By Gina Shaw
With federal vaccine policymaking in turmoil, state boards of pharmacy are scrambling to respond. The purge of the CDC’s Advisory Committee on Immunization Practices (ACIP) membership by Health and Human Services Secretary Robert F. Kennedy Jr., and the appointment of new members—including a number of vaccine skeptics—has disrupted what was once a tightly aligned national vaccine framework.
In response, state pharmacy regulators are now being forced to draft their own rules, clarify who can administer vaccines and under what conditions, and figure out whether pharmacists can legally continue vaccinating without prescriptions.
Lemrey “Al” Carter, PharmD, MPH, the executive director of the National Association of Boards of Pharmacy, noted that he had just returned from district meetings involving multiple states, where the subject was a hot topic. “State boards of pharmacy are working with their state health agencies on policies that will allow pharmacists to continue to be able to provide these vaccinations,” Dr. Carter said.
Attorney Brad Gallagher, JD, a co-leader of Barclay Damon’s Health Care Controversies and Pharmacy Teams, said states and pharmacies are having to navigate conflicting regulatory waters, between historic ACIP recommendations, new HHS policy guidance and emergent state-level actions, without a reliable central standard. “Pharmacists are caught in the middle of policy and science, and there is a real danger that legal liability will follow if the ground continues to shift under their feet,” Mr. Gallagher said.
On June 9, Mr. Kennedy dismissed all 17 sitting ACIP members, claiming conflict-of-interest concerns, and followed that up with the appointment of eight new members—many of whom have expressed anti-vaccine or vaccine-critical views. On Sept. 15, Mr. Kennedy appointed an additional five members to the panel, including a pediatric cardiologist who has raised concerns about mRNA vaccine safety, an OB-GYN who is opposed to COVID-19 vaccine mandates and an epidemiologist who has questioned federal public health policies. The group also includes a pharmacist focused on access and affordability and a transplant surgeon with prior research and whistleblower experience.
The panel’s overall composition marks a sharp break from the traditional ACIP roster of infectious disease and immunization experts. The new committee is scheduled to meet for the first time on Sept. 18-19.
Because ACIP’s recommendations have traditionally driven both CDC guidance and state vaccine policies, the shake-up has left many states without clear federal direction, especially in the interim period before the new committee acts. State boards of pharmacy are doing their best to keep up with the rapidly changing landscape, reviewing their statutes and regulations to clarify pharmacists’ scope for vaccine administration, Dr. Carter said. “They are in something of a predicament because most of their policies had stipulated that pharmacists could administer vaccines that were ACIP-recommended.”
In response to the uncertainty, a growing number of states have taken action to preserve vaccine access without individual prescriptions, often relying on state boards of pharmacy or state public health orders.
Responding to prompting by Gov. Josh Shapiro, Pennsylvania’s State Board of Pharmacy voted in early September to allow pharmacists to administer COVID-19 vaccines without prescriptions and to follow recommendations from trusted medical organizations, including the American College of Obstetricians and Gynecologists, American Academy of Pediatrics, and American Academy of Family Physicians, rather than strictly follow ACIP guidance.
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In Colorado, Gov. Jared Polis issued a public health order allowing individuals as young as 6 months to receive updated COVID-19 vaccines without a prescription. That order also instructed the state pharmacy board to adopt rulemaking to support pharmacists in delivering vaccines under that authority.
Massachusetts Gov. Maura Healey also directed insurers to continue coverage for state-backed COVID-19 vaccines and issued standing orders to pharmacies so shots can be given to residents older than 5 years of age without requiring an ACIP-based recommendation.
Regional coalitions are also taking shape. California, Oregon, Washington and Hawaii have announced a Western regional vaccine alliance to coordinate recommendations, which on Sept. 17 issued coordinated winter virus vaccine recommendations, including the 2025–26 COVID-19 vaccine, influenza and RSV, available online here.
The COVID-19 vaccine, for example, is recommended for:
• All 65 years and older
• All younger than 65 years with risk factors
• All who are in close contact with others with risk factors
• All who choose protection
That statement was followed by a Sept. 18 announcement from seven Northeastern states and New York City that they had formed the “Northeast Public Health Collaborative, a regional partnership to share expertise, improve coordination, and protect evidence-based public health, with work groups identifying opportunities for collaboration including public health emergency preparedness, vaccine recommendations, data collection, infectious disease management and laboratory services."
The coalition includes Connecticut, Maine, Massachusetts, New Jersey, New York State, Pennsylvania, Rhode Island and New York City.
