Evolution of Pneumococcal Vaccine Recommendations and Criteria for Decision Making in 5 Western European Countries and the United States

Abstract

Objectives: Pneumococcal vaccine recommendations have become increasingly complex. This study aims to understand how national immunization technical advisory groups (NITAGs) and health technology assessment (HTA) agencies of 5 European countries and the United States formed their pneumococcal vaccine recommendations, by providing reviewed evidence and key drivers for new recommendations. Methods: Centers for Disease Control and Prevention, European Centre for Disease Prevention and Control, and National Health Authorities Web sites were screened to capture the evolution of pneumococcal recommendations. A narrative review was conducted on NITAGs and HTA bodies’ Web sites. Assessments of pneumococcal vaccines published from 2009 to 2022 were included. Results: Thirty-four records were identified including 21 assessments for risk groups, 17 for elderly, and 12 for children. Burden of disease and vaccine characteristics were almost systematically reviewed during assessments. All 6 countries recommended the use of higher-valent pneumococcal vaccine (PCV; i.e., PCV10 and PCV13) in childhood vaccination programs, given their broader serotype coverage and their comparable profile to PCV7. PCV13 was progressively added to the vaccine schedule (in addition to polysaccharide vaccine) in at least the high-risk group, given the high burden in this population and expected additional benefits of PCV13. For the elderly, unlike the United States, European countries issued negative recommendation for PCV13 routine use because of substantial herd effects from childhood vaccination program making PCV13 likely not cost-effective. Conclusions: This research provides an overview of decision-making processes for higher-valent PCVs recommendations and could be of interest to anticipate the place of next generation of PCVs in the vaccination landscape. By describing evidence-based criteria for decision making, this study emphasizes the framework analysis of NITAGs and HTA bodies when assessing pneumococcal vaccines and demonstrates that variation exists between countries and also according to population evaluated. While the burden of disease and immunogenicity/efficacy data were almost systematically reviewed by national stakeholders, economic assessments were reported to a lesser extent but played a major role in the limited use of PCV13 in the adult population.