Illustration of a blue, filament-shaped Ebola virus particle twisting against a blurred microscopic background

EMA, AMA and African regulatory authorities join forces on Ebola outbreak response

Experts discuss clinical trials, treatments and vaccines
NewsHumanMedicines

EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum (AVAREF), to discuss possible clinical trial designs and medical countermeasures to be investigated in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC) and Uganda, caused by the Bundibugyo virus.

This is the first public health emergency where EMA collaborates with the AMA since it has come into operation, alongside participating African NRAs. This engagement, grounded in the ongoing scientific collaboration between EMA and AMA, is intended to support efficient, coordinated and timely regulatory responses to the outbreak. It also builds on the extensive experience gained through African regulatory collaboration during previous Ebola outbreaks, including joint reviews conducted via AVAREF, as well as the ongoing operationalisation of the AMA.

On 17 May, the World Health Organization (WHO) declared the Ebola virus disease outbreak caused by Bundibugyo virus in the DRC and Uganda a Public Health Emergency of International Concern.

Unlike for the more commonly detected Zaire Ebola virus, there are currently no authorised vaccines or treatments for Bundibugyo virus disease. Existing medical countermeasures targeting the Zaire Ebola virus are unlikely to be effective and therefore customisation is required. Some antivirals and investigational pan-filovirus monoclonal antibodies in development may have some efficacy against Bundibugyo and therefore need to be swiftly advanced into well-designed randomised clinical trials. Vaccine candidates should also be rapidly developed and could then be progressed into late-stage clinical trials by establishing regulatory criteria that would ensure both scientific rigour and speed.

EMA, through the ETF, supports the development and regulatory evaluation of vaccines and therapeutics in preparedness and in a public health emergency. The ETF has been exploring potential candidates as part of its horizon scanning. Through close contact with developers of investigational vaccines and treatments and the WHO, the following promising candidates for clinical trials have been identified for Bundibugyo virus:

  • Three possible vaccine candidates: a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine, a Bundibugyo virus vaccine using the ChAdOx1 modified adenovirus platform and an mRNA vaccine.
  • Three potential treatment candidates: MBP-134, a combination of two monoclonal antibodies active against different ebolaviruses including Bundibugyo virus, the antiviral remdesivir and the monoclonal antibody maftivimab.
  • One potential medicine for post-exposure prophylaxis, the antiviral obeldesivir.

The ETF, jointly with AMA and its African NRAs and experts, has already started selected discussions with developers, academia and funders to advance these medical countermeasures.

In the context of these meetings, discussions focus on critical aspects of development and clinical trial design, from early clinical trials to pivotal clinical trials, to demonstrate the safety and efficacy of candidate treatments and vaccines that can ultimately lead to approval and recommendation for use. Clinical trial design discussions are expected to cover the different use of medicinal products and vaccines, from prophylaxis, including post-exposure prophylaxis, to treatment of Bundibugyo virus disease across all ages. Prompt and flexible regulatory decisions that are anchored on solid scientific evidence are key to ensure an effective public health response in the context of this emergency.

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