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. Also read | Rise and fall of cholera-causing bacteria lineage 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. “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,” Mr.
Ella said, thanking the Central Drugs Standard Control Organisation of India and WHO Geneva for their regulatory guidance and support. On trials conducted for the vaccine, he said Phase I and Phase II clinical studies were conducted in Bangladesh. The Phase III efficacy study was conducted in India on 3,600 volunteers.
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