For the first time, a vaccine conceived and developed from scratch in India has been “pre-qualified” by the World Health Organisation.
The Rotavac vaccine, developed by the Hyderabad-based Bharat Biotech Limited last year, was included in India’s national immunisation programme. To be “pre-qualified” means that the vaccine can be sold internationally to several countries in Africa and South America.
While several vaccines from India have been pre-qualified, this is the first that was entirely developed locally and, according to experts, is a sign that there is a credible industrial, scientific and regulatory process in place to develop vaccines in India.
The Rotavac vaccine protects against childhood diarrhoea caused by the rotavirus and was built on strain of the virus isolated at the the All India Institute of Medical Sciences here over 30 years ago.
India included the Rotavac in its national immunisation in 2016, with about 35 million doses delivered till date. A dose costs between ₹55-60, according to the company.
Krishna Ella, chairman and managing director of Bharat Biotech, said that about 9 million children in nine Indian states have been vaccinated. Some medics have raised concerns that the rotavirus vaccine carried a small chance of causing infants to develop a bowel disorder; but the Rotavac vaccine, having been tested in the field for over a year, have not shown any negative effect, he claimed.
The Pune-based Serum International also has developed a rotavirus vaccine called Rabishield that has also been included in India’s immunisation programme.
Rotavirus is responsible for an estimated 36% of hospitalisations for childhood diarrhoea around the world and for an estimated 200,000 deaths in low- and middle-income countries.