FDA Blocks Publication of COVID-19 Vaccine Studies

The studies had been accepted by journals for publication.

Published: 5/5/2026, 11:19:06 PM EDT

FDA Blocks Publication of COVID-19 Vaccine Studies — The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. (Madalina Vasiliu/The Epoch Times)

The Food and Drug Administration forced the withdrawal of several studies on COVID-19 vaccination, the Department of Health and Human Services (HHS) told The Epoch Times on May 6.

“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” a spokesperson for HHS, the FDA’s parent agency, said in an email.

“The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards,” the spokesperson said.

The studies had been accepted for publication by journals before the FDA’s actions.

Both papers were authored by FDA officials and researchers with Acumen, LLC, a consulting firm based in California.

One of the papers was released as a preprint in January. The authors said that COVID-19 vaccines “are well-established as safe,” but that they wanted to carry out fresh surveillance of updated formulations to make sure they are also safe.

The researchers estimated adverse events among Medicare beneficiaries aged 65 years and older following immunization with the COVID-19 vaccine versions available in late 2023 and early 2024. The study’s method, known as a self-controlled case series, compared the outcomes among people within days or weeks of vaccination to outcomes among the same people for a period of time after those days or weeks came to an end. In other words, the same people served as the study population and the controls.

The researchers said they only identified one worrying sign: an elevated rate of severe allergic shock following Pfizer-BioNTech COVID-19 vaccination.

“Our study contributes to growing evidence on the safety of COVID-19 vaccines,” they wrote. “FDA continues to believe that the benefits of COVID-19 vaccination outweigh the risks.”

The FDA in 2025 approved new versions of COVID-19 vaccines, but only for certain populations. Officials said at the time that there was not evidence the vaccines were safe and effective for healthy, younger people.

An abstract of the other paper was released in the fall of 2025. Researchers with the FDA, Acumen, CVS Health, Carelon Research, and Optum drew data from health databases and used the same self-controlled case series method to try to figure out whether the vaccines caused problems. They found signs of febrile seizure among young children who received Moderna’s shot, which has previously been pegged as a potential side effect of that vaccine.

“No new safety concerns were found following 2023–2024 COVID-19 vaccination among U.S. health plan enrollees aged 6 months–64 years,” the researchers said.

Researchers who authored the papers either did not respond to requests for comment by time of publication, or could not be reached.

The decision to withdraw the papers came several weeks after the Centers for Disease Control and Prevention declined to publish a paper on COVID-19 vaccine effectiveness in its quasi-journal. Dr. Jay Bhattacharya, the CDC’s acting director, said that the paper used a faulty method called test negative design that has impossible-to-correct bias.

From The Epoch Times