The human medicines committee (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorisation for a new Ebola vaccine against Zaire ebolavirus species, in individuals over one year of age. The vaccine was evaluated under the EMA's accelerated assessment mechanism.
The new vaccine consists of two components; Zabdeno (Ad26.ZEBOV) administered first, and Mvabea (MVA-BN-Filo), administered eight weeks later as a booster. This prophylactic regimen is not suitable for an outbreak response but as a precautionary measure for individuals at imminent risk of exposure to Ebola virus, such as healthcare professionals, and those living or visiting areas with an ongoing Ebola outbreak. The 2-dose vaccine regimen must be completed four months prior to exposure.
The immune response to the virus after vaccination was studied in five clinical studies conducted in Europe, Africa and the USA. A total of 3,367 adults, adolescents and children, were included. The vaccine was safe and induced an immune response. Efficacy data in humans was extrapolated from animal studies. The level of protection remains unknown.
Efficacy data are being collected through an ongoing observational study in the Democratic Republic of Congo (DRC), which will continue to be included in post-marketing data.
Common side effects were injection site reactions, fatigue, headache, myalgia, arthralgia and chills.