Bharat Biotech's Hillchol Clears Phase-III Cholera Vaccine Trials

Key Highlights:

• Hillchol has completed successful Phase III trials across multiple age groups in India.
• The vaccine is effective against both major cholera-causing serotypes—Ogawa and Inaba.
• Bharat Biotech can produce up to 200 million doses annually, addressing global OCV shortages.

Bharat Biotech International Ltd announced that it successfully completed Phase III clinical trials for its oral cholera vaccine, Hillchol. The double-blind, randomized study evaluated Hillchol for safety, immunogenicity, and consistency, and included 1,800 participants (infants, children, and adults) at 10 sites in India.

Hillchol performed well in efficacy trials against both Ogawa and Inaba serotypes of Vibrio cholerae O1 (the bacteria that cause cholera), and was shown to be non-inferior to a comparator vaccine. Participants were stratified across three age groups and then randomized in a 3:1 ratio to receive either Hillchol or the comparator vaccine.

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"This publication reaffirms our commitment to advancing vaccines built on rigorous research, thorough clinical trials, and reliable clinical data. It highlights our continued commitment to providing affordable, effective, and accessible vaccines for the populations who need them the most," said Krishna Ella, Executive Chairman of Bharat Biotech.

Cholera is a severe diarrheal disease caused by contaminated food or water, and globally accounts for an estimated 2.86 million cases each year (and an estimated 95,000 deaths). Most cholera cases can be attributed to contaminated food or water. Presently the global demand for oral cholera vaccines (OCVs) is nearly 100 million doses per year, with only one main supplier of OC vaccines. Currently there is only one main supplier of OCVs. Bharat Biotech's production facilities in Hyderabad and Bhubaneswar are able to fill this gap, producing 200 million doses of Hillchol annually.