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.

For more information about COVID-19, see:

• Coronavirus disease (COVID-19)

Also on this topic

• COVID-19 vaccines: key facts
• Safety of COVID-19 vaccines
• COVID-19 medicines under evaluation
• COVID-19 medicines: Article 18 and Article 5(3) reviews
• Public-health advice during COVID-19 pandemic
• Transparency: exceptional measures for COVID-19 medicines

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	Arcturus Therapeutics Europe B.V.	Marketing authorisation issued: 12/02/2025	Latest news Kostaive: product information
Nuvaxovid	Novavax 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 LP.8.1 (adapted) authorised: 24/07/2025 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	Latest news   Spikevax: product information   Clinical data (login required)   Paediatric investigation plan
Comirnaty (developed by BioNTech and Pfizer)	BioNTech Manufacturing GmbH	Comirnaty LP.8.1 (adapted) authorised: 24/07/2025 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	Latest news   Comirnaty: product information   Clinical data (login required)   Paediatric investigation plan
Bimervax (previously COVID-19 Vaccine HIPRA)	HIPRA Human Health S.L.U.	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

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

• COVID-19 vaccines: Scientific evaluation and approval

Authorised COVID-19 treatments

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

Treatment	Status	More information
Kavigale	Marketing authorisation issued: 20/01/2025	Latest news Kavigale: product information
Gohibic	Marketing authorisation issued: 13/01/2025	Latest news Gohibic: product information
Paxlovid (PF-07321332 / ritonavir)	Marketing authorisation granted: 24/02/2023 Conditional marketing authorisation granted: 28/01/2022	Latest news Paediatric investigation plan
RoActemra	Marketing authorisation for COVID-19 indication granted: 07/12/2021	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
Regkirona (regdanvimab)	Marketing authorisation granted: 12/11/2021	Latest news Paediatric investigation plan
Ronapreve (casirivimab / imdevimab)	Marketing authorisation granted: 12/11/2021	Latest news
Xevudy (sotrovimab)	Marketing authorisation granted: 17/12/2021	Latest news

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

• COVID-19 guidance: assessment and marketing authorisation

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:

• Types - 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

Overview of authorised COVID-19 vaccines

Vaccine	Type*	Strain	Population
Comirnaty (BioNTech)	mRNA	Omicron XBB.1.5 variant (adapted) Comirnaty JN.1 variant (adapted) Comirnaty KP.2 variant (adapted)	For Omicron XBB.1.5 variant - authorised from 6 months onwards, all age categories For Comirnaty JN.1 variant - authorised from 6 months onwards, all age categories For Comirnaty KP.2 variant - 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 variant (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 variant (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.)	Protein	Alpha and Beta variants** Omicron XBB.1.16 variant (adapted)	For alpha and beta variants - authorised from 16 years onwards For Omicron XBB.1.16 variant - authorised from 16 years onwards
Kostaive (Arcturus Therapeutics Europe B.V.)	sa-mRNA	Original strain	For original strain - authorised from 18 years onwards

* See available types

** Only used as boosters

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

Available types of vaccine

mRNA / sa-mRNA

An mRNA vaccine contains a molecule of messenger RNA (mRNA) with instructions for producing the spike protein from SARS-CoV-2. A self-amplifying (sa-mRNA) vaccine also has instructions for making an enzyme called replicase, which makes additional copies of the mRNA.

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:

• Safety of COVID-19 vaccines

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):

• EU CTR: COVID-19 treatments

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:

• Clinical trials in human medicines