In a major boost for global public health, the Shanchol oral cholera vaccine, produced in Hyderabad, has officially received prequalification from the World Health Organization (WHO). This significant achievement comes shortly after its manufacturing was successfully restarted under new management, GCBC Vaccines, which took over the facilities of the original developer, Shantha Biotechnics.
This WHO endorsement is crucial, as it allows international procurement bodies like UNICEF, Gavi, and PAHO to readily acquire Shanchol. This ensures the vaccine can be deployed effectively in nations grappling with the persistent threat of cholera outbreaks. GCBC Vaccines, part of the Gland Family Office, acquired Sanofi’s manufacturing sites in Medchal and Muppireddypally, near Hyderabad, in April 2024, thereby reviving production of the vaccine initially created by Shantha Biotechnics in the 1990s and later acquired by Sanofi in 2009.
A Legacy of Life-Saving Production Continues
Ravi Penmetsa, Managing Director of GCBC Vaccines, emphasized the company’s commitment, stating, “By bringing Shanchol back into production, we are dedicated to maintaining the highest standards of reliability to ensure this life-saving vaccine is available globally.” Historically, nearly 40 million doses of Shanchol have been distributed worldwide through UNICEF-led immunization drives. Following a pause in production under its previous ownership, GCBC Vaccines successfully relaunched manufacturing after a thorough on-site inspection by the WHO, which subsequently transferred the essential prequalification.
Notably, Shanchol stands as the sole oral cholera vaccine produced in India to hold WHO prequalification, highlighting India’s critical contribution to sustaining the global supply of essential medicines, as announced by the company in a recent statement.
Vision for the Future of Immunization
K.I. Varaprasad Reddy, founder of Shantha Biotechnics, reflected on the vaccine’s origins: “Shanchol was envisioned as an affordable and readily accessible solution for countries frequently affected by cholera. The continued WHO prequalification ensures this foundational mission endures.”
Vishy Chebrol, Executive Director of GCBC Vaccines, underscored the broader objective: “Our primary focus is to reliably and affordably deliver these critical vaccines to the regions that need them most.” He added, “Concurrently, we are diligently working to introduce other cost-effective and innovative vaccines from our development pipeline into global markets, thereby upholding Shantha’s enduring legacy of broadening access to life-saving immunization.”
With its renewed WHO prequalification, Shanchol — a bivalent killed whole-cell oral cholera vaccine effective against both Vibrio cholerae O1 and O139 strains — is set to meet substantial international demand and fulfill crucial country-specific immunization requirements.