First-ever marketing authorisation for a vaccine against Ebola in the European Union

  • European Commission
  • European Commission
  • 11 Nov 2019

  • curated by Priscilla Lynch
  • Univadis
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The European Commission (EC) has granted the first-ever marketing authorisation for a vaccine against Ebola in the European Union (EU).

The vaccine, Ervebo (rVSV-ZEBOV-GP), had been in development since the Ebola outbreak in West Africa in 2014, through co-operation with public health stakeholders in Africa (notably in Sierra Leone, Liberia, and Guinea), as well as the World Health Organization, the Norwegian Institute of Public Health and Médecins Sans Frontières (MSF).

It is already used, as part of a specific protocol, to protect people at risk of infection with Ebola, such as healthcare workers or people who have been exposed to infected persons.

The rVSV-ZEBOV-GP vaccine has been tested in approximately 16,000 individuals involved in several clinical studies in Africa, Europe and the United States where it has been proven to be safe, immunogenic and effective against the Zaire Ebola virus that circulated in West Africa in 2014-2016.

The EC decision follows the positive recommendation from the European Medicines Agency (EMA) in October.

It also follows the recent announcement of a clinical trial for a second Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) that is now underway in the Democratic Republic of Congo, with the support of the EU's research and innovation programme Horizon 2020.