Moderna announced on Friday that the U.S. Food and Drug Administration (FDA) has approved its respiratory syncytial virus (RSV) vaccine for adults ages 60 and older. This will be the only RSV vaccine available in single-dose prefilled syringes and will be sold under the brand name mRESVIA.
The vaccine will be Moderna’s second product to enter the U.S. market after the FDA’s approval of the biotech company’s COVID-19 vaccine Spikevax in 2022. Although the FDA review had been delayed for two weeks, the approval came as a great win for Moderna, as the decline in Spikevax sales had caused a steep decline in revenue, from $19.3 billion in 2022 to $6.8 billion in 2023.
Good results from a Phase 3 trial
The mRESVIA vaccine is built from the same mRNA platform and uses the same lipid nanoparticles (LNPs) as Spikevax.
The FDA’s approval is based on a Phase 3 clinical trial conducted on approximately 37,000 adults ages 60 and older in 22 countries, which showed that the vaccine was 83.7% effective against RSV lower respiratory tract disease (LRTD) at around 3 months. And a follow-up study found this efficacy to have declined to 63.3% after 8.6 months.
According to the Centers for Disease Control and Prevention (CDC), RSV infections result in 6,000 to 10,000 deaths and 60,000 to 160,000 hospitalizations in the U.S. each year.
Although Pfizer and GSK both launched RSV shots last year, mRESVIA will be the only one available in a prefilled syringe, which Moderna says will save time and reduce the risks of administrative errors. Moderna expects that mRESVIA will be available in the United States by the 2024-2025 respiratory virus season.