FDA Approves Moderna's RSV Vaccine for Adults 60+
The U.S. Food and Drug Administration (FDA) has approved Moderna's respiratory syncytial virus (RSV) vaccine, mRESVIA (mRNA-1345), for adults aged 60 and older. This is the company's second approved mRNA product and the first mRNA vaccine approved for a disease other than COVID-19. The approval is based on data from the Phase 3 ConquerRSV clinical trial, which involved approximately 37,000 adults from 22 countries. The study reported an efficacy of 83.7% against RSV-associated lower respiratory tract disease and identified no serious safety concerns.
Moderna plans to make mRESVIA available for the 2024/2025 respiratory virus season. Analysts predict the vaccine will generate annual sales of $340 million in 2024, potentially growing to $830.5 million the following year. The new vaccine positions Moderna to compete in the U.S. fall vaccination campaign alongside market leaders GSK and Pfizer, which have also launched their RSV vaccines. The company is leveraging its mRNA technology to diversify its product portfolio, aiming to offset the declining demand for its Spikevax COVID-19 vaccine.
