By Rishika Sadam
HYDERABAD (Reuters) – 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.
Bharat Biotech’s vaccine will compete with South Korea’s EuBiologics Co, which is the only WHO-approved producer of cholera vaccines.
“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 doses.
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.
WHO’s pre-qualification will depend on “proof of efficacy, proof of safety and proof of good manufacturing process”, the agency’s spokesperson Margaret Harris told reporters.
The first six months of the year have seen 249,793 cholera cases and 2,137 deaths reported from 25 countries, compared to 166,442 cases and 69 deaths in the same period in 2023, according to the WHO.
That, the WHO said, has led to the request for 102 million doses of oral vaccines, double the 51 million produced.
Bharat Biotech said there is a global shortage of 40 million vaccine doses per year, and it plans to bridge that with Hillchol, which can be administered to people above the age of one.
The vaccine, developed under license from Singapore’s Hilleman Laboratories, would be administered in two doses, 14 days apart.
Unlike existing cholera vaccines that are developed using multiple strains, Hillchol uses only one strain with all the antigens, Hilleman Laboratories Chief Executive Officer Raman Rao told Reuters on Tuesday.
“Normally if you have to work with five different strains (to develop a vaccine), the production capacity is limited. If you have a single strain, it can give you better productivity of three to four times,” Rao said.
(Reporting by Rishika Sadam, Additional reporting by Emma Farge, Writing by Nandan Mandayam; Editing by Varun H K and Mrigank Dhaniwala)
