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 clinical trial designs and medical countermeasures for 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 came into operation. The engagement is intended to support efficient, coordinated and timely regulatory responses to the outbreak, building on experience from previous Ebola outbreaks and joint reviews conducted via AVAREF. On 17 May, the World Health Organization declared the outbreak a Public Health Emergency of International Concern.

The Challenge

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 Zaire Ebola virus are unlikely to be effective, meaning customisation is required. Some antivirals and investigational pan-filovirus monoclonal antibodies in development may have efficacy against Bundibugyo and need to be swiftly advanced into well-designed randomised clinical trials.

Candidates Identified

EMA, through the ETF, has identified the following promising candidates for clinical trials:

Three vaccine candidates have been identified: 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 are MBP-134 (a combination of two monoclonal antibodies active against different ebolaviruses), the antiviral remdesivir, and the monoclonal antibody maftivimab. One candidate for post-exposure prophylaxis is the antiviral obeldesivir.

Regulatory Collaboration

The ETF, jointly with AMA and its African NRAs, has initiated discussions with developers, academia and funders to advance these candidates. Discussions focus on clinical trial design from early to pivotal stages to demonstrate safety and efficacy, covering prophylaxis, post-exposure prophylaxis and treatment across all ages. Prompt and flexible regulatory decisions anchored on solid scientific evidence are key to an effective public health response.

Source: EMA News