Question Number: 308
PDR Number: SQ22-000684
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. The Office of the Gene Technology Regulator (OGTR) has no regulatory role in the assessment and approval of mRNA COVID-19 vaccines.
