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159. How many geneticists or other relevant specialists did the TGA have in 2020/21 reviewing the genotoxicity of the vaccine? Surely Genotoxicity studies should have been carried out given this was a gene-based vaccine?

Question Number: 177
PDR Number: SQ22-000547
Date Submitted: 21/11/2022
Department or Body: Department of Health

Genotoxicity studies are assessed by the toxicologists in the Toxicology Section, Scientific Evaluation Branch of the Therapeutic Goods Administration (TGA). During 2020/21 several toxicologists evaluated the genotoxicity data provided for the respective COVID-19 vaccines. A significant number of TGA staff have specialist training and experience at doctoral and postdoctoral level in toxicology and molecular genetics. Further information on the genotoxicity studies conducted for the COVID-19 mRNA based vaccines has been provided in response to SQ22-000355.

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