Vaccine policy in the U.S. is entering uncharted territory

Vaccines are facing new challenges from an unexpected quarter: the people who set vaccine policy for the United States.

Many people have never heard of the Advisory Committee on Immunization Practices, but its work keeps preventable diseases, from polio to measles to COVID-19, in check. The committee decides which population groups should get certain vaccines. Those decisions then determine which vaccines Medicare and Medicaid, and by extension private insurance, will cover. ACIP also determines which vaccines will be provided for free through the Vaccines for Children Program.

I’ve reported on ACIP meetings for years. Normally ACIP weighs reams of data, evaluating efficacy and risk versus benefit, before making its recommendations. The head of the Centers for Disease Control and Prevention then has the final say.

But from the opening moments of the June 25 and June 26 ACIP meeting, it was clear that this was not business as usual. Instead, debunked science, an apparent nonchalance about preventable deaths and confusion over basic testing procedures often took center stage.

Among other moves, the committee scrapped votes on expanding access to important vaccines, announced plans to reevaluate the childhood vaccine schedule and said established vaccines, including the hepatitis B shot for newborns, will be reviewed every seven years. The committee also resurfaced many long-debunked anti-vaccine talking points. Three of the committee’s five votes concerned a vaccine ingredient that has not been in childhood vaccines for two decades.

Some medical and pharmacists’ organizations have pledged not to follow some of the Trump administration’s vaccine policies. Among them is the American Academy of Pediatrics, a long-time collaborator of ACIP in setting vaccination schedules for children and adolescents. The group boycotted the meeting because it views the current committee as “illegitimate” and plans to publish its own childhood vaccine schedule.

“Some media outlets have been very harsh on the new members of this committee, issuing false accusations and making concerted efforts to put scientists in either a pro- or anti-vaccine box,” committee chair Martin Kulldorff, a biostatistician at Hillsdale College who is based at the Washington, D.C., campus, said during his opening remarks. “Such labels undermine critical scientific inquiry, and it further feeds the flames of vaccine hesitancy.” In contrast, Kulldorff had previously coauthored a controversial call to build immunity to COVID-19 through natural infection.

All of this is unprecedented for ACIP, and public health experts now worry that instead of boosting confidence and protecting health, just the opposite will happen.

“I am very concerned that we are going to lose policies and recommendations that save babies, infants, children and adults,” says Chari Cohen, a public health scientist and president of the nonprofit Hepatitis B Foundation.

Conflicts of interest and lack of expertise

The weeks leading up to the once-routine ACIP meeting hinted at the major shift under way.

Just two weeks prior to the meeting, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. abruptly fired all 17 members of the panel in a move he said was designed to restore public trust in vaccine science. Kennedy’s eight picks to replace the expert panel members included people with ties to anti-vaccine groups. One of the new panel members resigned over financial conflicts of interest before the meeting started, leaving just seven.

The panelists lack expertise in microbiology, immunology and vaccine science, U.S. Senator Bill Cassidy, a doctor and a Republican from Louisiana, said in a post on X calling for the meeting to be delayed until a permanent CDC director is instated. The nomination hearing for Trump’s pick, Susan Monarez, was happening at the same time as the ACIP meeting.

One panelist, Vicky Pebsworth, works at the National Vaccine Information Center, a Sterling, Va.-based group that has been accused of spreading vaccine misinformation. Others have also propagated misinformation on vaccines, while some have sold supplements and unproven treatments for COVID-19 and measles, challenged vaccine mandates or were paid to testify against vaccine makers in court. Those conflicts were not disclosed or were dismissed as irrelevant.

One panelist, Cody Meissner, a pediatrician at Dartmouth Geisel School of Medicine in Hanover, N.H., has previous advisory board experience at both the CDC and U.S. Food and Drug Administration. He was on the FDA committee that approved the COVID-19 vaccines. But he expressed approval of Kennedy’s decision to not recommend the shots for children and pregnant women despite a presentation of data from the CDC that indicated the vaccines were helpful for both groups. The committee did not vote on whether to recommend the COVID vaccines.

The panel’s overall lack of knowledge showed. CDC scientists and Meissner repeatedly had to correct or instruct the panelists on procedures, basic immunology and even how clinical trials work.

ACIP is now stocked with vaccine skeptics, says Sue Peschin, president and chief executive of the nonprofit Alliance for Aging Research in Washington, D.C., noting that the panel no longer contains members with geriatric experience, something her group has long advocated. “Any pretense of scientific objectivity on the part of ACIP has left the building,” she says. “They made clear, really from the get-go, that their intent is to upend the long-standing evidence-based immunization policies that ACIP is known for.”

If the bias against vaccines on the committee is extreme enough, it could be grounds for filing a suit against the restructuring, C. Joseph Ross Daval, an attorney and research specialist at Brigham & Women’s Hospital and Harvard Medical School in Boston, told me in a phone interview. But he and colleague Aaron Kesselheim reported in JAMA on June 26 that it’s not clear who would have the legal standing to bring such a suit. Fired ACIP members may be able sue, but none have done so yet.

