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Full notification Final report - General information Notification Number B/DE/22/PEI4817 Member State to which the notification was sent Germany Date of acknowledgement from the Member State Competent Authority 17/12/2022 Title of the Project Phase 3 Trial to Assess Clinical Efficacy, Safety and Reactogenicity of the Recombinant MVA BN-RSV Vaccine in in Adults ≥60 years of Age Proposed period of release: 01/07/2022 to 01/11/2024 Name of the Institute(s) or Company(ies) Bavarian Nordic GmbH, Fraunhoferstr. 13 82152 Martinsried Germany
Is the same GMO been notified elsewhere by the same notifier? No Has the same GMO been notified elsewhere by the same notifier? No GMO characterization GMO is a: DNA Virus Identity of the GMO: Recombinant Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) delivering the RSV surface proteins from both circulating RSV strains (A and B), as well as conserved internal antigens of RSV. Genus: Orthopoxvirus Species: Vaccinia virus. Information relating to the recipient or parental organisms from which the GMO is derived Common Name: Modified Vaccinia Ankara virus Genus: Orthopoxvirus Species: vaccinia virus Subspecies: Strain: Modified Vaccinia Virus Ankara-Bavarian Nordic (MVA-BN) Pathovar: European Commission administrative Information Consent given by the Member State Competent Authority: Not known
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