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QUESTION ON NOTICE

Question:

24 February 2022

70. Two adverse events 703379, a 6 year old girl and 703334, a 7 year old boy have no details. In order to ensure full transparency around adverse events from children vaccines, can ATAGI ask the TGA to disclose what these injuries are? 71. Given the large number of adverse events in children already, will ATAGI revise its decision to allow the rollout of the vaccine given case numbers have dropped significantly and models have overestimated the infection rate in the community? 72. I note that ATAGI is relying on passive surveillance of vaccinated in children in the USA rather than active surveillance. How does ATAGI know that every adverse reaction experienced amongst the 6 million children in the USA has been detected, if the FDA/Pfizer is not actively monitoring every child?

Answer:

Question Number: 199
PDR Number: SQ22-000124
Date Submitted: 24/02/2022
Department or Body: Department of Health

70. The remit of Australian Technical Advisory Group on Immunisation (ATAGI) does not extend to requesting the Therapeutic Goods Administration (TGA) to disclose details relating to adverse events. To protect patient confidentiality, the TGA does not disclose individual adverse event following immunisation reports that have been submitted. Individual reports contain identifying information about individuals and sensitive information about their health. De-identified adverse event reports received by the TGA are published in the Database of Adverse Event Notification on the TGA website 14 days after they are included in the TGA’s internal database.

71. The Australian Health Protection Principal Committee, ATAGI and the TGA will continue to constantly monitor the COVID-19 pandemic and the emerging evidence on vaccines – both domestically and internationally – and will continue to provide expert, independent advice to the Government.

72. ATAGI is not reliant on reports of passive surveillance of vaccinated children in the USA. ATAGI considers all available information, including clinical trials data, published research and reports from other international regulators, as well as real world experience of the particular vaccine in other population groups, in providing its advice to the Minister for Health.

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