Posted by Michael Wonder on 09 Nov 2019
Johnson & Johnson announces submission of European marketing authorisation applications for Janssen’s investigational Ebola vaccine regimen
7 November 2019 - Data from multiple preclinical, Phase 1, 2 and 3 studies support applications, which have been granted Accelerated Assessment by EMA.
Johnson & Johnson today announced that its Janssen Pharmaceutical Companies have submitted Marketing Authorisation Applications (MAAs) to the EMA seeking licensure for an investigational Ebola vaccine regimen for the prevention of Ebola virus disease caused by Zaire ebolavirus species.
Two MAAs have been submitted in parallel supporting each vaccine in the two-dose regimen (Ad26.ZEBOV, MVA-BN-Filo). In September 2019, the EMA’s CHMP granted an accelerated assessment for these applications.
