U.S. Food and Drug Administration Commissioner Marty Makary said on Saturday that federal data indicates 10 children may have died due to COVID-19 vaccination, confirming that the cases were being reviewed.
“There were, it appears, 10 deaths of children from the COVID shots… this was data accumulated during the Biden administration,” Makary told Fox News, adding that the agency would release the information once the reviews were complete.
An earlier New York Times report revealed that an internal FDA memo had reached a similar conclusion — that at least 10 child fatalities were likely linked to COVID vaccines, with myocarditis (heart inflammation) identified as a possible cause.
Policy Shift Under Health Secretary Robert F. Kennedy Jr.
The disclosures come as Health Secretary Robert F. Kennedy Jr. implements sweeping changes to U.S. vaccination policy. Access to COVID vaccines has now been restricted to:
- Individuals 65 and older
- People with underlying medical conditions
Kennedy, a longtime critic of vaccines before joining the Trump administration, has also questioned links between vaccines and autism and has moved to overhaul national immunization strategies.
FDA Pushes for Greater Oversight
Makary noted that while the 2020 vaccines were “amazing for people at risk and for older people,” continuing to vaccinate children annually “is not based on science.”
The internal memo, authored by FDA chief medical and scientific officer Vinay Prasad, did not disclose the children’s ages, health backgrounds, or which vaccines were involved. Prasad reportedly called the findings “a profound revelation” and announced plans to tighten oversight, including requiring randomized trials for all demographic groups.
The findings have not yet undergone peer review, and the CDC’s vaccine advisory committee is scheduled to discuss the issue next week.
