Drugs / mNEXSPIKE
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | mNexspike | — | 2026-02-12 | europa.eu ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT07051031 | Oct 2025 → Jun 2026 overdue | COVID-19 | Marcel Curlin | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2026-04-18 | Sanofi | Results Press Release: ESCMID: Sanofi's Nuvaxovid COVID-19 vaccine showed better tolerability than mNEXSPIKE in head-to-head study sanofi.com ↗
In the COMPARE study, when side effects did occur with Nuvaxovid, they were less severe and shorter in duration compared to mNEXSPIKE. |
| 2026-04-18 | Novavax | Results Nuvaxovid™ COVID-19 Vaccine Showed Better Tolerability than mNEXSPIKE in Head-to-head Sanofi-led Phase 4 Study novavax.com ↗
The study showed that Nuvaxovid demonstrated statistically significant lower systemic reactogenicity (the expected side effects that might occur following vaccination) compared to mNEXSPIKE across all pre-specified endpoints. |
| 2026-02-17 | ModernaTX, Inc. | Regulatory Moderna Receives European Commission Marketing Authorization for COVID-19 Vaccine mNEXSPIKE q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. |
| 2025-12-15 | ModernaTX, Inc. | Regulatory EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's mNEXSPIKE (COVID-19 Vaccine, mRNA) q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorization of mNEXSPIKE® (mRNA-1283), a new COVID vaccine, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 years and older. |
| 2025-05-31 | ModernaTX, Inc. | Regulatory Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mNEXSPIKE® (mRNA-1283), a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC). |
All press releases naming this drug 5 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mNEXSPIKE | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07051031 ↗ |
| Known as | mRNA-1283 | “mNEXSPIKE mRNA-1283” NCT07051031 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-based vaccine” NCT07051031 ↗ |