Marks decries lack of transparency in FDA's revamped COVID vaccine policy

Former US Food and Drug Administration (FDA) official Peter Marks critiqued the lack of public review in the agency’s recent COVID-19 vaccination policy in a New England Journal of Medicine article published on Wednesday.

Marks, who led the Center for Biologics Evaluation and Research (CBER) from 2016 until his resignation in March 2025, outlined changes in the way FDA and the Centers for Disease Control and Prevention (CDC) are now operating with respect to assessing vaccines and recommending them for particular demographic groups. He also called out what he perceives as flaws under the new administration and called out the lack of transparency in its decision making. (RELATED: Marks resigns, blames Kennedy for spreading ‘misinformation and lies’, Regulatory Focus 31 March 2025).

Marks’ criticism is in response to the new framework for COVID-19 vaccine policy established by FDA Commissioner Martin Makary and Marks’ successor at CBER, Vinay Prasad. As outlined in the May NEJM article titled An evidence-based approach to Covid-19 vaccination and in a streamed presentation, the government is moving away from universal recommendations for vaccine boosters.

Vaccination is now recommended for people over the age of 65, and for people between the ages of six months and 65 years with one or more risk factors, which include smoking and diabetes (RELATED: FDA unveils new COVID-19 framework restricting shots to elderly and high-risk people, Regulatory Focus, 20 May 2025). Other demographic groups should be enrolled in clinical trials to determine if vaccination is beneficial. Revisions to the CDC vaccine schedule have also raised concerns that pregnant women and children who have not previously been vaccinated will be vulnerable to COVID-19.

Dramatic policy departure

Marks acknowledges that there is room for discussion and debate about whether a change in policy was needed five years into the circulation of the SARS-Cov-2 virus but takes issue with the way changes were made. Traditionally, FDA has evaluated and approved vaccines, while the CDC’s Advisory Committee on Immunization Practices (ACIP) reviewed prescribing information and other available information to make recommendations in the best interest of public health, Marks noted.

“The recent announcement of an ‘evidence-based approach to Covid-19 vaccination,’ however, represents a dramatic departure not just from previous FDA vaccine policies, but also from the deliberate and measured way in which the FDA previously made such policy, with open public discussion and issuance of guidance,” Marks wrote. “It also diverges markedly from the past in its scope, since with it, the FDA has taken on aspects of policymaking that have previously been in the domain of the CDC.”

FDA issues guidance documents to help industry comply with regulations and drafts are published, with comments collected in a Federal Register docket, Marks noted. But there was no public discussion about changes to the roles of FDA and CDC or the substance of the vaccine policies, Marks noted. Aside from emergency situations, FDA and CDC should continue to have thoughtful and thorough dialogue about vaccines and vaccination policy, he suggested.

“This dialogue should continue to be held in a public setting by their respective advisory committees, with presentations representing a range of viewpoints expressed by scientists, clinicians, and regulators in the United States and globally who have expertise in addressing existing and emerging pathogens,” Marks wrote.

“Although the current federal administration has repeatedly stated that it is committed to ‘transparency and gold-standard science,’ the issuance of the new policy appears to achieve neither objective,” he asserted.

Will Marks have impact?

Marks’ article clearly defines the workings of the CDC and FDA on vaccine policy and is helpful for the scientific community to understand the traditional processes, commented Paul Offit, MD, a pediatrician at the division of infectious diseases at Children's Hospital of Philadelphia and a member of FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC).

“I think that he's exactly right in what he says – that the roles of the FDA and CDC, which up until the current administration were well-defined, are now ill-defined, and that the FDA, in some ways has usurped the typical role of the CDC, which is a recommending body,” Offit said in an interview. “And most important, those decisions that were normally made with the advice of experts or the public or both, are now being made behind closed doors by people who find themselves in no way accountable to anybody else.”

Marks did not address the legality of the changes in COVID-19 vaccine policy at FDA, but the government could be vulnerable due to the lack of transparency, commented Dorit Reiss, PhD, professor of law at UC Law San Francisco (formerly UC Hastings).

FDA is required under the Administrative Procedure Act to publish proposed and final rule changes in the Federal Register, but in the past has gone over and above the legal requirements in seeking stakeholder feedback about policy changes. This isn’t just out of the goodness of its heart, though, Reiss said. Being aware of stakeholder concerns helps protect the government from lawsuits. The explanations for the changes were vague in some areas, she said. It’s possible that a person harmed by the policy change and who gets COVID-19, for example a pregnant person or someone under age 65 living with an immunocompromised relative, could sue the government, arguing that FDA’s actions were arbitrary and capricious.

Also, one big unanswered question is where President Trump stands – if Trump does not agree with this and other new policies, he could decide to replace Health Secretary Robert F. Kennedy, Reiss said.

Will Marks’ article have an effect? Offit says Marks is credible and he hopes the paper has some impact but, on the other hand, writing in the NEJM is a bit like “preaching to the choir”.

“I think he would break through if he goes on Fox and says this, or goes to the White House,” Offit said.

NEJM

Marks decries lack of transparency in FDA's revamped COVID vaccine policy

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