In the latest update to COVID and vaccine-related discourse bubbling up at the FDA, agency officials have recently blocked the publication of several safety studies conducted on COVID and shingles vaccines, The New York Times reported Tuesday.
The studies saw FDA scientists work with data firms to go over millions of patient records, which found serious side effects of the vaccines to be “very rare,” according to the NYT.
The debacle goes back to October, when the researchers were made to withdraw two COVID vaccine studies that had already been accepted for publication in medical journals.
Then in February, FDA officials didn’t sign off on submitting abstracts of studies on GSK’s shingles vaccine Shingrix at a “major drug safety conference,” according to the report.
“The studies were withdrawn because the authors drew broad conclusions that were not supported by the underlying data,” Department of Health and Human Services (HHS) deputy assistant secretary for media relations, Andrew Nixon, told Fierce Pharma in an emailed statement. “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The withdrawn studies specifically went over COVID vaccines uses in 2023 and 2024. One such study was weighing their safety in older adults and evaluated 14 health outcomes that could be linked to immunization. It only found one concern, of anaphylaxis, a severe allergic reaction, with Pfizer’s Comirnaty, according to the NYT. Other than that, there were “no other statistically significant elevations in risk,” the researchers found.
The other COVID vaccine study still has an abstract available online and weighed safety risks after vaccination in individuals between 6 months and 64 years old. Although it found some rare cases of fever-related seizures and myocarditis, the study ultimately confirmed that the FDA “continues to conclude the benefits of vaccination outweigh the risks,” according to the NYT.
Meanwhile, the design of the Shringrix study, which reportedly found the vaccine to be effective, “fell outside the agency’s purview,” Nixon told the NYT.
The news comes after reports emerged in April that acting Centers for Disease Control and Prevention (CDC) head Jay Bhattacharya, M.D., Ph.D., blocked the publication of a COVID vaccine study that found the vaccines effective in reducing hospitalizations from the CDC’s Morbidity and Mortality Weekly Report. To this news, Bhattacharya asserts that he raised “specific concerns” about the methodology used in the study, he wrote in an op-ed published by the Washington Post.
“Scientific disagreement is not interference. When methodological limitations could meaningfully affect findings—especially on an issue as consequential as vaccine effectiveness—it is not only appropriate but necessary to pause, question and scrutinize,” Bhattacharya wrote. “It falls squarely within the CDC director’s responsibilities to ensure that CDC publications adhere to the highest scientific standards.”
HHS' vaccine safety focus
The Robert F. Kennedy Jr.-led HHS has been busy questioning and rewriting established vaccine policy since his appointment last year.
Notably, Kennedy last summer, purged the CDC’s panel of vaccine experts, replacing all sitting members of the Advisory Committee on Immunization Practices (ACIP) with his own picks under the reasoning of “prioritizing the restoration of public trust above any specific pro- or anti-vaccine agenda.” Since then, the new ACIP panelists, many of whom have a history of spouting vaccine skepticism, have voted against long-held universal vaccine guidance in favor of an “individual-based decision making” framework.
The ACIP’s new charter confirms that the panel is specifically targeting vaccine safety, stating that it looks to identify “gaps in vaccine safety research, including adverse effects following vaccination.” The panel, however, has recently been put on ice after a federal judge found that some HHS vaccine actions may not have followed proper protocol, such as the CDC’s abrupt removal of several vaccines from the childhood immunization schedule. The court also flagged issues with some recent appointments to the committee, granting a stay on the appointments that effectively prevents the panel from meeting.
As far as COVID vaccines specifically, former ACIP member Robert Malone, M.D., in January mentioned taking the mRNA COVID vaccines “off the market,” telling Make America Healthy Again (MAHA) Action to “stay tuned.” Malone stepped down from the panel in March, telling Roll Call he was “done with the CDC and ACIP” due to HHS spokesperson Nixon “trashing me in the press.”
At the end of last year, former director of the Center for Biologics Evaluation and Research (CBER) Vinay Prasad, M.D., voiced a similar COVID stance, telling CBER staffers in an internal memo that the agency “will acknowledge that COVID-19 vaccines have killed American children.”
When approving updated seasonal mRNA COVID shots from Pfizer and Moderna last summer, the FDA opted to restrict their usage in individuals younger than 65 to those with an underlying condition, as opposed to a previous broad endorsement. Prasad and FDA Commissioner Marty Makary, M.D., previously outlined the agency’s plans to take a stricter approach to COVID vaccine approvals with a policy that “balances the need for evidence,” the health officials wrote.
Prasad has left the agency at the end of April.