nixon, a spokesperson for the Department of Health and Human Services (HHS), stated that the agency is carrying out a thorough investigation that evaluates multiple age groups to determine potential links between deaths and vaccination.

Nixon explained that the FDA routinely reviews safety data and updates product labeling when research indicates that such action may be necessary.

His remarks contrast with internal statements from officials who have proposed new regulatory measures based on conclusions not supported by verifiable evidence, according to a recent report by The Washington Post.

Internal Proposals and Controversial Memorandum

The U.S. investigates whether the COVID-19 vaccine is related to patient deaths – https://t.co/vZgPmwgfe0

— LasNoticiasDominicanas (@LasNotiDom) December 10, 2025

An internal memorandum cited by The Washington Post indicated that Vinay Prasad linked—without detailing evidence—at least ten child deaths occurring between 2021 and 2024 to vaccination.

The document did not provide information on age, preexisting health conditions, or other factors that may have influenced the deaths of the minors mentioned.

It also failed to explain how the alleged connection between the vaccine and the deaths was established or clarify which manufacturers may have been involved in the internally reported cases.

In the memorandum, Prasad stated that he would propose new vaccine oversight and review measures, asserting that the number of deaths could be higher than initially reported.

FDA COVID Vaccine Investigation and Regulatory Tensions

FDA Investigation Into COVID-19 Vaccination PHOTO: Shutterstock

Prasad currently leads the FDA’s Center for Biologics Evaluation and Research, the division responsible for regulating vaccines and biological products widely used in the United States.

The official, a specialist in hematology and oncology, has been critical of the government’s response during the pandemic, questioning policies previously adopted by federal health authorities.

His stance aligns with that of Health Secretary Robert F. Kennedy Jr., who recently instructed the CDC to modify information to link vaccination and autism.

This ideological alignment has generated tensions within the agency, as some officials argue that the conclusions presented lack verifiable foundations within the appropriate regulatory process—an issue central to the FDA investigation into COVID-19 vaccine deaths.

Diverging Positions and Impact on Health Policy

Vaccines Under Review: FDA Analyzes Reported Deaths in the U.S. PHOTO: Shutterstock

The internal debate highlights the importance of determining whether reported deaths justify regulatory changes or are attributable to independent factors not directly related to vaccination.

Health authorities emphasize that safety reviews are ongoing and that decisions regarding labeling and warnings depend strictly on verified evidence gathered through formal procedures.

The discussion also affects public perception, as any regulatory review may influence public confidence in the safety of widely used vaccines.

The final results of the FDA investigation into COVID-19 vaccine deaths will be decisive in shaping future national health policy steps and public communication regarding vaccine safety in the United States.