Largeron, Nathalie, D'Agostino, Paolo, Chapman, Ruth, Danko, David, Eskola, Juhani, Godfroid, Philippe, Feldmajer, Gyorgyi, Hanley, Riona, de Pouvourville, Gerard, Postma, Maarten, Puig-Barberà, Joan, Schaible, Kassandra, Sabale, Ugne, Schmitt, Joe, de Waure, Chiara, Vicere, Anna, and Beck, Ekkehard
The appraisal of vaccines in the European Union (EU) currently involves many different decision-making bodies and processes. The objective of this study was to help inform the development of standardized methodology and vaccine-specific processes for use in the EU Regulation on health technology assessment (HTA). Literature reviews and expert consultation were conducted to identify current practices and gaps related to vaccine appraisals and to develop guiding principles for the joint clinical assessment of vaccines. We found that significant variation exists across the EU member states in the decision-making processes when clinically evaluating vaccines. Three guiding principles consisting of 13 recommendations were developed to help inform the development of decision-making frameworks for the joint clinical assessment of vaccines in the EU: (1) support the creation of appropriate terminology and measurements for clinical appraisals of vaccines; (2) develop inclusive, timely, and transparent vaccine appraisal processes to support stronger evidence generation for vaccine decision making and appraisal; and (3) improve the collection and interoperability of real-world data, including robust surveillance, to foster evidence generation and support the standardization of vaccine clinical appraisals. Given the significance of vaccines for public health, there is an urgency to develop standardized and vaccine-specific methodologies and processes for use in the EU joint HTA framework. The proposed guiding principles could support the effective implementation of the EU Regulation on HTA for vaccines and have the potential to ensure consistent, transparent, and timely access to new vaccines in the EU. • Vaccine assessment is a key component of immunization systems across European Union (EU) member states, determining not only when and which vaccines are included in National Immunization Programmes but also whether they are funded by the government. • In the context of the EU Regulation on health technology assessment (HTA), which will enter into force in January 2025, this article discusses how the joint EU HTA framework can contribute to unlocking the full value of vaccination as the main tool for primary disease prevention and address the significant variations that currently exist in vaccine evaluations and decision-making processes. • Three guiding principles consisting of 13 recommendations were developed to assist decision makers in considering vaccine specificities in the implementation of the EU Regulation on HTA to standardize assessment processes and methodologies for vaccines and ultimately reduce inequalities in population access to vaccines. [ABSTRACT FROM AUTHOR]