After Donald Trump’s victory on Tuesday, longtime vaccine skeptic Robert F. Kennedy Jr. is poised to have tremendous influence over the way the United States regulates and distributes its vaccines.
Kennedy has pushed the disproven idea that vaccines cause autism for decades, and founded the nonprofit Children’s Health Defense to promote theories linking vaccines to other conditions. Other leaders of the Trump-aligned Make America Healthy Again movement also have a history of anti-vaccine advocacy. Kennedy has backed off more inflammatory anti-vaccine rhetoric recently, instead emphasizing his desire for more transparency and data around the products. It’s unclear exactly what data he is seeking.
“If vaccines are working for somebody, I’m not going to take them away,” he told MSBNC on Wednesday. “People ought to have a choice and that choice ought to be informed by the best information.”
State health officials decide which vaccines to recommend in schools and for the broader population, but they rely upon the Food and Drug Administration and the Centers for Disease Control and Prevention to regulate and recommend vaccines, respectively. While Kennedy’s game plan may not include removing vaccines from the market, health experts worry that he could leverage the agencies to slow down approvals, fill advisory committee slots with fellow skeptics, and generally spread disinformation.
What Kennedy is able to do will depend on who ends up leading the FDA, CDC and the larger Department of Health and Human Services. The main guardrails against him going rogue on vaccines are pushback from the public, Congress, the drug industry, and other government employees.
“There’s nothing to stop it, it’s just that we have to deal with the aftermath,” said Bryant Godfrey, a partner at Foley Hoag and former regulatory lawyer at the FDA.
The FDA does not withdraw products “willy-nilly,” Godfrey said. A vaccine must present a clear safety concern for the agency to consider forcing companies to remove it. Manufacturers could easily sue if an RFK Jr.-influenced FDA penalized a product without evidence.
“If the FDA were to reverse the decision to approve a vaccine, absent any rigorous scientific evidence, that would be slapped down by even the most conservative Supreme Court,” said Lawrence Gostin, professor of Global Health Law for Georgetown University.
Kennedy could push FDA reviewers to request extra data from companies submitting their vaccines for approval, though the submission process is already rigorous. It’s not clear what impact that might have, as he has not clearly stated what extra data, and for which vaccines, he is seeking.
If Kennedy were to undermine vaccines through the FDA, he would face backlash both inside the agency and from powerful industry interests. The CDC, on the other hand, is more vulnerable to his influence.
One of the biggest guardrails for vaccine approval at the CDC is the Advisory Committee on Immunization Practices. The group makes vaccine recommendations that apply to the entire U.S. population. Currently, committee members are independent experts who pore over dozens of research papers and confer with each other to make recommendations. But that could change under Trump.
To be appointed to the committee, ACIP members must be approved by the HHS secretary — who the president handpicks. Gostin said Trump or Kennedy could quickly fill ACIP with Trump loyalists and vaccine skeptics, which could leave the group ill-equipped to deliver accurate vaccine recommendations. ACIP recommendations inform insurers on whether they should cover a certain vaccine, so stacking the panel could also impact vaccine affordability.
The role is tough, said pediatrician Paul Offit. When he helped develop a vaccine for a virus that causes stomach flu, the process from initial studies demonstrating its efficacy to final approval took 26 years. Every potential vaccine is treated similarly, even a disease as commonplace as chickenpox, said Offit.
“If you really want to be informed about [chickenpox], then you would have read the 300 papers that were published on it, which meant you would have had to have some expertise in neurology and immunology and statistics and epidemiology, which most people don’t have — and frankly, most doctors don’t have it,” said Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “That’s why they look to these expert committees.”
Further disruption of federal vaccine policy could emerge through the courts. In June, the U.S. Court of Appeals for the Fifth Circuit undermined the authority and constitutionality of advisory committees like ACIP. It ruled that the Affordable Care Act cannot mandate coverage of preventative care such as contraceptives or drugs like PrEP that prevent HIV, though the decision for a national mandate was kicked back to a lower court.
If the Supreme Court picks up the case, it could be like pouring gasoline on a campfire, said Leighton Ku, a George Washington University health policy professor. Administrative agencies like the FDA are already reeling after the Court’s ruling on the Chevron doctrine.
“[Kennedy] can interfere. There’s no question that he can interfere. The ways he can interfere are complicated…but I’m willing to believe that [he will] if he is sufficiently motivated,” said Ku.
The simplest thing that Trump and Kennedy can do to dismantle vaccine policy would be to continue their current actions: speaking from the pulpit and influencing the public’s perception of these immunizations safety and efficacy. Americans are increasingly unlikely to say childhood vaccines are important, and more jurisdictions are granting exemptions.
“RFK is already having influence in discouraging people from using vaccines, even though he is not part of the government at all right now,” said Ku.
This soft power is likely to produce the biggest changes, and it will only grow if Kennedy occupies an official federal position, said former HHS Secretary Kathleen Sebelius. During her tenure from 2009 to 2014, Sebelius met with the vaccine skeptic several times, and each time he reiterated his position. She doesn’t know how Kennedy will “go wild” in federal health agencies. But nevertheless, she’s worried.
“He was convinced that I was not getting accurate information from the CDC, that I was being misled by science, that we just needed to fire people and bring in new evidence,” she said.
Correction: This story incorrectly identified the nonprofit that RFK Jr. founded to foster skepticism around vaccines. It is Children’s Health Defense.
