Moderna has secured US approval for its first seasonal influenza vaccine, opening the door for a new mRNA-based option for adults aged 50 and older.

 

The US FDA approval of mFLUSIVA (mRNA-1010) for use in all adults 50 years of age and older marks a major expansion of Moderna’s mRNA platform beyond COVID-19 and RSV vaccines and makes mFLUSIVA the first mRNA-based flu vaccine approved in the US.

 

"The FDA approval of mFLUSIVA, our fourth approved product in the United States and the first mRNA-based flu vaccine, demonstrates the continued strength and versatility of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna. 

 

"Flu remains a significant public health challenge, and mFLUSIVA provides an important new option for America's seniors. This approval also reflects the ongoing potential of our mRNA platform to help address important public health challenges through continued scientific innovation. We are grateful to the clinical trial participants, investigators, regulators and Moderna teams whose contributions made this milestone possible."

 

For adults aged 50 to 64, the FDA based its approval on results from a randomized, observer-blind, active-controlled Phase 3 trial that enrolled 40,805 adults across 11 countries.

 

The study evaluated the vaccine’s safety and reactogenicity, as well as its relative vaccine efficacy compared with a standard-dose influenza vaccine against RT-PCR-confirmed influenza-like illness caused by influenza A or B strains.

 

For adults 65 and older, the FDA granted accelerated approval based on a separate randomized clinical trial involving 2,992 participants in the United States. That study compared mFLUSIVA’s immunogenicity with a high-dose inactivated influenza vaccine.

 

Moderna said the effectiveness of mFLUSIVA in the 65-and-older population is also supported by a descriptive analysis of relative vaccine efficacy from the larger Phase 3 trial. The company will conduct a postmarketing clinical trial to confirm clinical benefit in this age group.

 

Moderna said the Phase 3 program showed an acceptable safety profile for mFLUSIVA, with no new safety concerns identified, consistent with earlier studies of the vaccine.