131. Why is it okay to use invitro studies to justify the safety of the Covid vaccines but not Ivermection? 132. Why did Pfizer and or the FDA try to delay the release of the Covid-19 vaccine trial data for up to 55/75 years? Shouldn’t the TGA be alarmed by this? If not, why not?

Question Number: 246
PDR Number: SQ22-000616
Date Submitted: 21/11/2022
Department or Body: Department of Health

131. Please note that the spelling of the anti-parasitic medicine is ‘ivermectin’. It is grossly incorrect to say that (only) in vitro studies were used to “justify the safety of the Covid vaccines”. The safety of the COVID-19 vaccines currently registered in Australia was assessed by analysis of large in vivo studies (clinical trials) with tens of thousands of individuals and have since been supported by real world data from billions of individuals. All vaccines are assessed for safety by nonclinical studies in animals and human clinical trials before approval for clinical use. 132. The Therapeutic Goods Administration (TGA) cannot answer for either Pfizer or the United States Food and Drug Administration regarding their release of information, and the Senator should, direct his questions to these organisations. The TGA has released information under the Freedom of Information Act 1982, including reports and study information related to applications received for potential COVID-19 therapeutics. The release of these documents is in addition to the publication of standard regulatory documents such as the Product Information, Consumer Medicine Information and Australian Public Assessment Report on the TGA website.