The U.S. Food and Drug Administration (FDA) has approved Moderna’s respiratory syncytial virus (RSV) vaccine, marking the company’s second marketed product and providing a new revenue stream beyond its COVID-19 vaccine, Spikevax. The RSV vaccine, named mRESVIA, is approved for preventing RSV-associated lower respiratory tract disease in adults aged 60 and older.
RSV, which manifests symptoms similar to a cold, poses significant risks for young children and older adults, causing approximately 14,000 deaths annually in adults aged 65 and older.
The approval of mRESVIA, the first messenger RNA-based (mRNA) vaccine for a disease other than COVID-19 in the U.S., is a significant milestone for the company. mRNA vaccines work by teaching the body to produce specific proteins that trigger an immune response.
Moderna CEO Stéphane Bancel highlighted the significance of this approval, stating it underscores the strength and versatility of their mRNA platform.
Next month, a panel of advisers at the U.S. Centers for Disease Control and Prevention (CDC) will vote on usage recommendations for the vaccine. A positive outcome would enable Moderna to participate in the fall vaccination campaign in the U.S., competing with market leaders GSK and Pfizer.
GSK’s Arexvy, approved for adults aged 60 and over, is seeking to expand approval to adults aged 50-59. Pfizer’s Abrysvo is approved for adults aged 60 and older, and for pregnant women at 32-36 weeks to protect newborns.
As reported by Economic Times, Moderna’s FDA filing included data from a late-stage trial showing 83.7% effectiveness in preventing at least two symptoms of RSV, such as cough and fever. However, earlier this year, Moderna’s shares fell after data indicated faster declines in the efficacy of its RSV vaccine compared to those from GSK and Pfizer.