COVID-19 vaccines: authorised
Vaccines authorised in the European Union (EU) to prevent COVID-19, following evaluation by the European Medicines Agency (EMA).
EMA is not involved in advising on travel requirements in the 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: |
The table below lists the COVID-19 vaccines that were originally authorised and that can still be used in the EU.
The companies marketing these vaccines can submit an application to change their current marketing authorisation to include an adapted version.
Read more in the Adapted COVID-19 vaccines section.
| Vaccine | Marketing authorisation holder | Key milestones | More information |
|---|---|---|---|
| COVID-19 Vaccine (inactivated, adjuvanted) Valneva | Valneva Austria GmbH | Marketing authorisation issued: 24/06/2022 | |
| Nuvaxovid | Novavax CZ, a.s. |
Annual renewal issued: 03/10/2022 | Clinical data (login required) |
| Vaxzevria (previously COVID-19 Vaccine AstraZeneca) | AstraZeneca AB | Conditional marketing authorisation issued: 29/01/2021 Annual renewal issued: 09/11/2021 Standard marketing authorisation issued: 31/10/2022 | Clinical data (login required) |
| Moderna Biotech Spain S.L. |
Annual renewal issued: 04/10/2021 Standard marketing authorisation issued: 03/10/2022 | Clinical data (login required) | |
Comirnaty(developed by BioNTech and Pfizer) | BioNTech Manufacturing GmbH | Conditional marketing authorisation issued: 21/12/2020 Annual renewal issued: 03/11/2021 Standard marketing authorisation issued: 10/10/2022 | Clinical data (login required) |
| Janssen-Cilag International NV | Conditional marketing authorisation issued: 11/03/2021 Annual renewal issued: 03/01/2022 Standard marketing authorisation issued: 10/01/2023 | Clinical data (login required) | |
| VidPrevtyn Beta | Sanofi Pasteur | Marketing authorisation issued: 10/11/2022 | |
| Bimervax (previously COVID-19 Vaccine HIPRA) | HIPRA Human Health S.L.U. | Marketing authorisation issued: 30/03/2023 |
For more information on how EMA evaluated these vaccines, see:
The table below lists the adapted versions of authorised COVID-19 vaccines.
Adapted vaccines are intended to provide broader protection against different virus variants following initial vaccination.
Companies need to submit an application to change the marketing authorisation of the originally authorised vaccine.
The table lists adapted vaccines that are already authorised or under evaluation.
| Vaccine | Marketing authorisation holder | Key milestones | More information |
|---|---|---|---|
| Spikevax (previously COVID-19 Vaccine Moderna) | Moderna Biotech Spain S.L. | Spikevax bivalent Original/Omicron BA.1 Authorisation issued: 01/09/2022 Spikevax bivalent Original/Omicron BA.4-5 Authorisation issued: 20/10/2022 | |
Comirnaty(developed by BioNTech and Pfizer) | BioNTech Manufacturing GmbH | Comirnaty Original/Omicron BA.1 Authorisation issued: 01/09/2022 Comirnaty Original/Omicron BA.4-5 Authorisation issued: 12/09/2022 |
For more information, see:
The overview below summarises the characteristics of the COVID-19 vaccines authorised in the EU:
- Platforms - the type of technology used to develop the vaccine
- Strains - the type of virus the vaccine targets, i.e. 'wild-type' (original), a variant or a sub-variant of the virus
- Use - whether the vaccine is for primary or for booster vaccination
- Population - which age groups the vaccine is used in
This overview also details the composition of COVID-19 vaccines (Figure 1) and the milestones for authorisation of adapted vaccines (Figure 2).
Click on the images below for high resolution versions
Overview of authorised COVID-19 vaccines
* Figure 1: Available platforms
** Figure 2: Milestones for adapted COVID-19 vaccines
EMA monitors the safety of COVID-19 vaccines authorised in the EU extremely carefully. This enables the detection of any rare side effects that may emerge once many millions of people are vaccinated.
Safety information on each COVID-19 vaccine is available:
EMA is actively involved in approving new manufacturing sites to increase manufacturing capacity and supply of COVID-19 vaccines in the EU:
- Increase in manufacturing capacity for Vaxzevria (previously COVID-19 Vaccine AstraZeneca)(24/01/2022)
- Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer(16/12/2021)
- Increase in manufacturing capacity for COVID-19 vaccine from AstraZeneca(01/12/2021)
- New manufacturing sites and new formulation approved for COVID-19 vaccine from BioNTech/Pfizer(18/10/2021)
- Additional manufacturing site for COVID-19 Vaccine Janssen(07/10/2021)