Question Number: 177
PDR Number: SQ22-000193
Date Submitted: 24/02/2022
Department or Body: Department of Health
This question appears to be referring to the 42,086 case reports in the Pfizer report submitted to the United States Food and Drug administration (US FDA) and released under FOI in the US available at: https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf. The Pfizer report does include information on the number of doses supplied, which has been redacted from the report released under FOI.
The adverse event data included in the Pfizer report submitted to the US FDA was provided by Pfizer to the Therapeutic Goods Administration (TGA) in safety reports required as a condition of registration of their COVID-19 vaccine, Comirnaty, in Australia.
The TGA requires Pfizer to submit six-monthly periodic safety update reports, which provide a systematic review of global safety data over the period. These reports include information on the number of doses supplied. The TGA has also required Pfizer to submit global overviews of adverse events reported monthly from initial approval until October 2021, and every two months from October 2021.
