120. How many pages of data did Pfizer submit to the TGA when applying for permission to use its Covid vaccine? 121. Have the TGA reviewed independent toxicology report for Pfizer, AZ and Moderna Covid vaccines? If not why not? 122. Given the makers of the vaccines stand to profit from the sale of the vaccine why didn’t the TGA require independent toxicology and efficacy reports before approving the data? 123. How many pages of the above were raw data/data tables?

Question Number: 118
PDR Number: SQ22-000131
Date Submitted: 24/02/2022
Department or Body: Department of Health

120. As at 9 March 2022, Pfizer Australia Pty Ltd’s collective submissions for COMIRNATY (BNT162b2 [mRNA]) COVID-19 Vaccine for Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 contain 223,463 pages (2,087 documents). Of these, 199,285 pages (407 documents) are contained in Module 5 – Clinical Study Reports.

121. All toxicology studies were reviewed by the Therapeutic Goods Administration (TGA) before approving the vaccines.

122. Toxicity studies for all three vaccines were conducted by contract laboratories, which are independent of the vaccine sponsors, Pfizer, Moderna and AstraZeneca. The toxicology study reports are detailed and comprehensive; and include summary and individual animal data. They were assessed in detail by a team of highly trained specialist toxicologists at the TGA.

Efficacy studies are conducted as part of a clinical trial. Pivotal clinical trials for new vaccines are almost exclusively conducted by pharmaceutical sponsors. Conducting a clinical trial is expensive and resource intensive and therefore the company who is responsible for developing the product will typically conduct the trial.

All data submitted to the TGA to support the efficacy and safety of a medicine or vaccine undergo a comprehensive evaluation by independent specialist TGA staff before an approval decision is made. The TGA has long established processes, pathways, and data requirements for the evaluation of medicines in Australia based on adopted, internationally recognised guidelines.

123. See response to Q120.

Information provided in the clinical studies includes study design and objectives, dose regimens, number of subjects vaccinated, demographic characteristics of the study population, and the type of Clinical Study Report (CSR). It is estimated that 45-50 per cent of the data provided is raw data/data tables.

The data contained in Module 5 are a mix of aggregate/pooled data (for example, data used to demonstrate efficacy for a particular study population) and individual patient data (for example, case narratives of an adverse event). However, all submitted data is ultimately derived from individual patient level data, from the same studies that are publicly published in top-tier peer-reviewed journals.