The U.S. Food and Drug Administration (FDA) has announced it will release a report by the end of December detailing data on 10 alleged pediatric deaths linked to COVID-19 vaccines. This follows claims made in an internal memo by Vinay Prasad, director of the Center for Biologics Evaluation and Research (CBER), stating that “at least 10 children have died after and because of receiving COVID-19 vaccination.”
According to a spokesperson speaking with Endpoints News, the FDA is currently investigating additional adverse event cases and will not provide further details in the immediate future. The agency said it plans to make its findings public later this month.
BioSpace has contacted the FDA independently for confirmation regarding these developments.
Prasad’s memo, sent last week to FDA staff, cited an analysis conducted by newly appointed acting director of the Center for Drug Evaluation and Research (CDER), Tracy Beth Høeg, along with an internal CBER team. They reviewed 96 reported deaths from 2021 to 2024 and concluded that “no fewer than 10” were related to COVID-19 vaccinations. Prasad noted in his memo that this figure may be underestimated due to underreporting.
The claims have drawn criticism from several experts. Peter Lurie, a former associate commissioner at the FDA, told BioSpace: “After years of working at the FDA I’ve never seen a memo like that.” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, also commented: “When you make a sensational claim like that, a frightening claim like that, at the very least, you owe it to the public to provide the evidence.”
Prasad stated in his memo that these mortality signals were identified through reports submitted to VAERS—the Vaccine Adverse Event Reporting System—a platform open for submissions from healthcare professionals as well as members of the public. However, according to information published on its website, VAERS reports alone cannot determine whether a vaccine caused or contributed to an adverse event or illness.
Tracy Beth Høeg was named acting director at CDER shortly after news about Prasad’s memo became public. She replaces Richard Pazdur, who retired earlier this week after leading CDER for only several weeks but had been with the FDA since 1999.
