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MRNA·Moderna

mRNA-1083

INNmRNA-1083
mRNAcombination flu + COVID-19 mRNA vaccine

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.

Programs

1 program
completedVaccines

Seasonal Influenza

Seasonal influenza kills 290,000–650,000 people globally each year; current vaccines are manufactured with egg-based methods that vary in effectiveness and require separate administration from COVID-19 boosters. This Phase 3 trial tests mRNA-1083 as a single annual shot covering both influenza and COVID-19 for adults aged 50 and older; positive non-inferiority data versus licensed comparators were reported in April 2026, supporting a planned BLA filing.

Trial
NCT05955807n=8,000completed
P304: Phase 3 Efficacy Study of mRNA-1083 (Flu+COVID)
Primary completion: Apr 1, 2026
Readout
APR 152026·reportedEXACT
mRNA-1083 P304 Flu+COVID Phase 3 Topline

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