In July 2012, Novavax entered into a collaboration with PATH to develop our RSV (respiratory syncytial virus) vaccine to protect infants through maternal immunization in low-resource countries. Novavax was awarded approximately $2 million by PATH for initial funding under the partnership to partially support a Phase II dose-ranging clinical trial in women of childbearing age planned for the second half of 2012.
Thereafter, Novavax and PATH can elect to continue to collaborate on additional phases to develop the vaccine for maternal immunization in low-resource countries, with PATH potentially funding 50% of Novavax’s external clinical development costs. Novavax will retain global rights to commercialize the product and has made a commitment to make the product affordable and available in low-resource countries.
The goal of immunizing pregnant women is to transmit high levels of maternal RSV antibodies to their offspring through the placenta before birth, providing protection against infection in the early infancy period, when the disease burden is the highest. RSV is the most common cause of childhood respiratory infection globally, with a disease burden of 64 million cases and approximately 160,000 deaths annually. A severe episode of RSV bronchiolitis can lead to recurrent bouts of reactive airway disease/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.
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.