By Tsim Mavisi
Uganda has received more than 1,000 doses of Ebola Sudan vaccine for trials to help control the outbreak of the virus in the country.
The vaccines were delivered to the World Health Organization (WHO) by the Sabin Vaccine Institute, its manufacturer. Another 8500 doses will be made available on a rolling basis through January.
This follows the organization’s announcement that Sabin’s Ebola Sudan vaccine would be one of the three vaccines included in planned ring vaccination trials in Uganda, following the recommendation of a WHO-convened independent expert committee.
Sabin’s ChAd3 (chimpanzee adenovirus) Ebola Sudan vaccine is a single-dose vaccine and has been found to be safe and elicit rapid, robust, and durable immunity based on data from Phase 1 clinical trials and non-human primate studies.
A single shot of the non-replicating Ebola Sudan vaccine has been tested among 56 people in Phase 1 clinical trials and was found to be safe and immunogenic.
In pre-clinical studies with more than 120 non-human primates, the vaccine was found to provide rapid protection that lasted for up to a year. The ChAd3 vaccine platform has been shown to be safe and well-tolerated in more than 5,000 people and has little to no pre-existing immunity.
Sabin also plans to supply a further 25,000 doses early next year. There is no approved vaccine for Ebola Sudan yet; the outbreak, which is now waning, began in Uganda in September and to date has killed at least 55 people.
The WHO and the Uganda Ministry of Health are co-sponsoring the Ebola Sudan vaccination trial in Uganda. WHO Africa says the trials will be randomized and evaluate potentially efficacious candidate vaccines that could end the outbreak and protect populations at risk in the future.
“We feel fortunate to be part of the global response to the Ebola Sudan outbreak in Uganda,” said Sabin Chief Executive Officer Amy Finan.
“Sabin’s Research and Development (R&D) mission centers on developing life-saving vaccines for diseases that impact people in low-and middle-income countries and as a result, have little commercial value. Sabin’s outbreak response has been a team effort — our Research and Development (R&D) team has been at the helm working tirelessly during the last many weeks with support from our partners.”
Sabin’s ChAd3 Ebola Sudan vaccine program, including the doses being provided to WHO, is funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services.
Since the outbreak began, Sabin has worked closely with BARDA, the Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), the Coalition for Epidemic Preparedness Innovations (CEPI), and the WHO.
Italy-based ReiThera is Sabin’s manufacturing partner for the ChAd3 Ebola Sudan vaccine. In addition to manufacturing the drug substance, ReiThera is filling and finishing the first 9,600 doses.
“Our capabilities, speed, and experience to produce high-quality bulk vaccine doses express ReiThera’s commitment to support Sabin and the global health community to respond to the unfolding Ebola outbreak,” said Stefano Colloca, Chief Technology Officer and ReiThera co-founder.
Sabin has been developing ChAd3 vaccines for Ebola Sudan and Marburg viruses for over three years after licensing the program from GSK in August 2019. Sabin received a multi-year contract from BARDA to continue the development of the vaccines.
