The Serum Institute of India (SII) has produced and stockpiled 620,000 doses of the ChAdOx1 Bundibugyo ebolavirus (BDBV) vaccine candidate within two weeks for potential future use. It has also supplied 4,000 investigational doses for a Phase I trial.
The University of Oxford’s Oxford Vaccine Group has initiated the world’s first Phase I clinical trial, known as BD-Ebov, for a vaccine against the Bundibugyo ebolavirus in response to the ongoing outbreak in the Democratic Republic of the Congo and Uganda.
Adar Poonawalla, CEO of SII, said that the organisation is supporting this critical Phase I trial by providing investigational doses of the ChAdOx1 BDBV vaccine candidate for clinical evaluation. “During outbreaks, speed, preparedness, and global collaboration are essential for advancing vaccine candidates quickly and responsibly,” he said.
“If Phase 1 trials are successful, CEPI (Coalition for Epidemic Preparedness Innovations) is expected to collaborate with the University of Oxford and SII to support late-stage trials, generating data for emergency use authorisation or licensure.
CEPI, SII, and the University of Oxford are committed to ensuring the rapid and affordable supply of Bundibugyo virus vaccines to affected countries and their at-risk populations,” Poonawalla said.
To facilitate the swift launch of the study and the progression of the vaccine candidate, SII has manufactured and stockpiled the doses. This effort is supported by funding from CEPI to the University of Oxford and SII, as part of an $8.6 million program for the development of Bundibugyo vaccines.
The program builds on CEPI’s strategic partnership with the University of Oxford and SII’s participation in CEPI’s Vaccine Manufacturing Facility Network. The trial, which is being conducted in Oxford, will evaluate the safety and immune response of the ChAdOx1 BDBV vaccine in 50 healthy adults aged 18 to 55 years.
Recruitment of volunteers for the study is currently underway. The ChAdOx1 BDBV vaccine was developed by scientists at the University of Oxford’s Oxford Vaccine Group and the Pandemic Sciences Institute. It utilises the same viral vector platform as the Oxford/AstraZeneca COVID-19 vaccine.
This milestone was achieved in 57 days after the World Health Organisation declared the outbreak a public health emergency of international concern.
