Bharat Biotech International Limited on Tuesday announced the launch of a novel single-strain oral cholera vaccine called Hilchol after a successful Phase-III clinical trial that confirmed the safety of the vaccine.
Bharat Biotech Executive Chairman Krishna Ella said at a press conference that BBIL has set up large-scale manufacturing facilities in Hyderabad and Bhubaneswar with the capacity to produce up to 200 million doses of Hilcol.
He further said that the Drugs Controller General of India (DCGI) has given approval for manufacturing the vaccine at the company's plant here.
Hilcol (BBV131) was developed by Bharat Biotech under license from Hilleman Laboratories (funded by Merck USA and the Wellcome Trust) to fight cholera, the vaccine maker said.
He added, “Hilcol is an outstanding success story of partnerships leading to public health solutions. Our new large-scale cGMP production facilities in Hyderabad and Bhubaneswar will significantly scale up our production and supply capabilities for this oral cholera vaccine, boosting our efforts to fight cholera globally.”
He further added that BBIL will soon approach the World Health Organisation for pre-qualification to supply the vaccine across the world through international agencies.
The global demand for oral cholera vaccines (OCVs) is more than 100 million doses annually, making them critical for cholera control. There is a shortage of 40 million doses of OCV globally as there is only one manufacturer, he said.
A press release issued by the vaccine manufacturer said that the multi-phase, clinical development process, culminating in a Phase III study, confirmed the vaccine's safety, immunogenicity, and non-inferiority compared to existing OCVs, and established its potential for public health use.
The safety and efficacy of Hilcol have been rigorously tested in pre-clinical and Phase I and Phase II clinical studies. The multi-stage clinical evaluation process, which culminated in a Phase III study, confirmed the vaccine's safety, immunogenicity, and non-inferiority compared to existing OCVs, establishing its potential for widespread public health use, it said.
Although cholera is preventable and treatable, its cases and deaths globally have been rising steadily since 2021. A release issued by BBIL said that from the beginning of 2023 to March this year, 824,479 cases and 5,900 deaths were reported in 31 countries.
This vaccine is a single-dose respule, given orally as two doses 14 days apart, and is suitable for individuals above one year of age.
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