Jansen Pharmaceuticals submits 2 marketing authorization applications to EMA
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Last Update: 2020-06-07
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Source: Internet
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Author: User
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recently, Johnson and Johnson's JanssenPharmaceutical(http://company,(http:// announcedthat it had submitted two marketing authorization applications (MAA) to the European(http://Authority (MAA) for approval of a research Ebola vaccine program to prevent the ebola virus from the Zaire strain of Ebola virus (EVD)The vaccine program is:(1) ad26.ZEBOV as the first vaccine, the vaccine is based on Jansen's AdVac technology development, and(2) about 8 weeks later, MVA-BN-Filo as the second vaccine, the vaccine is based on Bavarian's Nordic's MVA-BN technology2 MAA is supported by data from Phase I, Phase II and Phase III clinical studies that assess the safety and immunogenicity of this vaccine program in adults and children, as well as preclinical studies anddata from the http:// of theanalysis
of immune bridgingJansen is currently in discussions with the U.SFood andDrug(http://Administration (
FDA(http://) to determine the data needed to submit the above-mentioned Ebola vaccine program under the FDA's animal (effect) regulationsIn addition, Jansen has partnered with the World Health Organization (WHO) to register the above-mentioned Ebola vaccine programme in African countriesAt the end of October, Jansen announced that up to 500,000trials(http://vaccine programme for new clinical trials organized by the Government of the Democratic Republic of the Congo and global health stakeholders to control the Ebola outbreak in the country
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