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168. I note FOI 3717 pertaining to metallic particle contamination in Moderna vaccines has not been displayed in the FOI Disclosure log. I note in the correspondence dated 27/08/21 that someone (can’t tell because the TGA redacted it) was concerned about visual testing and the fact that the TGA was not looking at or analysing the contents of the vial. When exactly did the TGA start analysing vials and in what way? Were they analysing from the start? If not, why not?

Question Number: 188
PDR Number: SQ22-000558
Date Submitted: 21/11/2022
Department or Body: Department of Health

The Therapeutic Goods Administration (TGA) can confirm that it analyses the contents of vaccine vials from each batch through batch release testing of the COVID-19 vaccines. Each batch of COVID-19 vaccine must undergo independent assessment by the TGA Laboratories before it is distributed. Every batch of all COVID-19 vaccines have been through the batch release process. The TGA Laboratories carry out a range of tests, including assessments for composition, identity, potency, purity and adventitious agents (contamination with microorganisms). Particulate contamination would also be detected. The results of testing are published on the TGA website, available at: www.tga.gov.au/batch-release-assessment-covid-19-vaccines.

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