Novavax, Inc.’s (NVAX) shares were up 4.1% after the company announced that it has received fast track designation for its experimental respiratory syncytial virus (RSV.V) F-protein nanoparticle vaccine (RSV F vaccine). The company is evaluating RSV F vaccine for the protection of infants via maternal immunization.
We note that the FDA grants fast track designation to those candidates that are being developed for the treatment of serious conditions with unmet medical need. The overall goal of the process is to get new drugs to patients faster.
The fast-track status will allow Novavax to interact with the FDA more frequently and make a rolling submission for the marketing approval of RSV F vaccine. This implies that Novavax can submit the marketing application in parts, as and when data is available. Moreover, RSV F vaccine could also be granted priority review.
We remind investors that in September this year, Novavax initiated the enrollment of 50 pregnant women in a phase II study to evaluate the safety and immunogenicity of the RSV F vaccine. Additionally, the study will assess the impact of maternal immunization on infant safety and RSV-specific antibody levels through one year and six months of life, respectively. The company expects to present data from this study in the third quarter of 2015.
According to the press release issued by Novavax, approximately 11,000 to 17,000 elders and high risk adults succumb to RSV infection or its complications every year in the U.S. Moreover, up to 180,000 people are hospitalized with serious respiratory symptoms. At present, there are no vaccines available to prevent RSV.
We are encouraged by the FDA granting fast track designation to RSV F vaccine. The fast track status will expedite the development process of the vaccine. Meanwhile, Novavax is also evaluating the candidate in the elderly and pediatric patient population who are vulnerable to RSV.
We expect investor focus to remain on the updates regarding RSV F vaccine.
Novavax currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are AMAG Pharmaceuticals, Inc. (AMAG), Biogen Idec Inc. (BIIB) and ANI Pharmaceuticals, Inc. (ANIP). All three carry a Zacks Rank #1 (Strong Buy).