Bharat Biotech, in collaboration with Hilleman Laboratories, has launched Hillchol, a new oral cholera vaccine in India, poised to address a critical global shortage. The launch follows the successful completion of Phase III clinical trials. Hillchol utilizes a single, genetically engineered inactivated Hikojima bacteria strain.
Addressing Global Cholera Vaccine Shortage
Cholera, a deadly bacterial disease causing severe diarrhea and dehydration, remains a significant public health threat in many parts of the world. N Erlyani Abd Hamid, assistant director at Hilleman Laboratories, noted the growing gap between cholera vaccine production capacity and projected public health needs. While production has increased from 4 million doses in 2012 to 35 million in 2022, an estimated 65 million doses will be needed by 2028, with only about 25 million available. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have the capacity to produce approximately 200 million doses of Hillchol, potentially mitigating this shortage.
Development and Manufacturing
Hillchol is currently manufactured in Hyderabad. Bharat Biotech intends to pursue prequalification for licensure from the World Health Organization (WHO) for global distribution, which can pave the way for the vaccine to be available in countries eligible for support by Gavi, the Vaccine Alliance. The University of Gothenburg and Gotovax AB developed the Hikojima strain for the Hillchol vaccine. Hilleman Laboratories then led subsequent development and manufacturing stages, including Phase II clinical studies, before transferring it to Bharat Biotech.
Innovation in Vaccine Development
A 2020 study highlighted Hillchol's potential advantages over existing oral cholera vaccines. The study noted that while current vaccines are effective, their multiple-strain composition and two-method inactivation make them more complex and expensive to produce. Raman Rao, CEO of Hilleman Laboratories, emphasized the mission to develop affordable vaccines against infectious diseases for countries with unmet medical needs. He credited the collaborative efforts of Hilleman Laboratories, Bharat Biotech, the University of Gothenburg, and Gotovax AB for the successful launch of Hillchol.
