OBJECTIVES: Clinical assessment of vaccines in the European Union (EU) significantly variates compared to other medicines, involving many different bodies and processes – most notably the National Immunization Advisory Technical Groups (NITAGs). To help inform the development of standardized and vaccine-specific evaluation 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 clinical appraisal of vaccines.

METHODS: Three complementary literature reviews were conducted to capture the current guidelines and recommendations for vaccine appraisals, identify methods used to assess evidence and outline the differences in recommendations for four selected vaccines. An expert consultation meeting was held to discuss the literature review findings, reflect on vaccine-specific considerations in the assessment of clinical domains of HTA and obtain insights into the EU’s future joint clinical assessments (JCAs) of vaccines.

RESULTS: Significant variation exists across the EU in the decision-making processes and criteria for vaccines clinical evaluation with vaccine specificities being rarely considered by HTA bodies across EU member states. Based on literature review findings and expert recommendations, three guiding principles (use of appropriate terminology and measurements for vaccines, vaccine-specific assessment process, data collection and evidence generation) and thirteen recommendations were proposed to foster development of standardized and vaccine-specific evaluation framework and facilitate the successful implementation of the EU Regulation on HTA for vaccines.

CONCLUSIONS: The review of the literature and discussion with experts raised concerns that JCAs for vaccines may not be able to appropriately capture the full value of vaccination, with the risk of delaying or limiting population access to vaccines. Guiding principles were proposed to help addressing vaccines-specificities under the EU Regulation on HTA - before it becomes effective in 2025.