First indigenous Indian rotavirus vaccine unveiled

The Department of Biotechnology (DBT) today unveiled India's first completely indigenous and affordable vaccine to prevent severe rotavirus diarrhoea, an infection that kills more than a lakh children under five in India every year.

DBT secretary Dr K Vijayraghavan said Phase III trials of the vaccine, developed after 28 years of research, showed that 'Rotovac' has excellent safety and efficacy profile.

The results of the Phase III clinical trials of the Rotavac vaccine, released at an international conference, pegged its efficacy at 56 per cent in the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any type.

Rotavac is an oral vaccine administered to infants in a three-dose course at the ages of six, 10 and 14 weeks alongside routine immunisations recommended at these ages.

The vaccine was developed in collaboration with Bharat Biotech under the public-private partnership mode.

''This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 100,000 deaths of small children in India each year,'' said Vijay Raghavan. ''The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India.''

''Rotavac significantly reduced severe rotavirus diarrhoea by more than half,'' M K Bhan, former secretary, DBT, who isolated the rotavirus strain in 1985 while pursuing research at AIIMS, told reporters.

However, commercial production of the vaccine would take some time, as it is yet to get clearance from the Drug Controller General of India (DCGI).

''We are planning to file a dossier with the DCGI in July. We will come to the market after getting the requisite regulatory clearances,'' Krishna M Ella, CMD, Bharat Biotech, said.

Vijay Raghavan said Bharat Biotech is expected to price the vaccine at $1 per dose, much cheaper than other rotavirus vaccines available in the market.

There were two licensed rotavirus vaccines introduced in more than 40 countries but they remain out of reach for many in the developing world.

''Vaccines work to save and protect children from diseases like rotavirus for a lifetime,'' said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. ''This public-private partnership is an exemplary model of how to develop affordable technologies that save lives.''

The vaccine development partnership has been supported by DBT, the Bill & Melinda Gates Foundation, the Research Council of Norway and the UK Department for International Development.

Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development.

The study partners also consulted with the state governments of Delhi, Maharashtra, and Tamil Nadu, as well as the ministry of health and family welfare.