Janssen Reports Submission of MAA to EMA for its Investigational Ebola Vaccine Regimen to Prevent Ebola Virus Disease
Shots:
- Janssen has submitted MAA to EMA for an investigational Ebola vaccine regimen in two doses Ad26.ZEBOV- MVA-BN-Filo for the prevention of Ebola Virus Disease (EVD) caused by Zaire ebolavirus species. In Sept’2019- EMA’s CHMP has granted an accelerated
- The MAA is based on multiple preclinical- P-I- II & III studies evaluating the safety and immunogenicity of the vaccine regimen in adults and children in 6-500+ volunteers across the US- EU and Africa
- The vaccine regimen includes Ad26.ZEBOV as the first dose- based on Janssen’s AdVac technology and MVA-BN-Filo as the second dose- based on Bavarian Nordic’s MVA-BN technology and is administered ~8wks. later. Additionally- Janssen is working with WHO to register Ebola vaccine regimen in African countries
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