The Coalition for Epidemic Preparedness Innovations (CEPI) has partnered with Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to develop a Chikungunya vaccine, providing as much as $14.1 million for manufacturing and clinical development.
On the line is a two-dose, live-inactivated vaccine for use against Chikungunya. Chikungunya is a mosquito-spread disease that causes fever, muscle pain, headaches, nausea, fatigue, rash, and joint pain that can last for years. CEPI is concerned that climate change could help spread the threat of Chikungunya, which originally came from Africa and Asia.
“Chikungunya continues to be a threat to public health in countries around the globe,” Dr. Richard Hatchett, CEO of CEPI, said. “It is a painful and debilitating disease for which there is no licensed vaccine or treatment. Through this partnership with Bharat Biotech and IVI, we will accelerate the clinical development of the Chikungunya vaccine candidate, with the aim of producing a vaccine and making it accessible to those most affected by the disease.”
The consortium formed by BBIL and IVI will also partner with Ind-CEPI, which will offer them a grant of up to $2 million. CEPI’s own award is further supported by the European Union’s Horizon 2020 program, which has an existing agreement with CEPI. In the case of Ind-CEPI, though, funds will go toward founding GMP manufacturing facilities for the vaccine in India, as well as the manufacture of clinical trial materials.
The partnership will finance a multi-center, phase 2/3 adaptive clinical trial set in Colombia, Panama, and Thailand in the search for safety and immunogenicity data. IVI will run that trial. The vaccine has already completed pre-clinical studies and yielded positive results in phase 1 clinical trials set in India.
“Vaccination is the most sustainable and cost-effective way of protecting millions of people from Chikungunya, a painful disease with no known cure or licensed vaccine,” Dr. Jerome Kim, Director General of IVI, said. “In line with IVI’s mission to develop vaccines against diseases that primarily impact low- and middle-income countries, our partnership with Bharat Biotech and CEPI seeks to develop and produce a safe, effective, and affordable vaccine that protects people from the debilitating effects of Chikungunya and enables them to live productive lives.”
The partnership also builds on BBIL’s experience in developing and supplying affordable vaccines and navigating the World Health Organization (WHO)’s prequalification procedures. Using this background, they hope to guarantee affordable access to any vaccine created across any countries where Chikungunya is endemic.
“We are hopeful that with accelerated clinical development in endemic countries, the candidate CHIK vaccine will be successful,” Dr. Krishna Ella, chairman and managing director of Bharat Biotech, said. “We are witnessing that today’s neglected diseases are susceptible to become tomorrow’s pandemics, and with this collaboration, we have the opportunity to tackle them proactively.”