“While the Northeast Public Health Collaborative members share common public health goals and objectives, they recognize that each state and city is independent with their own diverse populations and unique sets of laws, regulations and histories,” the statement said. “Members may choose to participate in or adapt those specific initiatives consistent with their particular needs, values, objectives, and statutory or regulatory requirements.”
Explicit Vaccination Orders Needed
Mr. Gallagher urged states to issue explicit standing orders or board “clarifications” so that community pharmacists are not left in legal limbo. “We’re advising boards to spell out which vaccine recommendations pharmacists can safely rely on, and by extension, what liability protections pharmacists have when using those guidelines,” he said.
These state-level interventions are not just stopgap measures, he said, emphasizing that ensuring broad vaccine access is essential, particularly for patients who rely on pharmacies as their most convenient or only point of care. But he cautioned that these measures also create new challenges: Which guidelines should pharmacists follow if ACIP and state policy diverge? Will insurers cover vaccines provided under state standing orders? And what happens if patients miss vaccines because of the confusion?
“Pharmacists are going to be caught between competing authorities,” he said. “If they give a vaccine because the state board or the governor has said they can, but ACIP hasn’t endorsed it, that could be a problem later,” he said. “Insurers may refuse to cover it, and if there’s an adverse event, plaintiffs’ lawyers will ask what standard of care the pharmacist was following. If patients miss vaccines because pharmacists are told to wait on ACIP, you can be sure someone will argue that access was denied, and that can turn into a liability question too. That’s why it’s so important for boards of pharmacy, state health departments and pharmacy leadership to be clear about which authority they’re relying on.”
Clarity is especially critical for COVID-19 vaccines, where FDA approvals have already narrowed eligibility, and where ACIP has delayed or modified recommendations. In Pennsylvania, for example, the board’s action clarified that pharmacists could continue to administer updated COVID-19 vaccines regardless of whether ACIP has issued a new federal recommendation. Mr. Gallagher called the Pennsylvania vote “a necessary and pragmatic fix” to cut through what he described as “administrative limbo.”
Dr. Carter stressed the importance of grounding any policy in the extensive scientific record supporting vaccine safety and effectiveness. “Every vaccine licensed in this country has been through rigorous clinical trials and is subject to ongoing safety monitoring,” he said. “Vaccines remain one of the most effective public health tools we have.”
The upcoming ACIP meeting is expected to be closely watched. On day 1, the panel will review measles, mumps, rubella and varicella and hepatitis B vaccines; day 2 will focus entirely on COVID-19 vaccines. State boards may have to revisit or revise standing orders, depending on how closely they tie to ACIP. “States that have put emergency standing orders in place can’t assume those will carry forward automatically,” Mr. Gallagher said. “Once ACIP acts, they’re going to have to look at those orders again, confirm they’re still valid, and in some cases update them so pharmacists aren’t left in limbo.”
Reimbursement a Challenge
Another key challenge is reimbursement. “Some states have regulations where reimbursement is directly tied to the ACIP recommendations, and they are working to remove those requirements,” Dr. Carter said. “So, whether it’s through the insurance commissioner or through working with individual plans, there may be options for emergency language stipulating reimbursement in the same manner that they would reimburse any other approved medication.”
A Sept. 16 statement from America’s Health Insurance Plans (AHIP) seems to clarify that the commercial and Medicare Advantage plans it represents will continue to cover vaccines on the previous ACIP-recommended schedule as it stood as of Sept. 1, at least through the end of the year. “Health plans will continue to cover all ACIP-recommended immunizations that were recommended as of Sept. 1, 2025, including updated formulations of the COVID-19 and influenza vaccines, with no cost-sharing for patients through the end of 2026,” the statement said.
“Health plans are committed to maintaining and ensuring affordable access to vaccines. Health plan coverage decisions for immunizations are grounded in each plan’s ongoing, rigorous review of scientific and clinical evidence, and continual evaluation of multiple sources of data,” it continued. “While health plans continue to operate in an environment shaped by federal and state laws, as well as program and customer requirements, the evidence-based approach to coverage of immunizations will remain consistent.”
As all of these policy and payment questions play out, one constant remains: pharmacists have a vital role to play in explaining vaccine science to patients, Mr. Gallagher said. “Patients need to hear consistent, evidence-based messages. Pharmacists are among the most trusted healthcare providers for delivering that information, especially when it comes to vaccines.”
The sources reported no relevant financial disclosures.