SII to manufacture Bavarian Nordic Mpox Vaccine
SII will be responsible for seeking and maintaining regulatory approval of the vaccine in India.
Denmark: Bavarian Nordic A/S has announced a license and manufacturing agreement for its MVA-BN mpox vaccine with Serum Institute of India Pvt. Ltd (SII).
Under the agreement, the companies will undertake a technology transfer of the current manufacturing process for MVA-BN to SII to enable supply for the Indian market, for which SII obtains the license to sell and distribute the vaccine. Furthermore, upon the relevant regulatory approvals, the agreement enables SII to perform contract manufacturing of MVA-BN for Bavarian Nordic which expands the manufacturing capacity, ensuring global access even during outbreaks of mpox.
The license agreement is based on a profit-sharing model with no associated upfront or milestone payments. SII will be responsible for seeking and maintaining regulatory approval of the vaccine in India. The parties will cover their own costs associated with the technology transfer.
Bavarian Nordic continues to explore additional opportunities to establish partnerships to ensure the equitable access to MVA-BN, including with local African manufacturers, the Company stated.
Adar Poonawalla, CEO, Serum Institute of India, said, “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. Partnering with Bavarian Nordic on the MVA-BN mpox vaccine reflects our shared commitment to protect millions at risk. Leveraging our manufacturing strength and rapid response capabilities, we aim to enhance epidemic preparedness and expand access to life-saving vaccines, safeguarding vulnerable populations and easing the global burden of mpox."
Paul Chaplin, President & CEO of Bavarian Nordic, said, “We are pleased to enter this license 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. While there are currently no capacity constraints, scaling of global manufacturing is an important step to ensure the continued equitable access to the vaccine for all countries, and we are pleased to establish this collaboration with SII, the world’s largest vaccine manufacturer by volume. We continue to work with partners globally to explore additional opportunities for local manufacturing to further support vaccine supply.”
