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Bharat Biotech International Ltd recently 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.
Key Details on Hillchol cholera vaccine
- BBIL has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses of Hillchol.
- The Drug Controller General of India (DCGI) gave the nod to manufacture the vaccine.
- 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.
- 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.
- 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.
- 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.
- While cholera is preventable and treatable, global cases and deaths have risen steadily since 2021.
- The vaccine, a single dose respule, is administered orally 14 days apart (two doses) and is suitable for individuals older than one year.
Source: IE
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