The International Vaccine Institute (IVI), which is committed to making vaccines available worldwide, has initiated a technology transfer for a simplified oral cholera vaccine (OCV-S) to Biological E. Limited (BE), a leading vaccine and pharmaceutical company based in India.

Announcing the agreement, the Director General of IVI, Dr Jerome Kim 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.”

Reacting to the announcement, the Managing Director of Biological E. Limited, Ms Mahima Datla, 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.”

Since the agreement was signed last November, IVI has been furnishing BE with the necessary technical details, expertise, and materials to produce OCV-S at their facilities. This transfer includes support for clinical development and regulatory approvals. This collaboration between IVI and BE comes at a crucial time, amidst a significant rise in cholera outbreaks globally. Their joint effort aims to boost the production of affordable cholera vaccines, not only in India but also for the global public market.

Pointing out that the cholera situation is dire, the Director of IVI’s Cholera Programme, Dr Julia Lynch, said, “The availability and use of oral cholera vaccines are 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,” she added.

As per the terms of the agreement, IVI plans to conclude the technology transfer by 2025. Afterwards, Biological E. Limited will be responsible for manufacturing the oral cholera vaccine, catering to both Indian and international markets.

This technology transfer and licencing agreement marks the sixth instance of IVI, extending such technology to manufacturers in India, the Republic of Korea, Bangladesh, and South Africa. These partnerships have either resulted in or aim to secure pre-qualification (PQ) from the World Health Organization. PQ status enables global agencies like UNICEF to obtain the vaccine for worldwide distribution.

BE already has nine vaccines in its portfolio with WHO PQ. IVI, and BE will now work towards WHO PQ for OCV-S after obtaining national licensure in India.

OCV-S is a simpler version of OCV that could help make producing cholera vaccines cheaper and faster for both existing and new OCV makers. IVI has been creating OCV-S and sharing its technology to fight cholera with three primary aims: ensuring there is enough OCV available, making cholera vaccines better, and helping to introduce and use OCV.

Since 2000, the Bill & Melinda Gates Foundation has been backing IVI's cholera program. They're also funding this new tech transfer to BE.