Novavax’s RSV F vaccine will quickly achieve strong US sales in the elderly due to a firm clinical case for its adoption and high vaccination coverage rates.
By Michael Haydock, Lead Analyst
7 July 2016
I am the Lead Analyst of the immunology and inflammation and infectious diseases and vaccines teams at Datamonitor Healt...
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In 2018, Datamonitor Healthcare expects that Novavax’s respiratory syncytial virus (RSV) fusion protein (F) nanoparticle vaccine will be the first vaccine to gain approval for use in elderly patients aged ≥60 years and will quickly be adopted into the US immunization schedule because of its potential to substantially reduce the clinical and economic burden of RSV disease. In the Phase II RSV-E-201 study in elderly individuals, vaccine recipients demonstrated a 41.3% reduction in all RSV disease compared to those receiving placebo, providing the first ever proof of efficacy data for an RSV vaccine. If the ongoing pivotal Resolve study in elderly patients displays similarly promising results, Datamonitor Healthcare believes that Novavax’s vaccine will quickly be recommended for use due to the lack of alternative preventative agents and the substantial disease burden posed by RSV in the elderly. Indeed, the US Centers for Disease Control and Prevention estimates that RSV is responsible for 177,000 hospitalizations and 14,000 deaths in persons aged ≥65 years each season.
Sales of the RSV F vaccine are expected to rise rapidly because Novavax will be able to capitalize on a lack of competition for at least one season, and will also benefit from existing infrastructure in place to support seasonal influenza vaccination in the elderly population. Combining RSV vaccination with seasonal influenza vaccination in a single physician visit would be a particularly lucrative strategy as influenza vaccination coverage in the elderly is currently approaching 70%. Novavax intends to investigate a combined RSV/influenza vaccine in a Phase I study in H1 2017, and it is possible that emerging data from this development program could support the concomitant use of standalone RSV and influenza vaccines before the combined vaccine reaches the market.
|Efficacy and immunogenicity data for RSV F vaccine in the RSV-E-201 study|
|Reduction in RSV disease with LRTI||43.2%|
|Reduction in all RSV disease||41.3%|
|Anti-F IgG seroresponse||>93.0%|
|F = fusion protein; IgG = immunoglobulin G; ITT = intention-to-treat; LRTI = lower respiratory tract infection; PCA = palivizumab-competing antibody; RSV = respiratory syncytial virus|
|Source: Datamonitor Healthcare’s respiratory syncytial virus pipeline, July 2016; Novavax, 2015|
Datamonitor Healthcare’s respiratory syncytial virus vaccines: pipeline evaluates the clinical and commercial attractiveness of early-phase and late-phase candidates, providing an assessment of future product positioning and competitiveness in the marketplace.
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