- Moderna on Wednesday said it’s submitted applications to regulatory agencies around the world in a bid to win approval of a new vaccine to fight respiratory syncytial virus, or RSV, in older adults.
- The company filed with regulatory agencies in Europe, Switzerland and Australia and began a rolling submission to the U.S. Food and Drug Administration for the vaccine, which is currently known as mRNA-1345. Future applications are planned for other nations as well.
- Moderna’s submissions come two months after the FDA approved the first RSV vaccine, developed by GSK. The agency cleared a second RSV shot from Pfizer weeks later. Both products are approved for use in patients who are at least 60 years old, the same group Moderna aims to treat.
After decades of fruitless efforts to find a vaccine for RSV, the market may soon be brimming with options. Bavarian Nordic is also developing an inoculation for older adults. And Sanofi and AstraZeneca recently won the backing of an FDA advisory committee for a preventive medicine for infants.
Like its successful COVID-19 vaccine, Moderna’s new shot is based on its messenger RNA technology, which may help it stand out from the pack. Moderna has told analysts that it believes its option will prove to be the best in the class for older adults and is also studying the shot in pediatric patients.
But first, Moderna has to catch up to rivals GSK and Pfizer, whose options won approval in time to be offered this fall ahead of the winter RSV season. And all of the companies will have to fight rising vaccine hesitancy and a lack of knowledge of the dangers of RSV.
For most people, an RSV infection causes a bad cold. But for infants and the elderly, the virus can be deadly. The Centers for Disease Control and Prevention estimates that RSV leads to tens of thousands of hospitalizations annually for young children and seniors, killing as many as 10,000 people aged 65 and over each year.
The companies are already engaged in educating primary care doctors with a goal of making RSV vaccines as common as flu shots. Moderna is also working on an mRNA vaccine that would combine RSV protection with inoculations for other viruses including COVID-19 and the flu.
If more than half of seniors are willing to take RSV vaccines, the market would be worth billions of dollars, according to analysts. That’s critical for Moderna, which needs a second act as demand for its COVID-19 vaccine declines with the end of the pandemic.