Novavax - Model RSV F - Vaccine
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.
We estimate that approximately 900,000 medical interventions are caused by RSV disease in this US population each year. We followed up the 2015 Phase 3 clinical trial of our RSV F vaccine, which failed to meet its prespecified primary or secondary efficacy endpoints, with a 2017 Phase 2 clinical trial in older adults, in order to assess safety and immunogenicity of 1- and 2-dose regimens of our RSV F vaccine, with and without aluminum phosphate or our proprietary Matrix-M™ adjuvant. Immunogenicity results from the 2017 trial indicate that both adjuvants increase the magnitude, duration, and quality of the immune response versus the nonadjuvanted RSV F vaccine. We continue to assess the development opportunities for our RSV F vaccine in older adults.