Bharat Biotech, an Indian pharmaceutical company headquartered in Hyderabad, India, has announced the successful completion of a late-stage trial for its oral cholera vaccine, Hillchol. The company plans to launch the vaccine globally, with the goal of producing up to 200 million doses annually. This development comes at a crucial time, as cholera outbreaks are expanding and there are shortages in treatment options. Bharat Biotech was the company that commercialized an Indian developed Covid vaccine during the pandemic. The cholera vaccine will be focused on India and Africa.
Hillchol has already received approval from India’s drug regulator. Bharat Biotech intends to apply for pre-qualification from the World Health Organization, which would allow them to supply the vaccine to major buyers such as UNICEF. Currently, South Korea’s EuBiologics Co is the only WHO-approved producer of cholera vaccines, making Bharat Biotech’s entry into the market significant.
The company’s primary focus is on helping African countries, where the cholera situation is particularly severe. They are open to collaborating with African nations for final manufacturing if those countries wish to procure the drug substance from Bharat Biotech.
Production will begin at the company’s Hyderabad facility, which has an annual capacity of 45 million doses. Bharat Biotech is awaiting approval for another facility to increase production to 200 million doses. The company has invested approximately $100 million in these facilities, though they have not officially disclosed the investment amount.
The late-stage trial of Hillchol involved around 3,600 participants from India and demonstrated that the vaccine is safe and “non-inferior” to existing oral vaccines. However, specific details of the trial results have not been released.
Hillchol is a novel single-strain Oral Cholera Vaccine (OCV) developed under license from Hilleman Laboratories, requires two doses administered orally on Day 0 and Day 14 and is suitable for individuals over one year of age. The single-strain nature of Hillchol distinguishes it from other OCVs, potentially enhancing manufacturing ease and efficacy.
The launch of Hillchol is particularly timely as the global demand for cholera vaccines currently exceeds production. There is an estimated deficit of nearly 40 million doses per year, which Bharat Biotech aims to address with Hillchol.
For WHO pre-qualification, Bharat Biotech will need to provide proof of efficacy, safety, and good manufacturing processes. If successful, this new vaccine could play a crucial role in addressing the global shortage of cholera vaccines and help combat the ongoing cholera outbreaks worldwide.
