How Can the European Medicines Agency Support an Appropriate Strategy of Adult Vaccination?

Abstract

The European Medicines Agency (EMA) has a legal mandate that includes authorisation of vaccines, risk management of vaccines (post-authorisation data collection and risk minimisation), collection of safety data and post-authorisation safety and efficacy studies. The EMA’s remit also includes monitoring the risk-benefit balance of vaccines, and if anomalies are observed or adverse events arise, regulatory action may be taken. Finally, the EMA also has a commitment to transparency, with the obligation to maintain a database of all products on the European Union (EU) market, the publication of clinical trials data and involvement of expert groups including academics to contribute to the assessment process. The EMA strives to address knowledge gaps, by ensuring enrolment of appropriate populations in trials, by providing specific guidance, by implementing risk management plans and by defining unmet needs to be addressed in future research supported by the provision of Scientific Advice. The EMA maintains regular and open discussions with various stakeholders, including public health institutes and centres for disease control, national health authorities, marketing authorisation holders, institutions or foundations as well as research organisations. The role of EMA is to support and enable appropriate adult vaccination strategies, and thus, strong attention is paid at European level to the safety, efficacy, effectiveness and risk-benefit ratios of vaccines.