European and African drug regulators are collaborating for the first time under a new partnership to respond to the ongoing Ebola outbreak in the Democratic Republic of the Congo and Uganda, caused by the Bundibugyo virus.

EMA’s Emergency Task Force is working with the African Medicines Agency and its national regulatory authorities, as well as the WHO-AFRO African Vaccines Regulatory Forum, to accelerate clinical trials and medical countermeasures. The World Health Organization declared the outbreak a Public Health Emergency of International Concern on May 17.

Unlike the more common Zaire Ebola virus, there are no authorized vaccines or treatments for Bundibugyo virus disease. Existing countermeasures for Zaire Ebola are unlikely to work, meaning researchers need to develop custom solutions quickly.

EMA identified several promising candidates. Three vaccine candidates have been selected: a recombinant vesicular stomatitis virus (rVSV)-based Bundibugyo vaccine, a ChAdOx1 adenovirus-based vaccine, and an mRNA vaccine. Potential treatments include the monoclonal antibody cocktail MBP-134, the antiviral remdesivir, and the monoclonal antibody maftivimab. The antiviral obeldesivir is being considered for post-exposure prophylaxis.

The task force has initiated discussions with developers, academia, and funders to advance these candidates, focusing on clinical trial design from early to pivotal stages across all ages. The collaboration is the first public health emergency since the AMA became operational, and regulators say prompt, flexible decisions anchored in solid science are key to an effective response.

Source: EMA News