Basic Information
Nuvaxovid
Regulatory Information
EMEA/H/C/005808
December 20, 2021
December 20, 2021
18
October 16, 2024
Company Information
Czech Republic
Bohumil 138 Jevany, 28163
NOVAVAX CZ a.s.
Drug Classification
Active Substances Detail
SARS CoV-2 (Original) recombinant spike proteinSARS-CoV-2 (Omicron XBB.1.5) recombinant spike protein
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Nuvaxovid 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. Nuvaxovid XBB.1.5 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.
Overview Summary
Nuvaxovid is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people aged 12 years and older. The originally authorised Nuvaxovid contains a version of a protein found on the surface of SARS‑CoV‑2 (the virus that causes COVID-19), which has been produced in the laboratory. As SARS-CoV-2 keeps evolving, Nuvaxovid has been adapted to target the most recent strains of the virus. This helps maintain protection against COVID-19. Therefore, Nuvaxovid is also authorised as two adapted vaccines, with Nuvaxovid JN.1 being the most recent: - Nuvaxovid XBB.1.5, which contains a version of the protein from the Omicron XBB.1.5 subvariant of SARS-CoV-2; - Nuvaxovid JN.1, which contains a version of the protein from the Omicron JN.1 subvariant of SARS-CoV-2.