Moderna receives FDA nod for RSV vaccine mRESVIA

Moderna has received the Food and Drug Administration’s approval for RESVIA (mRNA-1345), an mRNA respiratory syncytial virus vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marks the second approved mRNA product from Moderna.

“The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform,” said Stéphane Bancel, CEO of Moderna. “mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators’ time and reducing the risk of administrative errors. This approval is also the first time an mRNA vaccine has been approved for a disease other than COVID-19. With mRESVIA, we continue to deliver for patients by addressing global public health threats related to infectious diseases.”

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RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia that causes a particularly large burden of disease in infants and older adults. Each year in the U.S., approximately 60,000-160,000 older adults are hospitalized and 6,000-10,000 die due to RSV infection, Moderna noted. 

Moderna expects to have mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season.

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