The U.S. Food and Drug Administration (FDA) Commissioner Marty Makary revealed on Saturday that data indicate 10 children likely died as a result of COVID-19 vaccinations. Speaking in an interview with Fox News, Makary said the data were accumulated during the Biden administration and that the cases had been reviewed internally.
“There were, it appears, 10 deaths of children from the COVID shots,” Makary told Fox & Friends, citing internal FDA findings. The New York Times reported that an FDA memo concluded that myocarditis, or heart inflammation, may have been a contributing factor in these deaths.
The memo was prepared by the FDA’s chief medical and scientific officer, Vinay Prasad, who described the findings as a “profound revelation” and announced plans to tighten vaccine oversight, including requiring randomized studies for all subgroups.
The memo did not disclose the ages, underlying health conditions of the children, or the manufacturers of the vaccines involved. The findings have not yet been published in a peer-reviewed medical journal.
Following the revelation, Health Secretary Robert F. Kennedy Jr. has revised U.S. COVID vaccine policy, limiting access to those 65 and older or with underlying health conditions. Kennedy, who previously voiced strong anti-vaccine views, has linked vaccines to autism and has sought to overhaul national immunization policies.
Makary stressed that while the COVID vaccines were “amazing for people at risk and for older people” during the pandemic, administering certain COVID shots annually to children is “not based on science.” He emphasized that the vaccines were originally promoted as lifesaving under both the Trump and Biden administrations.
The Centers for Disease Control and Prevention (CDC) vaccine advisory committee is expected to meet next week to review these findings, as officials continue to assess vaccine safety and recommendations for younger populations.
This new internal review underscores ongoing scrutiny of COVID-19 vaccines and the importance of transparent reporting and oversight for all age groups.

