COVID-19 vaccines
Currently under rolling review
- Sputnik V,
Gam-COVID-Vac
(Gamaleya Institute) - COVID-19 Vaccine HIPRA (PHH-1V)
(HIPRA Human Health S.L.U.) - COVID-19 Vaccine (Vero Cell) Inactivated
(Sinovac)
When medicines are under rolling review, EMA’s human medicines committee (CHMP) evaluates clinical trial data as soon as these become available until it decides there is enough evidence for the developer to apply for marketing authorisation.
EMA cannot provide exact timelines as these depend on when developers provide the necessary data for CHMP review.
Information on COVID-19 vaccines that are no longer under rolling review following withdrawal from the process is available at COVID-19 vaccines under evaluation: Withdrawn from rolling review.
Once authorised, COVID-19 vaccines can be adapted to provide better protectin against a specific variant or variants of the SARS-CoV-2 virus.
EMA is not involved in advising on travel requirements in the European Union (EU), such as vaccination, quarantine or testing for travellers. Decisions about which COVID-19 vaccines are included, for example, in the EU Digital COVID Certificate, are taken by the EU Member States. EMA is in charge of the scientific evaluation of vaccines for EU marketing authorisation. The acceptability criteria for travel purposes are broader and can include, for example, World Health Organization (WHO) listed vaccines that have not necessarily undergone the EMA process of authorisation. Official information on this topic is available in all EU languages at: |
Potential COVID-19 vaccines under investigation whose developers have received EMA advice. | Potential COVID-19 vaccines currently undergoing evaluation by EMA. |
COVID-19 vaccines authorised for use in the EU, following evaluation by EMA, with links to detailed information on each authorised vaccine, including any adapted vaccines. | COVID-19 vaccines: Article 5(3) reviews COVID-19 vaccines reviewed for use in the EU under Article 5(3) of Regulation 726/2004. |
Key facts about COVID-19 vaccines in the EU. | COVID-19 vaccines: development, evaluation, approval and monitoring Detailed information on the development, evaluation, approval and monitoring of COVID-19 vaccines in the EU. |
COVID-19 vaccines: studies for approval Detailed information on the studies EMA requires to confirm a vaccine is safe, provides adequate protection and is of suitable quality. | The latest safety information for the COVID-19 vaccines authorised in the EU |
EMA holds public stakeholder meetings to discuss its work on the assessment, approval and safety monitoring of COVID-19 vaccines:
- Public stakeholder meeting on COVID-19 vaccines and therapeutics in the EU (25/11/2021)
- Public stakeholder meeting: approval, safety monitoring and impact of COVID-19 vaccines in the EU (26/03/2021)
- Public stakeholder meeting on the approval and roll-out of COVID-19 vaccines in the EU (08/01/2021)
- Public stakeholder meeting: development and authorisation of safe and effective COVID-19 vaccines in the EU (11/12/2020)