- Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections in infants and young children in the U.S. and the world, and can lead to lung damage and death in serious cases.
- Mid-stage trial data on third-trimester pregnant women showed that Novavax's RSV vaccine protected infants, without any negative effects on the mothers.
- According to Wedbush Securities analyst Heather Behanna, an RSV vaccine represents a $1 billion opportunity in the U.S., and a $2 billion opportunity worldwide.
According to the Centers for Disease Control and Prevention (CDC), "respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections among young children in the United States and worldwide. Most infants are infected before 1 year of age, and virtually everyone gets an RSV infection by 2 years of age."
However, the ubiquity and the danger of RSV is often not fully appreciated, and there is currently no vaccine for RSV. Novavax has been aggressively researching RSV, and working on a vaccine that it tested against a placebo in 50 healthy pregnant women. The results have been encouraging, and earlier this week, Novavax received an $89 million grant from the Bill & Melinda Gates Foundation to support further work on the vaccine.
This story is big news in part because of the seriousness of the threat, as well as a tragic backstory in which two toddlers died during a trial of another RSV vaccine almost 50 years ago. Fortunately, Novavax's vaccine's safety has been vetted, not only in infants, but in the elderly, who are also susceptible to RSV because of their relatively weakened immune systems. A phase 2 study involving 1,600 elderly subjects showed that the vaccine safely offered some protection against RSV.
Now, with $89 million in new funding, Novavax is moving the RSV vaccine into phase 3.