COVID-19 vaccines

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:

Vaccine

Marketing authorisation holder

Key milestones

Product information

Comirnaty

 

View product overview on EMA website

BioNTech Manufacturing GmbH (developed by BioNTech and Pfizer)

Conditional marketing authorisation issued: 21/12/2020 - see EMA press release

Annual renewal issued: 03/11/2021

Authorisation for adapted vaccine issued:

Comirnaty product information

SPC: see page 1

Package leaflet: see page 75

Spikevax

View product overview on EMA website

Moderna Biotech Spain, S.L.

Conditional marketing authorisation issued: 06/01/2021 - see EMA press release

Annual renewal issued: 04/10/2021

Authorisation for adapted vaccine issued:

Spikevax product information

SPC: see page 1

Package leaflet: see page 24

Vaxzevria

 

View product overview on EMA website

AstraZeneca AB

Conditional marketing authorisation issued: 29/01/2021 - see EMA press release

 

Annual renewal issued: 09/11/2021

Vaxzevria product information

SPC: see page 1

Package leaflet: see page 29

Jcovden

View product overview on EMA website

Janssen-Cilag International N.V.

Conditional marketing authorisation issued: 11/03/2021 - see EMA press release

 

Annual renewal issued: 03/01/2022

Jcovden product information

SPC: see page 1

Package leaflet: see page 31

Nuvaxovid

 

View product overview on EMA website

Novavax CZ, a.s.

Conditional marketing authorisation issued: 20/12/2021 - see EMA press release

Nuvaxovid product information

SPC: see page 1

Package leaflet: see page 23

COVID-19 Vaccine (inactivated, adjuvanted) Valneva

View product overview on EMA website

 Valneva Austria GmbH
Marketing authorisation issued - 24/06/2022 - see EMA press release
COVID-19 Vaccine (inactivated, adjuvanted) Valneva product information 

SPC: see page 1

Package leaflet: see page 15

Vidprevtyn Beta

View product overview on EMA website

 Sanofi Pasteur
Marketing authorisation issued - 10/11/2022 - see EMA press release
Vidprevtyn Beta product information

SPC: see page 1

Package leaflet: see page 29

Vaccines under evaluation 

The EMA is currently evaluating the following COVID-19 vaccines:

Vaccine

Vaccine developer

Current status

 Skycovion  SK Chemicals GmbH
Application for marketing authorisation submitted


See EMA press release
(18/08/2022)

Sputnik V (Gam-COVID-Vac)

Russia’s Gamaleya National Centre of Epidemiology and Microbiology

Evaluation ongoing under rolling review

 

See EMA press release (04/03/2021)

COVID-19 Vaccine (Vero Cell) Inactivated

Sinovac Life Sciences Co. Ltd

Evaluation ongoing under rolling review

 

See EMA press release (04/05/2021)



COVID-19 Vaccine HIPRA
(PHH-1V)

 HIPRA Human Health S.L.U
Evaluation ongoing under rolling review


See EMA press release
(29/03/2022)