Shanchol® Oral Cholera Vaccine Prequalified by WHO
In a significant development for global health, the World Health Organization (WHO) has granted prequalification status to Shanchol®, an oral cholera vaccine developed originally by Shantha Biotechnics. This vital recognition ensures that global procurement agencies, including UNICEF, Gavi, and the Pan American Health Organization (PAHO), can source Shanchol® for deployment in regions where cholera remains a critical public health issue.
Dr. K.I. Varaprasad Reddy, the founder of Shantha Biotechnics, noted that Shanchol® was designed as an affordable and accessible solution for nations repeatedly facing cholera outbreaks. He emphasized that this WHO prequalification is a testament to the founding mission of improving health outcomes in vulnerable populations.
Over the years, nearly 40 million doses of Shanchol® have been delivered across the globe through various vaccination campaigns led by UNICEF. Production of the vaccine was temporarily halted under its former ownership, but GCBC Vaccines Pvt. Ltd. has now resumed manufacturing. This move followed an on-site inspection by WHO, allowing them to transfer the prequalification status. Shanchol® is uniquely positioned as the only oral cholera vaccine produced in India that has received WHO prequalification, highlighting India's essential role in maintaining global supply continuity.
Dr. Ravi Penmetsa, Managing Director of GCBC Vaccines Pvt. Ltd., elaborated on the innovative manufacturing practices from India and their impact on global healthcare. By resuming production of Shanchol®, the company aims to guarantee that this life-saving vaccine is reliably available to those who need it most. Dr. Vishy Chebrol, Executive Director of GCBC Vaccines Pvt. Ltd., reiterated the company's commitment to global health. He stated, "Our focus is on ensuring that vaccines like Shanchol® reach the countries that need them, affordably and consistently." In addition to Shanchol®, GCBC Vaccines is exploring the development of other affordable vaccines to expand access to life-saving immunizations worldwide.
About Shanchol®
Shanchol® is a bivalent killed whole-cell oral cholera vaccine, effective against both Vibrio cholerae O1 and O139 serogroups. It has played an integral role in UNICEF-coordinated efforts toward outbreak response and preventive immunization campaigns, significantly contributing to the protection of millions globally. With the WHO prequalification, Shanchol® is set to be supplied at scale to meet the pressing international demand and fulfill country-specific immunization requirements.
Historical Context
Initially developed by Shantha Biotechnics, a pioneering biotech firm established in the 1990s, Shanchol® gained prominence under Sanofi, which acquired the company in 2009. Following its acquisition, it garnered global recognition as a reliable vaccine provider. In 2024, GCBC Vaccines Pvt. Ltd. took over Shantha’s facilities, revitalizing the brand and its mission to furnish high-quality, affordable vaccines. The revival of Shantha’s legacy stands as a testament to their dedication to enhancing public health through accessible immunizations.
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