New Delhi: A new article published on March 31, 2017 in the New England Journal of Medicine provides the results of a recent Phase 3 clinical trial conducted in Niger with a rotavirus vaccine candidate from India. The study, conducted by Médecins Sans Frontières (MSF) and Epicentre, evaluated the efficacy and safety of the pentavalent bovine-human reassortant rotavirus vaccine (BRV-PV) manufactured by Serum Institute of India in infants in Niger. Data from the trial revealed the BRV-PV to be highly efficacious for the prevention of severe rotavirus gastroenteritis and to have an excellent safety profile. In addition, the vaccine was transported and stored at ambient temperature, thus bypassing the typically challenging cold-chain requirements that apply to most other vaccines.
In a detailed statement, the PATH has welcomed this new data as an important contribution to inform global decision-making on the use of this vaccine in low-resource countries worldwide. Since 2011, PATH has been supporting Serum Institute’s clinical development of the BRV-PV. PATH and Serum Institute are partnering in the conduct of a similar Phase 3 efficacy study of the vaccine in India with 7,500 infants at six sites. The study was recently completed and the data are under analysis.
In 2013, of more than half a million deaths due to diarrhea, 215,000 were due to rotavirus.
PATH is also working with Serum Institute to conduct an additional Phase 3 study to gather data required for World Health Organization (WHO) prequalification, which would allow the vaccine to be purchased for use in developing countries worldwide. MSF’s results are a valuable addition to the BRV-PV’s prequalification application, as they demonstrate the vaccine’s safety and efficacy in an African setting.
Diarrheal disease is a leading cause of death among children under five years of age worldwide, and rotavirus is the most common cause of severe diarrhea. In 2013, of more than half a million deaths due to diarrhea, 215,000 were due to rotavirus. Several rotavirus vaccines are already available, but they remain out of reach for many in low-resource areas. The success of this additional rotavirus vaccine candidate is an exciting and encouraging milestone towards the public health goal of improving the supply of affordable rotavirus vaccines worldwide and saving the lives of thousands of children.
PATH applauds the Serum Institute’s commitment to supplying vaccines to protect low-income communities from devastating diseases. In 2002, Serum Institute joined PATH and WHO in groundbreaking work on the development and introduction of MenAfriVac® to combat meningitis A outbreaks in sub-Saharan Africa. PATH is also partnering with Serum Institute on the development of vaccines against influenza and pneumococcal disease.