Bavarian Nordic has forged a strategic partnership with the Serum Institute of India (SII) through a comprehensive license and manufacturing agreement for its MVA-BN mpox vaccine, marking a significant step toward expanding global vaccine accessibility.
The agreement centers on a technology transfer of Bavarian Nordic's existing manufacturing process to SII, enabling the Indian manufacturer to produce and distribute the vaccine within the Indian market. This collaboration is structured through a profit-sharing model, eliminating the need for upfront or milestone payments from either party.
Manufacturing and Regulatory Framework
Under the terms of the agreement, SII will assume responsibility for obtaining and maintaining regulatory approvals within India. Both companies will independently manage the costs associated with the technology transfer process. Additionally, SII will serve as a contract manufacturer for Bavarian Nordic once necessary regulatory approvals are secured.
Paul Chaplin, President and CEO of Bavarian Nordic, emphasized the significance of the agreement: "We are pleased to enter this licence and manufacturing agreement for MVA-BN as an mpox vaccine, which represents significant progress in our endeavors to expand access to the vaccine for all populations."
Global Access Initiative
The partnership comes at a crucial time, following the European Medicines Agency's recent approval of the vaccine for adolescent use in September 2024. This regulatory milestone potentially extends the vaccine's reach to younger populations, particularly in Africa, where Bavarian Nordic is actively seeking partnerships with local manufacturers.
SII CEO Adar Poonawalla highlighted the company's commitment to addressing global health challenges: "Our mission has always been to deliver high-quality, affordable vaccines worldwide. The recent mpox outbreak underscores the critical need for a swift and coordinated response."
Strategic Impact on Epidemic Preparedness
This collaboration strengthens global preparedness for mpox outbreaks by establishing additional manufacturing capacity and ensuring broader vaccine distribution channels. The partnership leverages SII's substantial manufacturing capabilities and rapid response infrastructure to enhance vaccine accessibility for vulnerable populations worldwide.
The agreement represents a significant advancement in Bavarian Nordic's ongoing efforts to establish global partnerships, with a particular focus on expanding vaccine access in regions with the greatest need. The company continues to explore additional opportunities for local manufacturing collaborations to further support worldwide vaccine supply.
