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Question:

21 November 2022

185. Studies have shown that neutrophils interact with spike proteins to create fibrils that lead to amyloids clots. Has the TGA examined this risk, and can they guarantee that amyloid clots arent being formed by the vaccine? 190. I note that the Europeans Medicine Agency has added heavy menstrual bleeding as a side effect of Pfizer and Moderna Covid jabs. Given this delayed warning what testing will the TGA do to ensure that the heavy bleeding isn’t the result of clots and that women are not at danger of having their fertility damaged?

Answer:

Question Number: 272
PDR Number: SQ22-000643
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 185 An in vitro study showed that the spike protein mixed in a test tube with neutrophil elastase formed amyloid-like fibrils, which might cause blood clots. However, there is no evidence of the spike protein from COVID-19 mRNA vaccines causing blood clots in humans (in vivo). Toxicity studies in animals with high doses of the COVID-19 vaccine in its final clinical formulation as administered to patients, showed no changes in platelets or coagulation parameters (e.g., platelet count/volume/distribution width, prothrombin time, activated partial thromboplastin time or development of blood clots. The Therapeutic Goods Administration (TGA) continues to monitor national and international data on the risk of blood clots with COVID-19 vaccination. We have not identified a causal link between mRNA vaccines and the formation of blood clots. Question 190 The TGA is aware that the European Medicines Agency (EMA) have made the decision to add heavy menstrual bleeding as a potential side effect of unknown frequency to the product information for COMIRNATY and SPIKEVAX. The EMA have noted publicly that cases have mostly been non-serious and temporary in nature and that there is no evidence to suggest that there is any impact on reproduction or fertility. The TGA is working with the vaccine sponsors and international regulators, including the EMA, to further elucidate this issue in the Australian context.

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28/11/2022

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