3.H. Workshop: The role of HTA for COVID-19 vaccines: present and future perspectives.

It is well known how vaccines typically require many years of research and testing before being on the market, but in 2020 the COVID-19 pandemic pushed scientists to embark on a race to produce safe and effective SARS-CoV-2 vaccines in record time. In such an emergency situation, striking the right balance between urgency and acceptable safety and efficacy evidence is challenging. Furthermore, other relevant issues need to be more comprehensively addressed, including cost-effectiveness of vaccination campaigns and real-world data on effectiveness and safety. Currently the European Medicines Agency (EMA) has approved for use four vaccines against COVID-19. Data on their efficacy and safety will continue to be collected beyond licensure and submitted to EMA, but the need for a more complete assessment, which includes contextual and societal considerations (e.g. impact on population health, population’s demand, attitudes and behaviours, ethical considerations) and economic analysis, is unquestionable to support national decision-maker processes. In this kind of ‘‘holistic’’ approach, the Health Technology Assessment (HTA) could be the answer in order to support the allocation of resources into different COVID-19 vaccines and to make it possible a timely and equitable access to vaccination. As also stated in the HTAi Position Paper on ‘‘HTA’s Critical Role in the (Early) Assessment of (potential) Vaccines to prevent the spread of COVID-19 globally’’, the following issues should be carefully tackled: 1) affordability, sustainability and distributional effects; 2) cost-effectiveness considerations; 3) fostering HTA collaborations; 4) need for early, adaptive and living HTA. Accounting for such issues is essential to ensure that HTA is successfully implemented in the field of COVID-19 vaccines, at the present time and in its future developments on a national and international scale. This workshop will discuss how HTA could help the EU-wide and national decision-making process about COVID-19 vaccines. Key messages: An adapted and living HTA framework considering the unique characteristics of COVID-19 vaccines could be an answer to current and future challenges in vaccination campaigns. There are several challenges in current and future HTA of COVID-19 vaccines, namely the evaluation of their broad economic impacts, their effectiveness and safety and organization issues. [ABSTRACT FROM AUTHOR]