Hyderabad’s Biological E to produce oral cholera vaccine with Korean tech

Seoul/Hyderabad: The International Vaccine Institute (IVI) announced that it has commenced a technology transfer of simplified Oral Cholera Vaccine (OCV-S) to Biological E Limited (BE), a leading Hyderabad-based vaccines and pharmaceutical company.

IVI, headquartered in Seoul, Republic of Korea with a Europe Regional Office in Sweden, will complete the technology transfer by 2025 and the oral cholera vaccine will be manufactured for India and international markets by Biological E Limited.

Following the signing of a technology license agreement in November last year, IVI has begun providing the technical information, know-how, and materials to produce OCV-S at BE facilities and will continue to support necessary clinical development and regulatory approvals.

Global cholera outbreaks

IVI and BE entered this partnership during an unprecedented surge of cholera outbreaks worldwide and aim to increase the volume of low-cost cholera vaccines in India as well as the global public market.

Dr Jerome Kim, director general of IVI, said: “In an era of heightened risk of poverty-associated infectious diseases such as cholera, the world needs a sustainable source of high-quality, affordable vaccines and committed manufacturers to supply them. We are pleased to partner with Biological E, a company with a proven history of making life-saving vaccines accessible globally, to address this supply gap and protect communities from this deadly, though preventable, disease.”

Mahima Datla, MD, Biological E. Limited, said: “We are glad to be in collaboration with IVI for the manufacture of a simplified Oral Cholera Vaccine. Our efforts are aimed at not only combating the disease but also being a part of a sustained legacy of innovation, collaboration, and health stewardship. Together with IVI, we are happy to be shaping a healthier and more resilient future by making this vaccine accessible globally.”

Sixth international collaborations

This technology transfer and licensing agreement is the sixth of its kind for IVI, transferring such technology to manufacturers in India, the Republic of Korea, Bangladesh, and South Africa. The partnerships have led to or seek to achieve, pre-qualification (PQ) from the World Health Organization, a designation that enables global agencies such as UNICEF to procure the vaccine for the global market.

BE already has nine vaccines with WHO PQ in its portfolio, and IVI and BE will pursue WHO PQ for OCV-S as well, following national licensure in India.

The vaccine

OCV-S is a simplified formulation of OCV with the potential to lower production costs while increasing production capacity for current and aspiring OCV manufacturers. IVI’s development of OCV-S and ongoing technology transfers are part of an institutional strategy to confront cholera with three main goals: ensure the supply of OCV, improve cholera vaccines and support OCV use and introduction. The Bill & Melinda Gates Foundation has been supporting IVI’s cholera program since 2000 and is funding this latest technology transfer to BE.