Blumenthal Calls Out Trump's FDA for Pattern of Political Interference in Lifesaving Scientific Research

[WASHINGTON, DC] - U.S. Senator Richard Blumenthal (D-CT), Ranking Member of the Senate Permanent Subcommittee on Investigations (PSI), today wrote to Food and Drug Administration (FDA) Commissioner Dr. Martin Makary, raising concerns about the Trump Administration's disturbing pattern of political interference in the publication of scientific research about vaccines. Blumenthal's letter comes after scientists at the FDA reportedly were ordered to withdraw from publication or refrain from submitting studies regarding the safety of vaccines against COVID-19 and shingles.

"Recent reporting indicates that, beginning last October, FDA officials ordered scientists to withdraw two studies about the benefits of COVID-19 vaccines that had already been accepted by prestigious medical journals. One of these, which had been accepted by the journal Drug Safety, looked at health outcomes for Medicare beneficiaries receiving COVID-19 vaccines in 2023 and 2024, and found that for people 65 and older there were 'no new safety signals,'" Blumenthal wrote.

Blumenthal continued, "The other COVID-19 vaccine study, which had been accepted by the journal Vaccine, examined people with private insurance between the ages of six months and 64 years of age who received COVID-19 vaccines during the same time period, found no safety concerns that had not already been acknowledged by health officials, and concluded that for people in this age group 'the benefits of vaccination outweigh the risks.'"

Blumenthal pointed to the Trump Administration's broader pattern of political interference at the FDA, "I am deeply concerned that under the Trump Administration the FDA is no longer concerned with ensuring that vaccines are safe and effective and is instead focused on presenting a distorted vision of vaccine science to the public. Just weeks into his tenure, HHS Secretary Robert F. Kennedy, Jr. cancelled the public meeting of the FDA advisory body responsible for selecting the strain for the flu vaccine."

Blumenthal continued, "This manipulation of science has only been possible because you and top political appointees have consolidated control while marginalizing FDA staff. Reports indicate that at least seven senior leaders in the agency's vaccine center were forced out of their positions, and that conditions became so dire, many people sought to leave for other parts of the agency."

"Anti-vaccine activists, including the current HHS Secretary, stake their authority on claims that the country's scientific agencies are hopelessly corrupt. But the current Trump Administration has overseen an unprecedented campaign of suppression and censorship of vaccine science, and wasted tens of millions of taxpayer dollars in the process by hiding the results of studies that had already been paid for," Blumenthal concluded.

In April, Blumenthal pressed Acting Centers for Disease Control & Prevention (CDC) Director Dr. Jay Bhattacharya about his reported interference in the publication of a study demonstrating that COVID-19 vaccination significantly reduced the likelihood of hospitalization and emergency room visits during the most recent respiratory virus season.

The full text of today's letter to Commissioner Makary is available here and below.

Dear Commissioner Makary:

I write regarding the latest incident in a disturbing pattern for Trump Administration health agencies: political interference in the publication of scientific research about vaccines. Over the last several months, scientists at the Food and Drug Administration (FDA) have reportedly been ordered to withdraw from publication or refrain from submitting studies regarding the safety of vaccines against COVID-19 and shingles ("the studies"). The studies, which apparently bolstered widely accepted scientific conclusions about the safety of approved vaccines, should be read and assessed by the research community, and the censorship that has blocked them from broader access should trouble anyone concerned about the fate of American science. Accordingly, I write to request that you immediately allow the FDA-employee authors to resubmit the studies and desist from further censorship of agency scientists.

Recent reporting indicates that, beginning last October, FDA officials ordered scientists to withdraw two studies about the benefits of COVID-19 vaccines that had already been accepted by prestigious medical journals. One of these, which had been accepted by the journal Drug Safety, looked at health outcomes for Medicare beneficiaries receiving COVID-19 vaccines in 2023 and 2024, and found that for people 65 and older there were "no new safety signals."^[1] The other COVID-19 vaccine study, which had been accepted by the journal Vaccine, examined people with private insurance between the ages of six months and 64 years of age who received COVID-19 vaccines during the same time period, found no safety concerns that had not already been acknowledged by health officials, and concluded that for people in this age group "the benefits of vaccination outweigh the risks."^[2] Then, in February, FDA officials declined to sign off on the submission of abstracts of two studies about a shingles vaccine for a scientific conference, one describing the safety of the shingles and the other its efficacy; the agency is apparently not permitting the studies to go forward.^[3]

