Seoul-headquartered non-profit organisation International Vaccine Institute (IVI) has commenced technology transfer of simplified Oral Cholera Vaccine (OCV-S) to Hyderabad-based vaccine maker Biological E.
This follows a technology license agreement in November 2023. IVI said it has begun providing the technical information, know-how and materials to produce OCV-S at BE facilities. It will continue to support necessary clinical development and regulatory approvals.
IVI and BE said they entered into the partnership during an unprecedented surge of cholera outbreaks worldwide and aim to increase the volume of low-cost cholera vaccine in India as well as the global public market. The technology transfer will be completed by 2025 and Biological E. will manufacture the vaccine for India and international markets, they said in a joint statement issued on March 20, 2024.
Low cost vaccine
Set up in 1997 at the initiative of the United Nations Development Programme to discover, develop and deliver safe, effective and affordable vaccines for global health, IVI’s portfolio includes vaccines at all stages of pre-clinical and clinical development for infectious diseases such as cholera, typhoid, chikungunya, shigella, salmonella, schistosomiasis, hepatitis E, HPV and COVID-19. IVI had developed the world’s first low-cost oral cholera vaccine, pre-qualified by the World Health Organization (WHO) and developed a new-generation typhoid conjugate vaccine that also achieved WHO pre-qualification (PQ) in early 2024.
“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. We are pleased to partner with Biological E. to address this supply gap and protect communities from this deadly, though preventable, disease,” IVI Director General Jerome Kim said.
WHO PQ
The technology transfer and licensing agreement is the sixth of its kind for IVI, transferring such technology to manufacturers in India, South Korea, Bangladesh and South Africa. All these partnerships have led to or seek to achieve, pre-qualification certification from WHO that enables global agencies such as UNICEF to procure the vaccine for the global market.
BE has nine vaccines with WHO PQ in its portfolio. IVI and BE will pursue WHO PQ for OCV-S as well national licence in India, the statement said.
“We are glad to be in collaboration with IVI for the manufacture of simplified oral cholera vaccine… make this vaccine accessible globally,” BE managing director Mahima Datla said.
Gates Foundation funding
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. The Bill & Melinda Gates Foundation has been supporting IVI’s cholera programme since 2000 and is funding this latest technology transfer to BE.
“The cholera situation is dire and availability and use of OCV is an essential as outbreaks increase and global vaccine supply remains strained. With more manufacturers like BE entering the market, future supply situation looks strong,” Director of IVI’s Cholera Programme Julia Lynch said.
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