The Food and Drug Administration has officially approved Moderna’s vaccine for respiratory syncytial virus (RSV) for adults aged 60 and above. This marks the second product from Moderna to enter the U.S. market and comes at a crucial time for the company as demand for its Covid vaccine declines. The approval is based on a successful late-stage trial involving older adults, who are more susceptible to severe cases of RSV.
Moderna’s RSV vaccine, marketed under the brand name mRESVIA, is the first messenger RNA vaccine to receive approval for a disease other than Covid. It is also the only RSV vaccine available in a pre-filled syringe, making it easier to administer to patients. An advisory panel to the CDC is set to vote on recommendations for the use and intended population of Moderna’s shot in June. The company is expecting a positive recommendation, which would allow it to compete with existing RSV vaccines from GSK and Pfizer.
Moderna’s full-year 2024 sales guidance includes revenue from its RSV vaccine, with the company projecting approximately $4 billion in sales. This approval highlights the versatility of Moderna’s mRNA platform beyond treating Covid, showcasing its potential in addressing various infectious diseases. The company currently has over 40 products in development, with a combination shot targeting Covid and the flu potentially receiving approval as early as 2025.
Investor Confidence and Future Growth
Investors have shown confidence in Moderna’s mRNA product pipeline, with shares of the company rising by more than 60% this year. Despite challenges faced in 2023, Moderna aims to return to sales growth in 2025 and break even by 2026 through the launch of new products. The company’s CEO, Stéphane Bancel, expressed optimism about the approval of mRESVIA and the continued development of solutions for global public health threats.
Moderna’s FDA approval for its RSV vaccine for adults 60 and over represents a significant milestone for the company and its mRNA platform. With a robust pipeline of products in development and strong investor confidence, Moderna is poised for continued growth and innovation in the field of infectious disease prevention and treatment.