mNexspike (COVID-19 mRNA vaccine)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- COVID-19 mRNA vaccine
- Company
- Moderna Biotech Spain, S.L.
- Status
- Authorised
- Therapeutic area
- COVID-19 virus infection
- CHMP opinion
- Thu 11 Dec 2025
- EU approval
- Thu 12 Feb 2026
- Designations
- Additional monitoring
- Application
- EMEA/H/C/006428
- ATC
- J07BN01
- Official record
- www.ema.europa.eu
Indication
mNEXSPIKE 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.
Regulatory milestones
Thu 12 Feb 2026🇪🇺 EU approval (EC decision)
mNexspike (COVID-19 mRNA vaccine) approved in the EU
Marketing authorisation to Moderna Biotech Spain, S.L.; Additional monitoring · source
Thu 11 Dec 2025🇪🇺 CHMP positive opinion
mNexspike (COVID-19 mRNA vaccine): CHMP positive opinion
Moderna Biotech Spain, S.L.; Additional monitoring · source
Same substance in other markets
- 🇪🇺 Comirnaty Authorised · BioNTech Manufacturing GmbH
- 🇪🇺 Spikevax (previously COVID-19 Vaccine Moderna) 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- 🇪🇺 CureVac’s COVID-19 vaccine (CVnCoV) Withdrawn from rolling review · CureVac AG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.