Before leaving office, President Biden’s health secretary approved the appointments of eight new candidates to a critical committee that helps set U.S. vaccination policy — a burst of activity within a matter of a few months that could, in theory, make it more difficult for the Trump administration to shape the panel with its own appointees, several sources have told STAT.
The late-in-the day move to fill four new spots on the Advisory Committee of Immunization Practices, and approve replacements for four members whose terms expire at the end of June, was motivated by a desire to try to insulate the scientific integrity of the panel from the incoming administration, one source told STAT, stacking it with people who, unlike President Trump’s pick as health secretary, Robert F. Kennedy Jr., have not expressed skepticism about vaccines.
“It was very intentional,” a former senior Health and Human Services Department official said. “It was our goal to fill every vacancy on every [federal advisory committee] the department has, with particular focus on ones like ACIP where maintenance of our scientific expertise was critical.”
The moves would seem to deprive Kennedy — should he be confirmed as HHS secretary — of a chance to name new members of the ACIP, which helps the Centers for Disease Control and Prevention determine the appropriate use of vaccines, until 2027.
Experts in public health and vaccine law believe, however, that any attempt to protect the status quo at the ACIP will prove to have been futile. People who sit on this committee have at-will appointments, they noted. Kennedy — or whoever replaces him, should the Senate reject his nomination — could easily take away what Xavier Becerra, health secretary in the Biden administration, bestowed.
“The latitude that CDC and by extension HHS and the secretary has to reshape, reconstitute, change the membership, change the mandate, change the scope of work, change how frequently ACIP meets, to decide whether or not the committee exists at all are absolutely within the purview of the new administration,” said Jason Schwartz, an associate professor at the Yale School of Public Health. “So their ability to shape this committee in whatever form they’d like it to take is effectively limitless.”
Asked by STAT to confirm the ACIP appointments, HHS did not respond.
The ACIP, which was created in 1964, plays a pivotal role in the setting of vaccination policy in this country. When a new vaccine is approved by the Food and Drug Administration, the committee reviews its safety and efficacy data to determine if the CDC should recommend its use — a prerequisite for insurance coverage. ACIP recommendations have to be formally accepted by the CDC director, but the number of occasions when the director has rejected a committee recommendation have been vanishingly rare.
It also regularly reviews the safety data on previously recommended vaccines, particularly if the various adverse events reporting systems operated by the CDC and the FDA detect possible signals that a vaccine may be causing harm to some recipients. At its 2024 February meeting, the ACIP concluded that older adults who get the new RSV vaccines marketed by Pfizer and GSK may be at a slightly higher risk of developing Guillain-Barré syndrome, a form of progressive but generally temporary paralysis. The committee’s concerns about the risk-benefit ratio of RSV vaccines for older adults have led it to slow-walk efforts by manufacturers to rapidly expand use of these vaccines.
Schwartz and others interviewed by STAT raised a number of possibilities about what might be in store for the ACIP under the Trump administration, with Kennedy as HHS secretary and Dave Weldon, who has espoused disproven theories that some vaccines trigger autism, as CDC director. Weldon, too, must be confirmed by the Senate, a first for the position of CDC director.
The future they can imagine unfolding includes: canceling or postponing upcoming meetings, the first of which is slated for the end of February; refusing to seat the approved members that Becerra teed up to join the committee; firing some or all of the existing members; having Weldon override ACIP’s recommendations more frequently, or disbanding the body entirely.
“I would think that you could almost guarantee that there’s going to be some interference with the committee’s work,” said Richard Hughes IV, a partner with the law firm Epstein, Becker, Green who advises a number of vaccine manufacturers — he declined to list them all — and teaches vaccine law at The George Washington University in Washington, D.C.
“They’ve already paused the MMWR,” Hughes noted, referring to the CDC’s Morbidity and Mortality Weekly Report, a tool for rapid dissemination of scientific findings that has been caught up in the “communications pause” imposed by the new administration. “I think that there will be anti-vax folks that see it as an opportunity to capture the committee, to reconstitute its membership. I think that as much as [Kennedy] is distancing himself right now [from his critiques of the safety of vaccines], I do think that he is held a little bit captive to them, and he will have to give them something.”
Before the Biden administration left office, Becerra made no public mention of having approved a batch of new appointments; typically the identities of new committee members are only revealed when they are introduced at their first meeting. It was long the practice to line up new ACIP members well before their terms would begin, with the CDC vetting would-be committee members and the HHS having the final say. But under Becerra’s tenure, the appointment process lagged to the point where it looked like the committee might fail to have a quorum to meet, a problem he eventually remedied with a spate of appointments. Eleven of the current roster of 15 members joined the committee last year.
Sources told STAT three of the new ACIP members will, theoretically, join when the committee next meets, in late February. The remaining members of this in-the-wings group will, in theory, see their four-year terms on the committee begin on July 1. Four of the July appointments are replacements for members due to cycle off the panel at the end of June, including chair and long-time member Helen “Keipp” Talbot, a respiratory infections expert at Vanderbilt University.
The February additions, and one of the people slated to join in July will increase the ACIP’s roster from 15 to 19, an expansion set out when the committee’s charter was renewed last April in response to the amount of work it undertakes.
