Comirnaty

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tozinameran / riltozinameran and tozinameran / famtozinameran and tozinameran / COVID-19 mRNA Vaccine (nucleoside modified)

Authorised
This medicine is authorised for use in the European Union.

Overview

Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months. 
The originally authorised Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19. 
Comirnaty is also available as three adapted vaccines: 

  •  Comirnaty Original/Omicron BA.1 contains tozinameran and riltozinameran, an mRNA molecule with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2; 
  • Comirnaty Original/Omicron BA.4-5 contains tozinameran and famtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2;
  • Comirnaty Omicron XBB.1.5 contains raxtozinameran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.

Comirnaty does not contain the virus itself and cannot cause COVID-19. 

This EPAR was last updated on 28/09/2023

Authorisation details

Product details
Name
Comirnaty
Agency product number
EMEA/H/C/005735
Active substance
Single-stranded, 5’-capped messenger RNA produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the viral spike (S) protein of SARS-CoV-2
International non-proprietary name (INN) or common name
  • tozinameran
  • riltozinameran and tozinameran
  • famtozinameran and tozinameran
  • COVID-19 mRNA Vaccine (nucleoside modified)
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J07BN01
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
BioNTech Manufacturing GmbH
Revision
44
Date of issue of marketing authorisation valid throughout the European Union
21/12/2020
Contact address

An der Goldgrube 12
55131 Mainz
Germany

Product information

31/08/2023 Comirnaty - EMEA/H/C/005735 - II/0183

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Comirnaty 30 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. 

Comirnaty 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older. 

Comirnaty 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. 

Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years. 

Comirnaty Original/Omicron BA.1 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older who have previously received at least a primary vaccination course against COVID-19.

Comirnaty Original/Omicron BA.4-5 (15/15 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.

Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years. 

Comirnaty Original/Omicron BA.4-5 (1.5/1.5 micrograms)/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years. 

Comirnaty Omicron XBB.1.5 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.

Comirnaty Omicron XBB.1.5 10 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.

Comirnaty Omicron XBB.1.5 10 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children aged 5 to 11 years.

Comirnaty Omicron XBB.1.5 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.

The use of this vaccine should be in accordance with official recommendations.

Assessment history

Changes since initial authorisation of medicine

Safety updates

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