Novavax products

In March 2020, we announced positive top-line results from our Phase 3 clinical trial of our nanoparticle seasonal quadrivalent influenza vaccine candidate, including our proprietary Matrix-M™ adjuvant (NanoFlu™). The trial was a randomized, observer-blinded, active-controlled trial in approximately 2,652 healthy older adults (aged 65 years and older) across 19 clinical sites in the United States. The trial evaluated the immunogenicity and safety of NanoFlu™ compared to a US-licensed quadrivalent vaccine, Fluzone® Quadrivalent. The trial’s primary objective was to demonstrate noninferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous seasonal influenza strains compared to a licensed seasonal vaccine and to describe its safety profile.

ResVax is our aluminum-adjuvanted RSV F vaccine for infants via maternal immunization. RSV is the most common cause of lower respiratory tract infections (LRTI) and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide. In the United States, RSV is the leading cause of hospitalization of infants and, globally, is second only to malaria as a cause of death in children under 1 year of age. There are currently approximately 18 million children in the United States between 6 months and 5 years of age. In the United States, RSV is responsible for approximately 57,000 hospitalizations of children under 5 years of age annually, the vast majority of which occur in infants less than 1 year of age, and especially those under 6 months of age.

Older adults (aged 60 years and older) are at increased risk for RSV disease due in part to immunosenescence, the age-related decline in the human immune system. RSV infection can also lead to exacerbation of underlying comorbidities such as chronic obstructive pulmonary disease, asthma, and congestive heart failure. In the United States alone, a reported RSV incidence rate of 5.5% in older adults would account for approximately 2.5 million infections per year.

With the ongoing development of our NanoFlu™ and RSV F vaccines, a strong rationale exists for developing a combination respiratory vaccine that is designed to protect susceptible populations against both diseases. Although testing is at an early stage, we believe that a combination vaccine against both seasonal influenza and RSV may be achievable.

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, as well as a vaccine candidate against SARS in 2005. In 2012, within weeks of obtaining the sequence of the circulating MERS strain, we successfully produced a vaccine candidate. Our MERS candidate was based on the major surface spike protein, which we had previously identified as the antigen of choice in our work with our SARS vaccine candidate. In 2014, in collaboration with the University of Maryland School of Medicine, we published results showing that our MERS and SARS vaccine candidates both blocked infection in laboratory studies. Although not in active development, our MERS and SARS vaccine candidates remain viable opportunities to develop independently or in conjunction with other coronavirus development activities.

Historically, we developed a vaccine candidate against MERS, a novel coronavirus first identified in 2012, as well as a vaccine candidate against SARS in 2005. In 2012, within weeks of obtaining the sequence of the circulating MERS strain, we successfully produced a vaccine candidate. Our MERS candidate was based on the major surface spike protein, which we had previously identified as the antigen of choice in our work with our SARS vaccine candidate. In 2014, in collaboration with the University of Maryland School of Medicine, we published results showing that our MERS and SARS vaccine candidates both blocked infection in laboratory studies. Although not in active development, our MERS and SARS vaccine candidates remain viable opportunities to develop independently or in conjunction with other coronavirus development activities.

We have developed an EBOV glycoprotein vaccine candidate (Ebola GP vaccine) expressed in insect cells, using our core recombinant baculovirus technology. In 5 separate studies, carried out in collaboration with the National Institute of Allergy and Infectious Diseases, active immunization with the Ebola GP vaccine was shown to be highly immunogenic and efficacious in preventing lethal disease in non-human primates challenged with EBOV. Our 2015 Phase 1 clinical trial demonstrated that our Ebola GP vaccine is highly immunogenic in humans, well tolerated, and, in conjunction with our proprietary Matrix-M™ adjuvant, showed marked antigen dose-sparing and induced significant increases in neutralizing antibody titers. Although not in active development, our Ebola GP vaccine is a viable development opportunity in the event of dedicated funding or a partnership arrangement.

Our recombinant nanoparticle vaccine technology combines the power and speed of genetic engineering to efficiently produce a new class of highly immunogenic particles that target a variety of viral pathogens. Our recombinant vaccine engineering takes a new approach to provide robust and functional immunity, which may be more efficacious than naturally occurring immunity or traditional vaccines. Using innovative proprietary recombinant nanoparticle vaccine technology, we produce vaccine candidates to efficiently and effectively respond to both known and emerging disease threats.

Novavax` saponin-based Matrix-M improves immune responses and enables vaccine dose-sparing. Matrix-M adjuvant is a valuable component of vaccine development, providing multiple immune system enhancements, a well-understood mechanism of action, and robust clinical experience where it was shown to be well tolerated in human studies to date.