The FDA has approved mRESVIA, an mRNA-based vaccine developed by Moderna for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults aged 60 and older. mRESVIA is the only vaccine available in single-dose pre-filled syringes.

Respiratory syncytial virus (RSV) is a seasonal virus that causes illness in both infants and older adults. In the U.S., RSV leads to approximately 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among older adults.

The FDA approval was based on data from the Phase 3 ConquerRSV clinical trial, which included approximately 37,000 participants aged 60 and older across 22 countries. The trial demonstrated a vaccine efficacy of 83.7% against RSV lower respiratory tract infection. The results, published in The New England Journal of Medicine, were confirmed in a follow-up analysis showing consistent efficacy over a median follow-up of 8.6 months.

The study reported no serious safety concerns, with the most common adverse reactions being injection site pain, fatigue, headache, myalgia, and arthralgia.

The manufacturer, Moderna, plans to make mRESVIA available for eligible populations in the U.S. by the 2024/2025 respiratory virus season. The company is also seeking regulatory approval for the vaccine in multiple international markets.

"The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform," Moderna CEO Stéphane Bancel said in a statement. "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."

mRESVIA works by encoding a stabilized prefusion F glycoprotein, which is a key target for neutralizing antibodies and is conserved across RSV-A and RSV-B subtypes. This vaccine uses the same lipid nanoparticles as Moderna's COVID-19 vaccines.