Yahoo Finance Moderna's (MRNA) Next-Gen COVID-19 Jab Study Meets Efficacy Goal
ModernaMRNA announced positive results from the pivotal phase III NextCOVE study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older.
The study achieved its primary efficacy endpoint, demonstrating the non-inferior vaccine efficacy of mRNA-1283 against COVID-19 when compared to mRNA-1273.222, Moderna’s previously approved bivalent Omicron BA.4/BA.5-targeting COVID-19 vaccine. A higher efficacy was also observed in these study participants when compared to mRNA-1273.222.
Moderna had previously reported positive interim immunogenicity results from the NextCOVE study in March. Individuals who received mRNA-1283 generated a higher immune response against both the Omicron BA.4/BA.5 and original strains of SARS-CoV-2 when compared to mRNA-1273.222.
Per management, mRNA-1283 offers the potential for longer shelf life and storage advantages.
Year to date, Moderna’s shares have rallied 46% against the industry’s 5.1% fall.
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The above results intend to reinforce confidence in Moderna’s combination vaccines. Earlier this week, management reported positive results from a late-stage study on mRNA-1083, which combines mRNA-1283 and its influenza vaccine mRNA-1010 in individuals aged 50 years and older. This study met its primary endpoints, showing that mRNA-1083 elicited higher immune responses against influenza and COVID-19 when compared with licensed standalone influenza and COVID-19 shots.
Moderna plans to engage with regulatory authorities for regulatory submissions on mRNA-1083, with an intent to market the same by 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.
As COVID-19 vaccinations have suffered a significant decline 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.
Moderna intends to initiate a regulatory filing with the FDA for mRNA-1010 as a standalone influenza vaccine later this year. Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating this flu vaccine. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared to the licensed vaccines marketed by GSK and Sanofi.
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.
With the mRNA-1083 results, Moderna has gained a lead over Novavax NVAX and BioNTech BNTX/Pfizer PFE, who are also developing their respective COVID-19/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.
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 top-line 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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Moderna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.
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