Third RSV Vaccine Approved

Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a press release on May 31, 2024, "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."

RSV is a highly contagious seasonal respiratory virus that is a leading cause of lower respiratory tract infections and pneumonia. It causes a particularly large burden of disease in infants and older adults.

Moderna expects to have mRESVIA available for eligible populations by the 2024/2025 RSV season in the U.S. Additionally, Moderna has filed for mRNA-1345 approval with regulators in multiple markets.

As of June 1, 2024, three RSV vaccines and one monoclonal antibody (Beyfortus™) were approved in the U.S.