Health experts have advised that all candidate treatments and vaccines for Ebola disease caused by the Bundibugyo virus should be used exclusively within clinical trials to ensure safe, ethical, and effective research.
A statement made available on Thursday said that the experts were convened by the World Health Organisation (WHO).
According to it, the recommendation comes in response to the current outbreak in the Democratic Republic of the Congo, with additional cases reported in Uganda, and follows assessments by multiple WHO experts and advisory groups.
โWHO convened meetings with its Research and Development (R&D) Blueprint technical advisory groups on candidate vaccines and therapeutics for Bundibugyo Virus Disease (BVD) to evaluate options for both prevention and treatment.
โIn parallel, the Strategic Advisory Group of Experts on Immunisation and its Ebola vaccine working group reviewed the potential role of licensed Ebola vaccines during BVD outbreaks,โ it said.
The statement said that there are currently no licensed therapeutics or vaccines specifically approved for the prevention and treatment of BVD, though several candidate products were identified as promising enough to prioritise for clinical trial evaluation.
It noted that for treatment of confirmed BVD cases, independent experts recommended prioritising three candidates: the monoclonal antibodies MBP134 and Maftivimabยฎ, and the antiviral remdesivir.
โCombination therapy using a monoclonal antibody and remdesivir was also recommended for evaluation in research settings.
โFor prevention, the oral antiviral obeldesivir was identified as a priority candidate for post-exposure prophylaxis among contacts of confirmed and probable cases,โ it said.
According to it, experts noted that post-exposure prophylaxis with obeldesivir depends on effective contact tracing, which remains operationally challenging in some affected areas of the DRC.
It said the most promising vaccine candidate is the single-dose rVSV Bundibugyo vaccine being developed by the International AIDS Vaccine Initiative, though it is expected to require 7โ9 months before it is ready for clinical trial assessment.
It said that another candidate, ChAdOx1 Bundibugyo from Oxford University and the Serum Institute of India, could potentially be available within two to three months for efficacy testing, pending additional animal data.
โExperts suggested a single-dose approach for contacts of cases, while a two-dose strategy might be considered for high-risk but unexposed populations such as health-care workers and frontline responders.
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โThe groups also reviewed Ervebo, the only licensed Ebola vaccine, which is approved for outbreaks caused by the most common Ebola virus in Africa but is not licensed for BVD and lacks conclusive evidence of cross-protection,โ it said.
The statement said that the WHO recommended that Ervebo should not be used outside carefully designed research settings to allow its performance against BVD to be properly assessed.
โWHO, the governments of the DRC and Uganda, Africa CDC, ANRS Emerging Infectious Diseases, and other partners are now working to develop protocols for clinical field trials.
โWhile continuing to rely on established Ebola response measures like surveillance, contact tracing, isolation, testing, community engagement, and safe burials to stop transmission,โ it said. (NAN)
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