Rises as FDA Clears mFLUSIVA for Adults Over 50

• Moderna shares gained 3.37% pre-market after the FDA approved mFLUSIVA nationwide.
• The FDA approved mFLUSIVA for all adults aged 50 and older across the U.S. market.
• A 40,805-person Phase 3 trial supported the vaccine’s safety and effectiveness.
• Moderna plans a U.S. launch during the 2026–2027 respiratory virus season nationwide.
• Regulators in Europe, Canada, and Australia are also reviewing Moderna’s mRNA-1010.

Moderna shares gained before Thursday’s opening bell after federal regulators cleared its mRNA influenza vaccine for eligible older adults nationwide. MRNA rose 3.37% to $58.15 after closing 1.29% lower at $56.26 during Wednesday’s session. The approval adds another commercial product and widens Moderna’s respiratory vaccine portfolio in the United States.

Moderna, Inc., MRNA

FDA Approves mFLUSIVA for Adults Aged 50 and Older

The FDA approved mFLUSIVA for adults aged 50 years and older across the United States. The decision followed unanimous support from the agency’s Vaccines and Related Biological Products Advisory Committee. Moderna now holds approval for four products in its home market after this decision.

The vaccine uses Moderna’s messenger RNA platform to target seasonal influenza strains. It provides another prevention option for older adults who face higher flu-related health risks. The company plans a commercial launch during the 2026-2027 respiratory virus season.

Moderna will market mFLUSIVA beside Spikevax, mRESVIA, and mNEXSPIKE across eligible populations. That lineup covers influenza, respiratory syncytial virus, and COVID-19 prevention. The broader range strengthens Moderna’s position in recurring seasonal vaccination programs.

Phase 3 Data Supports Safety and Effectiveness

The main Phase 3 trial enrolled 40,805 adults aged 50 and older across 11 countries. Researchers compared mFLUSIVA with a standard-dose influenza vaccine using laboratory-confirmed illness outcomes. The study also measured safety, side effects, and relative vaccine effectiveness.

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The FDA granted standard approval for adults aged 50 through 64 years. Regulators based that decision on efficacy and safety findings from the larger international trial. Moderna reported an acceptable safety profile without new concerns across the Phase 3 program.

The FDA granted accelerated approval to adults aged 65 years and older under a separate clinical pathway. A second trial enrolled 2,992 participants across the United States. Researchers compared immune responses against a high-dose inactivated influenza vaccine.

Global Reviews and Moderna’s Growth Strategy

Moderna must confirm clinical benefits for adults aged 65 and older through a postmarketing study. The company will also continue monitoring safety after commercial distribution begins nationwide. These requirements form part of the FDA’s accelerated approval process.

Regulators in the European Union, Canada, and Australia are reviewing mRNA-1010. Moderna also plans more regulatory submissions in additional countries during 2026. Wider approvals would expand the vaccine’s addressable market beyond the United States.

The FDA decision gives Moderna another product as it reduces reliance on COVID-19 vaccine sales. Influenza remains a major seasonal market with recurring demand across older populations during future seasons. MRNA’s pre-market gain followed the approval announcement and improved the stock’s near-term momentum.