Serum Institute Partners with Bavarian Nordic to Manufacture Mpox Vaccine for India
The collaboration aims to enhance access to the Mpox vaccine in India, with a focus on epidemic preparedness and global supply during outbreaks.
Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, has entered into a licensing and manufacturing agreement with Danish pharmaceutical company Bavarian Nordic to produce the MVA-BN Mpox vaccine. Under this agreement, Bavarian Nordic will transfer the technology for the vaccine’s current manufacturing process to SII, enabling the company to supply the vaccine for the Indian market.
SII will handle the sale and distribution of the vaccine in India and will also be able to contract manufacture the MVA-BN vaccine for Bavarian Nordic, subject to the necessary regulatory approvals. This partnership is expected to significantly scale up vaccine manufacturing capacity, ensuring global access to the vaccine, particularly during Mpox outbreaks.
The license agreement is structured around a profit-sharing model, with no upfront or milestone payments. SII will be responsible for seeking and maintaining regulatory approval for the vaccine in India, while both companies will cover their respective technology transfer costs.
Adar Poonawalla, CEO of SII, emphasized the company’s mission to deliver affordable, high-quality vaccines worldwide. He noted that the recent Mpox outbreak highlighted the urgent need for a swift and coordinated response to epidemics. Poonawalla added that leveraging SII’s manufacturing capabilities would help enhance epidemic preparedness and increase access to life-saving vaccines.
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Paul Chaplin, CEO of Bavarian Nordic, stated that although there are no current capacity constraints, scaling up global manufacturing is crucial to ensuring equitable vaccine access for all nations. The company continues to explore additional opportunities for local manufacturing in various regions to further support vaccine supply.
The Mpox vaccine is being explored by other manufacturers, including KM Biologics of Japan. However, the focus remains on ensuring equitable access to the vaccine globally. In September 2024, UNICEF, along with the Africa CDC, Gavi, and the World Health Organization (WHO), issued an urgent request for Mpox vaccines to assist countries heavily impacted by the outbreak.
India reported a case of Mpox in September, confirming the infection as travel-related and not from the strain that had triggered a global health emergency. However, additional cases have since emerged, and the outbreak has continued to affect over 122 countries, with over 65,700 recorded cases and 1,200 deaths in 2024.