FOI 5225 – FOI 2389 Decision Letters

Written by Claude Haiku 4.5 from the extracted text on 27 Feb 2026. It can miss or misread redacted and scanned pages. Check the source before relying on it.

This FOI decision letter documents the TGA's processing of a February 2021 request for documents related to Pfizer's COVID-19 vaccine (COMIRNATY BNT162b2). The requestor sought records covering exemptions from poison standard labelling, approval criteria and how the vaccine met safety and efficacy standards, differences between provisional and full approval, ingredient disclosure including potentially poisonous substances, and clinical trial data underlying the approval decision. The TGA initially deemed the scope too voluminous but worked with the requestor to narrow it to seven documents (approximately 632 pages) spanning the Delegate's Overview, approval letter, ACV External Committee background and ratified minutes, clinical overview, toxicology/non-clinical review, and Risk Management Plan. The processing involved multiple time extensions between March and April 2021, with the OAIC granting a 60-day extension on 1 April 2021