CHMP recommends approval of Zabdeno + Mvabea for Ebola.- Janssen-Cilag International

The EMA’s CHMP has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine Zabdeno (formerly Ad26.ZEBOV) + Mvabea (formerly MVA-BN-Filo), from Janssen-Cilag International, that provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged 1 year and older. The recommendation to grant a marketing authorisation for the new vaccine follows the approval of the first Ebola vaccine in November 2019. The new Ebola vaccine consists of two components, Zabdeno and Mvabea. Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. This prophylactic 2-dose regimen is therefore not suitable for an outbreak response where immediate protection is necessary. As a precautionary measure, a Zabdeno booster vaccination should be considered for individuals at imminent risk of exposure to Ebola virus, for example healthcare professionals and those living in or visiting areas with an ongoing Ebola virus disease outbreak, who completed the Zabdeno, Mvabea 2-dose primary vaccination regimen more than four months ago.

The most common side effects found in participants in the clinical trials were injection-site reactions (pain, warmth and swelling), fatigue, headache, myalgia, arthralgia and chills. Effectiveness data are being collected through an ongoing observational study in DRC. The results of this and other studies must be included in post-marketing safety reports which are continuously reviewed by EMA.