By IDSE News Staff
The FDA approved the first mRNA respiratory syncytial virus vaccine (mRNA-1345; mRESVIA, Moderna) to protect adults, 60 years of age and older, from lower respiratory tract disease (LRTD) caused by RSV infection.
The FDA’s approval of mRNA-1345 is based on positive data from ConquerRSV, a phase 3 global clinical trial conducted in approximately 37,000 adults 60 years and older in 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy (VE) against RSV LRTD of 83.7% (95.88% CI, 66.0%-92.2%) (N Engl J Med 2023;389[24]:2233-2244).
A follow-up analysis of the primary end point was performed during the FDA review and was included in the U.S. package insert. An additional long-term analysis showed continued protection against RSV LRTD with more than 8.6 months of median follow-up and found a VE of 78.7% (CI 62.9%-87.8%).
The mRNA-1345 vaccine consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection because it helps the virus enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles as the Moderna COVID-19 vaccines.
No serious safety concerns were identified in the phase 3 trial. The most common solicited adverse reactions were injection site pain, fatigue, headache, myalgia and arthralgia. For the full prescribing information, click here.
To report suspected adverse reactions, contact Moderna at (866) 663-3762 or the Vaccine Adverse Event Reporting System at (800) 822-7967, or online at www.vaers.hhs.gov.
Immunocompromised individuals may have a diminished immune response to mRNA-1345, the company said.
RSV is highly contagious 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 United States, approximately 60,000 to 160,000 older adults are hospitalized, and 6,000 to 10,000 die due to RSV infection.
The new vaccine “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,” said Stéphane Bancel, the CEO of Moderna, in a statement.
The approval was granted under a Breakthrough Therapy designation. Moderna expects to have mRESVIA available for eligible populations in the United States by the 2024-2025 respiratory virus season.
