Comirnaty
Tozinameran / COVID-19 mRNA Vaccine (nucleoside modified)
Overview
Comirnaty is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 5 years and older.
Comirnaty contains tozinameran, a messenger RNA (mRNA) molecule with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Comirnaty does not contain the virus itself and cannot cause COVID-19.
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Comirnaty : EPAR - Medicine overview (PDF/126.53 KB) (updated)
First published: 23/12/2020
Last updated: 15/06/2022
EMA/365655/2022 -
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Comirnaty : EPAR - Risk-management-plan (PDF/3.73 MB)
First published: 23/12/2020
Last updated: 13/04/2022
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. |
Conditional approval |
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation. |
Publication details | |
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Marketing-authorisation holder |
BioNTech Manufacturing GmbH
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Revision |
25
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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
04/05/2022 Comirnaty - EMEA/H/C/005735 - II/0104
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 10 micrograms/dose is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in children aged 5 to 11 years.
The use of this vaccine should be in accordance with official recommendations.
Comirnaty 30 micrograms/dose is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
Assessment history
Safety updates
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COVID-19 vaccines - Safety update: 17 June 2022 (PDF/235.43 KB) (new)
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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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