Bharat Biotech launches next-gen oral cholera vaccine, to help bridge global gap

Hyderabad: Pharma giant Bharat Biotech on Tuesday announced the launch of an oral cholera vaccine (OCV) to help combat cholera which continues to pose a significant global public health challenge, especially in regions with inadequate sanitation.

HILLCHOL (BBV131), a novel single-strain vaccine is to be administered orally on day 0 and day 14. It is suitable for babies older than one year.

In a statement, Bharat Biotech said the vaccine was developed under licence from Singapore-based Hilleman Laboratories, and added that large-scale manufacturing facilities have been established in Hyderabad and Bhubaneswar with a capacity to produce up to 200 million doses.

“Vaccines provide the best intervention to prevent, limit, and control cholera outbreaks 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,” said Dr. Krishna Ella, Executive Chairman of Bharat Biotech.

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.

While global demand for OCVs exceeds 100 million doses annually, there is currently only one manufacturer supplying OCVs worldwide, resulting in a yearly deficit of about 40 million doses.

The new vaccine will bridge the gap and also 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.

Notably, HILLCHOL's safety and efficacy have been established by pre-clinical, Phase I, II, and III clinical studies, the company said.

“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,” it added.

HILLCHOL vaccine is presented as a single-dose respule and should be stored between +2 degrees Celsius and +8 degrees Celsius. It is also presented in a mono-multidose format, one of the first such presentations for vaccines.