COVID-19

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: 

Originally authorised COVID-19 vaccines

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.

VaccineMarketing authorisation holderKey milestonesMore information
COVID-19 Vaccine (inactivated, adjuvanted) ValnevaValneva Austria GmbHMarketing authorisation issued: 24/06/2022

Latest news

Safety updates

Paediatric investigation plan

NuvaxovidNovavax CZ, a.s.


Conditional marketing authorisation issued: 20/12/2021

Annual renewal issued: 03/10/2022

Latest news

Safety updates

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)

Spikevax (previously COVID-19 Vaccine Moderna)

Moderna Biotech Spain S.L.


Conditional marketing authorisation issued: 06/01/2021

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)

Jcovden (previously COVID-19 Vaccine Janssen)

Janssen-Cilag International NV

Conditional marketing authorisation issued: 11/03/2021

Annual renewal issued: 03/01/2022

 

Clinical data (login required)
 
VidPrevtyn BetaSanofi PasteurMarketing authorisation issued: 10/11/2022Latest news

For more information on how EMA evaluated these vaccines, see:

Adapted COVID-19 vaccines

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.

VaccineMarketing authorisation holderKey milestonesMore 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: 

COVID-19 vaccines: strains, use and age ranges

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 

Information on the platforms used to develop COVID-19 vaccines.

** Figure 2: Milestones for adapted COVID-19 vaccines

Milestones for the authorisation of COVID-19 vaccines, including adapted vaccines.

Safety updates for authorised 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 updates on each COVID-19 vaccine are available:

Increasing manufacturing capacity

EMA is actively involved in approving new manufacturing sites to increase manufacturing capacity and supply of COVID-19 vaccines in the EU:

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