COVID-19 medicines

HumanCOVID-19

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. 

 
VaccineMarketing authorisation holderKey milestones                                                                                          More information
NuvaxovidNovavax CZ, a.s.

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 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 (developed by BioNTech and Pfizer)BioNTech Manufacturing GmbH

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.Marketing authorisation issued: 30/03/2023

Latest news

Bimervax: product information

Clinical data (login required)

Paediatric investigation plan

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:

TreatmentStatusMore information
Evusheld (tixagevimab / cilgavimab)Marketing authorisation granted: 25/03/2022Latest news
Kineret (anakinra)Marketing authorisation granted: 17/12/2021Latest news
Paxlovid (PF-07321332 / ritonavir)

Marketing authorisation granted: 24/02/2023

Conditional marketing authorisation granted: 28/01/2022

Latest news

Paediatric investigation plan

RoActemraMarketing authorisation for COVID-19 indication granted: 07/12/2021Latest 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

Regkirona (regdanvimab)Marketing authorisation granted: 12/11/2021

Latest news

Paediatric investigation plan

Ronapreve (casirivimab / imdevimab)Marketing authorisation granted: 12/11/2021Latest news
Xevudy (sotrovimab)Marketing authorisation granted: 17/12/2021Latest news

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

COVID-19 vaccines: strains, use and age ranges

Select the expandable panel below (via the arrow symbol) to get an overview of the characteristics of the COVID-19 vaccines authorised in the EU. This includes:

  • 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

VaccinePlatform*StrainPopulation
Comirnaty
(BioNTech)
mRNA
  • Original strain
  • Original strain and Omicron BA.1 variant (adapted)**
  • Original strain and Omicron BA.4-5 variants (adapted)
  • Omicron XBB.1.5 variant (adapted)
  • Comirnaty JN.1 (adapted)
  • Comirnaty KP.2 (adapted)
  • For original strain - authorised from 6 months onwards, all age categories
  • For original strain and Omicron BA.1 variant - authorised from 12 years onwards
  • For original strain and Omicron BA.4-5 variants - authorised from 6 months onwards, all age categories
  • For Omicron XBB.1.5 variant - authorised from 6 months onwards, all age categories
  • For Comirnaty JN.1 - authorised from 6 months onwards, all age categories
  • For Comirnaty KP.2 - authorised from 6 months onwards, all age categories
Spikevax
(Moderna)
mRNA
  • Original strain
  • Original strain and Omicron BA.1 variant (adapted)**
  • Original strain and Omicron BA.4-5 variants (adapted)
  • Omicron XBB.1.5 variant (adapted)
  • Spikevax JN.1 (adapted)
  • For original strain - authorised from 6 months onwards, all age categories
  • For original strain and Omicron BA.1 variant - authorised from 6 years onwards
  • For original strain and Omicron BA.4-5 variants - authorised from 6 months onwards, all age categories
  • For Omicron XBB.1.5 variant - authorised from 6 months onwards, all age categories
  • For Spikevax JN.1 - authorised from 6 months onwards, all age categories
Nuvaxovid
(Novavax)
Protein
  • Original strain
  • Omicron XBB.1.5 variant (adapted)
  • Nuvaxovid JN.1 (adapted)
  • For original strain - authorised from 12 years onwards
  • For Omicron XBB.1.5 variant - authorised from 12 years onwards
  • For Nuvaxovid JN.1 - authorised from 12 years onwards
Bimervax
(HIPRA Human Health S.L.U.)
ProteinAlpha and Beta variants**For alpha and beta variants - authorised from 16 years onwards

* See available platforms

** Only used as boosters

For more information on available platforms used to develop authorised COVID-19 vaccines, select the expandable panel below:

mRNA

The vaccine contains a molecule called messenger RNA (mRNA) with instructions for producing the spike protein from SARS-CoV-2.

Protein

The vaccine contains a version of the spike protein which has been produced in the laboratory.

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:

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