TAG: GS 3: SCIENCE AND TECHNOLOGY
THE CONTEXT: Recently, Bharat Biotech International Ltd., a prominent vaccine manufacturer, unveiled a new oral cholera vaccine (OCV) named Hillchol (BBV131).
EXPLANATION:
- Developed under a license from Hilleman Laboratories, the introduction of Hillchol is a significant advancement in the global fight against cholera, a severe diarrheal disease.
- Hilleman Laboratories is supported by Merck, USA, and the Wellcome Trust, UK, making this vaccine a product of international collaboration and expertise.
Addressing a Critical Shortage: The Global Demand for Oral Cholera Vaccines
- The global demand for Oral Cholera Vaccines exceeds 100 million doses annually.
- However, until now, only one manufacturer supplied OCVs worldwide, resulting in a shortage of approximately 40 million doses each year.
- This shortage has posed a significant challenge in controlling cholera outbreaks, particularly in regions with poor sanitation and limited access to clean drinking water.
- The introduction of Hillchol by Bharat Biotech aims to alleviate this shortage and improve global access to this life-saving vaccine.
Large-Scale Manufacturing Capabilities
- To meet the high demand for OCVs, Bharat Biotech has established large-scale manufacturing facilities in Hyderabad and Bhubaneswar.
- The total production capacity of these facilities is set to reach up to 200 million doses of Hillchol annually.
- Of this, 45 million doses will be produced at the Hyderabad facility, with the remaining capacity based in Bhubaneswar, where the company is constructing a significant production site.
- These facilities are expected to substantially increase the global supply of OCVs, helping to reduce the current shortfall and meet the rising demand for cholera prevention.
Regulatory Approval and Future Plans
- The Drug Controller General of India has licensed Bharat Biotech to market Hillchol, specifically the doses manufactured at its Hyderabad facility.
- This approval is a crucial step as the company prepares to seek pre-qualification from the World Health Organization (WHO).
- WHO pre-qualification is essential for the vaccine to be distributed internationally, particularly in developing countries where cholera is most prevalent.
- Bharat Biotech also plans to collaborate with international organizations and vaccine alliances such as GAVI to ensure that Hillchol reaches those in need across the globe.
- While Hillchol has yet to be incorporated into India’s national vaccination campaign, Bharat Biotech intends to initially ship the vaccines produced at its Hyderabad facility for international use.
- This strategy aims to address immediate global needs while setting the stage for potential inclusion in domestic immunization programs.
Vaccine Specifications: Dosage and Administration
- Hillchol is designed as a two-dose oral vaccine.
- The first dose is administered on Day 0, followed by a second dose on Day 14.
- This regimen is suitable for children older than one year, making it a valuable tool in protecting vulnerable populations, including young children, from cholera.
- The vaccine is presented in a single-dose respule, a format that simplifies administration and ensures precise dosing.
- Hillchol must be stored between 2-8°C, which is standard for many vaccines, to maintain its efficacy.
- Bharat Biotech has also highlighted that Hillchol features a mono-multidose format, marking one of the first instances of such a presentation for vaccines.
A Product of International Collaboration
- The development of Hillchol is the result of extensive collaboration among several organizations.
- Alongside Bharat Biotech and Hilleman Laboratories, the University of Gothenburg and Gotovax AB played pivotal roles in the vaccine’s development.
- This partnership brought together expertise from diverse fields, ensuring that Hillchol is a scientifically robust and effective vaccine.
- Hilleman Laboratories, founded by Wellcome and Merck Sharp & Dohme (MSD), has expressed pride in its role in this joint effort.
- The organization is dedicated to advancing global health equity by developing affordable, high-impact, and sustainable solutions for diseases like cholera, which disproportionately affect low-income communities.
Scaling Up Production to Combat Cholera Globally
- Bharat Biotech’s founder and co-founder emphasized the importance of the new large-scale cGMP production facilities in Hyderabad and Bhubaneswar.
- These facilities will significantly enhance the company’s ability to produce and supply Hillchol, advancing global efforts to combat cholera.
- The support and guidance provided by the Central Drugs Standard Control Organisation of India and WHO Geneva has been acknowledged, which have been instrumental in navigating the regulatory landscape for this new vaccine.
Clinical Trials and Efficacy Studies
- The development of Hillchol involved rigorous clinical trials to ensure its safety and efficacy.
- Phase I and Phase II clinical studies were conducted in Bangladesh, a country that has faced numerous cholera outbreaks in the past.
- These trials provided valuable data on the vaccine’s safety and dosage requirements.
- Following these initial studies, a Phase III efficacy study was conducted in India, involving 3,600 volunteers.
- This large-scale study further confirmed Hillchol’s effectiveness in preventing cholera, paving the way for its approval and eventual rollout.
