European CHMP recommends approval of 2-part vaccine containing Zabdeno and Mvabea for prophylaxis against Zaire ebolavirus disease

Approval is based on clinical trial data from 3,367 subjects which demonstrated that the vaccine regimen is safe and could induce an immune response against Ebola virus. Efficacy data in humans has been extrapolated from animal studies and are under regulatory review.

SPS commentary:

Currently, there are no therapies approved for Ebola. The CHMP has recommended approval of each component of the Ebola vaccine, both which were reviewed under EMA’s accelerated assessment programme.


European Medicines Agency

Resource links:

CHMP approval of Zabedeno

CHMP approval of Mvabea