A Former Member of ACIP on the Dismantling of the Vaccine Recommendation Process

On June 9, Lin Chen, an HMS associate professor of medicine at Mount Auburn Hospital and a specialist in infectious disease and travel medicine, awoke to a flurry of emails.

Chen and all sixteen of her colleagues on the Advisory Committee on Immunization Practices (ACIP), the group that makes vaccine recommendations to the Centers for Disease Control and Prevention, had been dismissed. Members had found out from reading the news.

“The suddenness was quite a surprise,” says Chen, who had contributed to ACIP’s work for more than ten years, first as a member of work groups and, more recently, as one of the seventeen voting members. “The other dismissed members were asking, ‘Are we fired?’”

“The U.S. faces a crisis of public trust,” wrote U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. in an op-ed in The Wall Street Journal announcing the change. “A clean sweep is needed to reestablish public confidence in vaccine science.”

Two days later, Kennedy named eight new members to ACIP (one withdrew shortly after being named to the committee). Then, on July 31, the Department of Health and Human Services notified more than two dozen organizations (referred to as liaison organizations) that have collaborated with ACIP — such as the American Medical Association and the American Academy of Pediatrics — that they would be barred from participating in the process of developing vaccine recommendations. These organizations have typically played an important role on the ACIP work groups that draft recommendations.

Chen and the other former members of ACIP dismissed by Kennedy published a July opinion piece in The New England Journal of Medicine outlining some of their concerns about the changes to ACIP. “The abrupt dismantling of the rigorously vetted process and the replacement of the Committee with an inexperienced and biased panel has engendered fundamental distrust in the Committee’s vital work,” the former members wrote.

Chen talked to Harvard Medicine editor Amos Esty about what the changes to the committee might mean for the future of vaccine recommendations in the United States. The interview has been edited for length and clarity.

How does ACIP do its work? What steps does it take in considering whether to recommend a vaccine?

ACIP is a federal committee that advises the CDC director on how to use vaccines that are licensed in the United States. If the CDC director approves these recommendations, they become the CDC’s recommendations.

Before the recommendations are formulated, there are work groups for each vaccine-preventable disease that assess all the scientific data. For instance, there is a work group on RSV [respiratory syncytial virus] vaccines. There is a work group on COVID-19 vaccines. The work groups include ACIP voting members as well as representatives from the CDC and liaison organizations and other subject matter experts and technical experts — such as clinicians, virologists, and epidemiologists.

The work groups meet regularly and look at the epidemiology, public health impact, potential benefit of an intervention with a vaccine or the potential harm, values and acceptability of the intervention, cost analyses, equity, and feasibility of implementing the vaccine. Then they present a summary of their findings to ACIP during public meetings. The agenda is placed on the Federal Register and the meetings are scheduled years in advance so people can plan on attending. Once the data are presented, the ACIP voting members — who are appointed by the Department of Health and Human Services — decide on the final recommendations. And even if the vaccine is licensed [by the FDA] for a broad range of the population, ACIP may designate the recommendation for a smaller group.

So the ACIP process is transparent. It’s always been nonpartisan until the past few months. And it’s always based on evidence, on scientific data. Those three key points have made ACIP a highly respected committee.

Once ACIP’s recommendations are finalized, who uses them, and how?

There are around thirty liaison organizations that adopt ACIP recommendations for their patient populations or consider them in insurance coverage. These organizations, like the American Academy of Pediatrics or the American Academy of Family Physicians, take care of populations for whom vaccine-preventable diseases rank highly for their target interventions. There are also health insurance groups and pharmacists’ groups. Many professional organizations see the value in adopting very rigorously vetted recommendations that are consistent throughout the United States.

Is there involvement from the general public in ACIP’s workflow?

There is a consumer advocate who represents the public. And that’s someone who is very aware of public concerns about vaccine-preventable diseases and vaccines and the public’s opinions about vaccines. Also, during the public comment period, people can submit their experiences and opinions. And some individuals may reach out to ACIP members to express their own perspectives.

You mentioned that ACIP’s work was nonpartisan until recently. What suggests to you that the new committee is more partisan?

The people named to be the new ACIP did not uphold the scientific rigor and evidence-based review by work groups expected of the ACIP. The clinical experience in taking care of patients and treating vaccine-preventable diseases was lacking for all but one of the members. Before the most recent meeting, the new ACIP changed the agenda late, without explanation, and invited the leader of an antivaccine group founded by RFK Jr., which showed the committee’s bias. Her citation of materials was biased or ideologically motivated to promote vaccine skepticism.

