The European Medicines Agency’s (EMA’s) emergency task force (ETF) is engaging with the African Medicines Agency (AMA) to plan clinical trials amid the ongoing Ebola outbreak.
The ETF has been exploring potential vaccine and treatment candidates for the virus, with several having been identified.
The possible vaccine candidates identified include: a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine, a Bundibugyo virus vaccine using the ChAdOx1 modified adenovirus platform, and an mRNA vaccine.
The ETF has also found three potential treatment candidates: Mapp Biopharmaceutical’s MBP-134, a combination of two monoclonal antibodies (mAbs) active against different ebola viruses, including Bundibugyo virus, Gilead’s antiviral Veklury (remdesivir), and Regeneron’s mAb Inmazeb (maftivimab).
Finally, it has identified a potential medicine for post-exposure prophylaxis, Gilead’s antiviral obeldesivir.
Based on these discoveries, the EMA and AMA, leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum (AVAREF), are now working on development and clinical trial design for these candidates, from early clinical trials to pivotal clinical trials.
Clinical trial design discussions are expected to cover the different uses of medicinal products and vaccines, from prophylaxis, including post-exposure prophylaxis, to treatment of Bundibugyo virus disease across all ages.
On 17 May, the World Health Organization (WHO) declared the Ebola virus disease outbreak, caused by Bundibugyo virus, in the Democratic Republic of the Congo and Uganda a Public Health Emergency of International Concern.
This is the first public health emergency where the EMA has collaborated with the AMA since its establishment in 2021.
Unlike for the more commonly detected Zaire ebolavirus, there are currently no authorised vaccines or treatments for Bundibugyo ebolavirus. The primary vaccine for Zaire is MSD’s Ervebo, while Johnson and Johnson (J&J) has also developed a two-dose regimen under the brand names Zabdeno and Mvabea.
Existing medical countermeasures targeting Zaire ebolavirus are unlikely to be effective, and therefore customisation is required.
Other antivirals and investigational pan-filovirus mAbs are in development and may have some efficacy against Bundibugyo.
