For decades, when health care providers in the United States made decisions about who among their patients should be vaccinated against which diseases and when, they knew where to look: the Centers for Disease Control and Prevention, which itself had been advised by a panel of independent experts, the Advisory Committee on Immunization Practices.
Those days, at least for now, may be coming to an end.
It appears the country is headed toward a balkanization of vaccination policy, where the vaccine recommendations that a pediatrician, family doctor, or geriatrician consults may come from their professional organizations instead of the CDC. Where parents who believe in vaccinating their children will turn to one information source, while parents who want permission to forgo some, most, or all vaccinations for their kids may take a “choose-your-own-adventure” approach to which vaccinations their children should get, and when they should get them, guided less by well-established science and more by unfounded claims.
The chaotic path that U.S. vaccination policy has been placed on stems from the appointment of a longtime vaccine critic, Robert F. Kennedy Jr., as secretary of the Department of Health and Human Services. In the four months since he was sworn in as the head of HHS, Kennedy has fired the entirety of the ACIP, replaced them with individuals with far less notable credentials and in some cases deep distrust of vaccines (one proudly embraces the term “anti-vaxer”), and taken the unprecedented step of rewriting Covid-19 vaccination recommendations, without input from experts and with a disregard for existing science.
(A document Kennedy’s department circulated among congressional offices explained his rationale for dropping a recommendation that pregnant people get Covid boosters. It cited research that either found the opposite of what HHS claimed — the studies actually found that Covid shots were not linked to the negative outcomes the document stated — or didn’t study Covid vaccination during pregnancy at all.)
The newly constituted ACIP is set to meet for the first time this week. Proponents of science-based vaccination policies are fearful the CDC’s vaccination schedules — already compromised by Kennedy’s unilateral decision on Covid boosters for pregnant people — will quickly become even more unreliable, particularly following the last-minute appearances on the agenda of disproved concerns that are core beliefs in anti-vaccine circles.
Though whether the committee — currently composed of only eight members — will meet this week was cast into doubt late Monday when a pivotal Republican senator, Bill Cassidy, called for its postponement until a fuller, more experienced committee has been named.
“Wednesday’s meeting should not proceed with a relatively small panel, and no CDC Director in place to approve the panel’s recommendations,” Cassidy wrote in a post on the social media site X. “The meeting should be delayed until the panel is fully staffed with more robust and balanced representation — as required by law — including those with more direct relevant expertise. Otherwise, ACIP’s recommendations could be viewed with skepticism, which will work against the success of this Administration’s efforts.”
There was no immediate response from the Department of Health and Human Services to the call from the senator whose vote was critical to Kennedy’s confirmation as secretary.
Whether the meeting proceeds this week or not, there remain serious concerns among vaccine proponents about the role ACIP will play going forward and the credibility of recommendations that will come from it. This attack on the ACIP and the established system for making vaccination policy has placed the country in “uncharted territory,” Michael Osterholm, director of the University of Minnesota’s Center for Infectious Disease Research and Policy, said in an interview.
“We’ve not ever been in a situation where we’ve had what would be considered an information-compromised ACIP … as well as now the entire organization, all of CDC,” said Osterholm, whose center has launched the Vaccine Integrity Project to try to counter the damage it sees coming.
“There are many outstanding researchers and policy experts at CDC. The challenge is we don’t know when their voice is being heard and when it’s the voice of an administration official,” he said.
That prospect raises important questions about how health care providers will decide what to advise their patients; whether insurance companies will continue to cover the cost of established vaccines should the new ACIP — or Kennedy himself — strike them from CDC’s official vaccination schedules; and whether the critical Vaccines for Children program, which pays for vaccines for about half the country’s kids, will continue to provide access to them.
Uncharted territory indeed.
For decades, the ACIP was the “north star” for medical professionals and public health officials who deliver vaccines, said Jason Schwartz, an associate professor of health policy and management at Yale University’s School of Public Health.
The committee was formed in 1964, created by then-Surgeon General Luther Terry to provide the CDC and the secretary of health with expert guidance on the use of a proliferating number of vaccines, which were then given mostly to children.
The American Academy of Pediatrics, the professional group for pediatricians, also independently developed and maintained its own vaccine recommendations. But in the mid-1990s, the AAP and the ACIP aligned their schedules and have been in virtual lockstep since, said Sean O’Leary, a pediatric infectious diseases specialist at Children’s Hospital Colorado and the AAP’s representative on the ACIP. (About 30 organizations involved in vaccination delivery have liaisons who attend ACIP meetings as non-voting members.)