They also fired the ACIP Secretariat [a group of CDC staff that supports the work of the committee], which has profound and tremendously broad knowledge from years of work with vaccine programs. And the announcement that the work groups will exclude participation by members of liaison organizations means that HHS intends to limit the representation of patients, of people who need to be, or want to be, protected from vaccine-preventable diseases.

It’s just one of the steps toward dismantling the vaccine program in the U.S., which is such an important part of our public health infrastructure. I think many medical and public health organizations have lost trust in the new ACIP, given the lack of transparency, the obviously biased perspective, the bypassing of the former robust process, and the lack of scientific rigor.

Are there potential ramifications for loss of insurance coverage of some vaccines?

Yes, there is great concern. Perhaps federally funded programs like Medicaid will pull back on covering vaccines. Perhaps children will lose access to vaccines through the Vaccines for Children program, which about 50 percent of U.S. children are eligible for. The vaccination programs in the Veterans Health Administration are based on ACIP. So, if recommendations from ACIP are changed, it’s possible that people will have to pay for their vaccines. Likely the overall vaccination rate in the population will fall, and more people will be exposed to these preventable diseases.

In addition to accusations related to conflicts of interest, Robert F. Kennedy Jr. wrote that he took the action in order to help restore the public’s trust in ACIP. Do you think there was a problem of public trust in the ACIP’s recommendations in recent years?

No, not at all. His claim is contrary to the opinion of most Americans, who trust ACIP and vaccines. As my fellow former ACIP members and I wrote in a recent JAMA article, “For the past 18 years, the National Immunization Survey has shown that 99 of every 100 children in the U.S. have received at least some recommended vaccines by 2 years of age, consistent with acceptance of ACIP recommendations implemented by trusted providers. This does not suggest the population is so distrustful that it warrants dismantling the process by which vaccines have been recommended.”

Many people may not fully understand the depth and the breadth of the former ACIP process and the thorough vetting of conflicts of interest and mitigation of potential conflicts of interest, but I think they have trusted the people who served on ACIP and the liaison organizations that adopt the recommendations. I also think the people disseminating misinformation and disinformation have been much more vocal than the trustful ones. They have attempted to overshadow the majority of people, the mainstream, who actually do trust vaccines and want to be protected from vaccine-preventable diseases.

Do you think that individual states might end up developing their own sets of recommendations related to vaccines?

With this chaos happening, some states started thinking maybe they would formulate their own recommendations. But if each state does that, the inconsistency will be confusing and it will be very challenging to achieve adherence. And if somebody were to move from state A to state B, how do you reconcile those vaccine recommendation differences?

The hope is that states will adopt vaccine guidance developed by a coalition of leading liaison organizations, such as the American Academy of Pediatrics, the American Academy of Family Physicians, the American College of Physicians, and the Infectious Diseases Society of America. I think these organizations and their collaborators can form a trusted voice. They will continue to assess vaccine needs, the best timing, the potential benefits versus harms, acceptability and feasibility, and the like. They can collaborate to aim for a more uniform set of recommendations.

In our article we also mentioned the Vaccine Integrity Project, which is based at CIDRAP [the Center for Infectious Disease Research and Policy]. They are supporting the process of rigorous data assessment needed for vaccine guidance and convening the key professional organizations to develop the guidance, as well as discussing adoption of this guidance with state health departments and other stakeholders.

It’s been about two months since the dismissal. Are you and other former members of ACIP trying to stay involved?

The disruptions to U.S. vaccine policy continue to alarm the former ACIP members. People apply to be on ACIP because it’s public service. It’s an expansion of our work on either vaccine development or clinical care of patients or seeing the benefit of vaccines. It’s a great public health effort, and the former ACIP members are still very committed to doing that. Some will continue to contribute to developing vaccine recommendations through other organizations. I will certainly continue to give vaccine-related advice, do my part in clinical care, and give the most appropriate evidence-based recommendations possible.

I think we’re all still trying to figure out what the best way forward is. The important thing is that we really want to make sure vaccine policy in the U.S. is transparent, based on science and evidence, and nonpartisan. And it’s sad that we’ve come to this point because of politics.