Testbiotech demands more precaution in the EU
20 August 2020 / While Russia might have started production of a vaccine that was not thoroughly tested, the EU has lowered its safety standards for the risk assessment of genetically engineered viruses used in vaccines. In doing so, the EU hopes to speed up the approval process for vaccines. In this context, Testbiotech is warning that risks to people and the environment cannot be excluded. Therefore, if there is any doubt about safety, precaution must be the most important principle in the development of any vaccine.
Already in July, the EU Parliament adopted an EU Commission proposal exempting genetically engineered viruses from environmental risk assessment, which is obligatory for all genetically engineered organisms. The Dutch competent authority COGEM had earlier warned against taking this measure which they consider to be disproportionate. The Green group in the EU Parliament tried to mitigate the EU Commission proposal by introducing amendments, but failed to gain sufficient support.
The EU is currently investing heavily in the development of vaccines and has high hopes of ending the corona crisis. At the same time, the shareholder value of companies working on these vaccines is soaring. However, it is still not possible to foresee whether a vaccine that is sufficiently safe and effective can be developed at all. Testbiotech is therefore concerned that a lack of precaution may very quickly turn potential solutions into new problems. The risks inherent in the different vaccine development strategies should for that reason be made transparent and examined thoroughly.
Furthermore, Testbiotech strongly criticises the fact that hardly any attention is being paid to scientists demanding stricter rules for re-synthesizing the genome of the viruses. In the meantime, the Sars-CoV-2 genome has been completely analysed and instructions on the technical process of synthesizing the genome were also published. This may increase the risk of intentional misuse and unintended escape of laboratory viruses. Internationally binding regulations for the handling of data related to gene synthesis are still not in place even though this has been under discussion for several years. The origin of the virus is still unclear and Testbiotech is therefore warning that politicians should not underestimate these risks. While genetic engineering offers chances in developing vaccines, there is also the possibility that it may give rise to new dangerous virus-related diseases.
Christoph Then, firstname.lastname@example.org, Tel + 49 (0) 151 54638040