US-based biotechnology company Moderna has received the US Food and Drug Administration (FDA) approval for its mRNA respiratory syncytial virus (RSV) vaccine mRESVIA (mRNA-1345).
mRESVIA contains an mRNA sequence encoding a stabilized prefusion F glycoprotein, which is expressed on the surface of the virus and is required for infection in the host.
The prefusion conformation of the F protein provides a significant target for potent neutralising antibodies and is highly protected across both RSV-A and RSV-B subtypes.
The vaccine is indicated for administration in adults aged 60 years and older to protect from lower respiratory tract disease caused by RSV infection.
RSV is a highly contagious seasonal respiratory virus and a major cause of lower respiratory tract infections and pneumonia in infants and older adults.
The vaccine has been approved under a breakthrough therapy designation and is the biotech company’s second approved mRNA product in the US.
Moderna CEO Stéphane Bancel said: “The FDA approval of our second product, mRESVIA, builds on the strength and versatility of our mRNA platform.
“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.”
The FDA approval of mRESVIA vaccine is supported by positive data from the Phase 3 ConquerRSV clinical trial in nearly 37,000 adults, aged 60 years or older, across 22 countries.
The primary analysis showed that the vaccine is 83.7% effective against RSV lower respiratory tract disease (LRTD) at 3.7 months of median follow-up.
The Phase 3 study results were consistent with the primary analysis and additional longer-term analysis showed continued protection against RSV LRTD over 8.6 months median follow-up.
In the study, the vaccine had no serious safety concerns, with the most common adverse reactions including injection site pain, fatigue, headache, myalgia and arthralgia.
Moderna intends to commercialise the mRESVIA vaccine for eligible populations in the US by the 2024 or 2025 respiratory virus season.The company has filed regulatory applications for mRNA-1345in multiple markets worldwide.
