India finally gets its magical vaccine

From a less publicized discovery at a lab in Delhi to an amazing journey full of challenges and expectations, the translation of hard work through joint effort into rotavirus vaccine is worth a celebration


PM launching the Rotavirus

India has realized its dream of developing an indigenous vaccine against the rotavirus, the main cause behind diarrhoea that results in 10 lakh hospitalizations and kills nearly 80 thousand children under the age of 5 years. Developed by Hyderabad-based Bharat Biotech, the oral rotavirus vaccine, ROTAVAC has been proved to be safe and effective in preventing rotavirus diarrhoea.

The vaccine was launched on March 09, 2015 by the Prime Minister, Mr Narendra Modi whose enthusiasm was visible given his focus on the ‘Make in India' initiative. The PM lauded the vaccine as an example of India`s capabilities for high-end research and development; manufacture of sophisticated pharmaceutical products in India; and an effective public private partnership model for finding affordable solutions to societal challenges. "The development of the rotavirus vaccine will inspire higher levels of research, development and manufacturing activities in India, not just in medical science, but also in other advanced areas of science and technology," remarked Mr Modi.

This announcement fulfilled Bharat Biotech's promise of a $1/ dose vaccine to governments in low income countries. The company has received commercial licensure and the vaccine is safe to use. The company that was involved in the development and production of the vaccine was selected in 1997-1998 by the India-US Vaccine Action Program and the standard government procedures. This is the third such vaccine available globally against Rotavirus and, at the current prices, the cheapest."ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards," said Dr Krishna M Ella, chairman and managing director of Bharat Biotech. "ROTAVAC is a testament of our strong vision and commitment to develop affordable health care solutions for infectious diseases." As per Dr Ella, "A novel vaccine innovated in India, developed in India and made in India, is a big boost to the ‘Make in India' initiative by the government. The launch fortifies our mission to identify public health problems and make affordable life-saving vaccines available to children wherever they are born."

It was a belief that was shown some twenty eight years ago and might have been looked at with a lot of scepticism back then. But it was Dr MK Bhan, former secretary of the Department of Biotechnology (DBT) whose dream of manufacturing an indigenous rotavirus vaccine one day kept the efforts multiplying and the project expanding.

Dr Bhan termed the launch as a culmination of decades of selfless efforts by researchers across the globe. He added, "Ideas are good only when they are pursued to the very end. The Rotavac story is a good mix of innovation and purpose."
Dr Harry Greenberg, associate dean, Stanford University added, "The ROTAVAC project is a beautiful example of the great power of team science. 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 diarrhoea in Indian children.

"The randomized, double-blind, placebo-controlled phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites-the Center for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Center in Vadu, Pune; and Christian Medical College (CMC) in Vellore. Infants enrolled in the study received ROTAVAC and the Universal Immunization Program (UIP) vaccines, including Oral Polio Vaccine (OPV). When the immune responses to OPV were tested, the result showed that infants receiving OPV at the same time as vaccine generated comparable immune responses to all three polio serotypes as the infants receiving OPV without ROTAVAC; this result supports the concurrent administration of OPV and ROTAVAC.


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