Bharat Biotech unveils oral cholera vaccine developed in partnership with Hilleman Labs 

Bharat Biotech launches Hillchol, a single-strain oral cholera vaccine with potential for global public health use.

Vaccine maker Bharat Biotech International Ltd on Tuesday (August 27, 2024) launched Hillchol (BBV131), a novel single-strain oral cholera vaccine (OCV) it has developed under licence from Hilleman Laboratories (funded by Merck, USA and Wellcome Trust, UK).

The rollout assumes significance amid a shortage of OCVs that exists globally. At present, there is only one manufacturer supplying OCVs worldwide and a shortage of around 40 million doses annually. Global demand for the vaccine exceeds 100 million doses annually, the Hyderabad company’s leadership told the launch function in Hyderabad.

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Bharat Biotech said it has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses of Hillchol, founder Krishna Ella and co-founder Suchitra Ella told media after the launch. Of this 45 million doses capacity has been established in Hyderabad, while the rest would be in Bhubaneswar, where the vaccine maker setting up a “big facility.”

The company has been licenced by the Drug Controller General of India to market the vaccine manufactured at the Hyderabad facility. This approval from the country’s regulator is important as it gears up to seek pre-qualification for the vaccine from World Health Organization (WHO) as well as work with international organisations and vaccine alliances such as GAVI.

With the OCV yet to form part of the national vaccination campaign in India, the company initially would like to ship the products made at its Hyderabad facility, they said. Hillchol is a two dose vaccine — administered orally on Day 0 and Day 14 — and suitable for children older than one year. It will be available as a single-dose respule and should be stored between plus 2-8°C. Hillchol is presented in a mono-multidose format, one of the first such presentations for vaccines, Bharat Biotech said in a release.

The launch of the vaccine is result of extensive international collaboration involving Hilleman Laboratories, Bharat Biotech, the University of Gothenburg and Gotovax AB. “Ever since it was founded by Wellcome and MSD, Hilleman Laboratories is proud of its role in this joint effort and its dedication to advancing global health equity through affordable, high-impact and sustainable solutions for those who are most susceptible to this disease,” Bharat Biotech said.