Regulation of Vaccines in Europe

Regulation of vaccines in Europe involves various entities at EU and national level, as reflected in different legislations. Vaccines can be authorised via the centralised, decentralised or national procedures, but in principle all vaccines can be evaluated centrally by EMA and this is the recommended approach. Several routes for approval of vaccines are available. An overview of the efficacy, immunogenicity and safety data required for approval or for vaccine strain change is provided in this chapter, including for vaccines which target a public health emergency and for situations where pivotal randomised efficacy trials are not feasible to conduct. Centrally, the role of the various EMA scientific Committees is described with focus on their role in providing the European Commission with a scientific opinion supporting authorisation and in providing vaccine developers with scientific advice on development programs. Authorisation and development of paediatric medicines and medicines intended for markets outside the EU are discussed separately as requirements are different. The EU Risk Management Plan is explained in general and specifically for vaccines, including vaccines against COVID-19. Vaccine performance monitoring for the duration of the product life cycle is key from a scientific and regulatory perspective. Evaluation of the risk/benefit balance continues after authorisation with specific requirements for pharmacovigilance, batch control and generation of real world evidence by means of observational safety and effectiveness studies. Some of these activities require extensive cross-collaboration including with ECDC and NITAGs. Communication to the public related to vaccines is paramount, and EMA together with ECDC has been mandated to tackle vaccine hesitancy including with the creation of a dedicated information portal. In Europe there is a solid legal framework supporting regulatory activities during public health emergencies and recently a new regulation has further strengthened and expanded the role of EMA including in pandemic preparedness. Especially during emergencies, EMA actively supports collaboration with stakeholders at EU and global levels to foster harmonisation and efficiency. Despite some challenges, the EU benefits from a robust regulatory and scientific network to ensure that safe and efficacious vaccines are authorised under thorough standards of assessment and monitoring pre- and post-authorisation to protect public health in the EU and globally.