146. Why doesn’t the TGA have mandatory reporting requirements of Health professionals for reporting adverse events? Shouldn’t it be mandatory given that the vaccines have only received provisional approval and data from ongoing trials are being assessed on an outgoing basis? 148. In the Post marketing surveillance data there is over 1,000 adverse events of interest – what exactly are adverse events of interest – are they reported adverse events? 149. If the current vaccines fall outside many of the international guidelines for testing vaccines, then isn’t it fair to say they aren’t vaccines. 150. In the post marketing surveillance data – what was the total population of the administered doses? I note this figure has been censored by Pfizer and the FDA – why is such an important indicator of safety being covered up and why won’t the TGA ask for that number and then disclose it? 151. Why did the TGA change death description to Adverse Event following immunisation to avoid scrutiny over cause of death regarding a number of young children were reported to have died from the vaccine?

Question Number: 270
PDR Number: SQ22-000641
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 146 This question has been previously addressed – see SQ21-001214 (Q115). To implement mandatory reporting would require parliament to pass changes to the Therapeutic Goods Act 1989. Question 148 Adverse Events of Special Interest (AESI) are defined as ‘a pre-specified medically-significant event that has the potential to be causally associated with a vaccine product that needs to be carefully monitored and confirmed by further special studies’. Further information on AESI can be found in the WHO publication ‘Covid-19 vaccines: safety surveillance manual – Monitoring and responding to adverse events of special interest’, available at: www.who.int/publications/m/item/WHO-MHP-RPQ-PVG-2021.5. Question 149 In Australia, and internationally, the COVID-19 vaccines have been regulated in the same way as other vaccines. They do not “fall outside many of the international guidelines for testing vaccines” – this assertion is baseless. Question 150 It has been inferred that this question is referring to the Pfizer report submitted to the United States Food and Drug administration (US FDA) and released under FOI in 2021. Questions regarding this report should be directed to the US FDA and Pfizer. The US CDC does publish information on the doses of COVID-19 vaccines that have been administered, including a breakdown by vaccine brand. This information can be found at: https:// covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total. Question 151 This assertion is incorrect – no changes to the “death description” were made. The TGA uses the Medical Dictionary for Regulatory Authorities (MedDRA) – a globally accepted process – to code adverse events into structured data. Each adverse event term is also coded with an outcome, with ‘fatal’ being one of the options. Death is considered an outcome in the context of safety reporting. If death is the only reported information, then for a vaccine the MedDRA term ‘adverse event following immunisation’ is used to capture that there was an adverse event, albeit unidentified, that had a fatal outcome. If another adverse event term is also provided in the report, such as cardiac arrest, then this term would be coded and the outcome recorded as fatal.