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. Strain diversity, too, has not apparently affected its efficacy.
Rotavirus is responsible for approximately 4,53,000 child deaths due to diarrhoea globally each year. It is particularly threatening in India where — according to a recent study — around 1,00,000 children die each year from severe diarrhoea and dehydration caused by rotavirus.
India accounts for 22 per cent of the estimated global deaths from diarrhoea-causing rotavirus.
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.
“Once sanitation and drinking water supply in the country improves, the efficacy of the vaccine is bound to go up. Rotavirus is also associated with gut infection and the vaccine is known to give ‘herd immunity.’ Even if 25 per cent infection is prevented, it will mean a substantial public health gain,” said M.K. Bhan, former Secretary, Department of Biotechnology.
“This is an important scientific breakthrough against rotavirus infections. Clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India,” K. Vijay Raghavan, Secretary, Department of Biotechnology, said.
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 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.