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Vaccine Trial Yields Results in India
May 15, 2013

Development of a rotavirus vaccine may help this Indian child reach adulthood.

By Charlene Porter
IIP Staff Writer
May 14,  2013

A vaccine that might save the lives of more than 400,000 children each year is producing hopeful results in India.

The vaccine to protect youngsters from rotavirus infection is showing positive results in a Phase III clinical trial involving about 6,800 infants. The Indian Department of Biotechnology and Bharat Biotech announced the success of the vaccine, more than a decade in the making, May 14.

The trial has shown the vaccine — ROTAVAC — reduces severe rotavirus diarrhea by 56 percent in the developing areas where the trial was conducted.

“This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhea, responsible for approximately 100,000 deaths of small children in India each year,” said Department of Biotechnology Secretary K. VijayRaghavan as the announcement was made in New Delhi.

The vaccine is the product of a partnership that brought together Indian, U.S. and international researchers from institutions in the public and private sectors. The origins of the work date to 1999, when the U.S. National Institute of Allergy and Infectious Diseases (NIAID) provided Bharat Biotech with an initial vaccine strain that the Indian company adapted, creating investigational vaccines for both animal and human clinical studies, according to an NIAID press release.

“The ROTAVAC trial represents a significant victory for India’s scientific community,” said NIAID Director Anthony Fauci in a statement released after the New Delhi announcement. “NIAID is proud to be among the scientific partners who have worked over the past decades to potentially make [rotavirus-caused illness] a thing of the past for the children of India.”

The World Health Organization recommended the inclusion of rotavirus vaccine in the standard array of childhood immunizations several years ago. But that’s been a difficult goal to fulfill in low-resourced countries where cost and inaccessibility to regular preventive health care can prevent the rapid adaptation of innovative treatments.

At about $1 a dose, ROTAVAC will be less expensive than other rotavirus vaccines on the market, helping to lift the cost barrier and allow inoculation of more vulnerable infants. Bharat Biotech has announced that it will soon file for registration and license of the vaccine in India.

“ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards,” said Dr. Krishna Ella, chairman and managing director of Bharat Biotech. The drug also demonstrates the company’s “commitment to develop affordable health care solutions.”

ROTAVAC is given to infants in a three-dose course at ages 6 weeks, 10 weeks and 14 weeks. An independent safety board has established that the trial run in three different parts of India was conducted with the highest ethical standards for patient care.

Rotavirus-induced diarrheal disease kills an estimated 435,000 children under 5 years old each year, and hospitalizes about 2 million. The very youngest — between 6 months and 2 years — are at greatest risk. UNICEF recently reported that diarrheal disease causes 11 percent of the deaths of children under 5.

The Bill & Melinda Gates Foundation, the Research Council of Norway and the United Kingdom’s Department for International Development were other members of the partnership that produced ROTAVAC.