Health Technology Assessment for Vaccines: Why It Matters and What Europe Must Get Right (George Valiotis)

The presentation was delivered and recorded during the 10th Lifecourse Prevention Summit, Paris, December 2025.

Mr George Valiotis, Executive Director of Health Technology Assessment International (HTAi), explores how health technology assessment is reshaping vaccination policy in Europe and what a landmark regulatory shift at the European Commission level means for how vaccines are evaluated and funded.

Health technology assessment — the structured, evidence-based process for determining whether a new intervention offers real added value — has long shaped how health systems make decisions. In Europe, national bodies like NICE carry out this work, though approaches differ significantly across member states. Sitting alongside these bodies, National Immunization Technical Advisory Groups (NITAGs) assess vaccination programs and advise on how new vaccines fit into existing schedules.

The most significant recent development is the European Commission's Joint Clinical Assessment (JCA) regulation, which entered into force in 2025 and will become mandatory for vaccines by 2030. The goal is to reduce duplication by conducting shared clinical assessments at the European level, a shift with the potential to streamline access, but one that will depend on real cooperation across countries with very different data systems, institutional capacity, and health infrastructure.

One of the clearest challenges ahead is methodology. Traditional HTA frameworks were not built with vaccines in mind. There is growing consensus that new approaches are needed; ones that draw on post-licensure, real-world evidence and that properly account for the broader societal value of immunization, not just clinical outcomes in isolation.

Valiotis acknowledges the uncertainty this transition brings, but his position is unambiguous: engagement is the only viable path forward. If the necessary expertise and cross-national collaboration can be mobilized, a harmonized European approach has the potential to deliver a more equitable, efficient, and sustainable framework for vaccine access across Europe, one equal to the ambition of the regulation itself.