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With rates of Lyme disease on the rise in Maine, physicians are eager for a Lyme vaccine to assist patients. One is on the horizon, but its future availability is up in the air because the Trump administration has effectively eliminated the federal committee that would provide guidance on the new vaccine.
The vaccine, developed by Pfizer in partnership with the pharmaceutical company Valneva, has completed its human trials. The companies are preparing to submit the final vaccine proposal to the U.S. Food and Drug Administration — but FDA approval is only one step in making the Lyme vaccine available.
After receiving FDA approval, a vaccine typically receives a recommendation from a group that has historically received little public attention: the U.S. Centers for Disease Control and Prevention’s independent Advisory Committee on Immunization Practices. The committee’s guidance has long been considered the gold standard for vaccination, and its recommendations inform which vaccines are covered by insurance and how physicians prescribe them.
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But the Advisory Committee on Immunization Practices is currently unable to give recommendations. In 2025, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. fired every member of the advisory committee, and the 13 replacements he appointed drew legal backlash. A group of medical organizations filed a lawsuit in July 2025 claiming that the new committee members had not been thoroughly vetted and did not have the necessary credentials to provide scientific counsel.
With the lawsuit ongoing, a judge ordered in March that the committee cannot meet or create recommendations about new vaccines.
What does this mean for the Lyme vaccine? According to vaccine law experts and former members of the Advisory Committee on Immunization Practices, there is no way to know whether the Lyme vaccine will receive the needed recommendations for the rollout to be accessible to consumers. According to a Pfizer spokesperson, it is “early to speculate” about when the vaccine might become available.
“All the rules are out the window,” said Paul Offit, a physician who previously served on the advisory committee. “I don’t know how this plays out.”
The growing problem
Before Republican U.S. Sen. Susan Collins voted to appoint Kennedy as head of the department responsible for public health, health care and social services, she questioned him in front of Congress about his commitment to combatting Lyme disease, mentioning the prevalence of ticks in Maine. Lyme disease is a bacterial infection that humans contract through tick bites. It can cause serious symptoms, including rashes, aches, stiffness, facial paralysis, fevers and an irregular heartbeat that can last for months, with residual pain and arthritis sometimes continuing for years after the initial bite.
Nationally, nearly half a million people are treated for Lyme disease each year, and Maine has one of the highest per capita rates of infection of any state. Maine saw its most active tickborne illness season in 2025, with providers reporting more than 4,000 Lyme disease cases, breaking the state’s record for the third year in a row.
Southern Maine sees particularly high numbers of ticks, with the population size dropping off north of Bangor. But tick season is getting longer, and tick territory is expanding northward. Griffin Dill, who manages a lab at the University of Maine Cooperative Extension in Orono that monitors tickborne pathogens, said that the combination of warmer, shorter winters — along with housing being built in ticks’ forest habitat — can create a “perfect storm” for ticks to expose people to Lyme.
Lyme disease can be difficult to diagnose. If the tick bite is identified within 48 hours, a standard course of antibiotics can effectively prevent it. But people may not recognize they’ve been bitten by a tick until symptoms begin days or weeks later. Similarly, practitioners don’t always consider testing for Lyme, and tests for the disease often return false negatives. With such limitations to diagnosis and treatment, experts recognize the importance of a vaccine.
“There is nobody who will fight harder to find a vaccine or a treatment for Lyme disease than me,” Kennedy testified to Congress.
Since being appointed, Kennedy’s interest in Lyme has been evident. He hosted a December 2025 roundtable discussion about the disease in Washington, D.C., that included Collins. More recently, on Aug. 17, he released a video with actor Dennis Quaid announcing that the federal government is “investing millions in innovation to develop AI-powered tools that improve patient care, enable earlier diagnoses and accelerate research to help eradicate Lyme disease and other tickborne illnesses.”
But Kennedy has said little about the potential for a Lyme vaccine and has repeatedly used his platform to discredit a wide range of vaccines despite overwhelming research showing their safety.
“We have an anti-vaccine activist making policy,” Offit said. “The world has turned upside down.”
‘A circus’
A new vaccine typically undergoes years of testing under the FDA’s oversight before it is officially submitted to the agency for approval to put the drug on the market. A review of the vaccine’s safety and effectiveness is also conducted by the FDA’s Vaccines and Related Biological Products Advisory Committee, a team of doctors and scientists who provide an independent recommendation to the agency. The ultimate decision for a vaccine’s approval is left to the health and human services secretary — currently Kennedy — and the FDA commissioner, a role that has been in flux. Heidi Overton, a doctor who has previously supported changes to children’s vaccines made by Kennedy and President Donald Trump, was nominated for the post by Trump and is awaiting U.S. Senate confirmation.
Pfizer and Valneva are currently preparing their final vaccine submission for FDA approval after multiple years of testing. Earlier this year, they concluded a clinical trial that involved 9,000 people at 97 testing centers in the U.S. and Europe, including patients with MaineHealth and Northern Light Health. After administering four doses of the vaccine to each patient, the trial found no safety concerns and a 73.2 to 74.8 percent efficacy rate — the percent reduction in Lyme infection caused by the vaccine. (The efficacy rates found in clinical trials for major COVID vaccines were in the low 90’s.)
