Serum Institute of India (SII) has entered into an exclusive licence agreement with French speciality vaccine company Valneva SE to manufacture and sell Valneva’s chikungunya vaccine in India and the rest of Asia.
Valneva’s chikungunya vaccine is the world’s first and only licensed vaccine. It is currently approved in the US, Europe, and Canada for adults. Regulatory reviews are underway to expand it to children up to 12 years.
Chikungunya virus is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes. It causes fever, severe joint and muscle pain, headache, nausea, fatigue, and rash. The joint pain is often debilitating and can persist for weeks to years.
India is currently enduring one of its worst chikungunya outbreaks. Nearly 3,70,000 cases were confirmed in India between January 2019 and July 2024, and it was rapidly increasing due to the current outbreak. Both companies will work to bring the vaccine to the Indian market and some Asian countries, after approval from local regulators.
SII has committed to a priority supply of the chikungunya vaccine at an affordable price to public health markets in low- and middle-income countries (LMICs).
The companies will conduct a technology transfer of the current drug product manufacturing process. Valneva will supply its chikungunya vaccine drug substance to SII, which will complete manufacturing and be responsible for seeking and maintaining regulatory approval of the vaccine in India and other Asian countries. Future commercialisation will be based on a profit-sharing model along with single-digit million milestone payments towards technology transfer and regulatory approvals to Valneva.
Adar Poonawalla, CEO of SII, said the collaboration with Valneva to bring this chikungunya vaccine to India and other parts of Asia was part of their focus on providing effective and accessible vaccines to address pressing public health needs.
“The current outbreak in India underscores the fact, that containing chikungunya is an international public health priority. This collaboration to help address this urgent medical need by accelerating further access to our highly differentiated vaccine,” Thomas Lingelbach, CEO, Valneva, said.