Good afternoon

Thank you for your email below dated 11 December 2021 in which you make the following request under the Freedom of Information Act 1982 (FOI Act):

"In regards to COVID 19 Vaccine death or injury it is mentioned "AEFI can be coincidentally associated with the timing of immunisation without necessarily being caused by the vaccine or the immunisation process".

Can the full data please be released of the amount of "coincidental" deaths for all australians with in 3 months of any COVID 19 vaccine?"

At the outset, I note that the purpose of the FOI Act is to provide access to documents, not to provide information or answer specific questions. Nonetheless, I wish to provide you with some publicly available information which is relevant to your request and may help you understand adverse event reporting in Australia.

The TGA, like other regulatory agencies around the world, continues to monitor the safety of vaccines and medicines after they are approved to contribute to a better understanding of their safety profile. General information about the safety of medicines and how the TGA monitors safety is available here: https://www.tga.gov.au/medicines-safety. This involves:
• reviewing and analysing reports of suspected side effects (also known as adverse events) submitted by health professionals and consumers.
• requiring pharmaceutical companies to have risk management plans for the vaccines they supply.
• proactively reviewing medical literature and other potential sources of new safety information.
• working with international regulators to assess significant side effects detected overseas.
• working with State and Territory health departments and clinical experts to ensure a coordinated approach.

The TGA has taken steps to encourage reporting of adverse events related to COVID-19 vaccines by health professionals and consumers. In particular, you can access information about all adverse events reported following vaccination with the COVID-19 vaccines in Australia via the Database of Adverse Event Notifications (DAEN), available on the TGA website. The DAEN contains information from reports of adverse events that the TGA has received in relation to medicines, including vaccines, used in Australia. If you are interested in this information, we refer you to: https://apps.tga.gov.au/PROD/DAEN/daen-e....

You can search the DAEN for “COVID” in the medicines report section, available here: https://apps.tga.gov.au/PROD/DAEN/daen-r.... You can also refine your search by date of the report and by reported adverse event. As of 19 August 2021, the TGA has reduced the time between adverse event reports being accepted into our database and published on the DAEN from 90 days to 14 days. This decision was made in response to the strong public interest in adverse event reports relating to COVID-19 vaccinations and allows reports for vaccines publicly available more quickly.

There are two types of results shown in two tabs: medicine summary and list of reports. Relevantly to your request, the medicines summary section includes the number of adverse events where death was a reported outcome. This figure includes all reported adverse events resulting in death, including those which have been causally linked to COVID-19 vaccine and those which have not been causally linked to a COVID-19 vaccine. Any deaths which the TGA concludes are causally linked to any of the COVID-19 vaccines are reported on by the TGA. They are all included in a weekly safety report for COVID-19 vaccines published on the TGA website. All weekly safety reports remain available on the TGA website at this address: https://www.tga.gov.au/periodic/covid-19....

The TGA analyses adverse event report data and reviews individual reports to identify possible safety issues for investigation, including reviewing all deaths reported in people who have been vaccinated. If these investigations confirm a safety signal, the TGA takes appropriate action. Reporting of an adverse event and publication of an adverse event in the DAEN does not mean the event was related to the vaccine. There might be no relationship between the adverse event and the medicine or vaccine - it may be a coincidence that the adverse event occurred when the medicine or vaccine was taken, and the symptom may be related to the underlying illness or to other factors. As the number of vaccinated people has increased, so has reporting of fatal events with a coincidental association with vaccination. This does not indicate a link between vaccination and the fatalities reported. Expert analysis and review of adverse event reports is needed to determine whether there may be a link between reported events and vaccination.

I wish to advise you that detailed causality assessment for every adverse event reported is not the function or intent of spontaneous reporting safety monitoring systems such as that operated by the TGA. Rather, adverse event reporting data provides a source from which to detect patterns of events that indicate a possible safety issue, or ‘safety signals’. The TGA conducts regular statistical analyses of adverse event data to detect signals, in addition to closely monitoring the occurrence of ‘adverse events of special interest’.

Investigation of safety signals may involve activities such as more detailed analysis and review of adverse event report data, consideration of published literature or information from medicines regulators in other countries, and review of safety data from international use of the vaccine provided by the vaccine sponsor. The TGA also uses background population incidence rates and comparator vaccine AEFI rates, sourced from the published literature and Australian datasets, to contribute to detection and investigation of possible safety signals associated with COVID-19 vaccines. As noted in the TGA’s COVID-19 Vaccine Safety Monitoring Plan (www.tga.gov.au/resource/covid-19-vaccine-safety-monitoring-plan), the TGA assesses rates of certain adverse events against background rates to see if the reported rate is higher than expected. Prior to the vaccine roll-out, the TGA established expected rates of vaccine-related adverse events and calculated background rates of certain health events in the general population.

The value of a system such as this is that it allows for detection of possible safety issues from real-world use of the vaccines by facilitating reporting of events even where detailed information required for an individual causality assessment (such as information about a patient’s medical history or test results) is not available. As a result, the TGA is able to capture a large number of adverse event reports for analysis (the TGA has received over 70,000 adverse event reports for COVID-19 vaccines), and to identify specific cases in which more detailed information is required from reporters to contribute to signal detection or investigation. Detailed causality assessment is not the function of the TGA’s adverse event monitoring and as a result, the TGA does not generate individual causality assessments for each DAEN entry.

I also note that AusVaxSafety is an active vaccine safety surveillance system that complements the TGA’s enhanced safety surveillance activities. Active vaccine safety surveillance uses SMS and a short survey to collect reports of AEFI directly from a subset of people receiving the vaccines. AusVaxSafety is an Australian Government-funded system that shares its findings with the TGA to assist safety investigations and responses. Please see details of AusVaxSafety’s latest COVID-19 safety data available here: https://www.ausvaxsafety.org.au/safety-d....

I trust that this information assists you. As the information you requested is largely publicly available, we would be grateful if you are able to clarify whether you agree to withdrawing your request for documents under the FOI Act.

We would be grateful for your clarification by COB Monday, 20 December 2021.

Regards

Freedom of Information

Therapeutic Goods Administration
Australian Government Department of Health
T: 02 6289 4630 | E: [email address] PO Box 100, Woden ACT 2606, Australia
Web: www.tga.gov.au

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Dear Sir/Madam

Please find attached correspondence in relation to your Freedom of
Information request.

If you have any questions, please do not hesitate to contact the FOI Team.

Kind regards

Emily

Freedom of Information

Therapeutic Goods Administration

Australian Government Department of Health

T: 02 6289 4630 | E: [1][email address]

PO Box 100, Woden ACT 2606, Australia

Web: [2]www.tga.gov.au

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