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
Marketing authorisation holder: Valneva Austria
Date of marketing authorisation: 24 Juni 2022
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva
Product information: https://www.ema.europa.eu/en/documents/product-information/covid-19-vaccine-inactivated-adjuvanted-valneva-epar-product-information_en.pdf
