FDA Blocks Publication of COVID-19 and Shingles Vaccine Studies
The FDA pulled back publication of several studies on COVID-19 and shingles vaccines. The blocked studies involved millions of patient records, and two COVID-19 papers were withdrawn in October 2025.
The Food and Drug Administration has pulled back the publication of several studies on the safety and efficacy of broadly used COVID-19 and shingles vaccines. The Department of Health and Human Services, which oversees the FDA, confirmed the decision and said the studies were blocked due to concerns about their conclusions.
The studies, which involved millions of patient records and taxpayer dollars, were conducted by FDA scientists and data contractors before they were blocked from publication. Two studies on COVID-19 vaccines that were accepted by medical journals were withdrawn in October 2025 before they were published. The FDA also failed to sign off on two safety studies on the shingles vaccine, Shingrix, which required the federal agency’s approval prior to their submission to a drug safety conference.
The COVID-19 safety studies reviewed side effects of these vaccines among millions of people with data collected by FDA scientists from Medicare and other insurance databases, and found the vaccine to be safe among those who are 65 and older and those between the ages of 6 and 64 years. A robust body of evidence supports the safety and effectiveness of both COVID-19 and shingles vaccines, which has experts concerned about the FDA’s decision to pull the recent studies.