The Advisory Committee on Immunization Practices (ACIP) met June 21–23 to discuss updates and review new immunizations for the prevention of respiratory syncytial virus (RSV), polio, influenza, pneumococcal, dengue, chikungunya, mpox, meningococcal and COVID-19 infections. ACIP significantly influences immunization guidelines, which, when endorsed by the Centers for Disease Control and Prevention (CDC), become national immunization policy and determine product coverage across markets. These recommendations may sometimes differ from indications for use that are developed and approved by the Food and Drug Administration (FDA). At its June meeting the ACIP voted on recommendations for four therapeutic areas:

Future Considerations for Vaccine Manufacturers and Other Stakeholders

In addition to voting on recommendations and preparing for the review of additional pipeline products, the committee’s discussions over the three-day meeting highlighted several topics that are important for vaccine manufacturers and stakeholders to consider.

• Safety of Respiratory Vaccines in Older Adults: With the new approval of RSV vaccines for adults, is the concurrent administration of RSV, Influenza, and COVID-19 safe and well characterized? What is the impact of effectiveness and the level of lasting protection for adults who receive multiple vaccines at the same time? What supplemental data would ACIP need from manufacturers and other stakeholders to address current gaps coadministration?
• Vaccine Cost-Effectiveness and Value: How does the committee use vaccine prices in its development of recommendations for use? What is considered the threshold for cost-saving vs. cost-effective vaccines? In the absence of a defined threshold to guide decision making, how has ACIP’s review of cost-effectiveness changed over time? Should manufacturers with pipeline vaccines adjust anticipated launch pricing based on the committee’s feedback on approved products and, if so, how?
• SCDM: How will an SCDM recommendation for older adult RSV vaccines impact individuals’ access and uptake? In practice, how well are such recommendations understood and implemented? Given coverage under Medicare Part D, how will pharmacies approach SCDM discussion with patients? What tools may support vaccine clinical decision making for patients and providers?
• Data in Immunocompromised/High-Risk Patients: What can be done to support ACIP’s calls related to clinical trial diversity in order to better represent and understand the safety and effectiveness of vaccines in older, high-risk, and pregnant populations? Given their increased susceptibility and severity of disease, what evidence can be collected to demonstrate the value of vaccination in these subgroups?
• Passive Immunizations: What criteria will be used to determine which future passive immunizations and monoclonal antibodies are reviewed by the ACIP? What preparation and planning is needed to understand the inclusion or exclusion of such products in federal programs such as Vaccines for Children?
• Complex Recommendations: As vaccine recommendations become more complex, particularly when multiple products are available, what strategies can be deployed to reduce implementation barriers and support patient/provider decision making?
• COVID-19: How will uninsured populations access COVID-19 prevention measures as previously government-purchased vaccine stockpiles are depleted? What policy and programmatic options exist to support patient access, and how will they be implemented? Can a simplified recommendation, harmonized with other seasonal adult vaccines like influenza, be expected for the fall?

How We Can Help

Avalere’s experts in vaccine policy, evidentiary review, and commercial strategy can help stakeholders appropriately prepare for ACIP review, and understand the implications of varying recommendation scenarios, including the impact on product coverage, reimbursement, and access. To learn how Avalere can support you in the strategic preparation of evidence and engagement ahead of advisory committee decision making, connect with us.