Applications for authorisation of COVID-19 vaccines are made centrally to the European Medicines Agency (EMA). If the EMA concludes that the benefits of a vaccine outweighs its risks in preventng COVID-19, it makes a recommendation to the European Commission to grant a conditional marketing authorisation. Once the European Commission grants a marketing authorisation for a medicine, this is valid and legally binding across all EU Member States, including Ireland.
Ireland, through the HPRA, is an active participant in all EMA reviews. The HPRA contributes directly to the assessment of all new medicines and the monitoring of their safety once in use. This is also the case for COVID-19 vaccines.
The EMA website contains further information about the development, evaluation, approval and monitoring of COVID-19 vaccines.
The tables below outline the current status of a vaccine in the EMA approval process and links to product information for approved vaccines.
The product information on the EMA website includes the:
- Summary of product characteristics (SPC) containing information for healthcare professionals
- Package leaflet containing information for members of the public
Authorised vaccines
The following vaccines can be used in the EU to prevent COVID-19:
Vaccines under evaluation
The EMA is currently evaluating the following COVID-19 vaccines: