Mumbai: Hyderabad-based vaccine manufacturer, Bharat Biotech, and Research firm, Hilleman Labs, are coming together for Phase 3 trials of a Cholera vaccine which can positively fill supply gap.
HillChol, the oral vaccine, will be put into Phase 3 of clinical trials by Bharat Biotech, following which the company will begin the development, production, and commercialization stage, said Krishna Ella, founder of Bharat Biotech.
The World Health Organization (WHO) has pre-shortlisted three oral vaccines, Dukoral, developed by Swedish company Velneva; Euvichol, manufactured by South Korea’s Eubiologics; and Shanchol, produced by Shanta Biotech (now part of French vaccine maker Sanofi).
Cholera is an acute diarrheal disease caused by water or food carrying the vibrio cholerae bacteria. Around 1 million children are infected by the bacteria each year around the globe, with South Asian and Sub-Saharan countries registering the largest number of cases. Mortality due to the Cholera infection ranges from 21,000 to 143,000 every year.
HillChol, developed at the University of Gothenburg, is unique from others due to its simpler manufacturing process. It consists of a single serotype, called Hikojima, which expresses the Ogawa and Inaba antigens, resulting in a simpler and shorter manufacturing process as compared to licensed oral cholera vaccines, as per the University of Gothenburg’s Jan Holmgren, who, along with his colleague Michael Lebens, leads the team that has produced the vaccine.
The vaccine is predicted to enter commercial production in the coming three years.