Spikevax (previously COVID-19 Vaccine Moderna) (COVID-19 mRNA vaccine)
- Region
- 🇪🇺 EU
- Active substance
- COVID-19 mRNA vaccine
- Company
- Moderna Biotech Spain, S.L.
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Mon 04 Jan 2021
- EU approval
- Wed 06 Jan 2021
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005791
- ATC
- J07BN01
- Official record
- www.ema.europa.eu
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. Spikevax XFG 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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Comirnaty Authorised · BioNTech Manufacturing GmbH
- 🇪🇺 mNexspike Authorised · Moderna Biotech Spain, S.L.
- 🇪🇺 mCombriax Authorised · Moderna Biotech Spain, S.L.
- 🇪🇺 CureVac’s COVID-19 vaccine (CVnCoV) Withdrawn from rolling review · CureVac AG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.