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Fighting Children’s diarrhoea: Advances with a rotavirus vaccine

Promising results from a major DBT supported rotavirus vaccine effort.

Prepared with inputs from Dr. Sandhya Shenoy

Childhood diarrhea is a major killer and rotavirus infections are a major cause. Available vaccines are expensive but a more affordable one may come soon, Dr. T. S. Rao, Senior Adviser at the DBT reported at recent meeting in Pune, highlighted in BioSpectrum recently. Here is the report reproduced with permission:

“Pune: The phase III trial of RotaVac, India’s first indigenously developed rotavirus vaccine, has been completed and the data is presently being analyzed for further development of the same. The announcement was made at the Vaccine World Summit, being held in Pune from March 5-7. While highlighting some of the developments in the vaccine space of India, Dr T S Rao, advisor, Department of Biotechnology under the Ministry of Science and Technology, India, said RotaVac, which promises to be a $1 per dose vaccine, has been tested on 6,800 subjects at three locations: SAS Delhi, CMC Vellore and KEM Mumbai. The vaccine is being developed by Bharat Biotech with support from institutions such as DBT, Gates Foundation, Program for Appropriate Technologies in Health (PATH), Centers for Disease Control, USA, National Institutes of Health NIAID, USA, Society for Applied Studes, Translational Health Sciences Technology Institute, Indian Institute of Science, All India Institute of Medical Science and Stanford University. In 2011, Dr Krishna Ella, chairman and MD, Bharat Biotech, had announced that Rotavac would be available at a price of $1 per dose. The company expects India licensure during 2014 and WHO pre-qualification in 2015 for supply to UN agencies. India’s vaccine market stands at $260 million at the moment. Centers for Disease Control estimates say rotavirus causes about 352,000-to-592,000 deaths each year in children below the age of five. Praising the effort of this public-private partnership, Dr Rao said, “This is the best model for vaccine development and a perfect PPP model. Seeing the efficiency of the Rotavac project, a similar model has been adopted for malaria vaccine development.” Discussing the challenges in vaccine development, he commented, “One of the challenges in vaccine space is clinical trials of new vaccines. DBT is closely working with the the Drug Controller General of India (DCGI) to solve this issue about clinical trials.” The event at Pune is providing a platform for leading vaccine players to explore partnership opportunities at various stages of the vaccine life cycle, from the earliest basic research to licensure of the vaccine. © Copyright © 2012. CyberMedia (I) Ltd All rights reserved.

Reproduction in whole or in part in any form or medium without written permission is prohibited.”

Support for rotavirus vaccine research and development has come from the Department of Biotechnology (DBT) since 1989. Following early work on identification of distinct strains of rotavirus independently both at the All India Institute of Medical Sciences (AIIMS, led by Dr. M. K. Bhan, later to become Secretary DBT), New Delhi and at the Indian Institute of Science (IISc, led by Professor C. Durga Rao) Bangalore, the AIIMS research team and the IISc investigators were provided the first funding by the DBT. This, seed money grew the program under the Indo-US Vaccine Action Program. As a part of the program, collaborations were established with the Center for Disease Control (CDC), USA, Stanford University and investigators from the Society for Applied Sciences (SAS), New Delhi, the Christian Medical College (CMC) Vellore and the King Edward Medical College, Pune. The CDC helped in rotavirus surveillance and in assisting with clinical design and laboratory issues related to the trials. The AIIMS and CMC Vellore research teams played strong roles in the laboratory. Stanford University remained a valued partner providing specific virology expertise as well as real world vaccine development knowledge. The Translational Health Science Technological Institute (THSTI, a DBT aided autonomous institution) established a rotavirus vaccine-testing lab to support clinical studies. Along the way, this collaboration led to a number of important advances in support of vaccine development in India by Bharat Biotech International Ltd., Hyderabad. Clearly, this long-term collaboration has had spinoff effects that have been incredibly valuable in terms of training several researchers, publications and most important the prospect of developing a novel vaccine for the prevention of rotavirus diarrhea in India and beyond.

Rotavac is India’s first indigenously developed rotavirus vaccine, made with an Indian strain 116E by clinicians and scientists at AIIMS, New Delhi in close collaboration with CDC, Atlanta, an Indian manufacturer, Bharat Biotech International Ltd. Hyderabad, Indian clinical trials through an Indo-US partnership initiated by the Indo-US Vaccine Action Program (VAP) and strongly supported by DBT, the Gates Foundation, Program for Appropriate Technologies in Health (PATH), National Institute of Health – National Institute of Allergy and Infectious Diseases (NIAID), USA, SAS, New Delhi, CMC Vellore, KEM Pune, THSTI Gurgaon, and Stanford University. The 116E vaccine has demonstrated good immunogenicity in Indian children and completed a Phase III efficacy trial. The analysis of the data is in progress.

Dr. T. S. Rao, Sr. Advisor, Medical Biotechnology Division with DBT is associated with the program since its inception and has worked closely with clinicians and scientists associated with the development of the rotavirus vaccine.

Gagandeep Kang from the Christian Medical College Vellore writes about the importance of research support for such efforts in the Deccan Herald and again in The Hindu. Kudos to scientists such as her who communicate their work and views.