FDA Blocks Publication of Vaccine Safety Studies. Why Experts Are Concerned

on PinterestThe FDA has blocked the publication of COVID-19 and shingles vaccine safety studies. What does this mean for public health?

on PinterestThe FDA has blocked the publication of COVID-19 and shingles vaccine safety studies. What does this mean for public health? Image credit: Gerardo Vieyra/NurPhoto via Getty Images

• The Food and Drug Administration (FDA) has blocked the publication of COVID-19 and shingles vaccine safety studies, citing concerns over their conclusions.
• Experts question the decision to withdraw the studies, since both vaccines have substantial evidence supporting their safety and effectiveness.
• Some experts say the decision may be influenced by HHS Health Secretary Robert F. Kennedy Jr.’s anti-vaccine agenda.

The Food and Drug Administration (FDA) 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 (HHS), which oversees the FDA, confirmed the decision, which was first reported by The New York Times.

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Two studies on COVID-19 vaccines that were accepted by medical journals were withdrawn in October 2025 before they were published.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, Shingrex, which required the federal agency’s approval prior to their submission to a drug safety conference.

The Department of Health and Human Services couldn’t be reached for comment, but an HHS spokesperson told The New York Times that the studies were blocked due to concerns about their conclusions.

“Scientists and physicians aren’t buying that explanation,” said Robert Glatter, MD, attending physician in the Department of Emergency Medicine at Lenox Hill Hospital in New York City, and assistant professor of Emergency Medicine at Zucker School of Medicine at Hofstra/ Northwell.

“The public health implications of blocking such studies are serious … secrecy can backfire. People who are already distrustful may see suppression where officials see caution,” Glatter told Healthline.

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.

Monica Gandhi, MD, MPH, a professor of medicine at the San Francisco, echoed Glatter’s remarks. “The COVID-19 vaccine safety studies had been peer reviewed and would have been extremely important to be published for reassurance of the public of the safety of these vaccines,” she said.

William Schaffner, MD, professor of preventive medicine and infectious diseases in the Department of Health Policy at Vanderbilt University Medical Center in Nashville, agreed.

“Both vaccines are in widespread use, not only here in the United States, but around the world. Having these data available so that professional people can look at them and make their own assessments when they see the data is very important.”

We spoke with infectious disease experts unaffiliated with the studies to find out why scientific research might be barred from publication, and why it’s potentially problematic to block it from public view.

These interviews have been lightly edited and condensed for clarity and length. The opinions expressed in this article do not necessarily reflect the views