45. Why do people have to lodge a FOI to get serious adverse event data from the TGA – shouldn’t it be made available with weekly reports? I refer to FOI-3520 that had to be lodged in order to get the total number of serious adverse events following Covid-19 vaccine injections? 46. Can the TGA point out where on the weekly reports are the total of serious adverse events listed as per John Skerritts comments in estimates that they are listed? There is nowhere that specifically states how many of the total adverse events reported are serious.

Question Number: 161
PDR Number: SQ22-000113
Date Submitted: 24/02/2022
Department or Body: Department of Health

45. The Therapeutic Goods Administration (TGA) does not routinely publish the number of adverse events reported as serious. This is because simple reporting of the number and type of adverse event reports, including the number of reports assigned by reporters to one of the seriousness criteria, is not a valid method for assessing vaccine safety.

Reporting of an adverse event to the TGA does not mean that the event was caused by vaccination. The TGA encourages reporting of all adverse health events after
vaccination, even if there is only a small chance that the vaccine caused them.
Instead, the TGA publishes information following its investigations of emerging safety signals, and the resulting regulatory actions, in the COVID-19 vaccine weekly safety report. These investigations are based on analysis and review of adverse event report data to identify and evaluate safety signals and provide meaningful information about the safety profiles of the vaccines.

46. The weekly safety report includes information about the TGA’s investigations of
emerging safety issues and identified serious adverse events, including the number of reports received for:

• Death in people who have been vaccinated with any COVID-19 vaccine
• Myocarditis and pericarditis associated with mRNA COVID-19 vaccines, and
• Thrombosis with thrombocytopenia syndrome (TTS), Guillain Barre syndrome (GBS) and immune thrombocytopenia (ITP) associated with the Vaxzevria (AstraZeneva) vaccine.