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Moderna (MRNA) COVID-Flu Combo Jab Meets Late-Stage Study Goal

Moderna MRNA announced positive results from an ongoing late-stage study evaluating mRNA-1083, its investigational mRNA-based combination vaccine against influenza and COVID-19, in older adults (50 years and older).

The phase III study met its primary endpoints, showing that mRNA-1083 elicited higher immune responses against influenza and COVID-19 compared with licensed standalone influenza and COVID-19 vaccines.

These results are based on a study that evaluated the vaccine in about 8,000 adults divided into two independent age group cohorts. The first cohort, which includes adults aged 65 and older, compared mRNA-1083 with a co-administration of Fluzone HD, a high-dose influenza vaccine marketed by Sanofi and Spikevax, Moderna's currently licensed COVID-19 vaccine. The second group consists of adults aged 50 to 64, comparing mRNA-1083 with Fluarix, a standard-dose influenza vaccine marketed by GSK, co-administered with Spikevax.

With these results, Moderna gains a lead over Novavax NVAX and BioNTech BNTX/Pfizer PFE, who are also developing their respective COVID/flu combination vaccines. Compared with peers, Moderna is the first one to report positive data from a late-stage study on a COVID-19/flu combination vaccine.

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Moderna intends to engage with regulatory authorities for regulatory submissions. Management intends to market mRNA-1083 by 2025.

Year to date, Moderna’s shares have surged 49.4% against the industry’s 5.9% fall.

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mRNA-1083 combines Moderna’s two investigational vaccines, influenza vaccine mRNA-1010 and mRNA-1283, a next-generation refrigerator-stable COVID-19 vaccine. Both vaccines have already achieved positive results in separate late-stage studies as standalone vaccines.

In March, Moderna reported positive interim results from a late-stage study evaluating mRNA-1283 in individuals aged 12 years and older. The study achieved its primary endpoint, demonstrating higher immune response in individuals compared with the company’s previously approved bivalent vaccine. Per management, mRNA-1083 offers the potential for longer shelf life and storage advantages.

Last year, Moderna provided a positive interim update from a phase III immunogenicity study (P303) on mRNA-1010 in older adults. Data from the study showed that mRNA-1010 elicited higher immune responses across all four A and B strains of influenza than GSK’s Fluarix. In a separate phase I/II head-to-head study, mRNA-1010 elicited a higher antibody response than Sanofi’s Fluzone HD. The P303 study is expected to support Moderna’s filing for mRNA-1010, which is expected later this year. If approved, a commercial launch is expected in second-half 2025.

If approved, a combination vaccine like mRNA-1083 could help improve vaccine uptake and convenience against two respiratory infections. Per the CDC (as of Jun 1, 2024), the 2023/2024 influenza vaccine uptake was more than double that of the updated COVID-19 vaccine for adults in the United States (48.4% vs. 22.4%). Management pointed out that the COVID-19 hospitalization rates were higher compared with influenza.

With COVID-19 vaccinations declining significantly when compared to previous years, approval for the combination vaccine could help increase the uptake of COVID-19 vaccinations. This could bring down hospitalization rates.

These upcoming commercial launches are part of Moderna’s plans to market 15 new products by 2028. Earlier this month, the FDA approved the company’s mRNA-based RSV vaccine mRNA-1345 to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years and above. The vaccine will be marketed under the trade name mResvia.

Novavax is also developing its own COVID-19-influenza combination (CIC) vaccine. NVAX expects to start a late-stage program on its CIC vaccine before this year's end, with the intent to market the same in 2026.

Last October, Pfizer/BioNTech reported positive topline results from a phase I/II study evaluating their mRNA-based combination vaccine against influenza and COVID-19. Data from the study showed that the vaccine demonstrated robust immune responses against influenza and SARS-CoV-2 strains. Based on these results, Pfizer and BioNTech are currently evaluating their combination vaccine in late-stage development.

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Zacks Rank

Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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