Bharat Biotech has successfully completed Phase III clinical trials for its oral cholera vaccine, Hillchol. The breakthrough comes at a critical time when global cholera cases continue rising. Vaccine shortages plague affected regions worldwide.
The Hyderabad-based company reported impressive efficacy data from comprehensive trials. Safety results showed only mild adverse events across all tested age groups. These findings position Hillchol as a potential game-changer in cholera prevention.
Hillchol demonstrated significant effectiveness against both major cholera strains. The vaccine showed a four-fold rise in vibriocidal antibodies with 68.3% efficacy for Ogawa serotype and 69.5% for Inaba serotype. The vaccine proved non-inferior to licensed vaccines including the comparator Shanchol. Clinical trials maintained a strong safety profile across all age groups with only mild adverse events reported.
The double-blind randomised Phase III clinical trial evaluated safety immunogenicity and lot-to-lot consistency of Hillchol. The study involved 1,800 participants ranging from infants to adults across 10 clinical sites in India. Participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years and infants aged 1 to under 5 years. The participants were randomised in a 3:1 ratio to receive either Hillchol or the comparator vaccine. The findings have been published in the ScienceDirect vaccine journal.
"Hillchol can play a significant role in addressing the global cholera crisis and vaccine shortages," said Bharat Biotech executive chairman Dr Krishna Ella. The new generation oral cholera vaccine features a simplified single stable O1 Hikojima strain which enhances production efficiency and affordability. This proves particularly beneficial for lower and middle-income countries. The company's facilities in Hyderabad and Bhubaneswar can produce 200 million doses of Hillchol annually. Currently global demand for oral cholera vaccines reaches 100 million doses per year with only one manufacturer resulting in critical shortages.
Cholera remains a serious global health threat causing acute diarrhoeal infection. The disease spreads through ingesting food or water contaminated with vibrio cholerae bacteria. Cholera causes an estimated 2.86 million cases and around 95,000 deaths globally every year.
Bharat Biotech has delivered over nine billion doses of vaccines globally with 145 global patents and a portfolio of 19 vaccines. The company has four biotherapeutics and registrations in over 125 countries. Beyond developing India's first indigenous Covid-19 vaccine Covaxin the company has created vaccines for influenza H1N1 Rotavirus Japanese Encephalitis Rabies Chikungunya Zika and the world's first tetanus-toxoid conjugate vaccine for Typhoid.
This success fills an important gap for global vaccine supply chains. Hillchol offers developing countries a low-priced option for cholera prevention, locally manufactured in India.
The achievement strengthens India's position as a reliable vaccine manufacturer. A cost-effective production could make cholera prevention accessible to high-risk populations who have so far been unable to afford the protection.
Bharat Biotech's track record suggests that Hillchol would receive international regulatory acceptances quickly. This could transform the way cholera is prevented in endemic regions throughout the world.