Overview
- HHS, which confirmed Tuesday that FDA leaders halted several vaccine studies, said the papers drew broad conclusions not supported by the data.
- FDA scientists were told in October to withdraw two Covid vaccine safety papers that had been accepted by journals, and in February officials declined to sign off on Shingrix study abstracts for a drug safety conference.
- The analyses drew on millions of records and reported only rare risks, including an estimated 1-in-1,000,000 rate of anaphylaxis in a Medicare study of 7.5 million recipients and isolated cases of myocarditis and fever seizures in a separate cohort of 4.2 million people.
- Outside experts, including Harvard’s Aaron Kesselheim and IDSA’s Jeanne Marrazzo, criticized the pullbacks as opaque and unnecessary, with some calling the moves censorship and urging greater transparency and possible oversight.
- The decisions track broader HHS shifts under Secretary Robert F. Kennedy Jr., including a CDC halt of a vaccine-effectiveness report in April and cuts to vaccine research, which critics say could slow clinical guidance and erode public trust.