On 1 May 2026, the European Commission withdrew the marketing authorisation for Mvabea (Ebola vaccine (MVA-BN-Filo \[recombinant\])) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Janssen-Cilag International N.V., which notified the European Commission of its decision not to market the product in the EU for commercial reasons. Mvabea was granted marketing authorisation under exceptional circumstances in the EU on 1 July 2020; the vaccine was indicated for prevention of disease caused by Ebola virus in people aged 1 year and older. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2025. The product had not been marketed in the EU. Mvabea was to be used with another Ebola vaccine called Zabdeno as part of a vaccine regimen; the marketing authorisation for Zabdeno has also been withdrawn. There is another vaccine authorised in the EU to protect people against Ebola virus disease.
Therapeutic Indication
### Therapeutic indication Mvabea, as part of the Zabdeno, Mvabea vaccine regimen, is indicated for active immunisation for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ≥ 1 year of age (see sections 4.4 and 5.1).
Therapeutic Area (MeSH)
ATC Code
J07BX
ATC Item
其它病毒疫苗
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP | N/A | recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp |
| recombinant Modified Vaccinia Ankara Bavarian Nordic Virus encoding the: Ebola virus Zaire (ZEBOV) Mayinga strain glycoprotein (GP); Ebola virus Sudan Gulu strain GP; Ebola virus Taï Forest strain nucleoprotein and the Marburg virus Musoke strain GP | N/A | recombinant modified vaccinia ankara bavarian nordic virus encoding the: ebola virus zaire (zebov) mayinga strain glycoprotein (gp); ebola virus sudan gulu strain gp; ebola virus taï forest strain nucleoprotein and the marburg virus musoke strain gp |
EMA Name
Mvabea
Medicine Name
Mvabea
Aliases
N/A