Johnson & Johnson Announces European Commission Approval for Janssen ’s Preventive Ebola Vaccine

Discussions with the U.S. Food and Drug Administration (FDA) have taken place to define the required data set for filing US licensure. About Janssen’s Ebola Vaccine Regimen The Janssen preventive Ebola vaccine regimen, Ad26.ZEBOV and MVA-BN-Filo, utilizes a non-replicating viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors carry the genetic code of several Ebola virus proteins in order to trigger an immune response.Janssen’s vaccine regimen originates from a collaborative research program with the NIH and received direct funding and preclinical services from the National Institute of Allergy and Infectious Diseases, part of NIH, under Contract Number HHSN272200800056C. Further funding for the Ebola vaccine regimen has been provided in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, BARDA under Contract Numbers HHSO100201700013C and HHSO100201500008C.The IMI provided funding through the IMI Ebola+ Programme to support a number of consortia that initiated multiple clinical trials and other vaccine development activities. The consortia funded by the Innovative Medicines Initiative 2 (IMI2) Joint Undertaking are EBOVAC1 (grant nr. 115854), EBOVAC2 (grant nr. 115861), EBOVAC3 (grant nr. 800176), EBOMAN (grant nr. 115850) and EBODAC (gran...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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