Rotavac is currently considered to be “pre-qualified” by the WHO. This means that the vaccine can now be sold to countries across the world and included in UNICEF procurement programmes. While not the first vaccine produced in India to reach the pre-qualified stage, it is the first that was developed entirely within India.
The vaccine, developed by Hyderabad-based Bharat Biotech, was released last year in India following clinical trials showing both efficacy and safety.
Assisting Bharat Biotech during the development process was the international non-profit organisation PATH, which focuses primarily on healthcare innovation with the goal of aiding impoverished nations. PATH was involved with the clinical trials of Rotavac alongside the Indian Department of Biotechnology and the Society for Applied Studies.
PATH released a statement congratulating the progress of the vaccine. “As a longstanding partner in the development of the vaccine since 2001, we know that achieving WHO prequalification of ROTAVAC brings us even closer to meeting the critical public health goal of improving the supply of affordable rotavirus vaccines worldwide,” said Dr. Fred Cassels, global head of Enteric and Diarrheal Diseases at PATH’s Center for Vaccine Innovation and Access.
Global recognition from the WHO as well as many other aid organisations could provide an indication to investors that India is capable of more than mass production of generics.
There are a number of Indian startups that have developed innovative solutions to various medical issues. From the 3D printing of prosthetic limbs to the development of a glove using AI technology to monitor potential epileptic strokes, Indian startups have shown the country is highly capable of innovation in terms of medical devices. Bharat Biotech could pave the way for increased Indian vaccine development.
Rotavirus infections pose a substantial public health threat, particularly in low and middle income nations. One of the primary symptoms of the virus is diarrhoea. Infants are the most commonly-affected group. Diarrhoea in infants can be fatal if there is no readily available source of clean water available for rehydration.
It is estimated that about 200,000 children die from rotavirus related diarrhoea in India every year. A widely available vaccine is therefore critical to reducing levels of infant mortality.
The Indian government included Rotavac in its National Immunisation Programme in 2016. Under the programme around 3.5 crore doses have been administered to date. By placing Rotavac into the pre-qualified classification, the vaccine is now available to many other nations and could go on to save the lives of thousands of children worldwide.