Drugs / mRNA-1083
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | influenza, COVID-19 | — | “Currently, the Company's mRNA-1083 filing is under review with the European Medicines Agency (EMA).” q4web.com ↗ |
| Filed | Other | — | influenza, COVID-19 | — | “Moderna submitted for approval to Health Canada in 2025.” q4web.com ↗ |
| Filed | US (FDA) | — | influenza, COVID-19 | — | “The Company has filed with the FDA for regulatory approval of mRNA-1083.” q4web.com ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05827926 | Apr 2023 → Dec 2024 | COVID-19, influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06864143 | Mar → Oct 2025 | Orthocoronavirinae infectious disease, influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT06508320 | Jul 2024 → Sep 2025 | COVID-19, influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06694389 | Nov 2024 → Nov 2025 | COVID-19, influenza | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT06097273 | Oct 2023 → May 2024 | Orthocoronavirinae infectious disease, influenza | ModernaTX, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-05-01 | ModernaTX, Inc. | Regulatory Moderna Reports First Quarter 2026 Financial Results and Provides Business Updates q4web.com ↗
We received two product approvals in Europe, including the world's first flu plus COVID combination vaccine, mCOMBRIAX. |
| 2026-04-21 | ModernaTX, Inc. | Regulatory Moderna Receives European Commission Marketing Authorization for mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mCOMBRIAX® (mRNA-1083), the Company's mRNA combination vaccine for active immunization for the prevention of influenza disease and COVID-19 caused by SARS-CoV-2 in individuals 50 years of age and older. |
| 2026-02-27 | ModernaTX, Inc. | Regulatory European Medicines Agency's Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Marketing Authorization of mCOMBRIAX, Moderna's mRNA Combination Vaccine Against Influenza and COVID-19 q4web.com ↗
mCOMBRIAX is the world's first flu plus COVID combination vaccine to receive a positive CHMP opinion recommending marketing authorization and represents Moderna's fourth vaccine to receive a positive CHMP opinion |
| 2025-05-21 | ModernaTX, Inc. | Regulatory Moderna Provides Update on BLA Submission for Combination Vaccine Against Influenza and COVID-19 q4web.com ↗
Moderna, Inc. (Nasdaq:MRNA), today announced that in consultation with the U.S. Food and Drug Administration (FDA), the Company has voluntarily withdrawn the pending Biologics License Application (BLA) for mRNA-1083, its flu/COVID combination vaccine candidate for adults aged 50 years and older. |
| 2024-06-10 | ModernaTX, Inc. | Results Moderna Announces Positive Phase 3 Data for Combination Vaccine Against Influenza and COVID-19 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced that its Phase 3 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial. |
| 2023-10-04 | ModernaTX, Inc. | Results Moderna Announces Positive Phase 1/2 Data from mRNA-1083, the Company's Combination Vaccine Against Influenza and COVID-19 q4web.com ↗
Moderna, Inc. (NASDAQ:MRNA) today announced positive interim results from the Phase 1/2 trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19. |
| 2023-04-11 | ModernaTX, Inc. | Regulatory Moderna Announces Clinical and Program Updates at 4th Vaccines Day q4web.com ↗
An investigational new drug (IND) application has been submitted for a next-generation Covid+Flu vaccine candidate (mRNA-1083). |
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-1083 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06864143 ↗ |
| Modality | Messenger RNA (mRNA) | “mRNA-based multicomponent vaccine (mRNA-1083), encoding seasonal influenza and SARS-CoV-2 antigens.” PMID 40102593 ↗ Mar 2025 |
| Route | Intramuscular | “single IM injection” NCT05827926 ↗ |