The vaccine did not meet its primary statistical goal in the trial, but Pfizer said the vaccine’s reduction of infections was still “clinically meaningful.” The companies are planning submissions to regulatory authorities, though getting approved is no guarantee.
After a vaccine is licensed by the FDA, it is passed to the Advisory Committee on Immunization Practices for its recommendation about how physicians should prescribe it and insurance companies pay for it. The advisory committee is made up of physicians, public health officials and scientists independent from the U.S. Centers for Disease Control and Prevention.
The U.S. Centers for Disease Control and Prevention typically forms a workgroup that includes advisory committee members and disease-specific experts several years before the vaccine is set to receive FDA approval. The group studies the disease alongside vaccine trial data and other documentation that pharmaceutical companies provide, and regularly presents to the full Advisory Committee on Immunization Practices to inform its eventual recommendation.
A workgroup for Lyme was announced in April 2025, just two months before Kennedy fired the entire 17-person committee on June 10. The workgroup’s first presentation was initially scheduled for a future meeting, but, after the committee membership changed, the Lyme presentation never happened. The disease was never added to the advisory committee’s list of active workgroups.
Charlotte Moser, a co-director of the Vaccine Education Center at Children’s Hospital of Philadelphia and one of the committee members who was fired by Kennedy last year, was supposed to be part of this workgroup.
“When we were fired, nobody at CDC knew that day. We all found out through the opinion piece in the Wall Street Journal,” she recalled.
Moser’s application to join the advisory committee took years of review and numerous interviews before she was appointed to the group. Adding new members to the Advisory Committee on Immunization Practices is usually a precise process, in part because the committee’s charter has historically stipulated that the roster must include people with a specific array of credentials on top of general standards for clinical expertise. When Kennedy announced a new slate for the committee within 48 hours of firing the previous one, Moser said it was clear the new members had not undergone a similarly rigorous selection process.
Public health officials voiced concern that the new members promoted debunked ideas about vaccines. Vaccine policy attorney Richard Hughes, on behalf of the American Academy of Pediatrics and several other medical groups, brought a lawsuit against Kennedy in July 2025, stating that the new appointments violated the committee’s charter because the members did not have the mandated expertise. The lawsuit also contested Kennedy’s January overhaul of the childhood immunization schedule.
“What happened after he appointed a lot of these people is they started presenting junk science at their meetings. They started platforming misinformation. It just became a circus,” Hughes said.
In March, a judge ordered a preliminary injunction in favor of Hughes and the American Academy of Pediatrics. The judge’s decision halted all recommendations made by the 13 advisory committee members Kennedy appointed last year.
Soon after, Kennedy announced updates to the advisory committee’s charter that would loosen the membership requirements, but the department of health later appealed the court’s preliminary injunction and backpedaled the charter changes. In June, Kennedy again announced loosened member requirements and refocused the committee on exploring the risks posed by vaccines and considering non-vaccine methods of intervention.
Hughes clarified that the injunction halts actions from the 13 advisory committee members appointed by Kennedy in 2025, but it does not prevent Kennedy from appointing qualified experts or re-appointing the previous officials who could then move forward with vaccine recommendations. So far, the secretary has not done so.
“We hope that we win our case,” Hughes said, “and that we can get back to a point where the administration is willing to put qualified experts in place.”
The U.S. Department of Health and Human Services did not respond to a request for comment for this story. The U.S. Centers for Disease Control and Prevention said that it would not comment on ongoing litigation.
Oral arguments for the lawsuit appeal could kick off as soon as September.
Patchworking a response
If the Advisory Committee on Immunization Practices was functioning, it would instruct providers on how to administer any FDA-approved Lyme vaccine, particularly to at-risk populations such as children, pregnant people and those highly exposed to the disease. Its recommendation is not only critical to a physician’s ability to administer a vaccine; under the Affordable Care Act, private insurance companies are required to cover the cost of vaccines recommended for patients by the committee.
Moreover, the Vaccines for Children Program relies on the committee’s recommendations to decide which vaccines to provide at no cost to people 18 and younger in the U.S. Without the committee, the prescription and insurance procedures become much less clear.
For seasonal vaccines such as the influenza shot, “vaccine production, coverage, and delivery is resilient enough to hold together for now” by relying in part on goodwill from insurers, according to Hughes. Providers and insurers can refer to their practices with previous iterations of the vaccines. But there is no precedent to fall back on for recommended use and coverage of the new Lyme vaccine by Pfizer and Valneva.
A number of independent medical groups have stepped up to provide recommendations to prescribers in place of the Advisory Committee on Immunization Practices and could do so for the Lyme vaccine. The American Academy of Pediatrics is distributing recommendations for children; the American College of Obstetrics and Gynecologists for pregnant people; the American Academy of Family Physicians for healthy adults; and the Infectious Disease Society of America for those who are immunocompromised.
