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.
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