On 1 May 2026, the European Commission withdrew the marketing authorisation for Zabdeno (Ebola vaccine (Ad26.ZEBOV-GP \[recombinant\])) 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. Zabdeno 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. Zabdeno was to be used with another Ebola vaccine called Mvabea, as part of a vaccine regimen; the marketing authorisation for Mvabea has also been withdrawn. There is another vaccine authorised in the EU to protect people against Ebola virus disease.
Therapeutic Indication
### Therapeutic indication Active immunization for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ? 1 year of age.
Therapeutic Area (MeSH)
ATC Code
J07
ATC Item
疫苗类
Pharmacotherapeutic Group
Vaccines
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| Recombinant Adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain | N/A | recombinant adenovirus type 26 (ad 26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain |
| recombinant adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain | N/A | recombinant adenovirus type 26 (ad 26) encoding the glycoprotein (gp) of the ebola virus zaire (zebov) mayinga strain |
EMA Name
Zabdeno
Medicine Name
Zabdeno
Aliases
N/A