Serum Institute of India will manufacture a chikungunya vaccine for the Indian market and a few other Asian countries under a licensing agreement between the Pune-based company and France-based Valneva SE, a joint statement from the two companies said on Thursday.
The collaboration to support broader access to the vaccine in low-and-middle-income countries (LMICs) 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 joint statement said.
“Valneva SE (“Valneva” or “the Company”), a specialty vaccine company, 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,” it said.
The development holds promise for India as the disease is endemic across the country with the government recording 11,477 cases last year, and 12,587 this year so far.
Chikungunya virus (CHIKV) is spread by the bites of infected Aedes mosquitoes that causes fever, severe joint and muscle pain, headache, nausea, fatigue and rashes. Joint pain is often debilitating and can persist for weeks to years.
{{/usCountry}}Chikungunya virus (CHIKV) is spread by the bites of infected Aedes mosquitoes that causes fever, severe joint and muscle pain, headache, nausea, fatigue and rashes. Joint pain is often debilitating and can persist for weeks to years.
{{/usCountry}}In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas.
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, said the statement.
The companies said they will work urgently to bring the vaccine to the Indian market, and certain other Asian countries, subject to local regulatory approvals.
“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 CEO Adar Poonawalla said in a statement.
Under the agreement, both 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,” read the joint statement.
Thomas Lingelbach, CEO of Valneva, said, “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.”
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, the statement said. Such research could provide additional data on the performance of the vaccine among local populations.
A separate 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.
“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,” said Richard Hatchett, CEO, CEPI.