FDA chief says Biden administration withheld data on heart risk from Covid vaccines

Myocarditis is a known — but small — side effect of the mRNA Covid vaccines from Pfizer and Moderna, information that federal ...
BioPharma Dive

12 former FDA chiefs blast Prasad’s move to toughen vaccine standards

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

Unpacking the FDA’s Black Friday Vaccine Memo

The head of the Food and Drug Administration's vaccine division claimed in a leaked email that “at least 10 children" died ...

F.D.A. Seeks More Oversight of Vaccine Trials and Approvals

The agency’s top vaccine regulator proposed broad changes, claiming that a new review linked 10 children’s deaths to the ...
Becker's Hospital Review

FDA floats changes to vaccine approval process: 5 notes

A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...
South Florida Reporter

FDA Announces Sweeping New Vaccine Approval Rules After Internal Review Flags Child Deaths

FDA demands larger trials, stricter safety proof before vaccines approved — citing internal link between COVID‑19 shots and ...