Moderna announced in May 2024 that the US FDA has approved mRESVIA (mRNA-1345), its mRNA respiratory syncytial virus (RSV) vaccine, for the protection of adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. This approval was granted under a breakthrough therapy designation and is the second mRNA product from Moderna to be approved. It is based on positive data from a Phase III clinical trial, ConquerRSV.
RSV is a “highly contagious” seasonal respiratory virus, a “leading cause” of lower respiratory tract infections and pneumonia that causes a “particularly large burden of disease” in infants and adults. Every year between 60,000-160,000 older adults are hospitalised and 6,000-10,000 die due to RSV infection. Moderna hopes to have the vaccine available for eligible populations in the US by the 2024/2025 respiratory virus season.
mRESVIA
The vaccine comprises an mRNA sequence encoding a stabilised prefusion F glycoprotein, which is expressed on the surface of the virus and is required for infection by helping the virus to host cells. Moderna states that the prefusion conformation of the F protein is a “significant target of potent neutralising antibodies” and is “highly conserved” across both RSV-A and RSV-B subtypes. The vaccine uses lipid nanoparticles (LNPs) like the Moderna COVID-19 vaccines.
The FDA’s approval of mRESVIA is based on data from the ConquerRSV study, which enrolled around 37,000 adults aged 60 or older across 22 countries. The primary analysis with 3.7 months of median follow-up found a vaccine efficacy against RSV lower respiratory tract disease (LRTD) of 83.7%. During the FDA review a follow-up analysis of the primary endpoint took place, with “consistent” results. Further longer-term analysis showed “continued protection” against RSV LRTD over 8.6 months median follow-up.
“No serious safety concerns were identified in the Phase III trial.”
Strength and versatility
Moderna’s CEO, Stéphane Bancel, commented that the FDA approval “builds on the strength and versatility” of the mRNA platform.
“mRESVIA protects older adults from the severe outcomes of RSV infection, and it is only RSV vaccine available in a pre-filled syringe designed to maximise ease of administration, saving vaccinators’ time and reducing the risk of administrative errors.”
Bancel stated that the approval is 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.”
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