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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI4227

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
02/09/2020

Title of the Project
An open, single-center Phase I trial to assess the safety, tolerability and immunogenicity of two ascending doses of the candidate vaccine MVA-SARS-2-S

Proposed period of release:
01/10/2020 to 31/03/2021

Name of the Institute(s) or Company(ies)
Universitätsklinikum Hamburg-Eppendorf (UKE), ;


3. Is the same GMO release planned elsewhere in the Community?
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 Virus Ankara (MVA) delivering the S-glycoprotein of the
Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), manufactured on chicken
fibroblast cell line DF-1: MVA-SARS-2-S.

Genus: Orthopoxvirus
Species: Vaccinia virus


Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
-Orthopoxvirusvaccinia-Modified vaccinia virus Ankara-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
03/09/2020 00:00:00
Remarks: