How Rfk Jr. Could Change Vaccine Recommendations — Without The Experts

Decision time is looming for Health Secretary Robert F. Kennedy Jr.

The Centers for Disease Control and Prevention usually approves changes to the vaccine schedule teed up by its external advisory panel. But there may now be some daylight between Kennedy and the CDC’s Advisory Committee on Immunization Practices, which last week made decisions that — at least on the surface — appeared surprising for a group whose members Kennedy handpicked.

Kennedy, himself or through his acting CDC director, Jim O’Neill, has the power to accept or reject ACIP’s recommendations — which, if approved, wouldn't alter the vaccine schedule as much as many public health advocates expected. The panel tabled a proposal to delay vaccinating certain newborns for hepatitis B; did not recommend that states and localities require prescriptions for the Covid-19 vaccine; and endorsed allowing anyone 6 months and older to get a Covid shot.

Kennedy could create new recommendations without a vote from the panel, giving the health secretary broad authority over the childhood vaccine schedule, though there’s little precedent for such a move.

President Donald Trump appears to have further complicated Kennedy’s decisionmaking by pushing dramatic changes to the vaccine schedule at a White House event Monday to address a supposed connection between Tylenol use by pregnant women and autism.

Trump linked childhood vaccines and the timeline in which they’re administered to autism diagnoses — a theory discredited by numerous scientific studies — and suggested that the schedule needed to be overhauled. He also said he thought hepatitis B vaccination should be pushed back from an infant’s first day of life to age 12.

It’s unclear when the CDC’s decision will be announced, though it could come any day now, or which way Kennedy is leaning. HHS spokesperson Andrew Nixon noted that the recommendations become “part of the CDC immunization schedule if it is adopted by the CDC director,” but declined to comment on Kennedy’s timing.

Still, many public health advocates are worried.

“I think [Kennedy] has ultimate power in terms of these sorts of things,” said Dr. Paul Offit, director of the Vaccine Education Center at Children's Hospital of Philadelphia and a former ACIP member. “That’s what makes it all so frightening, because he's a man on a mission, and his mission is to make vaccines less available, less affordable.”

There’s precedent for HHS ignoring its vaccine advisers. Then-CDC Director Rochelle Walensky overruled the committee in 2021 to more broadly recommend third doses of Covid vaccines than the panel recommended.

But Dr. Richard Besser, CEO of the Robert Wood Johnson Foundation and a former acting CDC director under President Barack Obama, said Walensky’s decision was understandable. The Covid pandemic was still raging, and ACIP’s advice to limit booster doses to older people and those with preexisting medical conditions came after a divided vote.

“Dr. Walensky’s decision expanded eligibility for potentially life-saving vaccines,” he said in an email. “Secretary Kennedy, on the other hand, seems determined to restrict access as much as he can.”

Kennedy has deviated from the normal process before. In May, he changed the Covid vaccine guidance without an ACIP vote, removing the recommendation that pregnant women get vaccinated and advising that healthy children “may” get the shot after conferring with their doctors.

Kennedy fired all 17 members of the advisory panel in June, citing conflicts of interest, and has replaced them with 12 handpicked members, many of whom share his longheld vaccine skepticism.

But events at the two-day meeting in Atlanta did not unfold as expected. The hepatitis B decision was tabled, and the vote on the prescription recommendation was tied until ACIP Chair Martin Kulldorff, a former Harvard Medical School professor famous for opposing Covid lockdowns, cast the deciding ‘no’ vote.

In an interview with POLITICO, Kulldorff stressed the panel’s independence from Kennedy and the political decisionmaking. He stressed that his goal is to put the science first.

“The ACIP provides independent advice to the CDC director,” Kulldorff told POLITICO.

While the CDC along with other HHS agencies helped set the agenda for last week’s meeting with the ACIP’s members, “as an independent committee, we vote without pressure from CDC or HHS,” Kulldorff said.

Another panel member, however, has said he views his role as carrying out Kennedy’s wishes.

“The only reason why I'm there is because I know that I have the support of the secretary,” Dr. Robert Malone said on a Wednesday call hosted by MAHA Action, an advocacy group that supports Kennedy.

