NEW DELHI —
India says it has developed a low cost vaccine to prevent diarrhea - a disease that claims the lives of tens of thousands of infants and young children in developing countries. It is expected to be on the market by next year, and is being hailed as a significant breakthrough.
Health officials say that clinical test results indicate the new vaccine is safe and effective against rotavirus, which causes severe diarrhea in children under the age of five.
Rotavirus is spread through contaminated hands and surfaces, and is common in poor communities across Asia and Africa. The severe dehydration that babies suffer due to a bout of diarrhea takes a toll of half a million children every year.
There are two vaccines in the market for rotavirus developed by multinational drug firms. But their high cost has kept them out of reach for many children across Asia and Africa.
The vaccine developed in India will be just $1 per dose, making it affordable for both families and governments who want to make it part of their national immunization programs.
Doctor M.K. Bhan, who helped develop the vaccine from a strain of the virus discovered in a hospital where he worked in New Delhi many years ago, said it cuts by more than half the risk of diarrhea for very young children. Bhan said it will be administered to infants when they are just a few weeks old.
“This is six, 10 and 14 weeks of age with other vaccines and three doses, so it will fit into our immunization program," he explained. "It gives protection for two years and almost 95 per cent of the rotavirus disease is over by two years of age. Part of the social contract is it will a dollar a dose vaccine for the entire world.”
The vaccine will go to the regulator in about a month and could hit the market in less than a year in India. It will have to be approved by the World Health Organization
before it can be distributed globally.
The development of the vaccine has been hailed by groups like the GAVI Alliance, which helps poor countries in vaccination programs. It says cheaper prices will make it possible to immunize more children, ease shortages and drive down the cost charged by other manufacturers.
Dr. Bhan, who is a pediatrician, says prevention of diarrhea is important because children who get it are not just at risk of dying. Treating it is also traumatic.
Dr. Bhan explains it is not easy to administer oral rehydration syrup (ORS) to children in hospitals to prevent dehydration.
“A nine-month old baby, who has some dehydration, if you have to administer ORS, even for me who is supposed to be an expert in this area, it is nightmarish," the doctor admitted. "I used to get frightened administering ORS to a nine-month old baby who was sick. And for poor mothers negotiating hospitals in the middle of the night, it is a tough task. We need prevention, I am all for prevention. The poorer the country, more important prevention is.”
The development of the vaccine is also being described as a path breaking example of an innovative collaboration between the Indian government, the private sector and groups such as the Bill and Melinda Gates Foundation
Part of the investment in the vaccine’s development has been borne by Bharat Biotech, a private Indian drug company. While India’s drug industry is well known for making low cost generic drugs, it is often faulted for not paying enough attention to supporting research.