Question Number: 169
PDR Number: SQ22-000105
Date Submitted: 24/02/2022
Department or Body: Department of Health

The premise of the statement by the Senator is wrong. Reporting of an adverse event to the Therapeutic Goods Administration (TGA) does not mean that the reporting doctor considers that it was caused by a vaccine.

The TGA encourages reporting of all significant health events after vaccination, even if there is only a small chance that they were caused by the vaccine. Under state and territory regulations in New South Wales, Western Australia, Queensland, Northern Territory and the Australian Capital Territory it is mandatory for health professionals to report adverse events following immunisation. In some cases, the reporter may state that they do not believe there is a link to vaccination, or other information provided in the report indicates that the vaccine is very unlikely to have contributed to the death. Nevertheless, these reports are retained in the TGA’s adverse event database to contribute to safety monitoring.

The TGA does not determine the medical condition that caused the death of an individual or ‘overrule’ the cause of death included on the death certificate. Treating health professionals, hospitals and coroners are best placed to investigate and identify the medical conditions that caused death.

The TGA’s review of fatal (and other) adverse event reports looks for cases that may represent new safety issues that could be caused by vaccination, so that these safety issues can be investigated and, if confirmed, regulatory action taken. Most health professionals are not familiar with or trained in causality assessment of individual adverse events following immunisation for the purposes of vaccine safety monitoring.

The approach to causality assessment is not subjective. TGA applies a structured and objective approach to assessing fatal cases, using an internationally accepted method for causality assessment recommended by the World Health Organization (WHO). The approach considers the evidence for a causal link between the vaccine and the diagnosis made by the relevant health professional who examined the patient. The same approach is used by Vaccine Safety Investigation Groups, which are panels of experts convened by the TGA to undertake causality assessments of individual cases that may have an impact on the benefit-risk balance of a vaccine.

Regardless of the outcome of the individual causality assessment, the TGA includes fatal adverse event reports in analyses to identify and investigate signals that may not be apparent through review of individual cases. This approach is consistent with the approach recommended by the WHO.