Spikevax (previously COVID-19 Vaccine Moderna)
COVID-19 mRNA vaccine / elasomeran / elasomeran / imelasomeran / elasomeran / davesomeran / andusomeran
Overview
Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.
The originally authorised Spikevax contains elasomeran, a molecule called messenger RNA (mRNA) with instructions for producing a protein from the original strain of SARS-CoV-2, the virus that causes COVID-19.
Spikevax is also available as three adapted vaccines:
- Spikevax bivalent Original/Omicron BA.1 contains elasomeran and an additional mRNA molecule, imelasomeran, with instructions for producing a protein from the Omicron BA.1 subvariant of SARS-CoV-2;
- Spikevax bivalent Original/Omicron BA.4-5 contains elasomeran and an additional mRNA molecule, davesomeran, with instructions for producing a protein from the Omicron BA.4 and BA.5 subvariants of SARS-CoV-2
- Spikevax XBB.1.5 contains andusomeran, an mRNA molecule with instructions for producing a protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2.
Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.
-
List item
Spikevax (previously COVID-19 Vaccine Moderna): EPAR - Medicine overview (PDF/178.35 KB) (updated)
First published: 20/01/2021
Last updated: 28/09/2023
EMA/360647/2023 -
-
List item
Spikevax (previously COVID-19 Vaccine Moderna): EPAR - Risk-management-plan (PDF/1.85 MB)
First published: 20/01/2021
Last updated: 24/08/2023
Authorisation details
Product details | |
---|---|
Name |
Spikevax (previously COVID-19 Vaccine Moderna)
|
Agency product number |
EMEA/H/C/005791
|
Active substance |
Single-stranded, 5’-capped messenger RNA (mRNA) 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 |
|
Therapeutic area (MeSH) |
COVID-19 virus infection
|
Anatomical therapeutic chemical (ATC) code |
J07BN01
|
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 | |
---|---|
Marketing-authorisation holder |
Moderna Biotech Spain, S.L.
|
Revision |
40
|
Date of issue of marketing authorisation valid throughout the European Union |
06/01/2021
|
Contact address |
Calle del Principe De Vergara 132 Plt 12 |
Product information
15/08/2023 Spikevax (previously COVID-19 Vaccine Moderna) - EMEA/H/C/005791 - II-111-G
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
Spikevax is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
Spikevax bivalent Original/Omicron BA.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19.
Spikevax bivalent Original/Omicron BA.4-5 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older.
Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID 19 caused by SARS-CoV-2 in individuals 6 months of age and older.
The use of this vaccine should be in accordance with official recommendations.
Assessment history
Safety updates
-
List item
COVID-19 vaccines - Safety update: 8 December 2022 (PDF/181.16 KB)
First published: 08/12/2022 -
List item
COVID-19 vaccines - Safety update: 10 November 2022 (PDF/193.65 KB)
Adopted
First published: 10/11/2022 -
List item
COVID-19 vaccines - Safety update: 6 October 2022 (PDF/179.91 KB)
Adopted
First published: 06/10/2022 -
List item
COVID-19 vaccines - Safety update: 8 September 2022 (PDF/194.49 KB)
Adopted
First published: 08/09/2022 -
List item
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 -
List item
COVID-19 vaccines - Safety update: 17 June 2022 (PDF/235.43 KB)
Adopted
First published: 17/06/2022 -
List item
COVID-19 vaccines - Safety update: 12 May 2022 (PDF/203.03 KB)
Adopted
First published: 12/05/2022 -
List item
COVID-19 vaccines - Safety update: 13 April 2022 (PDF/214.65 KB)
Adopted
First published: 13/04/2022 -
List item
COVID-19 vaccines - Safety update: 17 March 2022 (PDF/221.74 KB)
Adopted
First published: 17/03/2022 -
List item
COVID-19 vaccines - Safety update: 17 February 2022 (PDF/212.51 KB)
Adopted
First published: 17/02/2022 -
List item
COVID-19 vaccines - Safety update: 20 January 2022 (PDF/234.12 KB)
Adopted
First published: 20/01/2022 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 9 December 2021 (PDF/193.92 KB)
Adopted
First published: 09/12/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 11 November 2021 (PDF/90.72 KB)
Adopted
First published: 11/11/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 6 October 2021 (PDF/115.36 KB)
Adopted
First published: 06/10/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 8 September 2021 (PDF/111.73 KB)
Adopted
First published: 08/09/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 11 August 2021 (PDF/90.01 KB)
Adopted
First published: 11/08/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 14 July 2021 (PDF/100.36 KB)
Adopted
First published: 14/07/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 18 June 2021 (PDF/171.58 KB)
Adopted
First published: 18/06/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 11 May 2021 (PDF/83.58 KB)
Adopted
First published: 12/05/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 29 March 2021 (PDF/167.03 KB)
Adopted
First published: 30/03/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 4 March 2021 (PDF/84.83 KB)
Adopted
First published: 04/03/2021 -
List item
COVID-19 vaccine safety update for Spikevax (previously COVID-19 Vaccine Moderna): 5 February 2021 (PDF/189.9 KB)
Adopted
First published: 05/02/2021
News
-
15/09/2023
-
14/09/2023
-
21/07/2023
-
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
-
16/12/2022
-
06/12/2022
-
28/10/2022
-
19/10/2022
-
19/10/2022
-
16/09/2022
-
06/09/2022
-
01/09/2022
-
17/06/2022
-
08/04/2022
-
06/04/2022
-
11/03/2022
-
25/02/2022
-
24/02/2022
-
11/02/2022
-
16/12/2021
-
03/12/2021
-
10/11/2021
-
25/10/2021
-
04/10/2021
-
27/09/2021
-
24/08/2021
-
30/07/2021
-
23/07/2021
-
09/07/2021
-
09/07/2021
-
11/06/2021
-
11/06/2021
-
08/06/2021
-
07/05/2021
-
23/04/2021
-
26/03/2021
-
12/03/2021
-
02/03/2021
-
06/01/2021
-
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine17/12/2020
-
01/12/2020
-
16/11/2020