200. Who is responsible for acting on the safety signal in the DAEN database re Covid vaccines – the TGA or the sponsor? 214. I note that the Covid vaccines were provisionally approved subject to strict reporting conditions on safety and efficacy. Since provisional approval what has Pfizer reported to the TGA in regards to safety and efficacy since the rollout of the vaccine? 215. Can the safety reports provided by the Covid vaccine sponsors please be provided? 266. “The TGA’s vaccine safety monitoring system can rapidly detect, investigate and respond to any emerging safety issues identified for COVID-19 vaccines.” The TGA’s monitoring system is passive and therefore it can never “rapidly detect” safety issues! These pages are misleading the public are they not? https://www.tga.gov.au/products/covid-19/covid-19-vaccines/covid-19-vaccineapproval-process

Question Number: 219
PDR Number: SQ22-000589
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 200 Both the Therapeutic Goods Administration (TGA) and pharmaceutical sponsors undertake pharmacovigilance, which is the science of identification, investigation, and action to address emerging safety issues for a medicine or vaccine. Analysis of adverse event reporting data is used by the TGA and sponsors to look for patterns that might indicate an emerging safety issue for a product. If an issue is identified the TGA works with the sponsor to ensure appropriate action is taken. Analysis of adverse event reporting data forms just one part of the TGA’s COVID-19 vaccine safety monitoring system. Therefore DAEN reports do not equal “safety signals”. Question 214 Conditions of provisional registration for all new COVID-19 vaccines in Australia include submission of monthly safety summary reports for the first six months, and thereafter at the TGA-specified interval, and six-monthly periodic safety update reports (PSURs). Frequency of submission may be increased as required, based on emerging safety information. These reports include summaries of global post-market safety data. To date, Pfizer has provided 19 such reports to the TGA. Conditions of provisional registration for Pfizer COVID-19 vaccine also require the submission of study reports to collect confirmatory safety and efficacy data. These are listed in the Australian Public Assessment Report for BNT162b2 (mRNA) published on the TGA website at: www.tga.gov.au/sites/default/files/ausparbnt162b2-mrna-210125.pdf. Question 215 The TGA publishes all adverse event reports, including those submitted by sponsors, in our Database of Adverse Event Notifications (DAEN). For COVID-19 vaccines, the TGA has also published regular safety reports to provide the latest information available at: www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report. Potential access to other safety reports submitted by sponsors including periodic safety update reports and monthly summary safety reports can be requested under the Freedom of Information Act 1982. Question 266 It is totally wrong to assert that spontaneous adverse event reporting (sometimes called passive reporting) cannot rapidly detect safety issues – indeed globally it was the means by which rare but serious adverse events related to thrombosis with thrombocytopaenia were identified for the AstraZeneca vaccine and myocarditis for the mRNA vaccines. Spontaneous adverse event reporting is just one part of the TGA’s vaccine safety monitoring system. The TGA uses a range of data sources both nationally and internationally to rapidly detect, investigate and act on emerging safety issues. The TGA’s COVID-19 vaccine safety monitoring system has delivered clear results for the Australian public, including first in the world action on several emerging safety concerns, available at: www.tga.gov.au/news/covid-19-vaccine-safety-reports/covid-19-vaccine-safety-report-14- 07-2022. Outcomes of safety monitoring and regulatory actions are published every fortnight.