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

Moderna MRNA 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 PerformanceYear to date, the stock has plummeted 35% compared with the industry’s 4% decline. Image Source: Zacks Investment Research Recent Development With Moderna's StockThere 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 SpaceApart from Moderna, Pfizer PFE and Novavax NVAX 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. QuoteMRNA’s Zacks RankModerna currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.Zacks' Research Chief Names "Stock Most Likely to Double"Our team of experts has just released the 5 stocks with the greatest probability of gaining +100% or more in the coming months. Of those 5, Director of Research Sheraz Mian highlights the one stock set to climb highest.This top pick is among the most innovative financial firms. With a fast-growing customer base (already 50+ million) and a diverse set of cutting edge solutions, this stock is poised for big gains. Of course, all our elite picks aren’t winners but this one could far surpass earlier Zacks’ Stocks Set to Double like Nano-X Imaging which shot up +129.6% in little more than 9 months.Free: See Our Top Stock And 4 Runners UpWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Pfizer Inc. (PFE): Free Stock Analysis Report Moderna, Inc. (MRNA): Free Stock Analysis Report Novavax, Inc. (NVAX): Free Stock Analysis ReportThis article originally published on Zacks Investment Research (zacks.com).Zacks Investment ResearchWeiter zum vollständigen Artikel bei Zacks Weiter zum vollständigen Artikel bei Zacks