India's Bharat Biotech plans global launch for its oral cholera vaccine Hillchol

Indian biotechnology giant Bharat Biotech said on Tuesday (Aug 27) that its oral cholera vaccine Hillchol cleared a late-stage trial. Bharat Biotech said that India's drug regulatorapproved the vaccine, adding, it was now planning for a global launch.

The company said it would apply for the World Health Organization's (WHO) pre-qualification to supply to major buyers like the UNICEF. A report by the news agency Reuters said that Hillchol would compete withSouth Korea's EuBiologics Co, which is the only WHO-approved producer of cholera vaccines.

A look at Bharat Biotech's plan for Hillchol

Speaking to Reuters, Bharat Biotech said that its first intention was to 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 added.

Bharat Biotech would start the production of Hillchol from its Hyderabad facilitywith an annual capacity of 45 million doses. The company is also awaitinga key approval for another facility to ramp up production to 200 million doses.

A source told Reuters that $100 million was spent on the facilities which would be used to manufacture Hillchol.

The late-stage trial

Bharat Biotech said that the late-stage trial, which had around 3,600 participants from India, showed that Hillchol was safe and non-inferior to the existing oral vaccines (for cholera).

The company pointed out that there is a global shortage of40 million vaccine doses per year, and it plans to end this shortage with its vaccine.

How Hillchol will be administered?

Hillcholcan be administered to people above the age of one. The vaccinewould be administered in two doses, 14 days apart. The vaccine has been developed underlicense from Singapore's Hilleman Laboratories.

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Speaking to Reuters,Hilleman Laboratories' Chief Executive Officer (CEO) Raman Rao said on Tuesday that, unlike existing cholera vaccines that are developed using multiple strains, Hillchol uses only one strain with all the antigens.

"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 added.

Global demand for oral cholera vaccines

As per the WHO, the first six months of 2024 saw249,793 cases and2,137 deaths due to cholera. These figures were reported from 25 countries. In the same period last year, 166,442 cases and 69 deaths were seen.

The increasing numbers haveled to the request for 102 million doses of oral vaccines, double the 51 million produced, the UN health agency said.

(With inputs from agencies)