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Indian scientists have developed a low-cost rotavirus vaccine that could prevent severe infant diarrhea. At $1 per dose, it could save thousands of children's lives each year in Asia and Africa.
At a fraction of the cost of existing rotavirus vaccines, Rotavac could help prevent severe diarrhea and dehydration, which each year claim the lives of tens of thousands of infants in developing countries in Asia and Africa.
The rotavirus kills almost half a million children under the age of five each year.
India has the highest number of deaths - about 100,000 children die each year from severe diarrhea and dehydration caused by the virus.
Neighboring Pakistan and, in Africa, Nigeria, suffer a combined 80,000 child deaths annually.
Two existing vaccines are available on the Indian market. But they are relatively expensive at about $18 (14 euros) per dose. The new vaccine costs just $1 per dose.
It was developed in a public-private partnership in India by pediatric scientist, Dr. MK Bhan, and Dr. Roger Glass, director of the Fogarty International Center in the United States.
A boon for poor communities
Their phase three clinical trials involved 7,000 infants in three India states. The trials showed the vaccine to be safe and effective - even in response to various virus strains.
"Almost 40 to 50 percent of all severe diarrhea cases are due to rotavirus - it is now the predominant cause of diarrheal deaths and hospitalizations," said Bhan. "This is particularly important for us because diarrhea affects the poor and the outcome is the worst in them. And for most poor families and women, negotiating hospitals and negotiating doctors particularly in rural areas is very complex."
Glass said their work was spurred when they discovered a particular strain of rotavirus in newborn babies.
"Normally rotavirus does not affect newborns, but this strain did," he said. "The early research together was to show that this infection caused a good immune response, which is absolutely necessary for a good vaccine that children, who were infected as newborns, were protected from subsequent severe disease."
The World Health Organization recommends that rotavirus vaccines be included in all national immunization programs.
But while the Indian government provides subsidized vaccines for polio, tuberculosis, diphtheria, tetanus and Hepatitis B, it does not include rotavirus vaccines.
The two other, internationally licensed, rotavirus vaccines are available in more than 40 countries, but they remain out of reach for many people in developing countries.
Rotovac is cheaper than these existing vaccines, and, the researchers said, an effective alternative.
It is an oral vaccine, and would be given to infants in a three-dose course - at 6, 10, and 14 weeks of age.
India's Drug Controller body is currently considering whether to approve the new vaccine.
"We not only wanted a vaccine that was safe and effective but we wanted a vaccine that was affordable and could be used in the public sector and public program because that is where we will reach everyone," said Glass. "There are vaccines licensed in India from the outside. They are quite expensive for the routine Indian ... the poor Indian. This is the way to overcome the price hurdle as a safe and effective vaccine. I think, not only can it be helpful here in India, but in many of the developing countries."
A south Indian-based firm, Bharat Biotech, will offer Rotavac at $1 per dose. It plans to file for licensing in July.
"This matter will now go to the Drug Controller, who will take the matter into consideration, and we should make sure that we allow them to do this assessment fairly and correctly," said K Vijay Raghavan is the secretary of the Indian government's Department of Biotechnology.
"India has an effective vaccination program so the next step would be to take it through licensing to allow it to integrate into the vaccination program and make the largest possible impact. Once we make this impact we will see all sorts of changes in our society," Raghavan added.
If approved, Rotovac will become the first, entirely new vaccine developed and approved in India in over 100 years. But there is still much to be done to test its efficacy.
Unlike most clinical trials that take place in a hospital setting, for Rotavac the researchers and doctors had to go out to the communities, where they recruited appropriate volunteers, and monitored their progress.
"I feel like I am at [the start], where we have graduated to have something which is effective, but the true impact will only be known in the next couple of years when this is rolled out in the communities of India, where we can measure and monitor the impact on child health," said Glass.
First step to a new phara industry
For Bhan, the experience has given rise to hope that India is on track to developing a homegrown pharmaceuticals industry.
"It has given us tremendous experience through this global partnership to learn how to do these things from discovery [through] to the end product. We have science which is good, we have a generic industry which is good," said Bhan. "But we've not often had the privilege of trying to cover the whole value chain and this, with the help of some wonderful global partners, was possible to achieve."
Doctors have estimated that the entire project cost about $80 million, meaning the vaccine's development was also far less expensive than most other drugs.
If approved by authorities, the vaccine could be available as early as the end of 2013