Introduction
In a major step toward global health equity, Bavarian Nordic has announced a strategic license and manufacturing agreement with the Serum Institute of India (SII) for its MVA-BN® mpox vaccine. This partnership promises to bolster global vaccine production and ensure equitable access to vulnerable populations worldwide, particularly during outbreaks.
Drug and Technology Details
MVA-BN® is a non-replicating modified vaccinia Ankara-based vaccine developed by Bavarian Nordic. It is designed to protect against mpox and smallpox, offering a robust option for epidemic preparedness. The agreement involves transferring the manufacturing technology for MVA-BN® to SII, allowing them to produce the vaccine locally.
Manufacturing and Distribution Agreement
SII has obtained the license to manufacture, sell, and distribute MVA-BN® in India. The collaboration adopts a profit-sharing model without upfront or milestone payments. Beyond the Indian market, SII will contract-manufacture the vaccine for Bavarian Nordic, significantly expanding the global manufacturing capacity to address potential surges in demand.
Under the agreement, Serum Institute of India will seek and maintain regulatory approval for MVA-BN® in India. This marks a critical step toward ensuring local availability of the vaccine while also aligning with Bavarian Nordic’s broader efforts to secure equitable access globally.
Indication and Disease Context
Mpox, a zoonotic disease similar to smallpox, has seen recent outbreaks that highlight the need for coordinated global responses. Vulnerable populations, particularly in low-resource settings, are disproportionately affected, underscoring the importance of scalable vaccine access.
Other Relevant Information
This partnership reflects Bavarian Nordic’s broader mission to address vaccine equity through local partnerships. The company is actively exploring additional collaborations, particularly with African manufacturers, to enhance local production and distribution. Serum Institute’s world-class manufacturing capabilities and its extensive global reach across 170+ countries provide a solid foundation for the initiative’s success.
Conclusion
The agreement between Bavarian Nordic and SII exemplifies a collaborative approach to addressing global health challenges. By combining Bavarian Nordic’s innovative vaccine expertise with SII’s manufacturing strength, this partnership aims to mitigate the global burden of mpox, protect vulnerable populations, and enhance epidemic preparedness.
