Bharat Biotech International Ltd (BBIL) launched its Oral Cholera Vaccine (OCV), Hillchol, on Monday. It was developed under licence from Hilleman Laboratories to combat cholera.
BBIL developed the vaccine under licence from Hilleman Laboratories, which was funded by Merck, USA, and Wellcome Trust, UK.
“We want to work on neglected diseases which are mainly in Asia and Africa. One of the contributions in this regard is this cholera vaccine,” Krishna Ella, Executive Chairman, BBIL told newspersons after the formal launch of the vaccine here on Tuesday. ““The WHO has a target of eradicating Cholera by 2030, and we also want to be a part of it,” Ella said.
According to the company, 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.
Hyderabad-based Bharat Biotech received all necessary approvals from the Indian drug regulators to produce and market it in the domestic market. “Based on our national approvals, the process for obtaining pre-qualification for the World Health Organization (WHO) will be taken up,” Ella said.
The company aims to supply it to Unicef, mainly for Asian and African countries. It is also open to selling it to individual countries if required. In India, too, states like Bengal and Orissa have serious problems with cholera,” he added.
While Hillchol is not the first Cholera Vaccine, it is novel in some crucial ways. It can protect against a new strain of the disease. It also offers a simplified production process, which makes it “cheaper” than those available in the market now.
While not disclosing the likely price of the vaccine, Ella said it would be ‘affordable’ as the company has invested in achieving scale in the production and made some innovations in its packaging. Global demand for OCVs exceeds 100 million doses per annum. There is a shortage of about 40 million doses now, and Bharat Biotech hopes to bridge this gap with Hillchol. Currently, only one manufacturer supplies OCVs worldwide.
He said that to mitigate this global shortage of oral cholera vaccine, Bharat Biotech has established large-scale manufacturing facilities. The vaccine will be produced at BBIL’s facility in Hyderabad and an upcoming new facility in Bhubaneshwar.
As of now, the new vaccine’s production capacity in the Hyderabad plant is 45 million doses. After production commences in the upcoming Bhubaneswar facility in the next few months, it will increase to 200 million doses.
The two-dose Hillchol vaccine is administered with a gap of 14 days between the two doses and is suitable for all those older than one year. It is packed as a single-dose respule and presented in a mono-multidose format, one of the first such vaccine presentations.
The new OCV marks a significant milestone in global cholera prevention efforts, said Jan Holmgren who has been regarded as the `Father of Oral Cholera Vaccines’ by the Industry.
It will 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 water and sanitation infrastructure improvements.
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.
The launch of the Hillchol vaccine is the result of extensive international collaboration between Hilleman Laboratories, Bharat Biotech, the University of Gothenburg, and Gotovax AB.
The vaccine was developed by BBIL under licence from Hilleman Laboratories, funded by Merck, USA and Wellcome Trust, UK. 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.