Valneva SE, a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs, and Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine that enables supply of the vaccine in Asia.
The collaboration will support broader access to the vaccine in low- and-middle-income countries in the region falls within the framework of the $41.3 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union.
The companies will work urgently to bring the vaccine to the Indian market, and certain other Asian countries, subject to local regulatory approvals, as India is currently enduring one of its worst chikungunya outbreaks. Nearly 370,000 cases were confirmed in India between January 2019 and July 2024, a number rapidly increasing due to the current outbreak.
Under the agreement, 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 countries in Asia. Future commercialization will be based on a profit-sharing model along with single-digit million milestone payments towards technology transfer and regulatory approvals to Valneva.
Thomas Lingelbach, CEO of Valneva, commented, “The current outbreak in India underscores the fact that containing chikungunya is an international public health priority. SII has extensive manufacturing and commercialization infrastructure and broad market reach in the Asian territory. We are very pleased to enter into this collaboration to help address this urgent medical need by accelerating further access to our highly differentiated vaccine.”
Adar Poonawalla, CEO of Serum Institute of India, said, “We are pleased to collaborate with Valneva to bring this chikungunya vaccine to India and other parts of Asia. This collaboration reflects our focus on providing effective and accessible vaccines to address pressing public health needs.”
SII, Valneva and CEPI are committed to enabling equitable access to chikungunya vaccine doses manufactured and licensed by SII for the region.
Under the terms of the agreement, SII has committed to priority supply of the chikungunya vaccine at an affordable price to public health markets in low- and-middle-income countries.
SII will also make available a stockpile of 100,000 doses of the drug product to CEPI as an ‘investigational ready reserve’ that could be used in clinical trials in the region. Such research could provide additional data on the performance of the vaccine among local populations.
A safety stock of up to 100,000 doses of the chikungunya vaccine will also be made available and directly accessible to CEPI, at costs incurred by CEPI, for potential use when responding to a future chikungunya outbreak in the region.
Dr Richard Hatchett, CEO of CEPI, said: “Chikungunya continues to pose a troubling and debilitating danger to the world, including in Asia, with climate change threatening to worsen its spread. Today’s new collaboration is a historic achievement which provides a crucial launchpad for the manufacture of a chikungunya vaccine in Asia, for Asia, while also enhancing regional health security and guaranteeing the priority supply of affordable doses to local populations most in need.”
Valneva’s chikungunya vaccine is the world’s first and only licensed chikungunya vaccine, currently approved in the US, Europe, and Canada for the prevention of disease caused by the chikungunya virus in individuals 18 years of age and older. Regulatory reviews to expand the age range to individuals 12 years of age and older are currently ongoing.
Supported by CEPI and the European Union’s Horizon program, Valneva remains focused on expanding the vaccine’s access in low-and-middle-income countries. Under an earlier funding agreement with CEPI, Valneva partnered with Brazil’s Instituto Butantan to expand access to the vaccine in the Americas. Review of the marketing authorization application by the Brazilian Health Regulatory Agency is ongoing.
Chikungunya virus is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.
In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, Chikungunya virus has now been identified in over 110 countries in Asia, Africa, Europe and the Americas. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization has highlighted chikungunya as a major public health issues.