Clinical Stage Pipeline

Clinical Pipeline

Our product pipeline includes vaccine candidates engineered to elicit differentiated immune responses with the potential to provide increased protection. Our nanoparticle technology targets antigens with conserved epitopes essential for viral function. Unlike traditional vaccines that ‘mimic’ viruses and elicit naturally occurring immune responses to them, our nanoparticles are engineered to elicit differentiated immune responses, which may be more efficacious than naturally-occurring immunity. Our vaccine technology has the potential to be applied broadly to a wide variety of human infectious diseases.

Respiratory Syncytial Virus F-protein nanoparticle vaccine candidate (RSV F Vaccine)

We are developing our respiratory syncytial virus fusion (F) protein nanoparticle vaccine candidate (RSV F Vaccine) for three susceptible target populations: infants via maternal immunization, older adults (60 years of age and older) and children six months to five years of age (pediatrics). We believe our RSV F Vaccine represents a multi-billion dollar commercial opportunity. Currently, there is no approved RSV vaccine available.

Repeat infections and lifelong susceptibility to RSV are common and we currently estimate the annual global cost burden of RSV to be in excess of $88 billion. Despite decades of effort to develop an RSV vaccine, there are currently no licensed vaccines. Although the monoclonal antibody palivizumab (Synagis®) is indicated for the prevention of serious lower respiratory tract disease caused by RSV in children at high risk of RSV disease, it is not indicated for use in other populations. We made a breakthrough in developing a vaccine that targets the fusion protein, or F-protein, of the RSV virus. The F-protein has highly conserved amino acid sequences, called antigenic sites, which we believe are ideal vaccine targets. Palivizumab, which also targets antigenic site II, has demonstrated protection in five randomized clinical trials.

We genetically engineered a novel F-protein antigen resulting in enhanced immunogenicity by exposing these antigenic sites. The Novavax RSV F Vaccine assembles into a recombinant protein nanoparticle optimized for F-protein antigen presentation. We are seeking to bring the first RSV vaccine to market to combat the 64 million RSV infections that occur globally each year. [1],[2]

NOVAVAX’ maternal immunization
RSV vaccine candidate