Question Number: 184
PDR Number: SQ22-000554
Date Submitted: 21/11/2022
Department or Body: Department of Health
The request under FOI 2565 was a request for “histopathology/microscopic evaluation of gonads in relation to the Pfizer and AstraZeneca COVID-19 vaccines”. In order to respond to this request the full, nonclinical study reports would need to be supplied to provide the scientific context of any findings, and these reports were not just limited to the ovarian and testicular effects of the vaccines. As a result, the two decisions which were made in response to FOI 2565 were made on the basis that a practical refusal reason exists under section 24AA of the Freedom of Information Act 1982 (Cth) (FOI Act), as the material which would need to be reviewed and processed was too voluminous and would substantially and unreasonably divert the resources of the Therapeutic Goods Administration (TGA). It was estimated that it would take in excess of 200 hours for TGA employees to process the request. Accordingly, access was refused by both decision makers under s24 of the FOI Act. A separate applicant subsequently made a request for similar documents with a reduced scope insofar as they related to the Pfizer COVID-19 vaccine. The two documents which were released under that FOI request (FOI 3093) are available on the TGA’s disclosure log and have also been provided to applicant who made the request under FOI 2565. As is apparent from the lack of adverse findings in these reports, there were no treatment-related histopathological or microscopic findings in these organs from the nonclinical data.
