A new, heat-stable vaccine is safe and effective against rotavirus, according to results of a recent Doctors Without Borders/Médecins Sans Frontiéres vaccine trial in Niger, published in the New England Journal of Medicine.
The new vaccine - known as BRV-PV - is cheaper than existing vaccines, specifically adapted to the rotavirus strains found in sub-Saharan Africa, and does not need to be refrigerated. This will make it much easier to reach communities in remote areas that have limited access to health services. It could prevent large numbers of children from dying of diarrhea in Sub-saharan Africa.
"This is a game-changer," said Dr. Micaela Serafini, MSF medical director. "We believe that the new vaccine can bring protection against rotavirus to the children who need it most."
The trial, conducted by MSF's research and epidemiology branch, Epicentre, in collaboration with the Nigerien Ministry of Health, the Serum Institute of India Pvt Ltd, the Cincinnati Children's Hospital and other partners - involved more than 4,000 children younger than two years old. Results showed that the vaccine has no safety concerns and has been proven efficacious against severe gastroenteritis.
Rotavirus infection is the leading cause of severe diarrhea - the second largest cause of death in infants and children - and kills an estimated 1,300 children each day, primarily in sub-Saharan Africa. Most of these deaths occur in low-income countries where access to water and sanitation is limited, and where parents are unable to access the medical care that could save their child's life. In such regions, preventive measures such as vaccinations have an enormous impact.
Currently, two vaccines exist against rotavirus, but they must be kept refrigerated at all times. In addition to being heat-stable, BRV-PV is also cheaper than the other two rotavirus vaccines on the market, with a price of less than $2.50. This price should help ensure that countries quickly incorporate the new vaccine into routine immunization programs. The vaccine, manufactured by Serum Institute of India Pvt Ltd, will also fill the current supply gaps for the existing vaccines.
The BRV-PV vaccine is currently under review by the World Health Organization (WHO) for prequalification. Once approved, low-income countries will be able to procure the vaccine at an affordable price and make it available in their countries.
"The success of this trial shows that research and development into vaccines that are specifically adapted for use in low-income countries yield results," Serafini said. "The quicker this vaccine is prequalified by the WHO, the sooner it can be used to prevent the deaths of thousands of children in the countries where it is needed most."
Article: Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger, Sheila Isanaka, Sc.D., Ousmane Guindo, M.D., Celine Langendorf, Pharm.D., M.P.H., Amadou Matar Seck, M.D., Brian D. Plikaytis, M.Sc., Nathan Sayinzoga-Makombe, M.P.H., Monica M. McNeal, M.Sc., Nicole Meyer, M.Sc., Eric Adehossi, M.D., Ali Djibo, M.D., Bruno Jochum, M.S., and Rebecca F. Grais, Ph.D., New England Journal of Medicine, doi: 10.1056/NEJMoa1609462, published 23 March 2017.