Bharat Biotech launches oral cholera vaccine HILLCHOL to address global shortage

Bharat Biotech (BBIL) has launched HILLCHOL (BBV131), an oral cholera vaccine developed under license from Hilleman Laboratories. The vaccine, designed to combat cholera, addresses the global shortage of oral cholera vaccines (OCVs), which currently faces a deficit of approximately 40 million doses annually due to limited manufacturing sources.

HILLCHOL has been tested through pre-clinical and Phase I, II, and III clinical studies, demonstrating safety, immunogenicity, and non-inferiority to existing OCVs. To meet global demand, Bharat Biotech has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses of the vaccine annually.

Dr Krishna Ella, Executive Chairman of Bharat Biotech, commented, “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 is administered orally on Day 0 and Day 14 and is suitable for individuals older than one year. It is presented in a mono-multidose format, with storage requirements between +2°C and +8°C. This launch contributes to the Global Task Force on Cholera Control’s goal of reducing cholera-related deaths by 90 per cent by 2030.

Dr Ella also expressed gratitude to Bharat Biotech’s partners and regulatory bodies, stating, “I congratulate the team at Bharat Biotech, our partners for developing this novel vaccine and thankful to the CDSCO, Govt of India, and WHO Geneva, for their regulatory guidance and support.”

Cholera remains a significant public health challenge, particularly in regions with inadequate sanitation. The launch of HILLCHOL, supported by collaborations with Hilleman Laboratories, the University of Gothenburg, and Gotovax AB, marks a major step in global cholera prevention efforts. However, the vaccine is not a substitute for other preventive measures against the disease.