New Delhi: Almost 30 years in the making, the first India-developed vaccine for rotavirus – cause of severe diarrheoa in children – has shown positive results in third phase of clinical trials. The announcement was made by the Department of Biotechnology (DBT), Ministry of Science and Technology, on Tuesday.
Rotavirus is responsible for the deaths of approximately 100,000 children in India, every year. India has the highest mortality burden of rotavirus among all countries.
The most vulnerable are infants - 50 and 75 percent of rotavirus-associated deaths in India occur before 1 and 2 years of age, respectively.
Describing the successful clinical trials of rotavirus vaccine – Rotavac - as ‘historic’, DBT Secretary Vijay Raghavan, said, “Indian and international researchers of the public and private sector joined together to combat this terrible killer.
Rotavirus is the most severe and lethal cause of childhood diarrhoea and kills around 100,000 Indian children each year. The vaccine was developed by an Indian strain, by an Indian company and tested by Indian investigators in an effort led by the Indian government. We were helped our global scientists and friends and the result is a world-class vaccine for India’s children.”
The phase III trial enrolled 6,799 infants between the ages of six-seven weeks chosen from a ‘low socio-economic’ population. The trials were conducted by Society for Applied Sciences in Delhi, KEM Hospital in Pune and Christian Medical College in Vellore.
Underlining the significance of an affordable vaccine against diarrhoea in children, M K Bhan, former DBT secretary said, “We are interested in looking at preventive solutions in India. Particularly in rural areas, there are huge challenges in mobilising curative services and that is partly the reason why we are interested in a vaccine.” Bhan was among the group of scientists at the All Institute of Medical Sciences (AIIMS) who isolated the strain of rotavirus from which the vaccine originated.
Describing the safety profile of the vaccine as ‘outstanding’, Bhan said, “To the extent of results so far with 7000 children, we are very comfortable with what we see. We have an elaborate plan for post-marketing surveillance as per WHO guidelines, where extended safety data will be generated.”
The efficacy of the vaccine, said Bhan, was between 55 and 60 per cent. “Higher the socio-economic status better the vaccines work. We chose to do this trial in a low socio-economic population because we wanted a conservative estimate. We have taken the poorest population. So this is the least it will perform in worst circumstances.”
Asked in what way this vaccine, if licensed, would be better than that two existing licensed vaccines by Merck and GlaxoSmithKline (GSK) available in India, Bhan said, “In safety and efficacy terms, this vaccine and those by GSK and Merck are very comparable. The only difference will be cost. We have an agreement with Bharat Biotech to give us a 1$ (Rs 54) vaccine. Rotavac will cost Rs 54 a dose which is way below anything available in anywhere in the world.”
Rotovac is an oral vaccine administered to infants in three doses. The price of the licensed rotavirus vaccines presently available in India are in the range of Rs 2000-2500 for the complete course.
Making a case for rotavirus vaccines as part of a public health initiative in India, the DBT, quoting studies states, “Research indicates a national rotavirus vaccination programme in India would significantly reduce rotavirus-related hospitalisations and deaths and that vaccination would be highly cost-effective at a range of prices. A national rotavirus immunisation programme in India could prevent approximately one-third of the rotavirus deaths and significantly reduce medical treatment-related costs.”
Thus underlining the significance of having a Indian-manufactured licensed vaccine, Bhan says, “We cannot have immunization in India unless Indian companies make the vaccine. We have never introduced a vaccine made by an international company. This is a precondition of our public health programme.”
Krishna Nella, chairman and managing director of Bharat Biotech, the Indian private sector partner in the Rotavirus Vaccine Development Project, called it the “first social innovation project in science and technology in India.” Asked when he would be approaching the Drug Controller General of India (DCGI) for licensing the vaccine, he said, “We are planning to file a dossier with the DCGI in July.” Subject to approval by the DCGI, the vaccine will be ready for commercial production.
Collaborators from the US for the vaccine development project included National Insititutes of Health, Centers for Disease Control and Prevention, Stanford University School of Medicine and PATH, a non-governmental organisation.