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Moderna Secures FDA Nod for Next-Gen COVID-19 Vaccine mNexspike
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Key Takeaways
Moderna received FDA approval for mNexspike, its next-gen COVID-19 vaccine with limited use criteria.
Vaccine is cleared for older adults and high-risk individuals aged 12-64, not the broader group MRNA wanted.
The vaccine offers a better shelf life and matched or outperformed Spikevax in late-stage trial data.
Moderna (MRNA - Free Report) announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will be marketed under the brand name mNexspike.
This approval aligns with the FDA’s updated guidance from last month, which emphasizes vaccinating high-risk populations. mNexspike is approved for older adults aged 65 and for individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe COVID-19. Moderna had originally sought broader approval for use in individuals aged 12 and older, regardless of health status.
mNexspike becomes Moderna’s third FDA-approved product, joining Spikevax (original COVID-19 vaccine) and mResvia (RSV vaccine). Spikevax is approved/authorized for use by the FDA in individuals aged 6 months and older.
Per Moderna, mNexspike offers improved shelf life and storage benefits — key advantages for broad U.S. distribution, especially in areas with limited cold-chain infrastructure. The FDA approval is based on data from a late-stage study, which showed thatvaccination with mNexspike was at least as effective as Spikevax. Data showed that a 10 μg dose of mNexspike generated a 9.3% higher relative vaccine efficacy compared with a 50 μg dose of Spikevax.
Moderna expects to commercially launch the newly approved vaccine during the 2025-26 vaccination season.
MRNA Stock Price Performance
Year to date, the stock has plummeted 35% compared with the industry’s 4% decline.
Image Source: Zacks Investment Research
Recent Development With Moderna's Stock
There is currently a negative sentiment around MRNA’s stock, driven by a series of recent developments. Last week, the U.S. government terminated contracts worth $766 million awarded to the company for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine. This funding loss comes at a time when Moderna is working to scale back operating expenses and streamline its R&D pipeline.
The recently issued FDA guidelines for COVID-19 vaccine boosters restrict booster eligibility for healthy individuals under 65 years — a move that can reduce demand.
Apart from Moderna, Pfizer (PFE - Free Report) and Novavax (NVAX - Free Report) market their respective COVID-19 vaccines, Comirnaty and Nuvaxovid.
Like Moderna, Pfizer’s Comirnaty is based on mRNA technology developed in collaboration with BioNTech. The Pfizer vaccine is currently approved for use in the same population as Spikevax.
Notably, Novavax’s Nuvaxovid is the only non-mRNA-based vaccine in the United States. The NVAX vaccine was recently granted full approval by the FDA for use in older adults aged 65 and above, as well as use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Nuvaxovid is still not yet approved for those under 12 years.
Image: Shutterstock
Moderna Secures FDA Nod for Next-Gen COVID-19 Vaccine mNexspike
Key Takeaways
Moderna (MRNA - Free Report) announced the FDA approval for mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, though for a label narrower than initially targeted. The vaccine will be marketed under the brand name mNexspike.
This approval aligns with the FDA’s updated guidance from last month, which emphasizes vaccinating high-risk populations. mNexspike is approved for older adults aged 65 and for individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe COVID-19. Moderna had originally sought broader approval for use in individuals aged 12 and older, regardless of health status.
mNexspike becomes Moderna’s third FDA-approved product, joining Spikevax (original COVID-19 vaccine) and mResvia (RSV vaccine). Spikevax is approved/authorized for use by the FDA in individuals aged 6 months and older.
Per Moderna, mNexspike offers improved shelf life and storage benefits — key advantages for broad U.S. distribution, especially in areas with limited cold-chain infrastructure. The FDA approval is based on data from a late-stage study, which showed thatvaccination with mNexspike was at least as effective as Spikevax. Data showed that a 10 μg dose of mNexspike generated a 9.3% higher relative vaccine efficacy compared with a 50 μg dose of Spikevax.
Moderna expects to commercially launch the newly approved vaccine during the 2025-26 vaccination season.
MRNA Stock Price Performance
Year to date, the stock has plummeted 35% compared with the industry’s 4% decline.
Image Source: Zacks Investment Research
Recent Development With Moderna's Stock
There is currently a negative sentiment around MRNA’s stock, driven by a series of recent developments. Last week, the U.S. government terminated contracts worth $766 million awarded to the company for the late-stage development of an mRNA-based bird flu vaccine, as well as the right to purchase this vaccine. This funding loss comes at a time when Moderna is working to scale back operating expenses and streamline its R&D pipeline.
The recently issued FDA guidelines for COVID-19 vaccine boosters restrict booster eligibility for healthy individuals under 65 years — a move that can reduce demand.
Adding to the uncertainty, Moderna voluntarily withdrew a regulatory filing with the FDA seeking approval for its COVID-19/influenza vaccine after the agency requested additional efficacy data for the flu component. This setback derailed the company’s initial plans to secure potential approval for the vaccine before this year’s end.
Other Players in the COVID-19 Vaccine Space
Apart from Moderna, Pfizer (PFE - Free Report) and Novavax (NVAX - Free Report) market their respective COVID-19 vaccines, Comirnaty and Nuvaxovid.
Like Moderna, Pfizer’s Comirnaty is based on mRNA technology developed in collaboration with BioNTech. The Pfizer vaccine is currently approved for use in the same population as Spikevax.
Notably, Novavax’s Nuvaxovid is the only non-mRNA-based vaccine in the United States. The NVAX vaccine was recently granted full approval by the FDA for use in older adults aged 65 and above, as well as use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Nuvaxovid is still not yet approved for those under 12 years.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
MRNA’s 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.