Novavax’s clinical program includes vaccine candidates designed to address infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Our clinical pipeline is shown below.
Novavax is in advanced development of VLP vaccines against both seasonal and pandemic influenza. Novavax produced VLP vaccine against the 2009 H1N1 pandemic “swine flu” influenza. In a clinical trial of more than 4,000 subjects in Mexico – where the pandemic was first recognized, the H1N1 VLP vaccine was well tolerated and immunogenic even at the lowest dose tested of five micrograms and after one immunization.
Transmission of the highly pathogenic avian H5N1 flu virus “bird flu” in domestic poultry and humans is continuing in many countries worldwide and remains a serious pandemic threat with the potential to evolve into new strains where cross-protection and induction of neutralizing antibodies will be essential. Novavax has shown in a human studies that its H5N1 VLP vaccine was well tolerated, produced no vaccine-related serious adverse events and induced neutralizing antibodies that were cross-reactive with different avian H5N1 influenza viruses. This is the only report of an unadjuvanted vaccine inducing cross-reactive neutralizing antibodies against multiple clades of H5N1 influenza virus and demonstrates the significant potential of the VLP technology. Novavax is currently pursuing the advanced development of recombinant pandemic and seasonal influenza vaccines, under a contract with the U.S. Department of Health and Human Services’ Office of Biomedical Advanced Research and Development Authority.
Respiratory Syncytial Virus (RSV) Vaccine
Respiratory syncytial virus (RSV) is the primary cause of serious respiratory disease in infants and young children worldwide. The virus is also increasingly recognized as a significant pathogen in elderly populations. Bronchiolitis or pneumonia results in 25-40 percent of RSV infections of infants and between 0.5 and 2 percent of these infections result in hospitalization. Despite the incidence and severity of these infections, there is no RSV vaccine available. Immunoprophylaxis against RSV of high-risk infants remains the only effective defense against this viral disease and there are no approved preventatives for the elderly.
In October 2011, Novavax announced positive top-line results from a Phase I clinical study of its RSV fusion (F) recombinant nanoparticle vaccine candidate. Novavax reported that the RSV vaccine candidate was well-tolerated and highly immunogenic, inducing levels of functional immunity that could potentially correlate with protective immunity in future trials.