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184. Can the TGA provide a breakout of its revenue stream by organisation? 205. Leaked emails from the EMA show they lodged a Major objection with Pfizer, namely that the possibility of translated proteins other than the translated protein resulting from truncated or modified mRNA should be addressed. Were these concerns addressed? The European Medicines Agency’s COVID-19 Vaccine Leaks: Hacks, Regulatory Pressures And Manufacturing Concerns – Health Policy Watch (healthpolicy-watch.news)

Question Number: 211
PDR Number: SQ22-000581
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 184 In 2021-22, the Therapeutic Goods Administration (TGA) collected $173.9 million fees and charges revenue from 5,755 organisations.

Question 205 The TGA is aware that a cyberattack on the European Medicines Agency (EMA) resulted in unlawfully accessed documents, related to COVID-19 medicines and vaccines, being leaked on the internet. The TGA is aware that this included internal/confidential email correspondence relating to evaluation processes for COVID-19 vaccines. The TGA understands some correspondence may have been manipulated by the perpetrators prior to publication in a way which could undermine trust in vaccines. The TGA has no role in verifying the authenticity of the documents nor the allegations set out by the Senator in this question. This question should be directed to the European Medicines Agency.

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