J&J's Ebola vaccine approved by EU

By The Science Advisory Board staff writers

July 1, 2020 -- Johnson & Johnson announced that the European Commission granted marketing authorization for its Janssen Pharmaceutical Ebola vaccine regimen for the prevention of Ebola virus disease.

The company worked with the World Health Organization on vaccine prequalification to accelerate the registration of the Ebola vaccine regimen in African countries and facilitate broad access to the vaccine.

The Ebola vaccine marks the first major regulatory approval of a vaccine developed by Janssen and is the first vaccine approved using the company's AdVac technology platform. This technology is currently being employed to develop vaccines against SARS-CoV-2, Zika, respiratory syncytial virus, and HIV.

The approved two-dose regimen includes adenovirus serotype 26 (Ad26).Zebov as an initial dose, based on Janssen's AdVac viral vector technology, and modified vaccinia virus Ankara-Bavarian Nordic (MVA-BN)-Filo as a second dose, based on Bavarian Nordic's MVA-BN technology, eight weeks later. To date, over 60,000 people have been dosed with Janssen's vaccine as part of clinical trials and vaccination initiatives.

The company has initiated discussions with the U.S. Food and Drug Administration to define required data for filing U.S. licensure.


Copyright © 2020 scienceboard.net
 

To read this and get access to all of the exclusive content on The Science Advisory Board create a free account or sign-in now.

Member Sign In:
MemberID or email address:  
Do you have a Scienceboard.net password?
No, I want a free membership.
Yes, I have a password:  
Forgot your password?