Germany | BCH-LAW-DE-262241 | Biosafety Law, Regulation, Guidelines and Agreements | Biosafety Clearing-House

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Biosafety Law, Regulation, Guidelines and Agreements (LAW)

last updated: 01 Nov 2022
Amendment
No
General Information
Opinion of the ZKBS on the risk assessment of the recombinant adenovirus-based vaccine virus Ad26.ZEBOV according to § 5 paragraph 1 GenTSV
EN
Legislative details
Guidelines
National / Federal
Ad26.ZEBOV is a replication-defective human adenovirus of serotype 26 (Ad26) that contains the gene for the glycoprotein of Zaire ebolavirus (ZEBOV) and is used as a vaccine against ZEBOV. Ad26 belongs to the species Human mastadenovirus D and  is assigned to risk group 2 as a donor and recipient organism for genetic engineering work.
Compared to the wild-type virus, different deletions are present in Ad26.ZEBOV.  According to § 5 paragraph 1 GenTSV in conjunction with the criteria in Appendix 1 GenTSV, the recombinant adenovirus Ad26.ZEBOV is assigned to risk group 1 as a genetically modified organism.
EN
01 Jul 2021
Regulatory contact information
Additional Information
The Central Committee on Biological Safety (ZKBS) is an expert scientific committee made up of 20 members and 20 deputy members, who represent different specialist areas or spheres of corporate interest. Its offices are based at the Federal Office of Consumer Protection and Food Safety (BVL). Its members and deputy members are appointed by the Federal Ministry for Food and Agriculture (Bundesministerium für Ernährung und Landwirtschaft, BMEL) for three years. The ZKBS evaluates GMOs for possible risk potential, assigns genetic engineering operations to a biosafety level and recommends suitable safety measures. The german federal states obtain ZKBS position statements for genetic engineering operations in safety categories 3 and 4 and for operations in a lower safety category, whose classification is not clear. The ZKBS also evaluates approval applications for releases and for the placing of GMOs on the market and also issues a report to the BVL. An activity report is published annually. 
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