New Delhi: Hyderabad-based Bharat Biotech Ltd on Monday launched oral cholera vaccine (OCV) Hillchol, made in collaboration with Hilleman Laboratories, the University of Gothenburg and Gotovax AB.
The company’s facilities in Hyderabad and Bhubaneswar with a capacity of 200 million doses will manufacture Hillchol, a novel single-strain OCV. Global demand for OCVs is over 100 million doses a year, and given that only one manufacturer supplies them, there is a deficit of approximately 40 million doses every year.
Bharat Biotech said a multi-stage clinical evaluation process ending 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.
Dr. Krishna Ella, executive chairman of Bharat Biotech, said, “Vaccines provide the best intervention to prevent, limit and control cholera outbreaks. 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.”
“Hillchol’s safety and efficacy have been rigorously tested in pre-clinical and Phase I and Phase II clinical studies,” the company said in a statement.
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.
“Hillchol vaccine is administered orally on Day 0 and Day 14, and is suitable for individuals older than one year. It is presented as a single-dose respule and should be stored between +2°C and +8°C. HILLCHOL is presented in a mono-multidose format, one of the first such presentations for vaccines,” the company said.