WHO Prequalification of Shanchol Vaccine Supports Global Cholera Response Efforts

WHO Prequalification of Shanchol®: A Milestone for Global Health

In a significant advancement for global health, Shanchol®, an oral cholera vaccine developed by Shantha Biotechnics, has achieved prequalification from the World Health Organization (WHO). This pivotal designation allows major international procurement agencies such as UNICEF, Gavi, and the Pan American Health Organization (PAHO) to acquire this vaccine for distribution in countries grappling with recurring cholera outbreaks.

Addressing a Pressing Public Health Concern

Cholera continues to pose a severe threat to public health in many regions, particularly where sanitation and clean water access are lacking. The WHO prequalification ensures that Shanchol® can be used in routine immunization programs and emergency vaccination campaigns effectively across nations that are most affected by cholera.

"Shanchol® was conceived to be an affordable and accessible solution for countries facing the ongoing threat of cholera outbreaks," expressed Dr. K.I. Varaprasad Reddy, the founder of Shantha Biotechnics. This strategic goal emphasizes the mission of improving health outcomes for vulnerable populations.

A History of Impact

With nearly 40 million doses administered globally through UNICEF initiatives, Shanchol® has developed a track record of supporting cholera outbreak responses. The vaccine's initial production was temporarily halted during changes in ownership, but the new manufacturing entity, GCBC Vaccines Pvt. Ltd., has resumed operations with the approval from WHO. This marks Shanchol® as the only oral cholera vaccine manufactured in India currently holding WHO prequalification, reiterating India’s essential role in maintaining global vaccine supply continuity.

Dr. Ravi Penmetsa, Managing Director of GCBC Vaccines Pvt. Ltd., highlighted the importance of India’s expertise in sterile manufacturing for global healthcare. He emphasized that the resumption of Shanchol® production is an assurance of quality and availability of this lifesaving vaccine on an international scale. The milestone marks a resurgence of commitment to global health, with a clear focus on expanding access to critical vaccines.

Future Aspirations and Commitment to Global Health

Dr. Vishy Chebrol, Executive Director of GCBC Vaccines Pvt. Ltd., elaborated on the company's broader ambitions, stating, "Our focus remains on ensuring that vaccines like Shanchol® reach the countries that need them most, reliably and affordably." In addition to Shanchol®, GCBC Vaccines is actively working on introducing other innovative and cost-effective vaccines from its pipeline, adhering to the legacy of expanding access to vital vaccinations worldwide.

About Shanchol®

Shanchol® is a bivalent killed whole-cell oral cholera vaccine effective against the deadly strains Vibrio cholerae O1 and O139. This vaccine has been integral to UNICEF-led initiatives aimed at preventing and responding to cholera outbreaks, thereby safeguarding the health of millions. With the WHO prequalification, Shanchol® will be produced at a scale to satisfy both international demand and specific country immunization needs.

Manufacturer Background

Initially introduced by Shantha Biotechnics in the 1990s, Shanchol® earned global acclaim as a significant player in the vaccine market following its acquisition by Sanofi in 2009. In 2024, the vaccine’s facilities were acquired by GCBC Vaccines Pvt. Ltd., marking a new chapter in the history of this essential vaccine. The organization's goal remains steadfast in the commitment to deliver high-quality, accessible vaccines to the global population, ensuring that life-saving immunizations are readily available around the world.

By enabling the continued rollout of Shanchol®, the WHO's recent approval is poised to dramatically impact cholera prevention initiatives, promoting healthier communities worldwide and significantly reducing the burden of this preventable disease.