231. The non-clinical report noted there were no studies on the protection of older animals – given it was older people who are susceptible why were older animals excluded? 232. The non-clinical report noted that monkeys were not a good animal model of severe Covid 19 in humans – if this is case why use monkeys in a trial for a disease, they are not a good model for? 233. The non-clinical report noted vaccine induced auto immune diseases were not studied in the non-clinical program and should be addressed by clinical data. If this is the case, why are humans being used as guinea pigs? 259. How can the TGA discount the increased number of supernumerary ribs in vaccinated pregnant rats as not being a safety signal? Shouldn’t more testing have taken place? 268. Why is the TGA refusing to provide information relating to “All Developmental and Reproductive Toxicity Studies available to the TGA regarding the Pfizer and AstraZeneca COVID-19 vaccines including histology reports of gonads of vaccinated animals”

Question Number: 234
PDR Number: SQ22-000604
Date Submitted: 21/11/2022
Department or Body: Department of Health

231: Any drug or vaccine development includes nonclinical and clinical studies to ensure the efficacy and safety of the drug or vaccine. Even though older animals were not included in the protection studies with the Pfizer COVID-19 vaccine, more importantly older people were included in the vaccine clinical trials to ensure COVID-19 vaccine efficacy and safety in older people.

232: While monkeys are not a good animal model of severe COVID-19 disease in humans, they are susceptible to viral replication and develop lung pathology from SARS-CoV-2 infections. In addition, they are better animal models than other animal species and were therefore used to investigate COVID-19 vaccine safety and efficacy. The ACE2 receptors of monkeys have a high homology with human ACE2 receptors and greater binding activity for SARSCoV-2 than ACE2 receptors of other laboratory animals, available at: (https://pubmed.ncbi.nlm.nih.gov/31996437/). The nonclinical studies with Pfizer COVID-19 vaccine also indicated that the vaccine protected monkeys from SARS-CoV-2 infection based on decreased viral RNA load and radiographic lung lesions in immunised animals – supporting the use of monkeys in the study.

233: Nonclinical and clinical studies are conducted to investigate the risk of vaccine administration, including the risk of autoimmunity. No vaccine-related systemic intolerance or mortality or significant release of cytokines was observed in the nonclinical studies with the COVID-19 vaccine. The development of COVID-19 vaccines followed the same internationally recognised common practices related to pharmaceutical development. There is no clinical evidence to suggest that COVID-19 vaccines cause autoimmune diseases. 259: Supernumerary ribs are common findings in rats. The increased number of supernumerary ribs in vaccinated pregnant rats were within the normal range for the rat strain used in the studies conducted by the testing laboratory. Therefore, the finding is not considered to be adverse outcome from vaccine treatment. 268: See response provided in response to Question 88 (SQ22-000554).