FDA Approves First mRNA Vaccine Against RSV for Adults Aged ≥60 Years: Daily Dose

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This week, we reported on the US Food and Drug Administration (FDA) approval of mRESVIA (Moderna), previously mRNA-1345.

The approval

mRESVIA is the first mRNA technology-based vaccine against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older.

The FDA's approval of mRESVIA is based on findings from ConquerRSV, a global randomized, double-blind, placebo-controlled trial that included approximately 37 000 adults aged 60 years and older conducted across 22 countries. The dual primary efficacy endpoints were based on 2 definitions of RSV-LRTD—RSV-LRTD with 2 or more symptoms and RSV-LRTD with 3 or more symptoms of disease. Participants were randomly assigned to receive a single dose of the investigational vaccine or placebo.

Based on analyses conducted when at least half of the anticipated cases of RSV-LRTD had occurred, vaccine efficacy was 83.7% against the disease with at least 2 signs or symptoms and 82.4% effective against RSV-LRTD with at least 3 signs or symptoms.

There were no serious safety concerns observed in the phase 3 ConquerRSV trial and the most commonly reported solicited adverse reactions were Local injection site pain, fatigue, headache and arthralgias and myalgias.

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