The FDA reviewed 96 reports of child deaths following COVID-19 vaccination and found no cases that were “certain” to be linked to the vaccines, according to a Dec. 5, 2025, memorandum made public this month.
The reports were submitted to HHS’ Vaccine Adverse Event Reporting System and reviewed through Aug. 14, 2025. FDA classified five deaths as “possible” and two as “probably” linked to vaccination, though it said those classifications did not establish causation and alternative explanations could not be ruled out.
The analysis surfaced in a May 11 letter from Sen. Ron Johnson, R-Wis., chairman of the Senate Permanent Subcommittee on Investigations, to HHS Secretary Robert Kennedy Jr. Mr. Johnson has requested additional records tied to COVID-19 vaccine safety oversight and pediatric death reports.
The findings contrast with statements from former FDA vaccine chief Vinay Prasad, MD, who wrote in a November 2025 memo that “at least 10 children have died after and because of receiving COVID-19 vaccination.” The agency subsequently expanded the review to include adults.
Most of the reviewed cases involved myocarditis, according to the report. The FDA had previously instructed Pfizer and Moderna to update COVID-19 vaccine labels regarding myocarditis risk in June 2025, reflecting new incidence data from the 2023-2024 vaccine formulations and results from a cardiac MRI study of individuals who developed myocarditis following vaccination.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
