FDA expands probe into COVID-19 vaccine-linked deaths

The U.S. Food and Drug Administration (FDA) has expanded its investigation into reported COVID-19 vaccine-related deaths, widening the probe beyond children to include adults.

The development comes after federal officials previously confirmed that the agency was examining the deaths of 10 children who passed away after receiving COVID-19 vaccines.

A spokesperson for the U.S. Department of Health and Human Services (HHS) told The Defender that the “FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines,” but did not provide further details.

The expansion follows an “intense investigation” launched in September into the deaths of children, based on reports from the Vaccine Adverse Event Reporting System (VAERS) — a federal surveillance database jointly managed by the FDA and the U.S. Centers for Disease Control and Prevention (CDC).

As of press time, the FDA has not publicly explained why the inquiry has been broadened to include adults.

According to figures published by the OpenVAERS Project, VAERS had recorded 38,773 death reports across all age categories as of August 28.

Updated figures have not been released. Health analysts and critics have long argued that VAERS captures only a small fraction of actual adverse events, citing longstanding underreporting concerns.

The FDA’s expanded review comes roughly two weeks after an internal memo — reportedly leaked to the public — revealed that at least 10 children had died following COVID-19 vaccination.

The memo, attributed to Dr. Vinay Prasad, head of the FDA’s Center for Biologics Evaluation and Research, said an analysis of 96 reported deaths among children aged 7 to 16 found that “no fewer than 10” were linked to the vaccine. These cases were reported to VAERS between 2021 and 2024.

Prasad noted in the memo that the confirmed figure was “certainly an underestimate,” citing underreporting and challenges determining cause of death. He suggested that myocarditis — an inflammation of the heart muscle — appeared to be a significant factor in several cases.

“For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad wrote, calling the finding “a profound revelation” and indicating that the agency will revise its vaccine approval protocols.

An HHS spokesperson confirmed that the FDA has begun reviewing the petition and intends to formally respond. Under federal law, the FDA must issue a response within 180 days, although the timeline may be extended.

The petition asserts that the mRNA vaccines are “misbranded and adulterated,” and calls on FDA Commissioner Dr. Martin A. Makary to take regulatory action.

CHD is encouraging healthcare professionals, parents, service members, and the general public to submit comments and share their experiences.