Comirnaty
tozinameran / riltozinameran and tozinameran / famtozinameran and tozinameran / COVID-19 mRNA Vaccine (nucleoside modified)
Overview
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months. 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 two adapted vaccines:
- Comirnaty Original/Omicron BA.1 contains tozinameran and riltozinameran, another 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, another mRNA molecule with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2.
The adapted vaccines are authorised for use in people who have received at least a primary vaccination course against COVID-19.
Comirnaty and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.
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Comirnaty : EPAR - Medicine overview (PDF/174.67 KB)
First published: 23/12/2020
Last updated: 25/01/2023
EMA/30576/2023 -
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Comirnaty : EPAR - Risk-management-plan (PDF/5.06 MB)
First published: 23/12/2020
Last updated: 21/11/2022
Authorisation details
Product details | |
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Name |
Comirnaty
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Agency product number |
EMEA/H/C/005735
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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
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International non-proprietary name (INN) or common name |
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Therapeutic area (MeSH) |
COVID-19 virus infection
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Anatomical therapeutic chemical (ATC) code |
J07BX
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Additional 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 | |
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Marketing-authorisation holder |
BioNTech Manufacturing GmbH
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Revision |
41
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Date of issue of marketing authorisation valid throughout the European Union |
21/12/2020
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Contact address |
An der Goldgrube 12 |
Product information
09/03/2023 Comirnaty - EMEA/H/C/005735 - II/0139
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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. The use of this vaccine should be in accordance with official recommendations.
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. The use of this vaccine should be in accordance with official recommendations.
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. The use of this vaccine should be in accordance with official recommendations.
Comirnaty 3 micrograms/dose concentrate for dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 6 months to 4 years. The use of this vaccine should be in accordance with official recommendations.
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 (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.
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 who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recommendations.
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 who have previously received at least a primary vaccination course against COVID-19 (see sections 4.2 and 5.1). The use of this vaccine should be in accordance with official recom
Assessment history
Safety updates
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COVID-19 vaccines - Safety update: 8 December 2022 (PDF/181.16 KB)
First published: 08/12/2022 -
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COVID-19 vaccines - Safety update: 10 November 2022 (PDF/193.65 KB)
Adopted
First published: 10/11/2022 -
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COVID-19 vaccines - Safety update: 6 October 2022 (PDF/179.91 KB)
Adopted
First published: 06/10/2022 -
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COVID-19 vaccines - Safety update: 8 September 2022 (PDF/194.49 KB)
Adopted
First published: 08/09/2022 -
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COVID-19 vaccines - Safety update: 14 July 2022 (PDF/198.21 KB)
Adopted
First published: 14/07/2022
Last updated: 03/08/2022
Rev. 1 -
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COVID-19 vaccines - Safety update: 17 June 2022 (PDF/235.43 KB)
Adopted
First published: 17/06/2022 -
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COVID-19 vaccines - Safety update: 12 May 2022 (PDF/203.03 KB)
Adopted
First published: 12/05/2022 -
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COVID-19 vaccines - Safety update: 13 April 2022 (PDF/214.65 KB)
Adopted
First published: 13/04/2022 -
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COVID-19 vaccines - Safety update: 17 March 2022 (PDF/221.74 KB)
Adopted
First published: 17/03/2022 -
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COVID-19 vaccines - Safety update: 17 February 2022 (PDF/212.51 KB)
Adopted
First published: 17/02/2022 -
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COVID-19 vaccines - Safety update: 20 January 2022 (PDF/234.12 KB)
Adopted
First published: 20/01/2022 -
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COVID-19 vaccine safety update for Comirnaty: 9 December 2021 (PDF/192.42 KB)
Adopted
First published: 09/12/2021 -
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COVID-19 vaccine safety update for Comirnaty: 11 November 2021 (PDF/88.55 KB)
Adopted
First published: 11/11/2021 -
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COVID-19 vaccine safety update for Comirnaty: 6 October 2021 (PDF/141.93 KB)
Adopted
First published: 06/10/2021 -
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COVID-19 vaccine safety update for Comirnaty: 8 September 2021 (PDF/104.84 KB)
Adopted
First published: 08/09/2021 -
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COVID-19 vaccine safety update for Comirnaty: 11 August 2021 (PDF/88.96 KB)
Adopted
First published: 11/08/2021 -
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COVID-19 vaccine safety update for Comirnaty: 14 July 2021 (PDF/97.84 KB)
Adopted
First published: 14/07/2021 -
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COVID-19 vaccine safety update for Comirnaty: 18 June 2021 (PDF/171.28 KB)
Adopted
First published: 18/06/2021 -
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COVID-19 vaccine safety update for Comirnaty: 11 May 2021 (PDF/80.68 KB)
Adopted
First published: 12/05/2021 -
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COVID-19 vaccine safety update for Comirnaty: 14 April 2021 (PDF/77.06 KB)
Adopted
First published: 16/04/2021 -
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COVID-19 vaccine safety update for Comirnaty: 29 March 2021 (PDF/172.68 KB)
Adopted
First published: 30/03/2021 -
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COVID-19 vaccine safety update for Comirnaty: 4 March 2021 (PDF/85.12 KB)
Adopted
First published: 04/03/2021 -
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COVID-19 vaccine safety update for Comirnaty: 28 January 2021 (PDF/163.12 KB)
Adopted
First published: 29/01/2021
News
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06/12/2022
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 202211/11/2022
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28/10/2022
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19/10/2022
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16/09/2022
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12/09/2022
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06/09/2022
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01/09/2022
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15/06/2022
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08/04/2022
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06/04/2022
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24/02/2022
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11/02/2022
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08/02/2022
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16/12/2021
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03/12/2021
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25/11/2021
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18/10/2021
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18/10/2021
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04/10/2021
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09/09/2021
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06/09/2021
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03/09/2021
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24/08/2021
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09/07/2021
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22/06/2021
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01/06/2021
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28/05/2021
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17/05/2021
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07/05/2021
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03/05/2021
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23/04/2021
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26/03/2021
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12/03/2021
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29/01/2021
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28/01/2021
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15/01/2021
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08/01/2021
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21/12/2020
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Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application15/12/2020
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01/12/2020
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06/10/2020