The committee rejected the bias charge in a news release. “We came to this meeting with no pre-determined ideas and will make judgements as if we are treating our own families. Unbiased scientific thinking is fundamental to the committee’s charge.”

Reopening scientific debates

During the course of the meeting, though, the committee resurfaced scientific debates about vaccines that have been settled for decades.

Kulldorff opened the meeting by announcing two new working groups. One will study the number of vaccines children get, and another will reevaluate vaccines that have not been reviewed in the last seven years, including the hepatitis B vaccine for newborns. Infection with that virus is a major cause of liver disease and cancer. In particular, Kulldorff questioned whether every baby needs to get a hepatitis B vaccine at birth. Instead, he suggested limiting doses to babies whose mothers are infected with the virus.

The United States already tried screening mothers for hepatitis B and vaccinating only those babies at risk. The approach didn’t work because not every case of hepatitis B is caught and many people fall through the cracks in public health infrastructure, Cohen says. “The birth dose is the safety net for that.”

A suggestion to end universal coverage of a vaccine that prevents thousands of mother-to-child infections each year “marks a dangerous departure from evidence-based public health policy and places newborns at an unacceptable risk for chronic infection and liver cancer,” the Hepatitis B Foundation said in a statement.

Kulldorff also wrongly claimed that most people get hepatitis B mainly through sex or intravenous drug use. “In fact, most people in the world get hepatitis B at birth or early childhood,” Cohen says.

That’s not the only misstep the committee made, according to a coalition of public health researchers who fact-checked the meeting in real time. Those checks turned up more than 50 inaccuracies. For instance, Kulldorff questioned whether children get too many vaccines. But the panel discussion failed to mention that modern vaccine-makers have narrowed down the particular proteins or parts of proteins that the immune system recognizes to give protection. That means children today get fewer of these antigens while being protected against more diseases than ever before.

Callousness was also on display, many observers said, such as when ACIP member Robert Malone, a doctor and former mRNA researcher, said the 250 child deaths in the 2024-25 flu season was “a modest number.” Malone has previously downplayed the death of a child from measles and spread misinformation about vaccines.

“That’s actually a very high number for pediatric deaths from influenza,” Sean O’Leary, of the American Academy of Pediatrics, said in a news briefing June 26. “For every childhood death … there are scores of ICU admissions [and] thousands of hospitalizations.” In the 2024-25 flu season, about 25,000 children ages 4 and younger and an estimated 31,000 5- to 17-year-olds were hospitalized with flu, CDC’s Influenza Division director Vivien Dugan said June 25 at the ACIP meeting.

Giving debunked science a platform

The committee scrapped previously scheduled votes on some vaccines — including whether to expand access to a vaccine against human papilloma virus (HPV), which has been proven to lower cervical cancer rates among young women. But it did make time to revisit the use of thimerosal in vaccines. The preservative has been removed from most vaccines but is still used in a small number of multidose flu vaccine vials to prevent fungal and bacterial contamination.

Lyn Redwood is a former head of Children’s Health Defense, an anti-vaccine group founded by Kennedy. She charged that the preservative, which contains ethylmercury, contributes to inflammation in the brain that she linked to autism. Her report was not vetted by CDC researchers, which is the norm, and it cited at least one made-up study.

Multiple studies have uncovered evidence that vaccines do not cause autism. Even after thimerosal was removed from childhood vaccines in 2001 to encourage vaccination among hesitant people, rates of autism continued to climb. A CDC report countering many of Redwood’s claims was pulled by the HHS Secretary’s office.

Several ACIP committee members expressed concern that thimerosal used in multidose vials of flu vaccines could accumulate over time and cause harm. But ethylmercury is more easily cleared from the body than methylmercury, which is the type typically found in fish.

The committee voted to use only single-dose flu vaccines, which do not contain thimerosal, for adults and children. Meissner, who voted against the proposal, said it could mean fewer vaccines would be available to children in poor countries where busy health clinics often use multidose vials containing thimerosal.

The move could also limit access to flu vaccines in nursing homes and long-term care facilities that serve older adults, Peschin says. “There’s no good reason for this other than creating mass confusion and mass worry and unnecessarily sowing doubt on vaccines more broadly.”

Whether the committee can restore trust in vaccines may depend on demonstrating that its decisions are guided by science, an assertion many critics doubt. Several medical and scientific organizations are considering forming their own advisory body that draws on broad expertise to make recommendations on vaccines, as ACIP has traditionally done. Some scientific societies are also weighing whether to attend ACIP meetings in the future.

Christopher Busky, chief executive of the Arlington, Va.-based Infectious Diseases Society of America, said in a July 2 news briefing that its representatives “were either uninvited or not made aware of the recent ACIP meeting, so were not able to participate in that meeting.” The organization has not made an official decision about future attendance.

And the American Academy of Pediatrics has already said it won’t participate in ACIP meetings with the current committee’s membership. “This meeting showcased an ACIP that has drifted so far from its long-standing focus on science, evidence, public health [and] health,” O’Leary said in a June 26 news briefing. But he left room for reconciliation. “We are dedicated to protecting children and providing families and providers the best advice. And so, if ACIP returns to those same principles, we will happily reengage.”