JAMA

Combined flu and COVID vaccine shows encouraging results in older adults

May 12, 2025

Study details: This phase 3, randomized, observer-blinded trial (NCT06097273) assessed the immunogenicity and safety of the investigational mRNA-1083 vaccine, which targets both seasonal influenza and SARS-CoV-2, in adults ≥50 years. Conducted across 146 sites in the U.S., the study enrolled 8,015 participants between October 19, 2023, and November 21, 2023. They were divided into two age cohorts (50-64 years and ≥65 years) and randomly assigned to receive either the mRNA-1083 vaccine plus placebo or coadministered licensed quadrivalent influenza and COVID-19 vaccines.

Results: The mRNA-1083 vaccine demonstrated noninferior immunogenicity compared with the licensed vaccines against all vaccine-matched influenza and SARS-CoV-2 strains. Additionally, mRNA-1083 elicited higher immune responses than the standard-dose influenza vaccine in the 50-64 age group and the high-dose influenza vaccine in the ≥65 age group for most influenza strains and SARS-CoV-2. Adverse reactions were more frequent with mRNA-1083 but were mostly mild to moderate in severity and short-lived.

Clinical impact: The mRNA-1083 vaccine is a promising candidate for simultaneous protection against influenza and COVID-19 in adults ≥50 years. Its higher immunogenicity and acceptable safety profile suggest it could improve vaccine uptake and convenience, potentially reducing the burden on healthcare systems during flu and COVID-19 seasons.

Source:

Rudman Spergel AK, et al. (2025, May 7). JAMA. Immunogenicity and Safety of Influenza and COVID-19 Multicomponent Vaccine in Adults ≥50 Years: A Randomized Clinical Trial. https://pubmed.ncbi.nlm.nih.gov/40332892/