At the 2026 World Vaccine Congress, held in Washington, DC, Avalere Health got a front-row seat to discussions shaping the future of vaccine care and access. The event offered insights into shifts in the immunization and vaccine pipeline, increasing reliance on real-world evidence, and growing uncertainty around federal policymaking – all of which are adding complexity to access pathways and requiring more integrated and adaptable strategies to support successful adoption.

Our team also contributed to various discussions around:

• Hybrid use immunization products are making waves: Emerging biotech companies and established manufacturers are increasingly diversifying beyond traditional prophylactic vaccines targeting infectious disease pathogens to include therapeutic vaccines (e.g., for oncology or chronic infectious disease management), monoclonal antibodies for prevention and treatment, and next-generation vaccine platforms. While these products have been on the horizon for many years, clinical advancements and access pathways have converged to create a tipping point. As demand for these new products grows, early stage biotechs have unprecedented interest from leading commercialization partners who seek to diversify their asset portfolio, and care providers who have new optimism about near-term expansions in their arsenal of treatments. These innovations are expanding the role of immunization from a purely preventive modality towards disease modification and treatment, introducing new considerations for value assessment, pricing, and integration into existing immunization programs and/or therapeutic care pathways.
• Increased competition and policy sensitivity is driving earlier integration of RWE in lifecycle evidence planning: Manufacturers are increasingly prioritizing real-world evidence as an integral component of life cycle evidence generation strategy, not only to support post-marketing safety and effectiveness requirements but critically to differentiate products in ever-more competitive environments. Payers, regulators, and policymakers now look to longitudinal RWE as a complement to clinical trial data, especially as questions around durability of protection and differentiated benefit in distinct patient populations emerge.
• Access uncertainty persists amid evolving ACIP dynamics: Uncertainty surrounding ACIP recommendations and broader CDC leadership is creating significant ambiguity into vaccine access pathways, and challenges stakeholders in their planning for vaccine access and uptake. Changes in ACIP’s recommendation frameworks, governance, and impact complicates coverage, reimbursement, and adoption expectations, reinforcing the need for flexible policy and access strategies and proactive payer engagement.

Taken together, these trends signal a shift toward a more complex immunization ecosystem where innovation, product differentiation, evidence strategy, and policy must be carefully assessed and aligned on early to ensure successful launch, access, and uptake throughout product life cycle.

How We Can Help

Avalere Health’s vaccine experts support clients with end-to-end services spanning strategy, evidence generation and resource development.

To learn how Avalere Health can help you prepare flexible evidence, policy, and access strategies in the face of uncertainty, connect with us.