Malone, a vaccine researcher known for casting doubt on the safety of Covid shots, would like to see HHS push back children’s inoculations for hepatitis B, an infection that can lead to serious liver problems, more than the one month the ACIP was considering.

On the Wednesday MAHA Action call, Malone said he moved to table the hepatitis B vote because he didn’t think it pushed the series’ first dose far enough into childhood, calling the one month proposal “not sufficient.”

“A lot of people don’t understand what transpired there,” Malone said.

Trump endorsed a similar view during his Tylenol announcement.

“Wait til they’re 12 years old and formed,” Trump said.

Proponents of giving the shot to newborns point out that the number of infections among children has plummeted since the shot became recommended to all infants in the early 1990s.

Kennedy or O’Neill could implement the proposal ACIP members tabled — to vaccinate children whose mothers test negative for the infection after one month, instead of at birth. Kennedy could also go with Trump’s advice.

Such an action would be “highly unusual,” said Dorit Reiss, a vaccine law expert at the University of California College of the Law in San Francisco.

No HHS secretary or CDC director has changed the routine childhood vaccine schedule — except for Kennedy’s decision to change the covid recommendations — without a vote from the panel in recent memory.

Kennedy could also revive the recommendation that states require prescriptions for Covid vaccines — an action that, legal experts say, is outside the usual purview of both the CDC and the advisory panel. But it's unclear what tangible impact that would have other than creating confusion, said Jason L. Schwartz, an associate professor in the Department of Health Policy and Management at Yale School of Public Health.

“It would be a reach to say that a recommendation statement like that would be irrelevant or useless, because we know that many states have policies that do point back to CDC and ACIP recommendations in ways that are open to interpretation,” said Schwartz. “There could be some messiness in the details.”

Reiss said that a prescription recommendation could “undermine vaccine uptake,” or the willingness of people to receive the shots, but it would lack teeth. Neither ACIP nor CDC have the legal authority to tell states when to require prescriptions for vaccines.

ACIP Chair Kulldorff told POLITICO that he voted down that recommendation for that reason. “The CDC is not the agency that makes this decision,” he said.

That responsibility, lawyers said, would lie with state officials and the Food and Drug Administration.

Kulldorff said doctors’ prescriptions are unnecessary because “pharmacists are highly qualified professionals who can help patients make this decision just as physicians can.”

ACIP ultimately voted to allow anyone 6 months and older to access Covid vaccines under a concept known as “shared clinical decisionmaking” — when vaccination isn’t the default position and is decided upon after a discussion between provider and patient.

Several states tie pharmacists’ authority to provide vaccines to ACIP recommendations, meaning the vote should ensure they can continue to do so. Pharmacists administered 90 percent of the Covid shots given to adults during the 2024-2025 fall and winter season.

But pharmacy practice laws differ across state lines, and the FDA-approved label for Covid shots limits their indication to people 65 and older and to younger individuals with at least one underlying condition. That means some state boards may err on the side of requiring a prescription if their governors or lawmakers don’t clarify their role, public health experts say.

“In practice, anybody” 6 months and older should be able to get vaccinated under ACIP’s recommendation, said Dr. Helen Chu, an Infectious Diseases Society of America fellow and former ACIP member. “I think it’s still going to be tricky because this vaccine is going to be off-license for those who … don’t have a high-risk condition” and are under 65.

The prescription vote wasn’t the only area where the committee had tried to give advice outside of its purview, lawyers who follow ACIP said.

The panel also voted to recommend that all pregnant women get tested for hepatitis B — a recommendation that the CDC already makes and is not directly related to immunizations.

The ACIP meeting came after Kennedy ousted CDC Director Susan Monarez. She said she was fired because she would not promise to sign off on the ACIP recommendations in advance. Kennedy added five new members to the committee the week of the vote, a process that has in the past followed months or years of vetting. As a result, some members appeared confused during the meeting about ACIP procedures.

“With one exception, this was either our first ACIP meeting or our second,” Kulldorff said during the second day of the meeting. “There are various technical issues that we may not grasp as of yet.”