Bharat Biotech International Ltd on Tuesday announced the launch of Hillchol, a novel single-strain oral cholera vaccine following a successful phase-III clinical trial which confirmed the safety of the jab.

BBIL has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses of Hillchol, said Bharat Biotech Executive Chairman Krishna Ella at a press conference.

He further said the Drug Controller General of India (DCGI) gave the nod to manufacture the vaccine at the company’s plant here.

The vaccine maker said Hillchol (BBV131) was developed by Bharat Biotech under license from Hilleman Laboratories (funded by Merck USA and Wellcome Trust) to combat cholera.

"Hillchol is an excellent success story of partnership leading to public health solutions. Our new large-scale cGMP production facilities in Hyderabad and Bhubaneswar will significantly enhance our production and supply capabilities for this Oral Cholera Vaccine, advancing our efforts to combat cholera globally," he said.

He further said BBIL will soon approach the World Health Organisation for a pre-qualification to supply the vaccine worldwide through international agencies.

Global demand for Oral Cholera Vaccines (OCVs) exceeds 100 million doses annually, making them crucial for cholera control. Globally, there is a shortage of 40 million doses of OCVs as there is only one manufacturer, he said.

A multi-stage, clinical evolution process, culminating in a Phase III study confirmed the vaccine safety, immunogenicity and non-inferiority to existing OCVs, establishing its potential for white spirit, and public health use, a press release from the vaccine maker said.

Hillchol's safety and efficacy have been rigorously tested in pre-clinical and Phase I and Phase II clinical studies. A multi-stage clinical evaluation process, culminating in a Phase III study, confirmed the vaccine's safety, immunogenicity and non-inferiority to existing OCVs, establishing its potential for widespread public health use, it said.

While cholera is preventable and treatable, global cases and deaths have risen steadily since 2021. From early 2023 to March this year, 824,479 cases and 5,900 deaths were reported in 31 countries, the release from the BBIL said.

The vaccine, a single dose respule, is administered orally 14 days apart (two doses) and is suitable for individuals older than one year.

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