Moderna Shares Gain On FDA Approval For New COVID-19 Vaccine

(RTTNews) - Shares of Moderna, Inc. were gaining around 5 percent in the pre-market activity on the Nasdaq after its new Covid-19 vaccine, mNEXSPIKE, received approval from the U.S. Food and Drug Administration for limited use.

mNEXSPIKE (mRNA-1283), a new vaccine to protect against COVID-19, is for people who have received a COVID-19 vaccine before. It can now be used in all adults 65 and older, as well as individuals aged 12-64 years at high risk for severe COVID-19, with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention or CDC.

With the approval, mNEXSPIKE becomes Moderna's third FDA-approved product.

Moderna said it now expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company's approved respiratory syncytial virus or RSV vaccine.

The FDA's decision was based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial, which enrolled around 11,400 participants aged 12 years and older. The primary efficacy objective in the trial was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine.

In the trial, participants received either a 10 µg dose of mRNA-1283 or a 50 µg dose of mRNA-1273. The company noted that mRNA-1283 showed a 9.3% higher relative vaccine efficacy or rVE compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most common side effects were injection site pain, fatigue, headache and myalgia.

Stéphane Bancel, Chief Executive Officer of Moderna, said, "The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19. COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA's timely review and thank the entire Moderna team for their hard work and continued commitment to public health."

Moderna said mRNA-1283 is under review with regulators in multiple markets around the world.

The development comes as the U.S. Department of Health and Human Services last week notified Moderna that it would terminate funding for the late-stage development of pre-pandemic influenza vaccines, along with the right to purchase them. In January 2025, the HHS had announced that it would provide around $590 million to Moderna to accelerate the development of mRNA-based pandemic influenza vaccines and enhance mRNA platform capabilities.

Moderna meanwhile plans to explore alternatives for late-stage development and manufacturing of the H5 program consistent with the company's strategic commitment to pandemic preparedness.

In pre-market activity on the Nasdaq, Moderna shares were trading at $27.80, up 4.67%.

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