• Pune
  • 6 March 2013
  • News
  • By Manasi

Bharat Biotech's RotaVac completes phase III trials

India's first indigenously developed vaccine RotaVac, which will be available at $1 per dose, has completed its phase III clinical trials


The phase III trial of RotaVac has been completed and the data is presently being analyzed for efficacy

Vaccine World Summit, which is happening in Pune, aims to provide a meeting platform for leading vaccine players to explore partnership opportunities at various stages of the vaccine lifecycle, from the earliest basic research to licensure of the vaccine.

In the keynote address by Dr TS Rao, advisor, Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, highlighted some of the developments that are happening in the vaccine space in India.

RotaVac, India's first indigenously developed rotavirus vaccine is being developed by Bharat Biotech along with institutions such as DBT, Gates Foundation, Program for Appropriate Technologies in Health (PATH), Centers for Disease Control, USA, National Institutes of Health - National Institute of Allergy and Infectious Diseases (NIAID), USA, Society for Applied Studies, Translational Health Sciences Technology Institute, Indian Institute of Science, All India Institute of Medical Science, and Stanford University. Dr Rao announced at the summit that phase III trials for this rotavirus vaccine has been done on 6,800 subjects at three locations; SAS Delhi, CMC Vellore, and KEM Mumbai and now the data is being analyzed for the same.

It may be recalled that Dr Krishna Ella, chairman and MD, Bharat Biotech in 2011 had announced that Rotavac would be available at a price of $1 a dose. The vaccine expects India licensure during 2014 and WHO prequalification in 2015 for supply to UN agencies.

Praising the effort of this public-private partnership, Dr Rao mentioned, "This is the best model for vaccine development and a perfect PPP model. Seeing the efficiency of RotaVac project, similar model has been adopted for malaria vaccine development." He further said that "One of the challenges in vaccine space is clinical trials of new vaccines. DBT is closely working with DCGI to solve this issue regarding clinical trials."

India's vaccine market stands at $260 million at the moment. According to CDC estimates, rotavirus causes approximately 352,000-592,000 deaths each year in children below the age of five.

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