COVID-19 medicines

The European Medicines Agency (EMA) evaluates and recommends the authorisation of medicines marketed in the European Union (EU). This includes COVID-19 vaccines and treatments. Although COVID-19 in no longer defined as a public health emergency of international concern, EMA continues to monitor the safety of COVID-19 medicines.
HumanCOVID-19

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For more information about COVID-19, see:

Authorised COVID-19 vaccines

The table below lists the COVID-19 vaccines that are authorised for use in the EU, including originally authorised and adapted vaccines

Adapted vaccines are intended to provide broader protection against different virus variants following initial vaccination. 

Companies marketing originally authorised vaccines can apply to change the marketing authorisation to include an adapted version, which is shown in italics in the table below. 

 
Vaccine Marketing authorisation holder Key milestones                                                                                           More information
Kostaive Seqirus Netherlands B.V. Marketing authorisation issued: 12/02/2025

Latest news

Kostaive: product information

Nuvaxovid Novavax CZ, a.s.

Nuvaxovid XFG (adapted) authorised: 28/07/2026

Nuvaxovid JN.1 (adapted) authorised: 08/10/2024

Nuvaxovid XBB.1.5 (adapted) authorised: 31/10/2023

Standard marketing authorisation issued: 04/07/2023

Annual renewal issued: 03/10/2022

Conditional marketing authorisation issued: 20/12/2021

Latest news

Nuvaxovid: product information

Clinical data (login required)

Paediatric investigation plan

Spikevax (previously COVID-19 Vaccine Moderna) Moderna Biotech Spain S.L.

Spikevax XFG (adapted) authorised: 28/07/2026

Spikevax LP.8.1 (adapted) authorised: 25/07/2025

Spikevax JN.1 (adapted) authorised: 10/09/2024

Spikevax XBB.1.5 (adapted) authorised: 15/09/2023

Spikevax bivalent Original/Omicron BA.4-5 (adapted) authorised: 20/10/2022

Standard marketing authorisation issued: 03/10/2022 

Spikevax bivalent Original/Omicron BA.1 (adapted) authorised: 01/09/2022

Annual renewal issued: 04/10/2021

Conditional marketing authorisation issued: 06/01/2021

 
 
Clinical data (login required)
 
Comirnaty BioNTech Manufacturing GmbH

Comirnaty XFG (adapted) authorised: 28/07/2026

Comirnaty LP.8.1 (adapted) authorised: 25/07/2025

Comirnaty KP.2 (adapted) authorised: 26/09/2024

Comirnaty JN.1 (adapted) authorised: 03/07/2024

Comirnaty Omicron XBB.1.5 (adapted) authorised: 31/08/2023

Standard marketing authorisation issued: 10/10/2022

Comirnaty Original/Omicron BA.4-5 (adapted) authorised: 12/09/2022

Comirnaty Original/Omicron BA.1 (adapted) authorised: 01/09/2022

Annual renewal issued: 03/11/2021

Conditional marketing authorisation issued: 21/12/2020

Clinical data (login required)
 
Bimervax (previously COVID-19 Vaccine HIPRA)  HIPRA Human Health S.L.U.

Bimervax XFG (adapted) authorised: 28/07/2026

Bimervax LP.8.1 (adapted) authorised: 19/9/2025

Bimervax XBB.1.16 (adapted) authorised: 17/10/2024

Marketing authorisation issued: 30/03/2023

Latest news

Bimervax: product information

Clinical data (login required)

Paediatric investigation plan

mCombriax Moderna Biotech Spain S.L Marketing authorisation issued on 20/04/2026

Latest news

mCombriax: product information

mNexspike Moderna Biotech Spain S.L Marketing authorisation issued on 12/02/2026

Latest news

mNexspike: product information

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

Authorised COVID-19 treatments

The following treatments can be used in the EU to treat COVID-19:

Treatment Status More information
Kavigale (sipavibart) Marketing authorisation issued: 20/01/2025

Latest news

Kavigale: product information

Gohibic (vilobelimab) Marketing authorisation issued: 13/01/2025

Latest news

Gohibic: product information

Paxlovid (nirmatrelvir / ritonavir)

Marketing authorisation granted: 24/02/2023

Conditional marketing authorisation granted: 28/01/2022

Latest news

Paediatric investigation plan

RoActemra (tocilizumab) Marketing authorisation for COVID-19 indication granted: 06/12/2021 Latest news
Veklury (remdesivir)

Marketing authorisation granted: 08/08/2022

Conditional marketing authorisation granted: 03/07/2020

Latest news

Clinical data (login required)

Paediatric investigation plan

Avtozma (tocilizumab) Marketing authorisation issued on 14/02/2025

Latest news

Avtozma: product information

Tocilizumab STADA (previously Tofidence) Marketing authorisation issued on 20/06/2024

Latest news

Tocilizumab STADA: product information

Tuyory (tocilizumab) Marketing authorisation issued on 27/04/2026

Latest news

Tuyory: product information

Tyenne (tocilizumab) Marketing authorisation issued on 15/09/2023

Latest news

Tyenne: product information

Kineret (anakinra) Marketing authorisation issued on 08/03/2022

Latest news

Kineret: product information

For more information on how EMA fast-tracks its evaluation of promising potential COVID-19 medicines, see:

Safety information 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 information on each COVID-19 vaccine is available:

Ongoing clinical trials

Information on ongoing clinical trials for COVID-19 treatments in the European Economic Area (EEA) is available in the EU Clinical Trials Register (EU CTR):

Users can find information on:

  • phase II to phase IV adult clinical trials for COVID-19 treatments where the investigator sites are in the EEA;
  • any clinical trials in children with investigator sites in the EU and any trials that form part of a paediatric investigation plan, including those where the investigator sites are outside the EU.

Phase I clinical trials conducted solely in adults are not made publicly available in the EU CTR.

For more information on the EU CTR and how clinical trials are authorised and overseen in the EEA, see:

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in September 2026.

4 September 2026

  • Updated the table in the 'Authorised COVID-19 vaccines' section to list the latest versions of Bimervax, Comirnaty, Nuvaxovid and Spikevax vaccines
  • Removed the section on 'COVID-19 vaccines: strains, use and age ranges' as related information in available on the corresponding medicine pages on this website

1 September 2026

  • Removed Xevudy, Regkirona and Ronapreve from page section on authorised COVID-19 treatments 
  • Added Avtozma, Tocilizumab STADA, Tuyory, Tyenne and Kineret to page section on authorised COVID-19 treatments
  • Added mCombriax and mNexspike to page section on authorised COVID-19 vaccines 

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