Europe – New vaccine for prevention of Ebola virus disease recommended for approval in the European Union

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for a new Ebola vaccine that provides active immunisation to prevent Ebola virus disease (Zaire ebolavirus species) in individuals aged 1 year and older.

Ebola virus disease is a rare but severe and often fatal illness. Between 25% to 90% of the patients who contracted the disease died in past outbreaks. The largest outbreak to date occurred in West Africa in 2014-2016 with more than 11,000 deaths. Currently, the Democratic Republic of Congo (DRC) is fighting an Ebola epidemic. It was declared a public health emergency of international concern by the World Health Organization (WHO) in July 2019. So far, more than 3,400 people in DRC have been infected with the Ebola virus during the ongoing outbreak, and approximately 67% of those infected have died.

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 (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). 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…