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 five adapted vaccines, with Spikevax LP.8.1 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 LP.8.1 contains SARS‑CoV‑2 LP.8.1 mRNA, an mRNA molecule with instructions for producing a protein from the Omicron LP.8.1 subvariant of SARS-CoV-2. Spikevax and its adapted vaccines do not contain the virus itself and cannot cause COVID-19.
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. 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. Spikevax LP.8.1 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.
Therapeutic Area (MeSH)
ATC Code
J07BN01
ATC Item
covid-19, RNA-based vaccine
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| 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 | N/A | 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 | N/A | SARS-CoV-2 mRNA vaccine |
EMA Name
Spikevax (previously COVID-19 Vaccine Moderna)
Medicine Name
Spikevax (previously COVID-19 Vaccine Moderna)
Aliases
N/A
