The Asian Development Bank (ADB) on Wednesday approved a loan package of $336.5 million to establish domestic vaccine, therapeutics, and diagnostics manufacturing capacity and strengthen the national regulator to ensure vaccine supply security in Bangladesh.
“Our experience with the Covid pandemic exposed challenges in accessing diagnostic testing kits, availability of vaccines, and pandemic preparedness. It highlighted the need to improve self-sufficiency and establish capacity to manufacture vaccines,” said ADB Principal Health Specialist Dinesh Arora. “This project aims to build Bangladesh’s resilience against future pandemics, improve vaccine supply security, and reduce the incidence and severity of vaccine-preventable diseases.”
The project will establish a vaccine, therapeutic, and diagnostics manufacturing facility and warehousing unit in Essential Drugs Company Limited's (EDCL) existing location at Gopalganj, with a capacity to manufacture 58 million vials of vaccines per year, read a press release.
An in-house research and development center will be established to support the production of diagnostic kits and packaging of biosimilar therapeutics. It will also support the manufacture of at least two full-cycle vaccines by developing a seed bank, master cell bank, and working cell bank, in addition to at least five fill-and-finish vaccines.
The manufacturing facility will incorporate features to promote gender equality and social inclusion as well as green and resilient production using less energy and materials while reducing waste and carbon missions. The facility will seek certification from the World Health Organization (WHO) for good manufacturing practices (GMPs).
The ADB loan will support the Directorate General of Drug Administration (DGDA) to upgrade its regulatory capacity to WHO maturity level 3 and beyond. ADB will help strengthen laboratory quality management and regulatory inspection systems, while improving testing capacity modalities in compliance with WHO's Global Benchmarking Tool. It will create a stable, well-functioning, and integrated regulatory system; help foster international collaboration and trade; and improve private sector participation in Bangladesh's pharmaceutical industry. The project will help EDCL and DGDA train their staff in essential GMPs, quality assurance, quality control, validation, and calibration programs in compliance with the biosafety levels.
The project is financed through ADB’s $9 billion Asia Pacific Vaccine Access Facility, launched in December 2020 to provide rapid and equitable vaccine-related support to ADB developing member countries. It builds on ADB’s $940 million support to Bangladesh to purchase safe and effective vaccines against Covid in June 2021.