Spikevax (previously COVID-19 Vaccine Moderna)


COVID-19 mRNA Vaccine (nucleoside modified)

This medicine is authorised for use in the European Union.


Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 12 years and older.

Spikevax contains a molecule called messenger RNA (mRNA) with instructions for producing a protein from SARS-CoV-2, the virus that causes COVID-19. Spikevax does not contain the virus itself and cannot cause COVID-19.

This EPAR was last updated on 09/12/2021

Authorisation details

Product details
Spikevax (previously COVID-19 Vaccine Moderna)
Agency product number
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
COVID-19 mRNA Vaccine (nucleoside modified)
Therapeutic area (MeSH)
COVID-19 virus infection
Anatomical therapeutic chemical (ATC) code
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.

Conditional approvalConditional 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
Marketing-authorisation holder
Moderna Biotech Spain, S.L.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Calle Monte Esquinza 30
28010 Madrid

Product information

08/12/2021 Spikevax (previously COVID-19 Vaccine Moderna) - EMEA/H/C/005791 - IAIN/0045


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Pharmacotherapeutic group


Therapeutic indication

Spikevax 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.

Assessment history

Safety updates


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