mRNA-1083 P304 Flu+COVID Phase 3 Topline
Reported 2026-04-15: combination flu + COVID vaccine met non-inferiority vs. licensed comparators in adults ≥50. mRNA-1083 is Moderna’s first non-COVID respiratory commercial candidate and the basis for a planned BLA filing.
What’s at stake
mRNA-1083 is Moderna's combination influenza and COVID-19 vaccine, designed as a single annual shot protecting against both respiratory viruses simultaneously. The vaccine delivers mRNA instructions encoding influenza hemagglutinin antigens alongside the SARS-CoV-2 spike protein, training the immune system to defend against both pathogens in one dose. A Phase 3 trial in adults aged 50 and older reported positive non-inferiority results versus licensed comparators in April 2026, supporting a planned BLA filing as Moderna's first non-COVID respiratory commercial candidate.
No primer in glossary yet.
- BLAregulatoryBiologics License Application
FDA submission for approval of a biologic (antibody, gene/cell therapy, vaccine). Same clock as NDA.
Competitive landscape
| Drug | Company | Modality | Mechanism | Phase | Next catalyst |
|---|---|---|---|---|---|
| mRNA-1647 | MRNA | mRNA | pentavalent CMV vaccine | READOUT · Dec 26 |
Prior MRNA reactions to Readout events
| Date | Headline | Outcome | 1W | 1M | 6M |
|---|---|---|---|---|---|
| Apr 2026 | mRNA-1083 P304 Flu+COVID Phase 3 Topline | positive | +32.0% | +43.9% | +28.7% |
Disclosure trail
- Apr 15, 2026·15d agopinned · highest confidenceHIGH conf8-KEXACTtop claimAPR 152026
“Moderna today announced positive topline results from the Phase 3 P304 trial of mRNA-1083, a combination flu and COVID vaccine, demonstrating non-inferior immune responses versus separate licensed comparators in adults ≥50.”
conf 98%via llm