Basic Information
Spikevax (previously COVID-19 Vaccine Moderna)
Regulatory Information
EMEA/H/C/005791
January 6, 2021
January 4, 2021
55
May 14, 2025
Company Information
Spain
C/ Julián Camarillo nº 31 28037 Madrid
Moderna Biotech Spain, S.L.
Drug Classification
Active Substances Detail
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
SARS-CoV-2 JN.1 mRNA
EMA Resources
Detailed Information
Therapeutic Indication
### 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 6 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 6 months of age and older. The use of this vaccine should be in accordance with official recommendations. 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. Spikevax JN.1 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.
Overview Summary
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. As SARS-CoV-2 keeps evolving, Spikevax has been adapted to target the most recent strains of the virus. This helps maintain protection against COVID-19. Therefore, Spikevax is also authorised as four adapted vaccines, with Spikevax JN.1 being the most recent: - 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 JN.1 contains SARS‑CoV‑2 JN.1 mRNA, an mRNA molecule with instructions for producing a protein from the Omicron JN.1 subvariant of SARS-CoV-2. Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.