Downgrading of SARS-CoV-2 from risk group 3 to risk group 2

In 2019, a novel coronavirus was identified in the city of Wuhan in China, which Respiratory disease coronavirus disease 2019 (COVID-19) and later classified by the WHO as SARS-CoV-2 It spread rapidly worldwide, causing pandemic waves with over 777 million confirmed infections and more than 7 million deaths. Due to its genetic proximity to SARS-CoV, it was assigned to the same virus species, which was renamed Betacoronavirus pandemicum in 2023. Variants that showed increased pathogenic potential, were not inhibited by vaccines/medicines, or could lead to the overload of healthcare systems were designated by the WHO as Variants of Concern (VOC) In May 2023, the WHO declared the global health emergency caused by COVID-19 to be over, as the virus is now circulating endemic in the population worldwide. Currently, no SARS-CoV-2 variant is classified as a VOC. Due to vaccinations or natural infection, there is broad immunity against all known SARS-CoV-2 variants in Germany. The Betacoronavirus pandemicum, SARS-CoV-2, is now newly recognized by the ZKBS as a donor or recipient organism for genetic engineering work in accordance with Section 5 (1) GenTSV in conjunction with the criteria in Annex 1 GenTSV of the Risk group 2 However, if newly emerging variants are classified as VOCs by the WHO, they are initially assigned to the Risk group 3 However, genetic engineering work with SARS-CoV-2 that pursues one of the following objectives, as well as the handling of recombinant SARS-CoV-2 particles with the following properties, remains the responsibility of Security level 3 to assign:

1. Reduction of antibody-mediated neutralization
2. Reduction of recognition by cytotoxic T cells
3. Resistance to approved drugs
4. Expansion of cell or organ tropism or host range
5. Increase in the pathogenicity of SARS-CoV-2
6. Enhancement of the evasion of the innate immune response
7. Exchange of SARS-CoV-2 ORFs vs. homologous ORFs of other coronaviruses
8. certain untargeted changes in the SARS-CoV-2 genome.

The complete statement ( Ref. 08020204.0005.0008 ) can be found on the ZKBS website.