Bibliographic information
Guideline—
Year of Publication—
Issuing Institution—
Recommendation
New
WHO recommends that Ervebo® should not be used outside of controlled research settings in response to the current Bundibugyo virus ( BDBV ) outbreak.
Recommendation in research context
Only in research contexts
Certainty of evidence
Very low
Notes and Remarks
- Available evidence regarding potential cross-protection conferred by Ervebo® against BDBV is currently very limited. No human vaccine efficacy data are available, and findings from the limited number of preclinical studies conducted to date are inconclusive. Overall, the available evidence is insufficient to determine or reliably estimate the extent of any cross-protection against BDBV.
- Consequently, WHO recommends that Ervebo® should not be used outside of controlled research settings in response to the current BDBV outbreak.
- Programmatic use of Ervebo® may fail to convey protection against BDBV and could generate a false sense of security among affected communities and responders, potentially undermining trust and adherence to proven public health measures and damaging confidence in Ebola vaccination if breakthrough infections occur.
- WHO recognizes that there are a number of candidate BDBV vaccines and candidate products for post-exposure prophylaxis in the pipeline. WHO recommends accelerated investment in the 2 research, development and evaluation of both preventive and post-exposure vaccination. Related to vaccine research in the context of the current PHEIC, WHO will prioritize BDBV-specific and broadly protective pan-Orthoebolavirus vaccines. • Any consideration of Ervebo® use in research protocols lies within the remit of national health authorities should also take into account community trust. The operational and ethical complexities of conducting trials during BVD outbreaks, including the feasibility of evaluating Ervebo® alongside post-exposure prophylactic drugs or other investigational interventions should further be considered. Given the limited capacity to evaluate multiple vaccine candidates simultaneously in randomized controlled study during BDBV outbreaks, prioritization of pipeline vaccine candidates and/or therapeutics for advancement into clinical trials will be conducted by the WHO R&D Blueprint for Epidemics based on expert advice and consultation. As a general principle, all research, even in an outbreak or emergency setting, must be assessed against the highest ethical standards.
- Outbreak response and public health measures remain the most important activities currently underway, and should continue to be emphasized and enhanced. Proven public health measures include enhanced surveillance and contact tracing, timely diagnosis, isolation and clinical management of patients, infection prevention and control, and safe and dignified burials, all supported by strong risk and science communication and community engagement.
- Evidence-informed risk communication, dialogue and community engagement, remain paramount. Strategies and messages should be delivered through trusted local leaders and influencers, in local languages and culturally adapted formats, and tailored to reach underserved populations who face both heightened exposure and structural barriers.