#India #Hyderabad #cholera vaccine #Shanchol® #Shantha Biotechnics

WHO Prequalifies Shanchol® Cholera Vaccine

In a significant advancement for global health, the World Health Organization (WHO) has granted prequalification for Shanchol®, an oral cholera vaccine that was originally developed by Shantha Biotechnics. This milestone positions Shanchol® as a vital resource for worldwide health agencies such as UNICEF, Gavi, and the Pan American Health Organization (PAHO) to facilitate its procurement and distribution to countries grappling with recurring cholera outbreaks and public health challenges.

A Lifesaving Solution

Shanchol® was designed to be an affordable and accessible solution, aimed particularly at nations frequently affected by cholera. Dr. Varaprasad Reddy, the founder of Shantha Biotechnics, emphasized that the WHO's prequalification aligns perfectly with the company's founding mission – to improve health outcomes in cholera-stricken regions. With nearly 40 million doses distributed globally through vaccination campaigns led by UNICEF, the vaccine has played a pivotal role in combating cholera outbreaks and preventing further epidemics.

After experiencing a production halt when it was previously owned by GCBC Vaccines Pvt. Ltd. (originally Shantha), production has now resumed successfully. Following a site inspection and assessment by the WHO, the prequalification process was completed, allowing Shanchol® to continue leading efforts against cholera outbreaks. Currently, Shanchol® remains the only oral cholera vaccine that is both manufactured in India and prequalified by the WHO, highlighting India’s key role in maintaining a consistent global supply of this essential vaccine.

Commitment to Global Health

Dr. Ravi Penmetsa, CEO of GCBC Vaccines Pvt. Ltd., underscored the importance of high-quality sterile manufacturing in the country. He noted that the revival of Shanchol® production is a testament to India's capabilities in transforming global healthcare standards. The commitment shown by the company signifies not only a dedication to providing this life-saving vaccine but also an effort to innovate and introduce new affordable vaccines to global markets, following the well-established tradition of Shantha Biotechnics.

Dr. Vishy Chebrol, Executive Director of GCBC Vaccines Pvt. Ltd., mentioned that the overarching goal is to ensure that vaccines like Shanchol® consistently reach the countries in dire need, remaining accessible and affordable. Furthermore, the company is advancing efforts to commercialize additional innovative vaccines from its pipeline, adhering to its mission of expanding the reach of essential immunizations worldwide.

Vaccine Details

Shanchol® is a bivalent oral vaccine comprised of inactivated whole cells and is effective against the Vibrio cholerae O1 and O139 serotypes. It has been instrumental in both response efforts to cholera outbreaks and in preventive vaccination campaigns coordinated by organizations such as UNICEF. With the WHO's prequalification, the vaccine is poised for large-scale distributions, adequately addressing international demands and national vaccination needs.

Legacy of Shantha Biotechnics

Established in the 1990s, Shantha Biotechnics emerged as a pioneering biotechnology firm in India. The company came under the ownership of Sanofi in 2009, bolstering its reputation on a global scale as a trusted vaccine provider. In 2024, GCBC Vaccines Pvt. Ltd. acquired Shantha’s facilities, including those dedicated to Shanchol®. The legacy of Shantha is being perpetuated through this rebirth of the company and its ongoing mission to deliver high-quality, affordable vaccines to broaden access to critical immunizations across the globe.

For more information about Shanchol® and GCBC Vaccines Pvt. Ltd., visit their official website at gcbcvaccines.com.