India’s Bharat Biotech said on Tuesday its oral cholera vaccine cleared a late-stage trial and that it plans a global launch, aiming to make up to 200 million doses a year amid an expanding outbreak of the disease and treatment shortages. India’s drug regulator has approved the vaccine, called Hillchol, and Bharat Biotech will apply for the World Health Organization’s pre-qualification to supply to major buyers like the U.N.
children’s agency UNICEF, the company said. ”Our intention is to first help the African continent where the situation is worse. And if any African country wants to procure the drug substance from us and do the final manufacturing there, we’re also open to it,” the company told Reuters.
Bharat Biotech will start production from its Hyderabad facility with an annual capacity of 45 million doses, and is awaiting a key approval for another facility to ramp-up production to 200 million. About $100 million was spent on the facilities which would be used to manufacture Hillchol, a source aware of the matter told Reuters. Bharat Biotech refused to disclose the investment.
The late-stage trial, which had around 3,600 participants from India, showed the vaccine was safe and ”non-inferior” to existing oral vaccines, the company said, without disclosing further details. The WHO said 249,793 cholera cases and 2,137 deaths were reported from 25 countries in the first six months of the year, compared to 166,442 cases and 69 deaths in the same period in.