First rotavirus vaccine made in India is launched

India’s prime minister, Narendra Modi, launched the first oral rotavirus vaccine to be developed and manufactured in the country on 9 March.

Every year in India 80 000 children under 5 die, and up to one million are hospitalised, because of diarrhoea caused by rotavirus. Rotavac was developed by Bharat Biotech, Hyderabad, and is priced at just $1 (£0.67; €0.95; Rs63) a dose.1 2 The three dose vaccine will aid efforts to lower infant mortality due to diarrhoea.3

The vaccine originated from a rotavirus strain that was isolated at the All India Institute of Medical Sciences, New Delhi, from a neonate who shed the virus but had none of the symptoms. Clinical trials have shown it to have a similar efficacy to the current vaccines used in developing countries—the monovalent Rotarix (GlaxoSmithKline) and the pentavalent RotaTeq (Merck).4 Rotavac is currently the cheapest of the three vaccines.

Development of the new vaccine, from isolation in 1986 to commercial roll out, took over two decades and involved Indian and international researchers in both the public and private sectors. Over 60 international scientists were involved in the clinical trials. The vaccine was the result of a unique “social innovation partnership” that received support from various sources including the Indian government, the Research Council of Norway, the Bill and Melinda Gates Foundation, and the UK Department of International Development.

Bharat Biotech invested about $20m for the required infrastructure and manufacturing facilities and holds four patents for the vaccine. Other partners in the programme included the Indian Department of Biotechnology, Stanford University School of Medicine, and the US National Institutes of Health and Centers for Disease Control and Prevention, as well as PATH, a nongovernmental global health organisation based in Seattle.

Krishna Ella, chairman and managing director of Bharat Biotech, told The BMJ that with a first year efficacy of 56% and a second year efficacy of 49%, the vaccine was comparable if not better than the other available vaccines in low income settings. He also said that the low price did not indicate that it was a “cheap” vaccine.

Ella said that the government now planned to add the vaccine to the universal immunisation programme in four or five states initially, before expanding it nationwide.