World Health Organization prequalifies Shanchol® oral cholera vaccine

Shanchol®, the oral cholera vaccine originally developed by Hyderabad-based Shantha Biotechnics, has received prequalification from the World Health Organization (WHO). This milestone enables global procurement agencies such as UNICEF, Gavi, and PAHO to source Shanchol® for use in countries where cholera remains a major public health challenge.

“Shanchol® was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of vaccine carries forward that founding mission,” said Dr K.I. Varaprasad Reddy, Founder of Shantha Biotechnics.

Over the years, close to 40 million doses of Shanchol® have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines (formerly Shantha)- has resumed manufacturing, with WHO conducting an on-site inspection and transferring the prequalification. Shanchol® remains the only oral cholera vaccine manufactured in India with WHO prequalification, underscoring India’s critical role in ensuring continuity of global supply.

“As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform global healthcare. By resuming production of Shanchol®, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide,” said Dr Ravi Penmetsa, Managing Director, GCBC Vaccines.

Shanchol® is a bivalent killed whole-cell oral cholera vaccine, effective against Vibrio cholerae O1 and O139. It has been a cornerstone of UNICEF-coordinated outbreak responses and preventive immunization campaigns, protecting millions of people worldwide. With WHO PQ approval, Shanchol® will continue to be supplied at scale to international demand and to meet country-level immunisation needs.