Pune-based Serum Institute of India (SII) will be manufacturing Danish vaccine company Bavarian Nordic’s vaccine against mpox— MVA-BN— locally for the Indian market, according to latter’s statement issued on Monday on the license and manufacturing agreement signed between the two companies.
“… 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,” said the Bavarian Nordic statement.
“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.”
Mpox is a viral disease caused by the monkeypox virus. The infection can spread between people, mainly through close contact, and occasionally from the environment to people via things and surfaces that have been touched by a person with mpox. It can also be transmitted from infected animals to people who have contact with them.
The Bavarian Nordic-SII license agreement is based on a profit-sharing model with no associated upfront or milestone payments, said the Danish vaccine maker. 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.
{{/usCountry}}The Bavarian Nordic-SII license agreement is based on a profit-sharing model with no associated upfront or milestone payments, said the Danish vaccine maker. 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.
{{/usCountry}}“Bavarian Nordic continues to explore additional opportunities to establish partnerships to ensure the equitable access to MVA-BN, including with local African manufacturers,” read the statement.
On August 14, WHO declared mpox a Public Health Emergency of International Concern (PHEIC) for the second time in two years. India reported the first case of mpox disease caused by the “clade 1b” strain that prompted WHO to declare the infection a global health emergency in September this year, which was the second case of the viral disease so far this year. The first case reported earlier in the country was detected with the strain that was prevalent during the 2023 global outbreak.
Adar Poonawalla, CEO, Serum Institute of India, said, in a statement, “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 and CEO, 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.”