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# FDA Blocks Publication of Vaccine Safety Studies
- URL: https://www.fdaweb.com/fda-blocks-publication-of-vaccine-safety-studies/
- Published: 2026-05-05T12:00:00.000Z
- Updated: 2026-09-14T13:38:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161093

FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles vaccines, according to a [report by CNBC](https://www.cnbc.com/2026/05/05/fda-studies-covid-shingles-vaccines-safe.html?ref=fdaweb.com), a move that is drawing scrutiny in light of the agency’s stated commitment to “radical transparency.” A spokesperson for the U.S. Department of Health and Human Services confirmed that the studies were halted in recent months, saying they were “withdrawn because the authors drew broad conclusions that were not supported by the underlying data.”

The decision affects research conducted by FDA scientists using large-scale patient datasets, which reportedly found that adverse events linked to the vaccines were rare. Two Covid-19 vaccine studies had already been accepted for publication before being pulled, while additional research on Shingrix was not cleared for presentation at a scientific meeting, the *New York Times* [first reported](https://www.nytimes.com/2026/05/05/us/politics/fda-covid-vaccine-studies.html?ref=fdaweb.com) on 5/5.

Federal officials defended the move as necessary to maintain scientific rigor. “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 HHS spokesperson said.

Still, the intervention is notable because it involves internal agency research rather than external submissions, raising questions about how scientific disagreements are resolved within the regulator.

The episode also appears to contrast with recent statements by FDA commissioner **Marty Makary**, who has emphasized a policy of increased openness around regulatory decision-making.

In recent public remarks, Makary said the agency is embracing “radical transparency,” including publishing complete response letters to provide greater visibility into how approval decisions are made and to counter what he described as “corporate spin.”

However, the decision to halt publication of studies — particularly those that had already cleared peer-review hurdles — may complicate that message. While FDA argues the withdrawals reflect appropriate scientific gatekeeping, critics could view the move as limiting public access to data that might inform debates over vaccine safety.

The actions come amid broader shifts in federal vaccine policy under HHS secretary **Robert F. Kennedy Jr.**, who has long expressed skepticism about vaccines. Recent changes have included narrowing recommendations for Covid-19 shots and revisiting aspects of the childhood immunization schedule. Against that backdrop, the suppression of studies suggesting favorable safety profiles could intensify concerns among public health experts about the direction of federal vaccine oversight.

At the center of the issue is a familiar regulatory tension: how to balance scientific caution with timely dissemination of data. FDA maintains that conclusions must be tightly aligned with evidence, particularly when drawn from observational datasets.

But the unusual step of blocking publication of its own scientists’ work — rather than revising or contextualizing findings —invite further scrutiny from researchers, clinicians, and policymakers.

As FDA continues to promote greater openness in its regulatory decisions, how it handles internal scientific disagreements could become an increasingly important test of that “radical transparency” pledge.