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“Made-in-India” vaccine could save thousands of children

5559524166_510ebb57a0_zIndia reached a milestone this week with the introduction of a novel rotavirus vaccine, the first vaccine designed entirely in the developing world. The vaccine is not only safe and effective, but also affordable; the manufacturer, Bharat Biotech, has pledged to make it available for $1 to governments in low-income countries.

The vaccine, known as ROTAVAC, will be used to fight a disease that kills 80,000 children a year in India alone. On a global scale, rotavirus, which causes severe diarrheal disease, is responsible for some 450,000 childhood deaths and 2 million hospitalizations.

The vaccine was developed through a unique partnership supported by the Indo-U.S. Vaccine Action Program, which was chaired until recently by Harry Greenberg, MD, senior associate dean for research at the School of Medicine. Greenberg was a lead inventor of the first-generation vaccine for rotavirus.

“The ROTAVAC project is a beautiful example of the great power of team science,” Greenberg told me. “The vaccine is a culmination of a very large and disparate group of people and organizations, all working together for a common goal: to produce a safe, effective and affordable vaccine to prevent severe, rotavirus-associated diarrhea in Indian children.”

During a three-day visit to India in January, U.S. President Barack Obama and Indian Prime Minister Narendra Modi had praised the “highly successful collaboration” that lead to the development of the vaccine. Prime Minister Modi was on hand for ceremonies Monday announcing the launch of the vaccine, which the Indian government will make available in public clinics across the country.

The vaccine originated from a weakened strain of rotavirus that was isolated from an Indian child in the mid-1980s. It went through a long development process which included investigators from 13 institutions and culminated in a randomized, double-blind clinical trial involving nearly 6,800 infants in India. The results, published in the Lancet in 2014, showed it was as effective as two other licensed, commercial oral rotavirus vaccines.

The vaccine was developed with support from the National Institutes of Health and the U.S. Centers for Disease Control and Prevention, among others.

“The impact of this vaccine to improve child survival is enormous,” said Roger Glass, MD, PhD, director of the Fogarty International Center at the NIH. “Our groups at the CDC and NIH are proud to be an integral part of this longstanding and enormously successful collaboration with our Indian colleagues.”

Previously: President Obama and Indian Prime Minister praise partnership that led to rotavirus vaccine, Life-saving dollar-a-dose rotavirus vaccine attains clinical success in advanced India trial and Trials, and tribulations, of a rotavirus vaccine
Photo by The Bill and Melinda Gates Foundation

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