India set to get its indigenous rotavirus vaccine by 2014

The impressive data from phase III clinical trials has shown 60% efficacy of rotavirus vaccine, developed under public private partnership in India. Bharat Biotech, the industry partner will now soon register this vaccine with the DCGI


(L to R) Dr John Boslego, PATH's Vaccine Development Program, Dr Nita Bhandari, Society for Applied Studies , Dr Maharaj Kishan Bhan, former secretary, Department of Biotechnology, Dr K VijayRaghavan, secretary, Department of Biotechnology, Dr Krishna M Ella, CMD, Bharat Biotech, Dr TS Rao, Department of Biotechnology

It was a belief that was shown some twenty eight years ago and might have been looked at with lot of skepticism back then. But it was Dr M K Bhan, former secretary of department of biotechnology (DBT) whose dream of manufacturing an indigenous rotavirus vaccine one day kept the efforts multiplying and project expanding. Now, finally the announcement regarding the positive results from a phase III clinical trial of a rotavirus vaccine developed and manufactured in India, were made by the DBT and Bharat Biotech, on May 14, 2013. The data from the trial, presented at the International Symposium on Rotavirus Vaccines for India- The Evidence and the Promise, showed ROTAVAC to have an excellent safety and efficacy profile.

The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH. Dr MK Bhan, who recently completed his service as DBT secretary, was tireless in fostering the social innovation partnership and ensuring the highest standards for the vaccine

The clinical study demonstrated for the first time that the India-developed rotavirus vaccine ROTAVAC is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. ROTAVAC significantly reduced severe rotavirus diarrhoea by more than half; 56 percent, during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause.

"This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 1,00,000 deaths of small children in India each year," said DBT Secretary Dr K VijayRaghavan. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India."

ROTAVAC is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunizations in the Universal Immunization Program (UIP) vaccines recommended at these ages.The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors.


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