Moderna's mRNA-1010 Flu Shot Accepted for FDA Review

Biotech firm's stock rises as agency sets August 5 action date on vaccine application.

Published on Feb. 21, 2026

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Moderna (MRNA) shares gained in premarket trading after the U.S. FDA accepted the company's marketing application for its mRNA-based flu vaccine candidate mRNA-1010, reversing an earlier decision to refuse the review. The Cambridge, Massachusetts-based biotech said the FDA has set an August 5, 2026 action date for the application.

Why it matters

Moderna's mRNA technology platform has shown promise in developing effective vaccines, as demonstrated by the company's successful COVID-19 shot. The FDA's acceptance of the flu vaccine application is a positive step that could lead to Moderna expanding its product portfolio and revenue streams beyond the pandemic.

The details

The FDA's decision to accept Moderna's flu vaccine application for review comes after the agency had previously indicated it would refuse to review the application. This reversal suggests the agency sees potential in Moderna's mRNA approach to developing a new flu shot option.

  • The FDA accepted Moderna's flu vaccine application on February 18, 2026.
  • The FDA has set an action date of August 5, 2026 to review the application.

The players

Moderna

A biotechnology company based in Cambridge, Massachusetts that focuses on developing messenger RNA (mRNA) therapeutics and vaccines, including the COVID-19 vaccine.

U.S. Food and Drug Administration (FDA)

The federal agency responsible for regulating and supervising the safety of food, drugs, and other products in the United States, including the review and approval of new vaccines.

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What’s next

If approved, Moderna's mRNA-1010 flu vaccine would provide the company with a new revenue stream and help diversify its product portfolio beyond just COVID-19 vaccines.

The takeaway

Moderna's successful development of an mRNA-based flu vaccine and the FDA's acceptance of the application for review represents an important milestone for the company's technology platform and its efforts to expand beyond the pandemic.