Phase 3 Trial Begins for Combination Influenza and COVID-19 Vaccine

Investigators have dosed the first participant in a phase 3 trial for mRNA-1083 (Moderna), a combination vaccine candidate that provides protection against influenza and COVID-19. Investigators anticipate enrolling approximately 8000 individuals in the Northern Hemisphere for the trial, according to a Moderna press release.¹

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The goal of the study is to analyze the immunogenicity, safety, and reactogenicity of the vaccine compared to active control, co‐administered licensed influenza and SAR‐CoV‐2 vaccines in a pair of independent age‐group sub‐study cohorts, which will include approximately 4000 individuals 65 years of age and older and 4000 individuals 50 to <65 years of age.

Results from a phase 1/2 trial (NCT05827926) showed mRNA-1083 achieved hemagglutination inhabitation antibody titers similar to or greater than the 2 licensed quadrivalent influenza vaccines.²

The randomized, observer blind, phase 1/2 trial evaluated the safety and immunogenicity of mRNA-1083 compared to the standard dose of Fluarix, a quadrivalent influenza vaccine from GSK, in adults aged 50 to 64 years, and Fluzone HD, a high-dose quadrivalent influenza vaccine from Sanofi, in adults aged 65 to 79 years. The investigational vaccine was also compared against Spikevax in both age groups.²

Investigators found that mRNA-1083 resulted in geometric mean titer (GMT) ratios of 1.0 or greater relative to Fluarix for all 4 influenza vaccine strains. Additionally, the GMT ratios for the vaccine were also at 1.0 or greater relevant to Fluzone HD in all 4 vaccine strains. Compared to Spikevax, the GMT ratios were 0.9 or greater for those aged 50 to 64 years and 1.0 or greater for those aged 65 to 79 years.²

The rates of solicited local and systemic adverse reactions after mRNA-1083 administration were similar to the COVID-19 vaccine group, according to the statement. The majority of solicited reactions were grade 1 or 2 in severity, with grade 3 reactions reported in less than 3% of individuals aged 50 years and older. There were no new safety concerns identified for the investigational vaccine compared to the standalone vaccines.²

“mRNA‐1083 has the potential to efficiently reduce the overall burden of acute viral respiratory diseases by providing simultaneous protection against influenza and SARS‐CoV‐2 viruses in a single injection,” Moderna said in a company press release.¹ “mRNA‐1083 offers greater convenience and has the potential to lead to increased compliance with vaccine recommendations. This approach could benefit public health by synergistically increasing coverage rates against influenza and SARS‐CoV‐2 viruses.”

Moderna said it anticipates seeking initial regulatory approval for mRNA‐1083 in 2025. The company also previously announced plans to expand mRNA medicine.

The company’s respiratory franchise is currently targeting an approximately $30 billion annual market, with potential growth with more effective vaccines. Furthermore, the product sales for respiratory product sales in 2027 are expected to be approximately $8 billion to $15 billion.³

References

1. Moderna Announces First Participant Dosed in Phase 3 Study of mRNA-1083, a Combination Vaccine Against Influenza and COVID-19. Moderna. News release. October 24, 2023. https://investors.modernatx.com/news/news-details/2023/Moderna-Announces-First-Participant-Dosed-in-Phase-3-Study-of-mRNA-1083-a-Combination-Vaccine-Against-Influenza-and-COVID-19/default.aspx

2. 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 4, 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

3. Gallagher A. Moderna announces expansion of mRNA research across respiratory, oncology, rare disease franchises. Pharmacy Times. September 19, 2023. Accessed October 4, 2023. https://www.pharmacytimes.com/view/moderna-announces-expansion-of-mrna-research-across-respiratory-oncology-rare-disease-franchises