Moderna MRNA announced positive effects from an ongoing late-stage comparing mRNA-1083, its investigational mixed mRNA-based vaccine against influenza and COVID-19, in older adults (50 years of age and older).
The Phase III study met its primary endpoints, showing that mRNA-1083 elicited superior immune responses against influenza and COVID-19 compared to standalone legal influenza and COVID-19 vaccines.
These findings are based on a study that evaluated the vaccine in approximately 8,000 adults in two independent cohorts by age-based organization. The first cohort, which includes adults 65 years of age and older, mRNA-1083 to a co-administration of Fluzone HD, a high-dose influenza vaccine announced through Sanofi and Spikevax, Moderna’s recently legal COVID-19 vaccine. The current organization is comprised of adults 50 to 64 years of age and older, comparing mRNA-1083 to Fluarix, a standard-dose influenza vaccine announced through GSK, co-administered with Spikevax.
With those results, Moderna takes the lead over Novavax NVAX and BioNTech BNTX/Pfizer PFE, which are also introducing their respective combined COVID and flu vaccines. Compared to its peers, Moderna is the first to report positive late-stage data for a combined COVID-19 and flu vaccine.
Moderna intends to collaborate with regulators on regulatory filings. Management intends to commercialize mRNA-1083 through 2025.
Year-to-date, Moderna shares are up 49. 4%, a 5. 9% drop for the sector.
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mRNA-1083 combines Moderna’s two experimental vaccines, the mRNA-1010 flu vaccine and mRNA-1283, a next-generation COVID-19 vaccine that’s solid in the refrigerator. Both vaccines have already achieved effects in separate late-stage studies as standalone vaccines. .
In March, Moderna announced positive interim effects from a late-stage study comparing mRNA-1283 in Americans aged 12 and older. The study achieved its number one endpoint, demonstrating a superior immune response in Americans compared to the company’s in the past. Bivalent vaccine approved. According to the address, mRNA-1083 offers the possibility of longer shelf life and storage advantages.
Last year, Moderna provided a positive interim update of a phase III immunogenicity study (P303) of mRNA-1010 in older adults. The study data showed that mRNA-1010 caused superior immune reactions to all four influenza A and B strains than those of GSK. In a separate Phase I/II comparative study, mRNA-1010 elicited a superior antibody reaction to Sanofi’s Fluzone HD. The P303 study is expected to lead to Moderna’s submission for mRNA-1010, which is expected later this year. If approved, an announcement will be published It is expected to launch today, in 2025.
If approved, a combination vaccine such as mRNA-1083 could help vaccine acceptance and comfort against two respiratory infections. According to the CDC (as of June 1, 2024), the flu vaccination rate in 2023/2024 was more than double that of the updated COVID-19 vaccine for adults in the United States (48. 4% vs. 22. 4%). Management noted that hospitalization rates for COVID-19 were higher than those for influenza.
As COVID-19 vaccines decline especially compared to previous years, the approval of the mixed vaccine could simply increase the uptake of COVID-19 vaccines, which could simply decrease hospitalization rates.
These upcoming advertising launches are part of Moderna’s plans to bring 15 new products to market by 2028. Earlier this month, the FDA approved the company’s mRNA-based RSV vaccine, mRNA-1345, to prevent RSV-associated lower respiratory illness (RSV-LRTD) in adults 60 years of age and older. The vaccine will be marketed under the industrial name mResvia.
Novavax is also developing its own combination COVID-19 flu vaccine (CIC). NVAX plans to launch a late-stage program on its CIC vaccine before the end of this year, with plans to bring it to market in 2026.
Last October, Pfizer/BioNTech announced positive effects of a Phase I/II comparing its combined mRNA-based vaccine against influenza and COVID-19. The data showed that the vaccine demonstrated physically powerful immune responses against influenza and SARS-CoV. -2 vines. Based on those effects, Pfizer and BioNTech are lately comparing their late-stage mixed vaccine.
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