COVID-19 Vaccines New

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 New

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)

Comirnaty Original/Omicron BA.1 (15/15 micrograms) / dose injection dispersion. (Gray cap and a gray border around the label)

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

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

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

Spikevax (mRNA) - Moderna New

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

Spikevax 0.2 mg/mL dispersion for injection
Spikevax 0.1 mg/mL dispersion for injection
Spikevax 50 micrograms dispersion for injection in pre-filled syringe
Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection

Spikevax dispersion for injection

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

Product information: https://www.ema.europa.eu/en/documents/product-information/spikevax-previously-covid-19-vaccine-moderna-epar-product-information_en.pdf

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

Jcovden (Vector) - Janssen - Johnson und Johnson

Nuvaxovid (Protein) - Novavax New

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Further inquiry note