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.

Officials at the U.S. Food and Drug Administration reported that at least 10 children died after receiving the COVID-19 vaccine, according to an internal memo circulated last week. "These deaths are related to vaccination (likely/probable/possible attribution made by staff),

A study by Epi-Phare published on Thursday addresses misinformation surrounding vaccines that have been widely distributed around the world to combat the pandemic.

FDA commissioners lambasted the CBER head’s plans to use a probe into COVID vaccine safety to upend longstanding regulatory protocols.

In a French cohort, the incidence of all-cause mortality among those who received a first dose of an mRNA COVID vaccine was 0.4% after a median follow-up of 45 months, compared with 0.6% of those who were unvaccinated.

A dozen former leaders of the U.S. Food and Drug Administration (FDA) slammed the Trump administration Wednesday over its changes to vaccine policy, calling the moves a threat to public safety.

The FDA has named Tracy Beth Høeg, M.D., Ph.D., as acting director of its Center for Drug Evaluation and Research, continuing the rapid ascent of a physician who rose to prominence during the pandemic.

The agency’s top vaccine regulator proposed broad changes, claiming that a new review linked 10 children’s deaths to the Covid vaccine. But public health experts questioned the findings, wanting to examine the data.