Research Roundup: Research initiative to boost African vaccine access, Pfizer/BioNTech sign vaccine manufacturing agreement, and FDA approves all-oral sleeping sickness treatment
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The International Vaccine Institute (IVI) and Coalition for Epidemic Preparedness Innovations (CEPI) have announced a new clinical research program that will aim to improve and expand access to COVID-19 vaccines in Africa. CEPI will provide approximately $12.7 million to the Expanding Access and Delivery of COVID-19 Vaccines in Africa (ECOVA) initiative, which will be led by IVI, to conduct clinical trials of Sinopharm’s BBIBP-CorV vaccine. The BBIBP-CorV vaccine is already being deployed in more than 50 countries, and the COVAX vaccine-sharing facility is set to distribute around 170 million doses based on a deal announced July 12. However, there have been no clinical trials assessing BBIBP-CorV in African populations or against the variants of concern circulating in southern Africa. The ECOVA research initiative will aim to collect data that informs the utilization of the shot in Africa, as well as potentially expand its use to people with HIV/AIDS.
On Wednesday, Pfizer and BioNTech announced a new partnership with Biovac to produce more than 100 million doses annually of their mRNA-based COVID-19 vaccine for distribution within the African Union. Cape Town-based pharmaceutical company Biovac will manufacture the vaccine at the “fill-and-finish” stage using active ingredients produced by facilities in Europe. Technical transfer, on-site development, and equipment installation will begin immediately, according to the announcement, but manufacturing of finished doses will not begin until early 2022—meaning the deal will not have impact in the near term on vaccine supply shortages in the region. At full operational capacity, the facility will exceed 100 million doses produced per year, all of which will be distributed within the 55 member states of the African Union.
The US Food and Drug Administration (FDA) last week approved fexinidazole as the first all-oral treatment for both stages of sleeping sickness, also known as human African trypanosomiasis. About 65 million people in sub-Saharan Africa are at risk of sleeping sickness, which is transmitted by the bite of an infected tsetse fly and is almost always fatal if left untreated. Fexinidazole—developed by a partnership between the Drugs for Neglected Diseases initiative (DNDi), Sanofi, and national sleeping sickness programs of the Democratic Republic of Congo and Central African Republic—is the first all-oral treatment that works for both the first stage of the disease and the second stage of the disease in which the parasites cross the blood-brain barrier. The ten-day, once-a-day treatment method will expand options beyond those requiring hospitalization for infusion or injection. As a result of the approval, a priority review voucher (PRV) was also awarded to DNDi under the FDA’s Tropical Disease PRV program.