COVID-19 vaccines New

The current status of vaccine approvals can be found on the European Medicines Agency (EMA) website.

For product information of the approved COVID-19 vaccines, please also refer to the European Commission Register.

Product information of licensed COVID-19 vaccines

How to find the current German texts of a product on the EMA site?

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

This document is also available in German translation, see "available languages".

The SmPC and Package leaflets of the COVID-19 vaccines approved in Europe will be published as soon as they have been positively evaluated by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), approved by the Commission (EC) and are available in German.

Comirnaty (mRNA vaccine) - BioNTech Pfizer New

Marketing authorization holder BioNTech Marketing authorization on December 21, 2020

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/comirnaty

The contents of the previous amendments are available in a cumulative list on the EMA site:

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

Products

Comirnaty 30 microgram/dose concentrate for injection dispersion - adults and adolescents 12 years and older (cap purple)
Comirnaty 30 microgram/dose injection dispersion - adults and adolescents 12 years and older ( cap gray)
Comirnaty 10 microgram/dose concentrate for injection dispersion - children 5 to 11 years (cap orange)
Comirnaty 3 microgram/dose concentrate for preparation of injection dispersion - infants and children 6 months to 4 years (cap red-brown)
Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose of injection dispersion (cap gray and a gray border around the label)
Comirnaty Original/Omicron BA.4-5 (15/15 micrograms) / dose injection dispersion - for people 12 years and older (cap gray and a gray border around the label)
Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection (orange plastic cap and an orange border around the label)

Actual EPAR Product information (22.12.2022):  https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf

Spikevax (mRNA vaccine) - Moderna

Marketing authorization holder Moderna Marketing authorization on January 6, 2021

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/spikevax

The contents of the previous amendments are available in a cumulative list on the EMA site:

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

Products

Spikevax 0.2 mg/ml Injection Dispersion

Spikevax 0.1 mg/ml Injection Dispersion

Spikevax 50 micrograms Injection Dispersion in a ready-to-fill syringe

Spikevax bivalent Original/Omicron BA.1 (50 micrograms/50 micrograms)/mL dispersion for injection

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for injection

Spikevax bivalent Original/Omicron BA.1 25 micrograms/25 micrograms dispersion for injection in pre-filled syringe

Spikevax bivalent Original/Omicron BA.4-5 (50 micrograms/50 micrograms)/mL dispersion for injection

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms dispersion for injection

Spikevax bivalent Original/Omicron BA.4-5 25 micrograms/25 micrograms dispersion for injection in pre-filled syringe

EPAR Product information (22.12.2022):  https://www.ema.europa.eu/en/documents/product-information/spikevax-previously-covid-19-vaccine-moderna-epar-product-information_en.pdf

Vaxzevria (vector vaccine) - AstraZeneca

Marketing authorization holder AstraZeneca Marketing authorization on January 29, 2021

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/vaxzevria-previously-covid-19-vaccine-astrazeneca

The contents of the previous amendments are available in a cumulative list on the EMA site:

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

FAQ's about the use of the vaccine from AstraZeneca

Actual EPAR Product information (03.11.2022): https://www.ema.europa.eu/en/documents/product-information/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-product-information_en.pdf

Jcovden (vector vaccine) - Janssen - Johnson and Johnson New

Marketing authorization holder Janssen-Cilag Marketing authorization on March 11, 2021

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-janssen

The contents of the previous amendments can be accessed in a cumulative list on the EMA site:

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

The manufacturer Janssen-Cilag is a subsidiary of the US company Johnson and Johnson (J&J). Therefore, the vaccine is also referred to as "Johnson and Johnson vaccine".

Actual EPAR Product information (10.01.2023): https://www.ema.europa.eu/en/documents/product-information/jcovden-previously-covid-19-vaccine-janssen-epar-product-information_en.pdf

Nuvaxovid (protein vaccine) - Novavax

Marketing authorization holder Novavax Marketing authorization on December 20, 2021

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/nuvaxovid

The contents of the previous amendments can be accessed in a cumulative list on the EMA site:  Procedural steps taken and scientific information after the authorisation (nuvaxovide).

One dose (0.5 ml) contains 5 micrograms of the spike protein of SARS-CoV-2.

Actual EPAR Product information (10.01.2023): https://www.ema.europa.eu/en/documents/product-information/nuvaxovid-epar-product-information_en.pdf

VidPrevtyn Beta (protein vaccine) - Sanofi Pasteur

Marketing Authorization Holder Sanofi Pasteur Approval on November 10, 2022.

VidPrevtyn Beta solution and emulsion for the preparation of an emulsion for injection. Booster vaccination from 18 years of age. solution with SARS-CoV-2 spike protein (strain B.1.351) and emulsion with adjuvant. To be injected intramuscularly after mixing the two components.

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/vidprevtyn-beta

Actual EPAR Product information (11.11.2022): https://www.ema.europa.eu/en/documents/product-information/vidprevtyn-beta-epar-product-information_en.pdf

Valneva (inactivated virus) - Valneva

Marketing authorization holder Valneva Austria Marketing authorization on June 24, 2022

EPAR (European Public Assessment Report): https://www.ema.europa.eu/en/medicines/human/EPAR/covid-19-vaccine-inactivated-adjuvanted-valneva

The contents of the previous amendments are available in a cumulative list on the EMA site:Procedural steps taken and scientific information after the authorisation (Valneva).

EC community-register  (25.11.2022): https://ec.europa.eu/health/documents/community-register/2022/20221125157911/anx_157911_en.pdf

Email

Further inquiry note