In 2015, Novavax received a grant from the Bill & Melinda Gates Foundation to develop its vaccine in certain low and middle income countries as part of the development of its RSV F Vaccine for maternal immunization. The Bill & Melinda Gates Foundation has awarded Novavax up to $89 million to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016. This grant will also support regulatory licensing efforts, providing a path to World Health Organization (WHO) prequalification. Upon licensure, Novavax has agreed to make the RSV F vaccine affordable and accessible to people in the developing world.
Maternal immunization allows for the mother’s immunity to certain diseases to be passed to her baby during pregnancy, which can protect the baby during the first few months of life, until the baby can be effectively vaccinated. RSV is the most common cause of childhood respiratory infection globally, with a total disease burden of 64 million cases and approximately 160,000 deaths annually. A severe episode of RSV bronchiolitis can lead to recurrent bouts of asthma for many years after the initial event. RSV disease burden in low-resource countries is significant, and available data indicate that the virus is responsible for a high proportion of childhood acute lower respiratory infection in these settings, particularly in the first few months of life. Currently, there is no approved RSV prophylactic vaccine available. Maternal immunization is a widely practiced strategy for protecting infants in a variety of diseases, such as neonatal tetanus. Maternal immunization leads to heightened antibodies in infants and thereby protects them against the targeted disease, and thus may be a viable strategy to protect young infants from RSV illness.
Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people-especially those with the fewest resources- have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Sue Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.
As part of the development of the RSV F Vaccine for maternal immunization, in 2012 Novavax entered into a clinical development agreement with PATH to develop the RSV F Vaccine in certain low-resource countries. Novavax was awarded approximately $2.0 million by PATH for initial funding under the agreement to partially support our Phase 2 dose-ranging clinical trial in women of childbearing age. In October 2013, the funding under this agreement was increased by $0.4 million to support reproductive toxicology studies, which was necessary to begin conducting clinical trials in pregnant women. In December 2013, Novavax entered into an amendment with PATH providing an additional $3.5 million in funding to support the Phase 2 dose-confirmation clinical trial in 720 women of childbearing age. In October 2014, Novavax entered into an amendment with PATH providing an additional $1.0 million towards the development of a strategy for conducting Phase 3 clinical trials of our RSV maternal immunization program that expired in April 2015. Novavax retains global rights to commercialize the product and support the goal to make an RSV maternal vaccine product affordable and available in low-resource countries.
PATH is an international nonprofit organization that transforms global health through innovation. PATH takes an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving vaccines and devices to collaborative programs with communities. Through its work in more than 70 countries, PATH and its partners empower people to achieve their full potential.