Populations Addressed in Vaccines Approved via the European Medicines Agency

Therapeutic and prophylactic agents require robust evidence before patient use. Randomized controlled trials are essential for evaluating safety and efficacy but often exclude specific populations that are also targets for the intervention. This study assessed which populations are included in vaccine registration studies and/or addressed in label indications, and if special populations are considered at any point in the regulatory life cycle of vaccines approved in the European Union. We analyzed product labels, pivotal studies, risk management plans, and post-authorization studies for all vaccines centrally approved via the European Medicines Agency between 2012 and 2022. For the 31 vaccines approved, we identified 90 pivotal studies supporting initial marketing authorizations and 46 studies supporting product revisions. At the end of our follow-up, 27 vaccines (87%) were approved for adults, 19 (68%) for pediatric patients, 3 (11%) were recommended for pregnant populations, 4 (14%) for breastfeeding populations, and 7 (23%) for immunocompromised populations. Pregnant, breastfeeding, and immunocompromised individuals were rarely included in studies supporting regulatory actions. We observed a slight increase in the inclusion of special populations in post-marketing studies, yet this had limited impact on product indications or information availability on labels. Pivotal studies supporting vaccine registrations were also highly selective and predominantly conducted in high-income settings. These findings highlight significant variations in how different populations are considered during vaccine development and by regulators. Greater inclusion of special populations in the evidence-generation chain is essential to ensure that vaccines respond to unmet medical needs equitably.