India's Bharat Biotech to launch oral cholera vaccine amid global shortage – Firstpost

India's Bharat Biotech said on Tuesday its oral cholera vaccine has cleared final-stage trials and it plans a global launch, aiming to make 200 million doses a year amid growing disease outbreaks and a lack of treatments.

India's drug regulator has approved the vaccine, called Hilcol, and Bharat Biotech will apply for World Health Organisation pre-qualification to supply key buyers such as the United Nations 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 buy the drug from us and do the final manufacturing there, we are ready for that too,” the company told Reuters.

Bharat Biotech will begin production from its Hyderabad plant with an annual capacity of 45 million doses, and is awaiting key approvals for another plant to scale up output to 200 million.

A source familiar with the matter told Reuters that about $100 million has been spent on the facilities used to manufacture Hilcol. Bharat Biotech declined to disclose the investment.

The final-stage trials, involving about 3,600 participants from India, showed that the vaccine is safe and “not inferior” to existing oral vaccines, the company said, without giving details.

The WHO said 249,793 cholera cases and 2,137 deaths were reported in 25 countries in the first six months of the year, while 166,442 cases and 69 deaths will be recorded in the same period in 2023.

The World Health Organization said this resulted in requests for 102 million doses, double the 51 million doses produced.

Bharat Biotech said in a release that there is a global shortage of 40 million doses per year, and the company plans to meet this shortfall with Hilcol, which can be given to people above one year of age.

Developed under license from Singapore's Hillman Laboratories, the vaccine will be administered in two doses – on day 0 and day 14.

(Except for the headline, this story has not been edited by Firstpost staff.)