Confronted with these blatant acts of meddling in scientific research, the Department of Health and Human Services (HHS) has said the COVID-19 studies' "broad conclusions" were not supported by the gathered data.^[4] This vague critique is strikingly similar to the concerns about "appropriate methodology" invoked when Dr. Jay Bhattacharya, acting director of the Centers for Disease Control & Prevention, recently blocked from publication in the CDC's in-house journal a study demonstrating significant protection against hospitalization that COVID-19 vaccines provided last winter.^[5] Former FDA officials have reacted to this latest example of politicization at HHS by noting "a pattern here for not letting information out that might support the general safety of vaccines, with methodological rationales given by non-scientist spokespersons."^[6]

I am deeply concerned that under the Trump Administration the FDA is no longer concerned with ensuring that vaccines are safe and effective and is instead focused on presenting a distorted vision of vaccine science to the public. Just weeks into his tenure, HHS Secretary Robert F. Kennedy, Jr. cancelled the public meeting of the FDA advisory body responsible for selecting the strain for flu the vaccine.^[7] Kennedy subsequently fired Dr. Peter Marks, the head of the FDA division responsible for regulating vaccines, because Marks refused to allow Kennedy to "edit" entries in a database for reporting vaccine side effects.^[8] Several months later, you and Dr. Vinay Prasad, who at the time was FDA's top vaccine official, announced a new "approach" to evaluating COVID-19 vaccines but, as a former FDA advisory committee member pointed out, you failed to follow agency practice for such a change, and gave the scientific community no opportunity for public comment before announcing it.^[9]

In perhaps the most overt example of politicization at FDA, late last year Dr. Prasad issued a memo to agency staff-which was quickly leaked and widely reported on-calling for an overhaul of regulatory requirements for approval of vaccines based on an agency finding that at least 10 children had died "because of" COVID-19 vaccines, a finding scientists received with skepticism because it was accompanied by no supporting data.^[10] In that memo Prasad wrote, of you, "There is no doubt that without this FDA commissioner, we would not have performed this investigation and identified this safety concern."^[11] But despite the significant public attention it generated, to date you have provided no data to substantiate the claim of child deaths.

This manipulation of science has only been possible because you and top political appointees have consolidated control while marginalizing FDA staff. Reports indicate that at least seven senior leaders in the agency's vaccine center were forced out of their positions, and that conditions became so dire many people sought to leave for other parts of the agency.^[12] Among those demoted was Dr. Richard Forshee, a former top vaccine safety official who is also a listed author for both of the suppressed COVID-19 studies.^[13] Earlier this year, after he resigned as FDA's top drug regulator, Dr. Richard Pazdur described a climate of fear and politicized retribution under your leadership, and said that key decisions about approval of pharmaceuticals were being made "in a conference room that is adjacent to the Commissioner's personal office; there's not even enough room in that office for the entire review staff that has worked on the application to attend this meeting."^[14]

Anti-vaccine activists, including the current HHS Secretary, stake their authority on claims that the country's scientific agencies are hopelessly corrupt.^[15] But the current Trump Administration has overseen an unprecedented campaign of suppression and censorship of vaccine science, and wasted tens of millions of taxpayer dollars in the process by hiding the results of studies that had already been paid for. In order for the Permanent Subcommittee on Investigations to understand the Trump Administration's efforts to interfere in the publication of scientific reports, please provide the following information and records by May 26, 2026:^[16]

1. All communications between your office and the FDA staff listed as authors of the studies between September 2025 and the present;
2. All projections, budgets, or other documents related to money the agency had already expended on the studies at the time they were pulled from publication or submission;
3. All records reflecting policies currently in force related to publication in medical journals by agency staff, including requirements for review or clearance of studies by political appointees;
4. All records reflecting policies currently in force related to communication of scientific findings with the public, including the authority of political appointees to edit or modify work product of agency scientists;
5. A list of all studies or abstracts since January 20, 2025, on which agency employees are included as co-authors that, have been accepted for publication by a scientific journal or presentation at a scientific conference but have been otherwise blocked from public view, including:
6. 1. The names of the study's authors;
7. 1. A description of the study's subject matter;
8. 1. The names of the official or officials who ordered the study held back;
9. 1. A detailed description of the reason the study was held back from publication or submission.

Please contact the Subcommittee if you have questions about the procedures for transmitting documents. Thank you for your attention to this request.

Sincerely,

-30-

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