An ACIP recommendation must be endorsed by the CDC director to become part of one of the vaccine schedules. (There are separate versions for infants and pre-schoolers, school-aged children and teens, pregnant people, and other adults.) But instances in which one of the panel’s recommendations was rejected or rewritten by a CDC director are so rare even legal experts who follow the committee’s work struggle to remember when it has happened. The most recent case was when former director Rochelle Walensky overruled the ACIP’s recommendation on who should get the first round of Covid boosters in 2021; she did so to ensure health care workers could have access to the boosters.
Given the new composition of the committee — as well as Kennedy’s strong views on both vaccines and his prerogative to shape policy on their use — public health experts are worried that long-accepted recommendations could be stripped from the vaccine schedules, and new vaccines might not receive an ACIP-CDC endorsement. (Recommendations for a new meningococcal vaccine and expanded use of RSV vaccines for adults that were approved by the previous ACIP remain in limbo more than two months after they were voted on. The CDC has no director or acting director and Kennedy, who could accept them, has not.)
Schwartz and others believe that going forward, the CDC’s status as a one-stop-shop for science-based vaccine recommendations will not hold. “I think we’ll see increasing fragmentation in the guidance, the clarity regarding the optimal approach to vaccines,” he warned.
Heidi Larson has spent the past 20 years studying the decline in vaccine confidence. She foresees a period of increased confusion about vaccination policy. “What’s going to happen is [people] who don’t trust the new ACIP are going to look elsewhere, but the question is, where’s elsewhere?” she said.
Organizations that want to provide evidence-based alternatives to non-evidence-based ACIP recommendations — if they are issued — will have to work hard to ensure people know where to look for the information, said Larson, a professor of anthropology, risk, and decision science in the department of infectious disease epidemiology at the London School of Hygiene & Tropical Medicine. “We need to really ramp up accessible, evidence-based resources for those who now don’t trust the new ACIP.”
Many assume the AAP, which still publishes its vaccination schedule for children annually in its journal, Pediatrics, will play a more prominent role in the formation and maintenance of vaccination recommendations going forward. Similarly, organizations like the American Academy of Family Physicians, the American College of Obstetricians and Gynecologists, the Gerontological Society of America, and the Infectious Diseases Society of America will continue to share their views on appropriate vaccine use.
ACOG, the group representing obstetricians and gynecologists, has been especially vocal in its objection to Kennedy’s decision to drop the recommendation for Covid boosters for healthy pregnant people, noting in a statement that infection during pregnancy can be “catastrophic.”
“I will do everything I can to use my voice to help patients know that the science hasn’t changed and that for the health and wellbeing of the pregnant individual and the baby in the first six months, we have very clear safety and efficacy evidence from all over the world. How to help patients understand those competing voices is definitely a new reality,” Linda Eckert, a professor of obstetrics and gynecology at the University of Washington and a member of ACOG’s immunization, infectious disease, and public health preparedness committee, told STAT.
All these professional organizations are cooperating with the Vaccine Integrity Project, which plans to convene a meeting in late summer to discuss who should receive flu, Covid, and RSV shots in preparation for the inevitable surge of viral illnesses next winter.
Richard Hughes, a lawyer with the firm Epstein Becker Green who follows vaccine policy closely, said the recommendations of the various professional organizations are solid, and offer a reasonable alternative, under the circumstances, for ACIP guidance.
“Those are good guidelines and if you direct providers back to those, if you direct patients to say, ‘This is a good source of truth, this is what’s relevant for you,’ I think that that’s a pretty simple way,” he said. “This is going to go on for years, potentially. And so the contingency plans need to be just very, very, very practical and not overengineered.”
“But we need to really make sure that payers are going to maintain coverage,” said Hughes, who consults for vaccine manufacturers and worked for Moderna for a time during the Covid pandemic.
That last point Hughes raised is a key question: Will insurers pay for vaccines that the CDC drops from or doesn’t add to its vaccination schedules? By law, insurers must pay for vaccines that are recommended by the ACIP, if the recommendation is accepted by the CDC.
Experts believe it’s too soon to say what might happen, arguing that at least some insurers will understand that the pertussis vaccine, for instance, costs far less than emergency room care for a toddler struggling to breathe.
“We have had discussions with everyone in the vaccine enterprise system, from the R & D all the way to the needle in the arm, and one of the areas that we recognize is going to be an incredibly important consideration is the payer issue,” said Osterholm of the Vaccine Integrity Project. “And at this time, I think it would be premature to say that ACIP recommendations will be the only things that payers will use to make determinations for what will be covered.”
“We have no promises or no factual data that can show you that they will consider alternative sources,” he continued. “But I think there surely are discussions that are being held right now that do raise that point that if you have a recommendation from ACIP that is not in keeping with the best science we have, then you, in a sense, have almost an obligation to seek other sources of expert review and input. So we’ll see where that goes.”
