 "Serum Institute ties up with Bavarian Nordic to manufacture Mpox vaccine")
Danish vaccine firm Bavarian Nordic and Serum Institute of India (SII), the world’s largest vaccine maker by volume, have entered into a licence and manufacturing agreement to make the Denmark-based firm’s Mpox vaccine MVA-BN.
Bavarian Nordic will transfer technology of the current manufacturing process to SII to enable supply for the Indian market, the company said in a statement on Monday.
SII will sell and distribute the vaccine in India. Further, the agreement also enables SII to contract manufacture MVA-BN for Bavarian Nordic upon relevant regulatory approvals. This would significantly enhance manufacturing capacity ensuring global access even during Mpox outbreaks.
“The licence 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 said.
However, the Danish major continues to explore ‘additional opportunities’ to establish partnerships to ensure equitable access to MVA-BN, including with local African manufacturers, it said.
Adar Poonawalla, CEO, SII, 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.”
“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," Poonawalla said.
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Apart from Bavarian Nordic, KM Biologics of Japan also has an Mpox vaccine, but experts and not profits have raised concerns around equitable access of this vaccine globally.
Paul Chaplin, president and CEO of Bavarian Nordic, said, "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.”
In September, UNICEF, in collaboration with Africa CDC, Gavi, and the World Health Organization (WHO), had issued an urgent request to secure Mpox vaccines for countries severely affected by the outbreak. This emergency tender involved setting up agreements with vaccine manufacturers allowing UNICEF to purchase and deliver vaccines without delay once the funding, demand, and regulatory approvals are confirmed.
In September, India had confirmed that a patient, a young male, had tested positive for Mpox. The government had, however, clarified that it was a Clade II strain of the virus, and not the Clade 1 for which WHO had sounded a public health emergency. The case was verified as a travel-related infection. Later during the month, India also reported a case with Clade 1b strain.
The Mpox virus is classified into two main clades. The newly identified clade Ib, and clades IIa and IIb, were responsible for the 2022 global outbreak. The ongoing outbreak has been reported in 122 countries. So far this year, over 65,700 cases of Mpox have been recorded, including 1,200 deaths. Democratic Republic of Congo has been one of the worst affected countries.