Hyderabad, Mar 20 (Representative) Headquartered in Seoul, Republic of Korea, the International Vaccine Institute (IVI), an international organisation with a mission to discover, develop, and deliver safe, effective, and affordable vaccines for global health, announced on Wednesday that it has commenced a technology transfer of simplified Oral Cholera Vaccine (OCV-S) to Hyderabad-based Biological E. Limited (BE), a leading India-based Vaccines and Pharmaceutical Company.Following the signing of a technology licence 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, the Hyderabd-based vaccine maker said in a release here. IVI will complete the technology transfer by 2025, and the oral cholera vaccine will be manufactured for India and international markets by Biological E. Limited. 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, Managing Director, 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 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, she added. This technology transfer and licencing agreement is the sixth of its kind for IVI, transferring such technology to manufacturers in India, the Republic of Korea, Bangladesh, and South Africa.
All these partnerships have led to or seek to achieve pre-qualification (PQ) from the World Health Organisation, 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. Dr. Julia Lynch, Director of IVI’s Cholera Programme, said, “The cholera situation is dire, and the availability and use of oral cholera vaccines is an essential part of a multifaceted approach to cholera control and prevention, especially as outbreaks increase and the global vaccine supply remains strained. With more manufacturers, like BE, entering the market, the future supply situation looks strong. IVI remains committed to ensuring the availability of the oral cholera vaccine and to developing new and improved vaccines that are equally safe, effective, and affordable and made around the world, for the world.” 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: ensuring supply of OCV; improving cholera vaccines; and supporting OCV use and introduction. The Bill & Melinda Gates Foundation has been supporting IVI’s cholera programme since 2000 and is funding this latest technology transfer to BE.