India's Bharat Biotech announced on Tuesday that its oral cholera vaccine has successfully completed a late-stage trial and is planning a worldwide launch. The company aims to produce up to 200 million doses annually to address the growing cholera outbreak and treatment shortages. The Indian drug regulator has already approved the vaccine, known as Hillchol, and Bharat Biotech intends to seek World Health Organisation pre-qualification to supply major buyers such as UNICEF.
The company expressed its commitment to initially aid the African continent, where the cholera situation is more severe. Bharat Biotech is also open to African countries procuring the drug substance from them for final manufacturing locally. Production will commence at the company's Hyderabad facility, which has an annual capacity of 45 million doses, with plans to expand to 200 million doses pending approval for another facility. An investment of approximately $100 million was made in these facilities, though Bharat Biotech declined to disclose the exact amount.
The late-stage trial, involving about 3,600 participants from India, demonstrated that the vaccine is safe and at least as effective as existing oral vaccines, according to the company. The WHO reported 249,793 cholera cases and 2,137 deaths from 25 countries in the first half of the year, prompting a demand for 102 million doses of oral vaccines, double the 51 million produced. Bharat Biotech highlighted a global shortage of 40 million doses annually and plans to fill this gap with Hillchol, which is suitable for individuals aged one and above. The vaccine, developed under license from Singapore's Hilleman Laboratories, requires two doses administered on day 0 and day 14.
