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Notification report


Full notification file


General information

Notification Number
B/DE/20/PEI4191

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
06/08/2020

Title of the Project
A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older

Proposed period of release:
01/08/2020 to 31/12/2020

Name of the Institute(s) or Company(ies)
Janssen Vaccines & Prevention B.V., Archimedesweg 4-6
2333CP Leiden, The Netherlands;


3. Is the same GMO release planned elsewhere in the Community?
Yes:


Has the same GMO been notified elsewhere by the same notifier?
No

GMO characterization

GMO is a:
DNA Virus

Identity of the GMO:
The identity of the GMO is Ad26.COV2.S and is a replication incompetent adenovirus vector containing the sequence for the spike (S) protein of SARS-CoV-2. The Ad26.COV2.S vector is derived from the human adenovirus group D type 26 (genus Mastadenoviridae)

Information relating to the recipient or parental organisms from wich the GMO is derived
Common NameGenusSpeciesSubspeciesStrainPathovar
Human adenovirus type 26Mastadenovirus--Type 26-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
01/09/2020 00:00:00
Remarks: