Zabdeno

Withdrawn

This medicine's authorisation has been withdrawn

ebola vaccine (Ad26.ZEBOV-GP [recombinant])

Overview

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another Ebola vaccine called Mvabea, as part of a vaccine regimen; the marketing authorisation for Mvabea has also been withdrawn.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.

Zabdeno : EPAR - Medicine overview

Reference Number: EMA/298997/2020

Zabdeno : EPAR - Risk management plan

Product information

Zabdeno : EPAR - Product information

Zabdeno : EPAR - All authorised presentations

Product details

• Name of medicine:
  Zabdeno
• Active substance:
  recombinant adenovirus type 26 (Ad26) encoding the glycoprotein (GP) of the Ebola virus Zaire (ZEBOV) Mayinga strain
• International non-proprietary name (INN) or common name:
  ebola vaccine (Ad26.ZEBOV-GP [recombinant])
• Therapeutic area (MeSH):
  Hemorrhagic Fever, Ebola
• Anatomical therapeutic chemical (ATC) code:
  J07

Pharmacotherapeutic group

Vaccines

Therapeutic indication

Active immunization for prevention of disease caused by Ebola virus (Zaire ebolavirus species) in individuals ? 1 year of age.

Authorisation details

• EMA product number:
  EMEA/H/C/005337
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Opinion adopted:
  28/05/2020
• Marketing authorisation issued:
  01/07/2020
• Withdrawal of marketing authorisation:
  01/05/2026
• Revision:
  10

Assessment history

Changes since initial authorisation of medicine

Zabdeno : EPAR - Procedural steps taken and scientific information after authorisation

Zabdeno-H-C-5337-P46-009 : EPAR - Assessment report

Adopted Reference Number: EMA/529497/2023

Initial marketing authorisation documents

Zabdeno : EPAR - Public assessment report

Adopted Reference Number: EMA/323670/2020

CHMP summary of positive opinion for Zabdeno

Adopted Reference Number: EMA/CHMP/138172/2020