FDA Blocks Publication of COVID-19, Shingles Vaccine Studies

Food and Drug Administration officials have blocked the publication of several studies on the safety of COVID-19 and shingles vaccines conducted by agency scientists in recent months, according to a Department of Health and Human Services spokesperson.

The studies, which analyzed millions of patient records through contracts with data firms costing millions of public dollars, found serious side effects from the vaccines to be rare. Two COVID-19 vaccine safety studies were withdrawn in October after acceptance for publication in medical journals. One examined records of about 7.5 million Medicare beneficiaries over age 65, comparing health outcomes in the 21 days after vaccination to the following 20 days. It identified a potential increased risk of anaphylaxis, a severe allergic reaction, at about one in a million doses from the Pfizer vaccine, but no other statistically significant risks for conditions such as heart attacks, strokes or Guillain-Barré syndrome. The other study reviewed 4.2 million recipients aged 6 months to 64 years for 17 conditions, including myocarditis and fever-related seizures, both known rare associations with COVID-19 vaccines. It concluded that the...