The agency’s scientists and data contractors reviewed millions of patient records for studies that were pulled back before release.
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 spokesman 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 F.D.A. 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, most recently a paper on Covid vaccine effectiveness by career scientists from the Centers for Disease Control and Prevention.
Asked about the withdrawal of the Covid vaccine safety studies, Andrew Nixon, a spokesman for the Department of Health and Human Services, said in an email: “The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data.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 F.D.A. 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.
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The withdrawn F.D.A. studies examined the safety of the Covid vaccines used in 2023 and 2024. The agency’s scientists worked with outside data firms that compile and analyze massive data sets under contracts that cost taxpayers millions of dollars each year.
Both studies saw some light of day before they were pulled from publication. One, which examined the Covid vaccine in people older than 65, was posted on a preprint server, which is a repository for studies that have not yet undergone peer review. The study reviewed the records of about 7.5 million Medicare beneficiaries who got the vaccine. The researchers focused on the period of about 21 days after they got the vaccine and compared it to the next 20 days. They were looking to see if there were more health problems in the period right after vaccination.
The study looked at 14 health outcomes potentially caused by the vaccine, including heart attacks, strokes and Guillain-Barré syndrome, an autoimmune condition sometimes associated with vaccines.
They only found a concern with one outcome, anaphylaxis, a severe allergic reaction affecting about 1 in a million people, from the Pfizer vaccine. “No other statistically significant elevations in risk were observed,” the study said.
The study was withdrawn after it had been accepted by the peer reviewed journal Drug Safety, according to people familiar with the work. Michael Stacey, a spokesman for the journal, said it deems submissions to be confidential and would not comment on them.
The Times obtained a copy of the Covid vaccine safety study of people who were 6 months to 64 years old. An abstract of the study appeared at one conference and remains online. Its withdrawal was first reported by STAT News.
That study examined the records of 4.2 million Covid vaccine recipients and examined their later experience with 17 conditions, including swelling of the brain, major blood clots, stroke and heart attacks. The study found rare cases of fever-related seizures and myocarditis, or inflammation of the heart muscle, known to be associated with Covid vaccines.
“Given the available evidence, F.D.A. continues to conclude the benefits of vaccination outweigh the risks,” the study said.
Angela Rasmussen, an editor in chief of the journal Vaccine, said the paper had been withdrawn by the authors.
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Dr. Jeanne Marrazzo, a former high-ranking National Institutes of Health official and chief executive of the Infectious Diseases Society of America, said that F.D.A. leaders withdrawing papers from publication is a “pretty active act of sabotage.”
“This black box of decision making around data suppression should be having people very alarmed and very worried,” said Dr. Marrazzo. She filed a whistle-blower complaint against the N.I.H., was fired by Mr. Kennedy and has since sued the agency, claiming that she was ousted for objecting to its policies.
By contrast, Mr. Kennedy’s team has had lower standards for releasing information critical of vaccines. A memo by Dr. Prasad, the former head of the F.D.A.’s vaccine division, drew widespread news coverage by claiming that the Covid vaccine had been linked to the deaths of 10 children, a conclusion the agency has not backed up or explained.
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