Novavax is a clinical-stage vaccine development company headquartered in the US. Although it currently has no actively marketed products, Novavax is pursuing the development and approval of a respiratory syncytial virus (RSV) vaccine for three key patient populations, namely infants via maternal immunization, older adults (60 years of age and older) and pediatrics. No such RSV vaccine is indicated across the spectrum of patients the Novavax vaccine is targeting. If approved, not only will this establish a foothold for Novavax in the RSV market, it will likely make it one of the fastest-growing players.
However, clinical trials results produced by the therapy have so far been mixed. Recently released top line results from a Phase III trial in elderly patients indicated the drug did not achieve primary or secondary objectives relating to the prevention of RSV symptoms. In contrast however, there have been some more positive Phase II trial results, such as those published by Novavax in 2015 relating to the use of the vaccine to protect infants via maternal-immunization, as well as use in elderly patients. The Phase II trial in elderly patients’ demonstrated efficacy of an active RSV immunization, the first trial to do so, producing statistically significant vaccine efficacy in prevention of all symptomatic RSV disease and RSV disease with symptoms of lower respiratory tract infection.
RSV places a significant burden on a broad range of patient populations, particularly in the elderly, where it is difficult to prevent and can often lead to severe complications. Indeed, the development of a RSV specific vaccine would represent a significant advancement in the field. Following the positive Phase II trials, it was therefore hoped that the Novavax RSV vaccine could be the therapy that meets this patient need, whether that be in neonatal, pediatric or elderly patients. However, the negative recent Phase III trial has cast some doubt over the therapies route forward, although Novavax are continuing to invest in the product, building upon findings with new trials.
If Novavax are able to replicate the more positive Phase II results in larger Phase III trials, across a broad spectrum of patients, the vaccine will have substantial commercial potential, generating multi-billion dollar revenues, and making Novavax one of the fastest-growing biotech companies in the respiratory complications market. This would be in stark contrast to the company’s outlook if the drug fails further late-stage trials.