Bharat Biotech on June 3 said it has secured $14.1 million funding from the Coalition for Epidemic Preparedness Innovations (CEPI) to advance the development of a Chikungunya vaccine.
The vaccine maker in consortium with the International Vaccine Institute (IVI) is developing vaccine against Chikungunya.
There is no vaccine to prevent or medicine to treat chikungunya virus infection.
CEPI will fund the consortium with up to $14.1 million for vaccine manufacturing and clinical development of a two-dose live-inactivated vaccine (BBV87) against Chikungunya. This grant is supported by the European Union’s (EU’s) Horizon 2020 programme through an existing framework partnership agreement with CEPI.
The consortium will be further supported with a grant of up to $2 million from the Indian government’s Ind-CEPI initiative which will fund the set-up of GMP manufacturing facilities for the vaccine in India, and the subsequent manufacture of clinical trial materials.
In addition to manufacturing, the partnering agreement will finance a multi-centre Phase 2/3 adaptive clinical trial to be conducted by IVI in Colombia, Panama and Thailand which will provide crucial data about the safety and immunogenicity of the vaccine candidate.
"The partnership will build on Bharat Biotech's experience of developing and supplying affordable vaccines, and WHO prequalification procedures, to ensure affordable access to the vaccine in countries where Chikungunya is endemic, in line with CEPI’s core commitment to equitable access," it said in a release
The investment is part of CEPI’s third call for proposals which was launched in January 2019. Since the launch of this call, over $80 million of CEPI core funding has been committed to three Chikungunya vaccine candidates and two Rift Valley Fever vaccine candidates.
CEPI was founded in Davos by the governments of Norway and India, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the World Economic Forum. CEPI has secured $750 million toward its $1billion funding target, with multi-year funding from Norway, Germany, Japan, Canada, Australia, the Bill & Melinda Gates Foundation, and Wellcome Trust. The agency priority diseases include Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus.
Bharat Biotech vaccine candidate called as BBV87 vaccine is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype.
The vaccine has completed standard pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India.
Inactivated virions technology has a safety profile which potentially makes this vaccine accessible to special populations, such as immunocompromised and pregnant women, that some other technologies cannot reach.
“Chikungunya continues to be a threat to public health in countries around the globe. It is a painful and debilitating disease for which there is no licensed vaccine or treatment," said Dr Richard Hatchett, CEO of CEPI.
"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,” Hatchett said.
Krishna Ella, Chairman and Managing Director of Bharat Biotech said with accelerated clinical development in endemic countries, the Chikungunya vaccine candidate will be successful.
“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,” Ella added.
"Through these late-phase clinical trials under GCCDP, we’re looking forward to generating additional safety and immunogenicity data from three endemic countries to support use of this vaccine in outbreaks and routine immunization in endemic countries,” said Dr Sushant Sahastrabuddhe, Principal Investigator and Director of the Global Chikungunya vaccine Clinical Development (GCCDP) consortium.
Chikungunya is an RNA virus. It was first identified in Tanzania in 1952, with sporadic outbreaks of the disease reported subsequently across Africa and Asia. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world.
Since the re-emergence of the virus, the total number of cases has been estimated at over 3.4 million in 43 countries.
Chikungunya is spread by the bites of infected female Aedes mosquitoes and causes fever, severe joint pain, muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years.
Climate change could further amplify the threat posed by Chikungunya. As the climate warms, more areas across the world will become habitable for the mosquito vectors that transmit the virus, thereby increasing the size of the human population at risk of infection.
In 2006, Chikungunya re-emerged in India after 32 years, causing the epidemic affecting more than 1.4 million people across the 13 States, and post epidemic, a declining trend was seen till 2011. From 2011 to 2015, the National Vector Borne Disease Control Programme (NVBDCP) reported an average of about 20,000 suspected CHIK cases across the country every year.
For example, in 2007, an outbreak of Chikungunya virus infections was declared for the first time in Europe with more than 200 human cases reported in Italy. Since 2014, in the USA, local-transmission of the virus has been reported in Florida, Puerto Rico, Texas and the US Virgin Islands.