Positive Early-Phase Data Announced for Combination COVID-19/Flu Vaccine


Moderna plans to begin a phase 3 trial of the combination vaccine this year.

Moderna has announced positive interim results from a Phase 1/2 clinical trial of mRNA-1083, an investigational combination flu and COVID-19 vaccine, according to a company news release.1

The ongoing trial (NCT05827926) is a randomized, observer-blind study evaluating safety and immunogenicity of mRNA-1083 vs 2 flu vaccines: a standard dose flu vaccine (Fluarix) in adults aged 50 to 64 years, and an enhanced flu vaccine (Fluzone HD) in adults aged 65 to 79 years). For safety and immunogenicity against COVID-19 in both age groups, mRNA-1083 was compared with the Spikevax booster shot.

The mRNA-1083 candidate selected to advance to Phase 3 research achieved hemagglutination inhibition antibody titers similar to the Spikevax bivalent booster during the Phase 1/2 study. Geometric mean titer ratios of ≥1.0 relative to Fluarix were noted for all 4 influenza vaccine strains. Geometric mean titer ratios relative to Fluzone HD were also ≥1.0, for all 4 strains. Ratios of mRNA-1083 relative to the Spikevax bivalent booster were ≥0.9 in adults aged 50 to 64 years, and ≥1.0 in adults aged 65 to 79 years.

Reported rates of both solicited local and systemic adverse reactions after vaccine administration were similar to the standalone COVID-19 vaccine group, and the majority of solicited adverse reactions were grade 1 or 2 in severity.

“Flu and COVID-19 represent a significant seasonal burden for individuals, providers, health care systems, and economies,” said Stéphane Bancel, Moderna CEO.1 “Combination vaccines offer an important opportunity to improve consumer and provider experience, increase compliance with public health recommendations, and deliver value for health care systems.”

Moderna intends to begin a Phase 3 trial of mRNA-1083 in 2023, targeting potential approval for the combination vaccine in 2025.

Moderna announces positive phase 1/2 data from mRNA-1083, the company’s combination vaccine against influenza and COVID-19. News release. Moderna. October 4, 2023. Accessed October 6, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-Positive-Phase-12-Data-from-mRNA-1083-the-Companys-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx
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