In the latest update on the coronavirus and vaccine-related debate heating up at the FDA, FDA officials recently blocked publication of several safety studies conducted on coronavirus and shingles vaccines, The New York Times reported Tuesday.
The study, in which FDA scientists worked with data companies to examine millions of patient records, found that serious side effects of the vaccine were “extremely rare,” according to the NYT.
The debacle dates back to October, when researchers were forced to withdraw two coronavirus vaccine studies that had already been accepted for publication in medical journals.
Then in February, FDA officials said they did not agree to submit a summary of research on GSK’s shingles vaccine Shingrix to a “major drug safety meeting.”
“The study was retracted because the authors drew broad conclusions that were not supported by the underlying data,” Andrew Nixon, assistant secretary for media relations at the Department of Health and Human Services (HHS), told Fierce Pharma in an emailed statement. “FDA acted to protect the integrity of the scientific process and ensure that all FDA-related work meets high standards.”
The retracted studies specifically looked at the use of coronavirus vaccines in 2023 and 2024. One such study weighed the safety of vaccines in older adults and evaluated 14 health outcomes potentially associated with vaccination. According to the NYT, Pfizer’s panel found only one concern about anaphylaxis, a severe allergic reaction. Other than that, there were “no other statistically significant increases in risk,” the researchers found.
Another coronavirus vaccine study, an abstract of which is available online, weighed the safety risks after vaccination in individuals aged 6 months to 64 years. The study also found rare cases of fever-related seizures and myocarditis, but ultimately confirmed that the FDA “continues to conclude that the benefits of vaccination outweigh the risks,” according to the NYT.
Meanwhile, planning for the Shringrix study in which the vaccine was reported to be effective “was outside the authority of the agency,” Nixon told the NYT.
The news comes after reports surfaced in April that Jay Bhattacharyya, M.D., acting director of the Centers for Disease Control and Prevention (CDC), blocked publication of a coronavirus vaccine study from the CDC’s Morbidity and Mortality Weekly Report that confirmed the vaccines were effective in reducing hospitalizations. In response to the news, Bhattacharya said in an op-ed published in the Washington Post that he raised “specific concerns” about the methodology used in the study.
“Scientific disagreement is not interference. Particularly on critical issues like vaccine efficacy, where methodological limitations can have a significant impact on findings, pausing, questioning, and scrutinizing are not only appropriate, but necessary,” Bhattacharyya wrote. “It is squarely within the responsibility of the CDC Director to ensure that CDC publications comply with the highest scientific standards.”
HHS focuses on vaccine safety
HHS, led by Robert F. Kennedy Jr., has been busy questioning and rewriting established vaccine policy since he took office last year.
Notably, President Kennedy last summer purged the CDC’s Vaccine Expert Committee and replaced all current members of the Advisory Committee on Immunization Practices (ACIP) with members of his own choosing, citing a desire to “prioritize restoring public trust over any specific pro-or anti-vaccine agenda.” Since then, ACIP’s new panelists, many of whom have a history of spouting vaccine skepticism, have voted against long-held universal vaccine guidelines in favor of an “individualized decision-making” framework.
ACIP’s new charter confirms that the committee specifically targets vaccine safety, stating that it seeks to identify “gaps in vaccine safety research, including post-vaccination side effects.” But the committee was recently put on ice after a federal judge found that some of HHS’ vaccine efforts, including the CDC’s sudden removal of some vaccines from its childhood immunization schedule, may not have followed proper procedures. The court also noted that some recent appointments to the committee were problematic and granted a stay of appointments that effectively prevented the committee from meeting.
Regarding COVID-19 vaccines in particular, former ACIP member Dr. Robert Malone in January talked about taking mRNA COVID-19 vaccines “off the market” and told people to “pay attention” to the Make America Healthy Again (MAHA) action. Mr. Malone resigned from the committee in March, telling roll call that he was “done with the CDC and ACIP” after Mr. Nixon, the HHS press secretary, “beat me down in the press.”
Late last year, Dr. Vinay Prasad, former director of the Center for Biologics Evaluation and Research (CBER), expressed a similar position on COVID-19, telling CBER officials in an internal memo that the agency “will admit that COVID-19 vaccines are killing America’s children.”
Last summer, when it approved the latest seasonal mRNA coronavirus vaccines from Pfizer and Moderna, the FDA opted to limit their use in individuals under 65 to those with underlying health conditions, in contrast to previous sweeping approvals. President Prasad and FDA Commissioner Dr. Marty McCulley previously outlined the agency’s plan to take a stricter approach to approving coronavirus vaccines, “balancing the need for evidence,” health officials wrote.
Mr. Prasad left the company at the end of April.
