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Notification report


Full notification file


General information

Notification Number
B/NL/20/007

Member State to which the notification was sent
Netherlands

Date of acknowledgement from the Member State Competent Authority
08/07/2020

Title of the Project
Clinical trials with Ad26COVS1

Proposed period of release:
01/07/2020 to 01/07/2021

Name of the Institute(s) or Company(ies)
Leiden University Medical Center, Albinusdreef 2
2333 ZA Leiden
PO Box 9600
2300 RC Leiden
The Netherlands;


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

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 Ad26COVS1 and is a replication incompetent adenovirus vector containing the sequence for the spike (S) protein of SARS-CoV-2. The Ad26COVS1 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
Ad26MastadenovirusHuman adenovirus group D-Type 26-

European Commission administrative information

Consent given by the Member State Competent Authority:
Yes
10/07/2020 00:00:00
Remarks: