Spikevax (previously COVID-19 Vaccine Moderna)

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elasomeran / imelasomeran and elasomeran / davesomeran and elasomeran / COVID-19 mRNA vaccine (nucleoside-modified)

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

Overview

Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.

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 two 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.

The adapted vaccines are authorised for use in people who have previously received at least a primary vaccination course against COVID-19.

Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.

This EPAR was last updated on 03/02/2023

Authorisation details

Product details
Name
Spikevax (previously COVID-19 Vaccine Moderna)
Agency product number
EMEA/H/C/005791
Active substance
CX-024414 (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
  • elasomeran
  • imelasomeran and elasomeran
  • davesomeran and elasomeran
  • COVID-19 mRNA vaccine (nucleoside-modified)
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
J07BX03
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
Moderna Biotech Spain, S.L.
Revision
35
Date of issue of marketing authorisation valid throughout the European Union
06/01/2021
Contact address

Calle del Principe De Vergara 132 Plt 12
28002 Madrid
Spain

Product information

16/12/2022 Spikevax (previously COVID-19 Vaccine Moderna) - EMEA/H/C/005791 - II/0083/G

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

Spikevax 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.

Spikevax bivalent Original/Omicron BA.1 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. The use of this vaccine should be in accordance with official recommendations.

Spikevax bivalent Original/Omicron BA.4-5 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.

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

Assessment history

Changes since initial authorisation of medicine

Safety updates

News

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