RFK Jr.'s FDA Adds to Agenda Putting Pressure on Vaccine Access

The FDA has played an active role in US Health Secretary Robert F. Kennedy Jr.’s agenda to scrutinize vaccines, even if the moves haven’t been as deeply examined as those at agencies like the CDC, immunization experts say.

Kennedy moved rapidly in 2025 to investigate and overhaul the US vaccine schedule, with one of the latest actions from the Centers for Disease Control and Prevention’s vaccine committee voting to delay the hepatitis B shot for newborn babies. The CDC also recently awarded an unsolicited $1.6 million grant to Danish researchers, who have been defended by anti-vaccine activists, to study the hepatitis B shots in newborns in Africa.

But the FDA’s activity matters as well, as the agency possesses the powerful authority to regulate vaccines by overseeing safety and efficacy, licensing, and involvement in whether the shots are accessible to the public. The latest moves include investigating whether the Covid-19 vaccine caused deaths in adults and children, and proposing to require more trials for vaccine approvals.

“The CDC can scare people with votes, but the FDA can make vaccines less available,” said Paul Offit, a former member of the FDA’s Vaccines and Related Biological Products Advisory Committee.

“They are the regulatory agency here,” added Offit, who’s now director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.

Powerful leaders inside the FDA have been steering the agency’s thinking around vaccines.

FDA Commissioner Marty Makary tapped Vinay Prasad, who has long held criticisms around mRNA and Covid-19 shots, to lead the Center for Biologics Evaluation and Research, which oversees the safety and efficacy of vaccines.

In recent weeks, Prasad reportedly said in a leaked internal memo the agency will impose stricter standards for immunizations and claimed a review found at least 10 children died because they received a Covid vaccine.

New acting director of the Center for Drug Evaluation and Research, Tracy Beth Høeg, has also been skeptical of childhood vaccines.

A spokesperson for the Department of Health and Human Services said in an email that “the American people deserve evidence-based science” and the “FDA is doing a thorough investigation, across multiple age groups, of deaths potentially related to COVID vaccines.”

FDA’s Moves

The email Prasad sent to CBER staff in November offered little evidence that the children’s deaths were linked to vaccination. Rather, Prasad pointed to reports from the Vaccine Adverse Event Reporting System, a notoriously crowdsourced database to which anyone can contribute.

There have been cases of myocarditis, or inflammation of the heart muscle, after young men received the Covid vaccine, but studies have shown that they are rare.

“There was no evidence, no data presented, no methodology of how he came to that conclusion,” said Jeff Coller, professor of RNA biology and therapeutics at Johns Hopkins University. “If we make scientific claims, we put it out there. We don’t work behind closed doors.”

The plans to impose stricter standards for vaccines demanded premarket randomized trials assessing clinical endpoints for most new products. The agency will also revise the annual flu vaccine framework, Prasad said.

The email faced pushback from almost every former FDA commissioner, who wrote in a joint article that the changes stand to threaten policies governing vaccine development.

An agency spokesperson said, “Prasad’s email lays out a philosophical framework that points us toward that higher standard.”

Media reports also indicated the FDA was preparing to add a black box on the Covid-19 vaccine—the strongest level of warning the agency can grant on a product.

Makary said in an interview with Bloomberg TV on Dec. 15 that the agency has no plans to put the boxed warning on the vaccines, but some agency officials had recommended it.

The move would have been a “drastic step coming from an approval that FDA initially didn’t see any risks rising to the level of a black box,” said Nathan Downing, managing attorney at Gardner Law.

“There’s always a risk benefit assessment that the FDA undertakes with any product, but it’s important that those standards are based in science,” Downing said.

‘Overlap’ in Authority

Vaccine experts are also eyeing the FDA’s actions as they appear to collide with authorities at other agencies, particularly the CDC’s Advisory Committee on Immunization Practices.

While the FDA approves and licenses vaccines, the CDC recommends the shots.

When Kennedy announced that he would be pulling the Covid-19 shot off the vaccine schedule for healthy children and pregnant women, Makary joined the secretary’s announcement in a video on X.

The agency earlier this year also approved Novavax Inc.’s Covid vaccine, but cleared the shot for adults 65 and older and those ages 12 to 64 who have at least one underlying condition.

“They’re treading a little bit into ACIP territory,” said William Schaffner, professor of medicine in the division of infectious diseases at Vanderbilt University. “The two seem to have gotten into a bit of an overlap in what it is they do.”

Still, it’s crucial that the FDA distinguishes itself from other agencies as it has significant power over the products, health experts say.

“The FDA’s role is to really do a deep dive on the safety and efficacy of therapeutics,” said Georges Benjamin, executive director of the American Public Health Association. “There is an art and an expertise to doing these kinds of studies.”

“Everybody carries biases to the table, but a balanced presentation and balanced understanding of the information is needed,” Benjamin said.