FDA blocked publication of research finding COVID and shingles vaccines were safe

WASHINGTON – Officials at the Food and Drug Administration have blocked publication of several studies supporting the safety of widely used vaccines against COVID-19 and shingles in recent months, a spokesperson for the Department of Health and Human Services confirmed.

The studies, which cost millions of dollars in public funds, were conducted by scientists at the agency, who worked with data firms to analyze millions of patient records. They found serious side effects to be very rare.

In October, the scientists were directed to withdraw two COVID-19 vaccine studies that had been accepted for publication in medical journals. In February, top FDA officials did not sign off on submitting abstracts about studies of Shingrix, a shingles vaccine, to a major drug safety conference.

The withdrawal of the studies is the latest step by the administration to try to limit access to vaccines. It has sharply cut research funding for vaccine development, released unvetted information casting doubt on vaccines, and blocked other information supporting their safety.

Asked about the withdrawal of the COVID vaccine safety studies, Andrew Nixon, a spokesperson for the Department of Health and Human Services, said in an email, “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data. The FDA acted to protect the integrity of its scientific process and ensure that any work associated with the agency meets its high standards.”

Of the shingles study that found the vaccine to be effective, he said, “The design of that study fell outside the agency’s purview.” He did not address a question about the Shingrix safety study, which found the vaccine to be safe.

A senior administration official said the decisions about the research had not reached Dr. Marty Makary, the FDA commissioner, or Health Secretary Robert F. Kennedy Jr. Dr. Vinay Prasad was the head of the FDA vaccine office at the time. Prasad, who recently left the agency, did not respond to a request for comment.

Dr. Aaron S. Kesselheim, a Harvard University medical professor who studies FDA regulation, said the request to pull the papers was an act of “censorship.” He added, “At any other time in history, this would be a major scandal that would lead to congressional hearings and resignations of leadership, and I hope that’s what happens next.”

This article originally appeared in The New York Times.