INDIAN scientists on Tuesday (May 14) announced a low-cost vaccine against a deadly diarrhoea-causing virus that kills some 100,000 children in the country every year.
Rotavirus, which causes severe diarrhoea, is globally responsible for some 453,000 deaths annually and is particularly dangerous in the developing world where swift health care is often out of reach.
K Vijaraghavan, secretary of India’s Department of Biotechnology which led the quest for an affordable vaccine, said it was a product of international cooperation although it has yet to be approved by Indian drug authorities.
“The result is a world-class vaccine for India’s children,” he told a press conference.
“For the first time, we have taken a vaccine from the earliest discovery to every stage of development and that is a very remarkable thing for India,” he said, adding that the $1(£0.66)-a-dose oral vaccine was ready for production.
While international pharmaceutical giants GlaxoSmithKline and Merck produce similar vaccines, each dose costs around Rs 1,000 (£12/$18), said Sushmita Malaviya of PATH, an international health care organisation.
Rotavirus causes up to 884,000 hospitalisations in India a year, at a cost to the country of Rs 3.4bn (£47/$72m), and kills around 100,000 small children annually in the country, the government says.
The Indian vaccine named Rotavac will be made by Hyderabad-based Bharat Biotech, which has said it has the capacity to mass-produce tens of millions of doses after clearance is given, expected in eight or nine months.
Rotavac vaccination consists of three doses.
Sheela Panicker, a Bharat Biotech spokeswoman, said the drops will be used in India and in other developing countries.
“We have pledged it to the government and the vaccine will also be supplied to developing countries through a UN agency,” she said.
India has been a powerhouse in developing cheap medicines to treat diseases such as cancer, tuberculosis and AIDS for those who cannot afford expensive branded versions across the developing world.
The government said the third and final round of clinical trials involving 6,799 infants began in March 2011 and was monitored by private and state health agencies.
It said an independent experts’ group called the Data Safety Monitoring Board (DSMB) oversaw the clinical trials.
“In February 2013, the DSMB determined that the trial met the highest standards of ethics and patient care and complied with international standards for good clinical practices,” a government statement said.
Public health researcher Nita Bhandari, who was part of a 400-member team involved in the large-scale trial, said the health officials operated under the “strictest ethical guidelines” set by the government.
“We have now added to our know-how and capacity in ways which will pay dividends for development of future solutions,” said Vijaraghavan, secretary of India’s Department of Biotechnology.
Vijaraghavan’s predecessor, MK Bhan, pioneered the vaccine project after scientists discovered a local strain of rotavirus 23 years ago in a New Delhi hospital.
“A total 25 per cent of all diarrhoeal hospital admissions will be prevented by this vaccine,” Bhan said.
“That means you will have 25 per cent fewer diarrhoeal illnesses of a severe nature in India, which is a very substantial public health gain,” he said.
