ReiThera is manufacturing the drug substance for Sabin Vaccine Institute’s ChAd3 Ebola Sudan vaccine and performing fill/finish for the first 9,600 doses.
Contract development manufacturing organization (CDMO) ReiThera will produce Sabin’s ChAd3 (chimpanzee adenovirus) Ebola Sudan single-dose vaccine at its Castel Romano Technopole plant, Italy, which it opened in November.
ReiThera claims Sabin is the first organization to provide the World Health Organization (WHO) its Ebola Sudan vaccine to support the Ebola Sudan outbreak in Uganda. Around 1,100 doses of Sabin’s vaccine are already in Uganda and a further 8,500 doses will be accessible to WHO throughout January.
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“A vaccine bulk was already produced for Sabin Vaccination Institute by using an innovative process. We then use our fill and finish suite capabilities with the already available vaccine bulk to produce the vaccination doses,” a spokesperson for ReiThera told Bioprocess Insider.
“The remaining vaccination doses will be delivered on a rolling basis through January. Sabin is planning to also supply a further 25,000 doses early next year.”
There is not an approved vaccine for Ebola Sudan at this time, however, Sabin’s Ebola Sudan Vaccine is one of three vaccines selected to take part in a planned ring vaccination trial in Uganda.
The Uganda Ministry of Health and the WHO are jointly funding the Ebola Sudan vaccination trial in the country. Additionally, WHO Africa has said the trial will be randomized and will establish potentially efficacious candidate vaccines that could stop the outbreak and protect populations now and in the future.
“We feel fortunate to be part of the global response to the Ebola Sudan outbreak in Uganda,” says Sabin CEO Amy Finan.
“Sabin’s 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 R&D team has been at the helm working tirelessly during the last many weeks with support from our partners.”
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