Have you heard of RSV? Respiratory Syncytial Virus, better known as RSV, is a very “democratic” virus and a leading cause of pneumonia in kids in developing and developed countries. The global RSV mortality estimates are in the range of 52,000 - 199,000 deaths in children per year and we still don’t know the true extent of mortality due to RSV in remote underserved communities such as tribal areas. The majority of deaths occur in developing countries but cost of care including hospitalization is a huge burden in developed countries as well. Sixty years after discovery of this virus, there is no RSV vaccine licensed as yet; there is a licensed monoclonal antibody that is neither accessible nor affordable in developing countries.
As a young doctor, my first encounter with RSV dated back to 1987 when for the first time I investigated an outbreak in young infants in the tribal area of central India. I saw the severity and impact of RSV disease in young infants and felt helpless at the time to see kids die of a viral illness without access to clinical care and without any specific tools to prevent the illness. It is the same story globally today for kids affected with RSV in areas without access to care.
Fast forward to late 2015 - I am optimistic and hopeful of soon having preventive tools to tackle RSV attributable mortality in early infancy. Research and development of new vaccines for RSV has been accelerated in the last few years. WHO has recognized this huge unmet public health need and recommended the development of an RSV vaccine as their top priority for new vaccine development. As of now, up to 52 vaccine candidates are at various stage of clinical development.
Very recently Novavax, Inc. initiated the first ever RSV vaccine phase 3 trial with a respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) to be given to pregnant volunteers in their third trimester, with the goal of protecting infants early in life via maternal immunization. This could be the first vaccine to seek a label indication for use in pregnancy, with a global phase 3 trial being conducted in both developed and developing countries. Based on data from this trial, if this vaccine is licensed, Novavax would proceed to apply for World Health Organization prequalification. With an $89 million grant from the Bill & Melinda Gates Foundation this vaccine could provide an opportunity to close the gap in access to RSV prevention between developed and developing countries by enabling accessible and affordable tool for developing countries.
The advancement of a novel vaccine for pregnant women to a phase 3 trial is a remarkable achievement for the maternal immunization approach and may pave the way for accelerating industry R&D for newer products in this field to protect kids by vaccinating moms - truly a better way for moms to protect their newborns.