World Health Organisation (WHO) prequalification is necessary for the UN agencies and Gavi, the Vaccine Alliance to purchase vaccines in partnership with developing countries.
Vaccine maker Bharat Biotech today said WHO has granted prequalification to its rotavirus vaccine ROTAVAC, used for prevention of infant deaths and hospitalisations due to rotavirus diarrhoea. World Health Organisation (WHO) prequalification is necessary for the UN agencies and Gavi, the Vaccine Alliance to purchase vaccines in partnership with developing countries. “The WHO prequalification will ensure access of the vaccine to almost 100 countries,” Bharat Biotech Chairman and MD Krishna Ella told reporters. This vaccine is innovated and made in India. The true impact of vaccines can be seen when vaccinations are carried out in affected populations, he added. “ROTAVAC has been supplied to low income countries at USD one per dose, with the feasibility for further 30 per cent price reductions, based on the procurement of around 100 million doses for these countries,” Ella said. The vaccine has been developed as a result of a multi country – multi partner collaborative model for over two decades. On being asked about the cost of developing the vaccine from clinical trials stage to its manufacturing, Ella told PTI: “From inception of the vaccine to trials to manufacturing facility would have cost at least Rs 1,000 crore”.
Out of these almost Rs 700 crore was given as grant by the Department of Biotechnology, Bill and Melinda Gates Foundation, Research Council of Norway, UK Department for International Development, he added. The expenditure made by the company has been around Rs 300 crore. Out of which Rs 150 crore was on manufacturing facility, Ella said. The vaccine is already being supplied to nine states in the country under the government immunisation programme and is also available in markets across the nation, Ella said. Rotavirus is the leading cause of severe diarrhoea and death among children less than five years of age around the world, the company said. “The advent of a locally manufactured, WHO prequalified rotavirus vaccine offers promise to protect children in India, Africa, the Americas and the rest of Asia from this debilitating disease,” said Duncan Steele, Enteric Diarrhoeal Diseases Team Deputy Director, Bill & Melinda Gates Foundation. Bharat Biotech has successfully miniaturised the dose volume of ROTAVAC to 0.5 ml dose in a ready to use format, Ella said.