But even if these organizations give useful guidance to prescribers, they do not mandate insurance coverage the way an official Advisory Committee on Immunization Practices recommendation would.
“I think there’s a really heightened risk that consumers just are confused about all vaccines including this one,” Hughes said, adding that incomplete insurance coverage can “cause patients not to get vaccinated.”
There are ways around the now-defunct advisory committee, but they create a more scattershot approach to vaccines. For instance, states have the authority to require vaccine insurance coverage beyond any federal requirements. (Maine is one such state that follows the American Academy of Pediatrics’ childhood immunization schedule rather than the Trump administration’s.)
Health insurance companies could also offer coverage of a Lyme vaccine on their own. In statements to The Maine Monitor, Maine Community Health Options and Anthem stressed that they consult clinical evidence and the recommendations of medical organizations when determining insurance coverage for vaccines. Insurance companies sometimes decide to cover vaccines before it is mandated, especially for high-risk populations.
But a patchwork of review and recommendation processes cannot be a long-term solution, said Stanford pediatrics professor Yvonne Maldonado.
“We don’t have the resources or the data to really analyze and understand the data the way the federal government does,” said Maldonado, a former member of the Advisory Committee on Immunization Practices who was removed by Kennedy. For instance, the advisory committee could use the large staff of the U.S. Centers for Disease Control and Prevention to conduct additional research to answer important questions.
Without the advisory committee’s meetings, which are open to the public, the trial data produced by pharmaceutical companies is less available, which may further compromise public trust in vaccines.
“One of the victims of what’s going on is transparency,” said vaccine law expert Dorit Reiss. “It’s a mess.”
(The Lyme vaccine’s trial results will be “presented at an upcoming scientific congress and submitted for publication in a peer-reviewed journal,” a Pfizer representative said.)
Moser, one of the former advisory committee members, emphasized that the piecemeal efforts of pharmaceutical companies, medical organizations and state governments to keep the vaccine recommendation system afloat do not constitute a functional public health infrastructure.
“There is work that’s not being done right now that should be being done when it comes to just understanding vaccines and making them available in this country,” Moser stressed. “When we have chaos and confusion, there will be people who suffer outcomes that could have been prevented.”
A ‘specter’ on the project
Pfizer and Valneva’s Lyme vaccine would not be the first. Another Lyme vaccine, known as LYMErix, was sold from 1998 to 2002 before being abruptly removed from the market due to poor sales and lawsuits from patients.
The short lifespan of LYMErix could be explained in part by an Advisory Committee on Immunization Practices decision, said Offit, who was on the committee at the time. Instead of giving a full recommendation, the committee recommended that LYMErix be “considered” for patients with high risk of exposure. Offit said this recommendation was politically motivated, and it left the manufacturer vulnerable to litigation.
It’s not yet clear if the new vaccine by Pfizer and Valneva will fare better. Both have targeted the same protein, and the new vaccine has shown a slightly lower efficacy rate than LYMErix, meaning the vaccine appears less effective at lowering the risk of Lyme. LYMErix also required fewer doses than the Pfizer vaccine would.
A Pfizer spokesperson responded that the company is confident in the vaccine and that one “cannot and shouldn’t make comparisons to other manufacturers’ vaccines.”
Awareness of Lyme disease has grown in the nearly three decades since LYMErix was sold, so Pfizer’s vaccine may face fewer issues with uptake. But Reiss said that public trust will need to be earned under the “specter” of the previous Lyme vaccine and the Trump administration’s messaging.
“There’s a sense that this administration — even if they approve the Lyme vaccine and even if they come home with the recommendation — will message it in a way that will undermine uptake and undermine the vaccine in other ways,” Reiss said.
Pfizer and Valneva’s Lyme vaccine is furthest along in the approval pipeline, but it is not the only Lyme drug in development. Moderna is currently testing two mRNA Lyme vaccines. Tonix Pharmaceuticals also licensed a Lyme antibody last year as part of its effort to one day provide seasonal protection against Lyme. Tonix CEO Seth Lederman is looking for hospitals in Maine to work with for Tonix’s upcoming clinical trial.
Lyme disease is not the only tickborne illness. In addition to promoting the Lyme vaccine, the state should pursue environmental strategies to stem the tick population’s growth, said former Maine Center for Disease Control and Prevention Director Dora Mills. The Lyme vaccine would not offer protection against other tickborne illnesses such as the bacterial disease anaplasmosis, she said, and wearing protective clothing, using repellents and doing tick checks would still be important.
Dill, of the UMaine Tick Lab, said he predicts a Lyme vaccine “would be relatively popular given how common tickborne illness has become in Maine.”
It’s possible that a vaccine could prove particularly helpful for those working in the state’s forests where ticks are prevalent. But loggers will look for evidence that they can trust the vaccine first, said Dana Doran, executive director of the Professional Logging Contractors of the Northeast.
“They want to make sure that a product is worthy of utilization before they just go ahead and use it,” Doran said.