Pune: The Serum Institute of India (SII) has dispatched 4,000 investigational doses of a newly manufactured Ebola vaccine targeting the Bundibugyo strain, thus paving the way for phase I human trials in London.The shipment left the Pune-based vaccine manufacturer’s Manjari facility on July 11.The trial, to be conducted by the University of Oxford, will involve 50 healthy volunteers in the age group of 18 to 55 years, who will be vaccinated and monitored for their immune response over 30 days. Subsequent phase II/III trials are planned in African countries.SII CEO Adar Poonawalla told TOI: “We received the master viral seed from the University of Oxford on June 6 and readied the new Ebola vaccine against the Bundibugyo strain in a record 14 days. We used the same vaccine platform employed for Covishield.”The company has kept 6.2 lakh doses in various stages of readiness. Of these, 1.1 lakh doses are in finished form, while the remaining doses require a final processing before being released as finished products.The UK’s Medicines and Healthcare products Regulatory Agency cleared the phase I trial within a week of being approached, SII officials said.The master viral seed developed by Oxford was used to inoculate the cell bank for manufacturing the vaccine.The vaccine uses the ChAdOx1 platform, based on a weakened version of an adenovirus that has been genetically modified so that it cannot replicate in humans. The same vector platform was used for the Oxford-AstraZeneca Covid-19 vaccine, manufactured in India by SII as Covishield. The latter was produced at SII’s Pune facility using technology transferred by the University of Oxford and AstraZeneca.SII has previously manufactured vaccine candidates against other high-risk viral diseases. In 2022, it supplied a bivalent Ebola vaccine candidate targeting the Zaire and Sudan strains within 62 days. It has also manufactured vaccine doses targeting the Marburg and Rift Valley fever viruses within 17 days, the company said.“Our expedited manufacturing capability demonstrates India’s ability to respond to emerging and re-emerging pathogens by rapidly producing vaccines,” Poonawalla said.The phase I study will primarily assess the vaccine’s safety and its ability to generate an immune response. Larger phase II/III studies will be required to further evaluate its performance in populations at risk of Ebola infection.The ongoing Ebola (Bundibugyo virus) outbreak in the Democratic Republic of the Congo (DRC) is spreading rapidly. According to the WHO and the Centers for Disease Control and Prevention, there have been over 1,792 confirmed cases and 625 deaths in the DRC.The new Ebola vaccine work is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI), to the University of Oxford and SII, as part of a US$8.6 million programme to advance the development of Bundibugyo vaccines. The programme builds on CEPI’s strategic partnership with the University of Oxford and SII’s participation in CEPI’s vaccine manufacturing facility network.
