Moderna Secures FDA Nod for Next-Gen COVID-19 Vaccine mNexspike

From Nasdaq: 2025-06-03 12:16:00

Moderna’s FDA approval for mRNA-1283, now branded as mNexspike, is limited to older adults and high-risk individuals. This aligns with updated FDA guidance emphasizing high-risk populations. mNexspike joins Spikevax and mResvia as Moderna’s third FDA-approved product, offering improved shelf life and storage benefits for broad distribution.

Despite Moderna’s new vaccine approval, MRNA stock has dropped 35% year to date, contrasting with the industry’s 4% decline. Recent negative sentiment stems from the U.S. government terminating contracts with Moderna, FDA guidelines restricting booster eligibility, and the withdrawal of a regulatory filing for a COVID-19/influenza vaccine.

In the COVID-19 vaccine space, Pfizer’s Comirnaty and Novavax’s Nuvaxovid are notable players alongside Moderna. Comirnaty, like Spikevax, is based on mRNA technology, while Nuvaxovid is a non-mRNA vaccine recently approved for individuals aged 12-64 with underlying conditions. Novavax’s vaccine is the only non-mRNA option in the U.S.

Moderna’s stock is currently facing challenges with recent developments impacting its performance. The company’s Zacks Rank sits at #3 (Hold) amidst funding losses, FDA guideline restrictions, and setbacks in regulatory filings. Moderna’s stock performance reflects these uncertainties in the market.

Zacks Investment Research highlights potential stock picks with strong growth opportunities, emphasizing the importance of innovative companies in the financial sector. Moderna, Pfizer, and Novavax are among the companies discussed, with a focus on their performance and market trends in the healthcare sector.



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