CEPI, the University of Oxford and Serum Institute of India Pvt Ltd. (SII), part of the Cyrus Poonawalla Group, have announced a collaboration to create an investigational ready reserve of a Nipah virus vaccine candidate.
CEPI funding of up to US$7.3 million will support SII in process development and manufacturing of the University of Oxford’s ChAdOx1 NipahB vaccine candidate. SII will manufacture doses for a Phase II clinical trial in a Nipah-affected country and create a reserve of up to 100,000 doses which could be deployed under emergency use during a future Nipah virus outbreak. SII will supply clinical trial material to the University of Oxford, which is conducting the CEPI-funded clinical trials. These mid-stage trials are planned to be the first Phase II trials for a Nipah virus vaccine candidate globally.
Nipah virus belongs to the paramyxovirus family and has a reported fatality rate of up to 75 percent. Outbreaks have primarily occurred in India and Bangladesh since its identification in Malaysia in 1999. There are currently no approved countermeasures. CEPI has committed around US$150 million to Nipah virus vaccine, biologics and enabling science programmes.
“By advancing clinical testing and manufacturing thousands of vaccine doses against one of the world’s deadliest viral pathogens, in a region where the virus persistently occurs, we’re creating a state of readiness against Nipah outbreaks,” said Dr Amadou Sall, CEPI’s Executive Director of Manufacturing and Supply Chain.
The ChAdOx1 NipahB vaccine uses the same viral vector platform as the Oxford-AstraZeneca COVID-19 vaccine. SII produced over 2 billion doses of the ChAdOx COVID-19 vaccine and will store the investigational reserve at its facilities in Pune.
Dr Umesh Shaligram, Executive Director, Serum Institute of India, said, “The collaboration with CEPI and the University of Oxford to develop and manufacture an investigational reserve of the ChAdOx-Nipah vaccine candidate marks a significant step forward in our pandemic preparedness efforts. Leveraging our proven manufacturing capabilities and past success with the ChAdOx platform, we are proud to help establish the world’s largest investigational reserve against Nipah virus—one of the deadliest pathogens known. Our aim is to ensure that life-saving doses reach those most in need, particularly across the Global South.”
Professor Brian Angus, University of Oxford and Chief Investigator of the trial at the Oxford Vaccine Group, said, “Developing a Nipah vaccine that can be tested and used in regions where Nipah outbreaks occur regularly is a vital step toward ensuring communities most at risk are protected.”
Because Nipah outbreaks are typically small and unpredictable, traditional large-scale efficacy trials are unlikely to be feasible. Phase II data combined with outbreak-associated safety and immunogenicity data may help support regulatory pathways in affected regions.
The collaboration aligns with CEPI’s 100 Days Mission to accelerate vaccine development and is linked to CEPI’s manufacturing facility network and strategic partnership with the University of Oxford. CEPI, SII and the University of Oxford have committed to equitable access in line with CEPI’s Equitable Access Policy, including availability of vaccines to populations at risk in the Global South.