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Rotavac • First indigenous rotavirus vaccine

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IN News: Rotavirus vaccine Rotavac

  • Rotavac is the first indigenous rotavirus vaccine.
  • Rotavac has been developed by a joint vaccine development initiative supported by Department of Biotechnology, Government of India, the Bill & Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development with Bharat Biotech investing on important activities towards vaccine development.
  • The Phase-III clinical trial of low cost Indian-made rotavirus vaccine Rotavac has demonstrated strong efficacy and excellent safety profile and if approved by the Drugs Controller General of India, it would be available at Rs. 54 per dose.
  • This vaccine, developed under a public-private partnership, will be the third to hit the Indian market, but will be more affordable than the two vaccines now available costing more than Rs. 1,000 per dose.
  • The clinical study has demonstrated for the first time that Rotavac is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India, and developing countries in Asia and Africa.

Rotavac: Clinical Trials

  • The randomised, 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 Centre for Health Research and Development, Society for Applied Sciences, in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research centre in Vadu; and Christian Medical College in Vellore.
  • Infants received Rotavac and the UIP (Universal Immunization Programme) vaccines, including the oral polio vaccine (OPV).
  • Result showed that infants receiving OPV at the same time as Rotavac generated comparable immune responses to all three polio serotypes as the infants receiving OPV without Rotavac, supporting the concurrent administration of OPV and Rotavac.

Rotavac vaccine: How it is administered?

  • 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 immunisations in the Universal Immunisation Programme (UIP) vaccines recommended at these ages.

Rotavac: The cost-effect analysis

  • Several rotavirus vaccines research projects are under way in India. Cost effectiveness of rotavirus vaccine has been evaluated in two separate studies. In one of the studies third stage clinical trial of ROTAVAC is over.
  • At a price of US $ 1 (Rs. 50/- approx), the price set by Bharat Bio-Tech, cost effectiveness in terms of disability adjusted life year, satisfy the WHO/ UNICEF criteria for a cost- effective intervention.

Conclusion

  • ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards. The clinical trial results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.

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