A related question also isn’t answerable at the moment. If the new ACIP drops a vaccine recommendation, will the Vaccines for Children program still pay for that immunization? A separate vote would have to be held, Hughes said, though that would hardly be a serious hurdle. At that point, eyes would turn to Congress to see if elected officials would be on board with the notion that children whose parents had insurance or the means to pay for a vaccine out of pocket would be protected while children from uninsured or Medicaid-eligible families probably would not.
While there are concerns about whether the new ACIP will pull apart existing vaccine recommendations, some other experts also worry about how the U.S. will incorporate new vaccines, or new uses of existing vaccines, under a vaccine-dubious administration.
In the previous iteration of ACIP, work groups were created for each vaccine that the committee needed to consider; these large groups were staffed with a mix of ACIP members, CDC staff, and academic experts on the disease under study. The work groups met regularly in anticipation of a vote that might come if a new vaccine was approved by the Food and Drug Administration, if the FDA authorized a new use for an existing vaccine, or if the committee wanted to reconsider use of an existing vaccine, as it planned to do with Covid vaccine recommendations before Kennedy fired the committee. The work of these subcommittees was fueled by analyses generated by CDC staff who mined data from clinical trials and observational studies, if there were any, and generated cost-benefit analyses on use of the vaccine in question.
Anna Durbin, director of the Center for Immunization Research at the Johns Hopkins Bloomberg School of Public Health, worries about the data that will be presented to ACIP work groups and the whole committee in the future, pointing to the way HHS leadership cherry-picks and misquotes studies to support its positions.
“One of the things that I’ve already noticed and I think others have as well is that we’re not getting data out of CDC the way we used to. Can we trust the data coming out of CDC? Not that I’m questioning current CDC employees. But what will this [health] secretary allow? We don’t know,” she said.
“How are the people making decisions going to get good scientific data?”
Larson suggested U.S. organizations that advise medical professionals on vaccines may need to look to the deliberations of vaccine advisory committees in other countries — groups like Canada’s National Advisory Committee on Immunization, the United Kingdom’s Joint Committee on Vaccination and Immunization, or the World Health Organization’s Strategic Advisory Group of Experts on Immunization.
That there are other reliable sources of vaccine information is clear. But experts who study vaccine acceptance and vaccine hesitancy worry that the fracturing of information — one set of recommendations here, a competing set there — will inevitably lead to confusion and a further decline in vaccination rates.
“We know if patients hear competing recommendations from competing voices, many of whom have the credentials after their names and the job titles that convey expertise, the more that there’s that noise, it’s understandable that some patients and some families will say, ‘Even the experts seem to be all over the place. I don’t know what to do.’ And that will suppress the vaccination rates,” Schwartz said.
Even slight changes in wording, shifting a recommendation from a vaccine someone should get to saying it is something they may get after consulting with their doctor, will drive down vaccination rates, said Rupali Limaye, an associate professor of global health at George Mason University who studies vaccine acceptance.
“We need to keep this as simple as possible, in my opinion,” Limaye said.
She worries that in this new balkanized environment, people who are most likely to get their children or themselves vaccinated will find the information to support their decisions, but others who are unsure may fall down rabbit holes an internet search led them to.
“I think the people that are going to go to the AAP are those that are already pro-vaccine,” Limaye said. “The people that I’m worried about are the people that have concerns, that are hesitant. And my worry is that they’re not going to AAP or Mayo [Clinic], they’re going to some social media site.”
Competing recommendations and declining vaccination rates lead in one direction, warned José Romero, a former chair of the ACIP and a former director of the CDC’s National Center for Immunization and Respiratory Diseases:
More preventable disease.
Romero did his medical training when now-preventable illnesses like Haemophilus influenzae type b — often referred to as Hib — routinely hospitalized high numbers of children.
“You didn’t spend a night on call where you weren’t admitting some child with [Hib] cellulitis, bacteremia, meningitis, or some complication of Haemophilus influenzae,” said Romero. Some children who suffered from severe Hib were left with developmental delays; others had hearing loss. Some lost limbs.
And then, while he was still a resident, an effective Hib vaccine was introduced “and the disease went away.”
That’s to say the severe manifestations of it became rare, because widespread use of the vaccine. But Haemophilus influenzae type b still circulates, Romero said. Hib, pertussis, and other threats that used to regularly hospitalize and severely sicken children have not been vanquished, only kept at bay. And they will return, he warned.
“And that’s what the public has to understand: That these diseases are here. They’ve never gone away,” Romero said. “These are diseases that will come back quickly if we stop vaccinating for them.”
