ResVax vaccine milestones
Novavax (NVAX) completed enrollment of its ResVax infant vaccine program through maternal immunization in the second quarter of 2018. On July 12, the last mother in the trial gave birth. Based on this progress, Novavax expects to release final efficacy data in the first quarter of 2019. If the outcomes are positive, it expects to file a BLA (Biologics License Application) with the FDA and a marketing authorization application in Europe in the first quarter of 2020.
According to Novavax’s second-quarter 2018 earnings conference call, since the FDA has granted fast-track designation to the ResVax program, the company becomes eligible for priority review of its BLA. That could reduce the review time to less than the typical four months.
Market growth prospects
The above diagram is a snapshot of Novavax’s investor presentation, which shows that 85% or more of infant hospitalizations could have been prevented if they had been immunized with the RSV (respiratory syncytial virus) vaccine. The statistic is highly significant since RSV is the number-one cause of infant hospitalizations.
According to the presentation, ~69% of infants are infected with RSV before the age of one year. Of those, 77% are younger than six months of age. Those patients require 400,000 medical interventions, including doctor visits and hospitalizations. That’s indicative of the significant burden of RSV hospitalizations on the US healthcare system, especially in the patient group younger than six months of age. Preventing RSV by maternal immunization could be significant.
According to Novavax, maternal immunization is currently used for vaccinating infants against infections such as influenza and neonatal tetanus. There’s also a steady increase of initiatives, both by the government and non-government bodies in the United States, to increase the reach of maternal immunizations across diseases.
In the next part of this series, we’ll look at the market opportunity for the ResVax vaccine.