Overview
- HHS, which confirmed Tuesday that FDA halted several vaccine safety studies, said the authors overstated what the data showed.
- The unpublished analyses drew on records for about 7.5 million Medicare patients and 4.2 million other recipients and found serious side effects were rare.
- One COVID study flagged anaphylaxis at roughly 1 in 1 million Pfizer doses and reported no other statistically significant risks across 14 outcomes.
- After two COVID papers were withdrawn from journals in October, FDA leaders in February declined to let staff submit Shingrix safety abstracts to a drug safety meeting.
- Outside researchers labeled the decisions censorship and warned that the opaque process erodes trust, while a senior official said the calls did not reach FDA chief Marty Makary or HHS Secretary Robert F. Kennedy Jr.