Bharat Biotech is set to launch its oral cholera vaccine, making it the second company in the world to produce this vaccine, following a South Korean manufacturer. The company plans to start distributing the vaccine in the coming months to address a significant global shortage of cholera vaccines.
The worldwide demand for oral cholera vaccines is nearly 100 million doses annually. Currently, only one manufacturer is supplying this vaccine, leading to an ongoing shortage.
Cholera is an acute diarrheal infection caused by ingesting food or water contaminated with the Vibrio cholerae bacteria. It is estimated that there are approximately 2.86 million cases and around 95,000 deaths from cholera each year.
Bharat Biotech’s oral cholera vaccine, named Hillchol, has successfully completed Phase III clinical trials, which involved 1,800 individuals, including infants and adults, across 10 clinical sites in India. The company has scaled up its production capacity at its facilities in Hyderabad and Bhubaneswar to produce up to 200 million doses of Hillchol.
Dr. Krishna Ella, the executive chairman of Bharat Biotech, noted that there has been a surge in cholera outbreaks along with a severe shortage of vaccines. According to the World Health Organisation (WHO), there is currently no stockpile of oral cholera vaccines, as demand is outpacing supply, increasing the risk of disease spread.
EuBiologics is currently the only manufacturer of this vaccine and holds more than 80% of the market share, with a production capacity of up to 50 million doses, which is expected to increase to 70 million doses in 2025.
“Cholera is a vaccine-preventable disease. The new generation oral cholera vaccine Hillchol aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats,” Dr. Ella stated.
Hillchol has demonstrated strong immunogenicity, showing more than a four-fold increase in vibriocidal antibodies against both the Ogawa (68.3%) and Inaba (69.5%) serotypes, proving to be non-inferior to licensed vaccines. The adverse events reported were mild and similar between Hillchol and existing vaccines. The vaccine was well-tolerated and immunogenic across all age groups, including infants under one year, children, and adults, according to the company’s findings published in the ScienceDirect vaccine journal.
