Drugs / mRNA-1283
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | — | “The Company filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher in 2024.” q4web.com ↗ “The Company has filed for regulatory approval of mRNA-1283 with the FDA using a priority review voucher.” q4web.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04813796 | Mar 2021 → Jul 2023 | COVID-19 | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07808697 | Sep 2026 → Aug 2029 expected | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05137236 | Dec 2021 → Mar 2023 | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07863635 | Oct 2026 → Jan 2027 expected | Orthocoronavirinae infectious disease | ModernaTX, Inc. | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07266558 | Nov 2025 → Jun 2027 expected | COVID-19 | ModernaTX, Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 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). |
| 2024-06-13 | ModernaTX, Inc. | Results Moderna Announces Positive Phase 3 Efficacy Data for mRNA-1283, the Company’s Next Generation COVID-19 Vaccine q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1283, an investigational next-generation COVID-19 vaccine, has met its primary efficacy endpoint, demonstrating non-inferior vaccine efficacy against COVID-19 compared to Spikevax. |
| 2024-03-27 | ModernaTX, Inc. | Results Moderna Advances Multiple Vaccine Programs to Late-Stage Clinical Trials q4web.com ↗
A recent announcement of positive interim results from the NEXTCove Phase 3 trial showed that mRNA-1283 elicited a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2 compared to mRNA-1273.222, Moderna's licensed COVID-19 vaccine. |
| 2024-03-26 | ModernaTX, Inc. | Results Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine q4web.com ↗
In the NextCOVE (NCT05815498) Phase 3 pivotal trial, mRNA-1283 was shown to elicit a higher immune response against both the Omicron BA.4/BA.5 and original virus strains of SARS-CoV-2, compared to mRNA-1273.222. |
| 2022-03-24 | ModernaTX, Inc. | Results Moderna Announces Clinical and Program Updates at 3rd Annual Vaccines Day q4web.com ↗
In a Phase 1 study of mRNA-1283, preliminary results indicate that when administered as primary series at lower doses levels (10 µg, 30 µg), mRNA-1283 elicits a robust anti-SARS-CoV-2 neutralizing antibody response comparable to the 100 µg mRNA-1273 primary series. |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mRNA-1283 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05137236 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-1283, a next-generation SARS-CoV-2 messenger RNA (mRNA)-based vaccine” PMID 37074202 ↗ Apr 2023 |
| Route | Intramuscular | “2 intramuscular (IM) injections of mRNA-1283” NCT04813796 ↗ |