RFK Jr. ends COVID-19 vaccines for children, pregnant people

Overriding regulatory recommendations

This online announcement bypasses the CDC's Advisory Committee on Immunization Practices (ACIP), the regulatory body that develops vaccine use recommendations and provides them to the CDC director. However, as of March 24, 2025, the agency currently lacks an acting director, as Susan Monarez advances to a Senate hearing confirmation to become the next CDC director.

"ACIP goes through all the data [and] makes evidence-based decisions," the chair of infectious diseases at the American Academy of Pediatrics, Sean O’Leary, said to NPR. "This recommendation essentially completely ignores that," sparking concern from industry experts.

"There is a process, and it hasn’t been followed," Dorit Reiss, law professor at UC Law San Francisco who focuses on vaccine policy issues, told STAT News. "Administrative decisions actually have to be made on the basis of something, not just because the agency feels like it."

Without proper procedure, the decision could be at risk of being overturned if brought before a court, which would likely expect proof that the policy shift was reached through a reasoned and deliberate process, Reiss suggested.

Industry impact

On May 20, 2025, the FDA's Commissioner and the Center for Biologics Evaluation and Research director published an updated COVID-19 vaccine regulatory framework that limits COVID-19 boosters to seniors and younger individuals with underlying medical conditions, pending further research on vaccine use for healthy adults and children.

The removal of booster recommendations could significantly impact whether insurers continue covering COVID-19 vaccines at no cost, as mandated by the Affordable Care Act for ACIP-endorsed vaccines. Without formal ACIP backing, insurers could opt out of coverage, potentially leading to inconsistent vaccine access across regions and healthcare plans.

In a news release, the president of the American College of Obstetricians and Gynecologists, Steven J. Fleischman, MD, MBA, FACOG, voiced strong opposition to the change, noting CDC data that show most infants hospitalized for COVID-19 were born to unvaccinated mothers.

"COVID infection during pregnancy can be catastrophic and lead to major disability, and it can cause devastating consequences for families," Fleischman emphasized in the new release. "The COVID vaccine is safe during pregnancy, and vaccination can protect patients and their infants." 

Adding to the uncertainty, the CDC's website still lists COVID-19 vaccines in the pediatric immunization schedule, further complicating guidance for insurers and providers.

Insurers could also begin to reevaluate their coverage policies in response to Kennedy's decision, potentially creating a patchwork of access and reimbursement practices that complicate patient access and further exacerbate vaccine hesitancy.

"We are worried about our patients in the future, who may be less likely to choose vaccination during pregnancy despite clear and definitive evidence demonstrating its benefit," Fleischman continued. "We are concerned about access implications and what this recommendation will mean for insurance coverage of the COVID-19 vaccine for those who do choose to get vaccinated during pregnancy. And as ob-gyns, we are very concerned about the potential deterioration of vaccine confidence in the future."

As the pharmaceutical industry faces heightened uncertainty in the COVID-19 vaccine market, companies might reevaluate their market access strategies, supply forecasts and payer engagements in light of potential shifts in coverage and demand amid rising rates of vaccine hesitancy.

RFK Jr.'s announcement came just ahead of a June ACIP meeting, at which the committee was expected to revisit and potentially revise universal COVID-19 vaccine recommendations.

Alivia Kaylor is a scientist and the senior site editor of Pharma Life Sciences.