Presentation (CTI)

OBJECTIVES: The European Union (EU) Health Technology Assessment (HTA) Regulation (2021/2282) introduces Joint Clinical Assessment (JCA) to harmonise clinical evaluation of new medicines across member states. As vaccines enter scope from 2030, their preventive nature and distinct evidence needs may challenge a process designed largely for therapeutics. This review explored how the JCA process may apply to vaccines and identified vaccine-specific methodological and procedural considerations.
METHODS: A targeted literature review was conducted in April 2026 across Embase, Google Scholar, Vaccines Europe, EU Commission and HTA Coordination Group materials, and ISPOR and HTA international outputs. Records were screened for relevance to vaccines under the EU HTA Regulation. Publications were included if they referenced vaccines in the context of the JCA process, discussed anticipated methodological or procedural implications, or presented expert, academic, or stakeholder perspectives. Findings were synthesised narratively.
RESULTS: Eleven sources published during 2021-2026 were included. Four suggested the JCA framework aligns more closely with therapeutics than preventive technologies. Anticipated vaccine-specific challenges were defining populations and comparators across varied immunisation programmes and trial designs, selecting outcomes beyond immunogenicity to capture indirect and population-level benefits, and managing uncertainty from limited pre-authorisation follow-up and sparse long-term effectiveness data. Real-world evidence was considered important to address these gaps, although guidance on its use in JCAs was limited. Uncertainty also remains around how EU-level assessments will interface with national immunisation decision-making and National Immunization Technical Advisory Groups.
CONCLUSIONS: The JCA framework is not yet fully fit for prevention: a “one size fits all” approach risks undervaluing vaccines’ clinical and public health impact. To ensure the JCAs capture the clinical value of vaccines while remaining fit for purpose within national immunisation decision-making, methodological flexibility, early scientific dialogue to align evidence expectations and assessment scope, and vaccine-specific expertise will be essential.