Manufacturers should be prepared for a period of uncertainty and potential disruption in vaccine policy. The recent overhaul of the CDC’s Advisory Committee on Immunization Practices (ACIP) signals a shift that could affect vaccine recommendations, public trust, and payer coverage decisions.
After Robert F. Kennedy Jr. was sworn in as the new secretary of the U.S. Department of Health and Human Services in February, the agency has taken several steps that could undermine confidence in vaccines. Manufacturers must remain transparent and proactive in communicating the value and safety of their products.
HHS Halts Flu Vaccine Investments, Narrows COVID-19 Vaccine Recommendations
So far, HHS’s focus has been largely on influenza and COVID-19 vaccines.
On Feb. 28, the FDA — which at the time had not yet sworn in a new director — revealed that it was cancelling the March 13 advisory meeting on the influenza vaccine strains for the 2025-2026 flu season. On May 28, HHS cancelled more than $700 million in funding for Moderna to develop its human bird flu vaccine.
Also being questioned are COVID-19 vaccines. On May 27, Kennedy said that the COVID-19 vaccine for healthy children and healthy pregnant people had been removed from the CDC’s recommended immunization schedule. Currently, ACIP recommends COVID vaccines for all people at least 6 years old.
That decision came one week after an article in The New England Journal of Medicine by Vinay Prasad, M.D., the director of the FDA’s Center for Biologics Evaluation and Research (CBER), and FDA Commissioner Martin Makary, M.D., called for limiting COVID vaccines to people older than 65 and to people older than 6 months who are at high risk for the disease.
Conditions listed as putting a person at high risk of COVID included “pregnancy and recent pregnancy.”
Since Prasad assumed his role at CBER on May 8, he has overruled FDA vaccine reviewers’ recommendations three times, instead placing tighter restrictions on the use of COVID-19 vaccines.
Understanding ACIP’s Role in Vaccine Guidance and Coverage Mandates
In 1964, the U.S. Surgeon General established ACIP, a federal advisory agency consisting of medical and public health experts that creates recommendations for vaccine use in the U.S. for children and adults. The director of the CDC then reviews those recommendations, and, if approved, the recommendations are published in the CDC’s Morbidity and Mortality Weekly Report (MMWR), resulting in the official immunization schedules.
Individual and employer-sponsored private health plans that are subject to the Affordable Care Act’s preventive services coverage standards must provide coverage for people to receive ACIP-recommended vaccines without cost sharing.
ACIP Dismissals and Replacements Raise Concerns
On June 9, Kennedy dismissed all 17 members of ACIP due to their “conflicts of interest.” According to Kennedy, “A clean sweep is needed to re-establish public confidence in vaccine science.” Two days later, he named eight new members, many of whom have spread misinformation about vaccines and are affiliated with anti-vaccine groups.
The new ACIP is now reviewing longstanding childhood vaccine schedules, including those for hepatitis B and the combination measles, mumps, rubella and chickenpox vaccine, which could lead to narrowed recommendations.
Payers Uneasy with ACIP Overhaul, Citing Risk of Reduced Access to Vaccines
In a June MMIT Indices Market Event Primer, more than half of the payers surveyed said that removing the previous ACIP members was not necessary. And half said that action will decrease trust in vaccine policy.
According to one respondent, it’s important to ensure regular turnover of the committee to keep its membership dynamic and representative, but another said the removal “was not justified, given ACIP’s essential role in evidence-based vaccine guidance. It raises concerns about politicization of science and potential impacts on public trust and vaccine access.”
Forty percent said that they are concerned about potential delays in vaccine development in general, while 80% said that member/patient confusion is a challenge that could arise due to changes in ACIP-recommended vaccines.
In situations where ACIP doesn’t recommend coverage of a vaccine, 65% of payers said they would continue coverage of vaccines based on FDA approval and internal reviews. Others, however, said they may align strictly with the committee.
If ACIP updates its recommendations to limit annual COVID-19 vaccination to adults older than 65 and immunocompromised individuals, 25% of respondents said they will fully align with ACIP guidelines to limit coverage.
Medical Organizations, Advocacy Groups Establish New Vaccine Guidance
The ACIP overhaul has prompted widespread concerns that the committee’s guidance may no longer reflect the most reliable public health principles, so other industry groups are providing alternate approaches.
The American Academy of Pediatrics (AAP) announced it will no longer take part in ACIP meetings, stating that the dismissal of the committee members has undermined the credibility of the process. Instead, the AAP will continue to issue its own immunization guidelines, which it describes as being grounded in scientific evidence and trusted by pediatricians and families nationwide.
And Michael Osterholm, Ph.D., an infectious disease expert and director of the University of Minnesota’s Center for Infectious Disease Research and Policy (CIDRAP), has started the Vaccine Integrity Project. CIDRAP is now discussing vaccine recommendations with a variety of industry stakeholders, including insurers and several medical organizations, such as the AAP, the American College of Obstetricians and Gynecologists, the Infectious Diseases Society of America and the American Academy of Family Physicians.
How Pharma Can Navigate Vaccine Policy Disruption
Given the uncertainty around ACIP’s future recommendations, manufacturers with vaccines in the pipeline should evaluate the potential for delays or changes in demand. It may also be beneficial if they strengthen clinical and real-world evidence to support vaccine efficacy and safety.
Manufacturers should also ensure alignment with FDA guidance, which may become more influential in payer decisions than CDC/ACIP recommendations. Drugmakers with currently available vaccines should take several steps:
- Invest in education and transparency: Combat misinformation by supporting evidence-based education for providers and the public.
- Monitor policy closely: Track developments in ACIP recommendations and FDA approvals, as these will shape market access.
- Prepare for payer variability: Some payers may continue to follow ACIP guidelines while others may rely more on the FDA or internal reviews. Forty percent of payers surveyed for the June Market Event Primer said ACIP guidelines are “extremely influential” on their coverage decisions; however, if those guidelines are narrowed, only 10% of payers said they would still hold this opinion.
If ACIP drops recommendations for certain vaccines, the result could very well be a widespread lack of payer coverage coupled with vaccine hesitancy among members of the public—ultimately leading to a decrease in demand for these products. Manufacturers should take steps now to educate on vaccine efficacy and safety to lessen the possibility of those potential outcomes.
