New Delhi: Hyderabad-based Bharat Biotech Ltd on Monday launched oral cholera vaccine (OCV) Hilcol, developed in collaboration with Hillman Laboratories, University of Gothenburg and Gotovax AB.
The company's 200 million dose capacity facilities in Hyderabad and Bhubaneswar will manufacture Hilchol, a new single-strain OCV. The global demand for OCVs is over 100 million doses per year, and given that only one manufacturer supplies them, there is a shortage of about 40 million doses every year.
Bharat Biotech said the multi-phase clinical evaluation process culminating in the Phase 3 study confirmed the vaccine's safety, immunogenicity, and non-inferiority compared to existing OCVs, establishing its potential for widespread public health use.
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Dr. Krishna Ella, Executive Chairman, Bharat Biotech, said, “Vaccines provide the best intervention to prevent, limit and control cholera outbreaks. 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 enhance our production and supply capabilities for this oral cholera vaccine, boosting our efforts to fight cholera globally.”
“The safety and efficacy of Hilchol have been rigorously tested in pre-clinical as well as Phase I and Phase II clinical studies,” the company said in a statement.
Although cholera is preventable and treatable, cases and deaths globally have been rising steadily since 2021. From the start of 2023 to March this year, 824,479 cases and 5,900 deaths were reported in 31 countries.
“The Hilchol vaccine is administered orally on day 0 and day 14 and is suitable for individuals over one year of age. It is presented as a single-dose respule and must be stored between +2°C and +8°C. Hilchol is presented in a mono-multidose format, one of the first such presentations for a vaccine,” the company said.