U.S. Food and Drug Administration officials said COVID-19 vaccines killed at least 10 children, providing no evidence for the statement. Citing these deaths, the agency said it plans to make existing vaccine regulations more strict.

Vaccine experts said the memo was irresponsible and omits key details about how officials arrived at the conclusion.

Food and Drug Administration officials say they will ratchet up requirements for vaccine studies, citing concerns about COVID shots for kids. But public health experts question the agency's analysis.

The top vaccine chief at the Food and Drug Administration sent out a memo saying the FDA will seek a stricter review and approval protocol for vaccine trials.

FDA chief medical officer Vinay Prasad told reporters that the agency would be changing its vaccine approval process.

In a leaked memo sent to staff on Black Friday, November 28, the director of the Center for Biologics Evaluation and Research (CBER) – a branch of the Food and Drug Administration (FDA) – called for significant changes to vaccine policy on the basis that “at least 10 children” had allegedly been found to have died due to receiving a COVID-19

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal agencies have discussed openly since 2021.

Data in this new study shows that the 2024–2025 COVID-19 vaccines provide similar protection to the previous formulation. They were found to be most protective four weeks after vaccination, providing 44.7% effectiveness against infection, 45.1% ...

A leaked internal memo from Dr. Vinay Prasad, a senior FDA vaccine official, has set off a political firestorm after alleging that multiple child deaths occurred “after and because of” COVID vaccination.