Hyderabad: Bharat Biotech launches oral cholera vaccine Hillchol

Hyderabad: Bharat Biotech International Limited (BBIL) announced the launch of HILLCHOL® (BBV131), a novel single-strain Oral Cholera Vaccine (OCV).

Hillchol was developed by Bharat Biotech under license from Hilleman Laboratories (funded by Merck, USA and Wellcome Trust, UK), to combat cholera.

Only one manufacturer supplies OCVs worldwide, resulting in a yearly deficit of 40 million doses approximately. To mitigate this global shortage of oral cholera vaccine, Bharat Biotech has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses of Hillchol.

Global impact due to cholera

While cholera is preventable and treatable, global cases and deaths have risen steadily since 2021. From early 2023 to March this year, 824,479 cases and 5,900 deaths were reported in 31 countries.

Cholera continues to pose a significant public health challenge, especially in regions with inadequate sanitation. The spread of cholera is primarily attributed to the faecal contamination of water and food supplies, a problem exacerbated by natural disasters and among people living in crowded conditions with insufficient access to clean water.

Given the data, the global demand for Oral Cholera Vaccines (OCVs) exceeds 100 million doses annually, making them crucial for cholera control

Hillchol’s aims to reduce cholera deaths by 90%

Hillchol is aimed to contribute substantially to the Global Task Force on Cholera Control (GTFCC)’s goal of reducing cholera-related deaths by 90 per cent by 2030, alongside improvements in water and sanitation infrastructure.

Dr Krishna Ella, executive chairman of Bharat Biotech, said, “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’s efficacy in protecting against cholera

The launch of the Hillchol vaccine resulted from an extensive international collaboration involving Hilleman Laboratories, Bharat Biotech, the University of Gothenburg and Gotovax AB, the company said. Hillchol’s safety and efficacy have been rigorously tested in pre-clinical, Phase I and Phase II clinical studies.

Bharat Biotech stated that a multi-stage clinical evaluation process, culminating in a Phase III study, confirmed the vaccine’s safety, immunogenicity and non-inferiority to existing OCVs, establishing its potential for widespread public health use.

Hillchol cholera vaccine is administered orally on Day 0 and Day 14 and is suitable for individuals older than one year. It is presented as a single-dose respule and should be stored between +2°C and +8°C. Hillchol is presented in a mono-multidose format, one of the first such presentations for vaccines.

Although the cholera vaccine provides additional protection against infections, it is essential to emphasise that it does not substitute for other preventive measures.