If all these new appointees were allowed to take seats on the panel, the next set of vacancies would not come open up until 2027, giving Kennedy or his successor a long wait before getting a chance to start shaping this critical group in a way that is more reflective with his views on vaccines. The committee’s charter must be renewed by April 1, 2026, which would present an earlier opportunity for the health secretary to increase the size of the panel or make other changes to it. Schwartz noted there is nothing blocking the HHS secretary from approving a rewritten ACIP charter before the existing one expires.
People who monitor the operations of ACIP think it is most likely that the February meeting — slated for Feb. 26 through 28, with votes scheduled on flu vaccines, RSV vaccines for adults, and the first ever chikungunya vaccine, among others — will be postponed. A meeting of the National Vaccine Advisory Committee, a different HHS vaccine advisory group, that was slated for earlier in February has already been canceled. And on Wednesday, STAT reported that members of the Health Information Technology Advisory Committee were informed that future meetings of that committee have been indefinitely postponed.
As for the waiting-in-the-wings ACIP members, the experts STAT interviewed believe they are unlikely to get a chance to serve during this administration.
“Given it’s a regime change, I don’t see anybody that is in any kind of appointed position, especially just somebody who has not even taken their spot yet, I don’t see them surviving,” Hughes said.
Withdrawing those appointments so that he could fill them with people who share his views on vaccines would not give Kennedy a majority of the committee, however. If he wanted to fundamentally change the thinking on vaccines on the ACIP, more vacancies would have to be created. “I think even the current committee members could be thanked for their service and dismissed, even if their terms are not yet expired,” Schwartz said.
Dorit Reiss, a law professor at UC Law San Francisco (formerly UC Hastings), agreed this is possible, though she pointed out it would be a first.
Kennedy may have signalled how he intends to proceed when he appeared this week before two Senate committees, telling both he wants to rid the vaccine evaluation process of people with conflicts of interest. In his testimony to the Senate Committee on Finance, he alleged that 97% of the ACIP members had conflicts of interest. “I don’t believe that that’s right. I think we need to end those conflicts and make sure that scientists are doing unobstructed science.”
In reality, the conflict of interest rules facing committee members are strict. People with existing conflicts of interest are not considered for membership on ACIP. New members must file a confidential financial disclosure on appointment; it is reviewed by the ACIP Secretariat, the Federal Advisory Committee Management Branch and the Office of General Counsel at CDC. These reports must be updated annually during a member’s term. If a conflict does arise — for instance, a member was part of the team that conducted a clinical trial the committee is reviewing — the member must recuse him or herself from any votes related to it.
Another way the incoming secretary could shift the thinking of the ACIP is by changing the composition of the work groups that review individual vaccines and recommend the approach the full committee should take. Work groups, which are chaired by an ACIP member, are typically composed of CDC staff and academic experts on the disease in question; the membership can number in the dozens. Loading them with people who distrust vaccines could gum up the workings of the ACIP as it pertains to new vaccines coming to market, or revising existing vaccine recommendations, Reiss said, noting the ACIP charter doesn’t spell out who can be on the committee’s work groups. (In fact, it does not mention them.)
Why not just do away with the committee altogether? That might hold some appeal to the people who make up Kennedy’s political base. “I think there’s a lot of disdain in the anti-vax community toward ACIP,” Hughes said. But axing the committee could actually make it hard to achieve some ends to which Kennedy might aspire, Reiss argued.
“Even if he does away with ACIP, there are still the existing recommendations. There just won’t be additional ones,” she said. “To roll back [existing] recommendations, he’d have to have an obedient committee that is rolling back recommendations. Somebody would have to actively cancel these recommendations.”
Schwartz agreed: “I think the committee could serve as a vehicle to translate lots of what we’ve been hearing into actual concrete changes to the proposals in ways that wouldn’t happen if the thing was just wiped off the books. So that’s why I expected it to have a new chapter. And just what exactly it looks like and who’s sitting around that table over the next couple of years, I think, is very, very much an open question.”
Many of the existing vaccine recommendations suggest people “should” get the vaccine in question, whether that’s chickenpox vaccine for young children, HPV vaccine for pre-teens or teens, or annual flu shots for everyone over the age of six months. Sometimes, though, the committee doesn’t issue such an affirmative recommendation, suggesting people “may” get vaccinated, after consultation with a health professional. This type of recommendation is called “shared clinical decision-making.”
Reiss cited the example of the HPV vaccine, which protects against sexually transmitted viruses that cause cervical, penile, and a range of other cancers. A two-dose vaccine, it is recommended for all girls and boys. The highly effective vaccine is radically reducing the incidence of cervical cancer where it is used effectively. But vaccine critics have targeted it, and evidence suggests concerns about its safety are growing. Reiss suggested one outcome Kennedy might like to see would be to have the existing “should” recommendation replaced with one calling for shared clinical decision-making.
This type of recommendation would likely depress vaccine uptake, sending a signal that the vaccination is optional. Medical professionals have complained about shared clinical decision-making recommendations, saying doctors often do not have the time needed for this type of conversation with a patient, and pharmacists, whose role in vaccine delivery has expanded dramatically in recent years, may neither have the time nor the background to have the discussion.