mRNA-1083 is Moderna's investigational single-injection combination vaccine candidate against influenza and COVID-19. It has been studied in large Phase 3 trials in adults and is intended to improve convenience and vaccination compliance by providing simultaneous protection against both respiratory viruses. The program remains listed in Moderna's development pipeline.
The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing authorization for Moderna's mCOMBRIAX, the world's first combination Covid-19 and influenza vaccine, for individuals 50 years and older.
The FDA agreed to review Moderna's mRNA-1010 seasonal flu vaccine after initially refusing to file the application, setting a decision date of August 5, 2026. If approved, it would be the first mRNA-based seasonal influenza vaccine on the market.
The FDA's Center for Biologics Evaluation and Research issued a refusal-to-file letter to Moderna for its investigational influenza vaccine mRNA-1010, citing concerns over the Phase 3 trial control arm and whether it reflected the best-available standard of care.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06694389 |
Study to Investigate the Immunogenicity, Reactogenicity, and Safety of mRNA-1083 Vaccine (SARS-CoV-2 [COVID-19] and Influenza) in Adults ≥50 Years of Age |
COMPLETED | PHASE3 |
| NCT06508320 |
A Clinical Study to Investigate the Safety and Immunogenicity in Relation to Product Attributes of mRNA-1083 (Severe Acute Respiratory Syndrome Coronavirus 2 [SARS-CoV-2] and Influenza Vaccine) |
COMPLETED | PHASE2 |
| NCT06097273 |
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age |
COMPLETED | PHASE3 |
| NCT05827926 |
A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults |
COMPLETED | PHASE1/PHASE2 |
