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Notification report


Full notification file


General information

Notification Number
B/DE/21/PEI4373

Member State to which the notification was sent
Germany

Date of acknowledgement from the Member State Competent Authority
02/02/2021

Title of the Project
A Randomized, Double-blind, Placebo-Controlled Phase 3 Study to Evaluate 3 Dose Levels of Ad26.COV2.S Administered As Single-Dose And Two-Dose Schedules in Healthy Adults

Proposed period of release:
30/01/2021 to 30/04/2022

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:
Germany; Spain; Netherlands;

Has the same GMO been notified elsewhere by the same notifier?
Yes

If yes, notification number(s):


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
Ad26MastadenovirusHuman adenovirus group DN/AType 26N/A

European Commission administrative information

Consent given by the Member State Competent Authority:
Not known