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Hyderabad, August 27, 2024 – Pharma giant Bharat Biotech has announced the launch of HILLCHOL (BBV131), a next-generation oral cholera vaccine (OCV) aimed at combating the ongoing global public health threat posed by cholera. This novel single-strain vaccine, developed under license from Singapore-based Hilleman Laboratories, is designed to be administered orally on day 0 and day 14, and is suitable for children aged one year and above.
Cholera, a preventable and treatable disease, continues to be a major health challenge, particularly in regions with inadequate sanitation. Despite global efforts, cholera cases and deaths have seen a troubling rise since 2021. From early 2023 to March this year, the World Health Organization (WHO) reported 824,479 cases and 5,900 deaths across 31 countries, underscoring the urgent need for effective interventions.
Dr. Krishna Ella, Executive Chairman of Bharat Biotech, emphasized the significance of vaccines in curbing cholera outbreaks: “Vaccines provide the best intervention to prevent, limit, and control cholera outbreaks. 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.”
The introduction of HILLCHOL comes at a critical time when global demand for OCVs far outstrips supply. Currently, only one manufacturer is supplying OCVs worldwide, leading to an annual deficit of approximately 40 million doses. The launch of HILLCHOL is expected to help bridge this gap and contribute significantly to the Global Task Force on Cholera Control (GTFCC)’s goal of reducing cholera-related deaths by 90 percent by 2030, alongside efforts to improve water and sanitation infrastructure.
Bharat Biotech has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar, capable of producing up to 200 million doses of the vaccine annually. The company highlighted that HILLCHOL’s safety and efficacy have been thoroughly evaluated through pre-clinical, Phase I, II, and III clinical trials. The Phase III study confirmed the vaccine’s safety, immunogenicity, and non-inferiority to existing OCVs, establishing its potential for widespread public health use.
In terms of storage and presentation, the HILLCHOL vaccine is presented as a single-dose respule and should be stored at temperatures between +2 degrees Celsius and +8 degrees Celsius. It also features a mono-multidose format, one of the first such presentations for vaccines, which enhances its accessibility and usability in various public health settings.
The launch of HILLCHOL marks a significant advancement in the global fight against cholera, offering hope to millions in regions where the disease remains a persistent threat.
