The FDA has approved mRESVIA, an MRNA vaccine from Moderna meant to protect adults aged 60 years or older from lower respiratory tract disease caused by RSV infection. Moderna's website has the news.
According to Stéphane Bancel, Chief Executive Officer of Moderna, this approval is the “first time an mRNA vaccine has been approved for a disease other than COVID-19.” It is also the only RSV vaccine “available in a pre-filled syringe designed to maximize ease of administration.”
RSV is a leading cause of lower respiratory tract infections and pneumonia that causes a “particularly large burden of disease in infants and older adults.” Approximately 60,000 to 160,000 older adults are hospitalized yearly due to an RSV infection, and 6,000 to 10,000 die each year.
The FDA approved mRESVIA due to a global study conducted in about 37,000 adults aged 60 or older. Vaccine efficacy against RSV lower tract respiratory tract disease was 83.7%.
