COVID-19 Vaccines

Vaccines and drugs for the treatment of COVID-19 are predominantly approved through the European Centralized Procedure. The current status of the can be found on the website of the European Medicines Agency (EMA).

Product information of approved COVID-19 medicinal products in all EU languages can also be found in the European Commission Register.

Product information of the authorised COVID-19 vaccines

The EMA publishes an EPAR (European Public Assessment Report) for each centrally approved product.
e.g.: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Here is the link to the "EPAR- Product information" with the content:

Annex I - Summary of product characteristics (SmPC)
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet

COVID-19 vaccines, currently authorised:

Comirnaty (mRNA) - BioNTech Pfizer

Marketing authorisation holder: BioNTech
Date of marketing authorisation: 21 December 2020

Comirnaty 30 micrograms/dose concentrate for dispersion for injection - for individuals 12 years of age and older (purple cap)
Comirnaty 30 micrograms/dose dispersion for injection - for individuals 12 years of age and older (grey cap)
Comirnaty 10 micrograms/dose concentrate for dispersion for injection - for children aged 5 to 11 years (orange cap)

EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

Procedural steps taken and scientific information after the authorisation (Comirnaty)

https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf

Spikevax (mRNA) - Moderna

Marketing authorisation holder: Moderna
Date of marketing authorisation: 06 January 2021

Spikevax dispersion for injection

EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax

Procedural steps taken and scientific information after the authorisation (Spikevax)

Vaxzevria (Vector) - AstraZeneca

Marketing authorisation holder: AstraZeneca
Date of marketing authorisation: 29 January 2021

Vaxzevria suspension for injection

EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

Procedural steps taken and scientific information after the authorisation (Vaxzevria)

Jcovden (Vector) - Janssen - Johnson und Johnson

Marketing authorisation holder: Janssen-Cilag
Date of marketing authorisation: 11. March 2021

COVID-19 Vaccine Jcovden (Vector) - Janssen - Johnson und Johnson

EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen

Procedural steps taken and scientific information after the authorisation (Janssen)

Nuvaxovid (Protein) - Novavax

Marketing authorisation holder: Novavax
Date of marketing authorisation: 20 December 2021

Nuvaxovid dispersion for injection

EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid

Procedural steps taken and scientific information after the authorisation (Novaxovid)

Valneva (inactivated virus) - Valneva New

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Further inquiry note