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QUESTION ON NOTICE

Question:

21 November 2022

203. Professors from UCLA and Stanford have highlighted the risk of vaccine injuries at 11 in 10000. How can the TGA refute these prestigious institutions – Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials by Joseph Fraiman, Juan Erviti, Mark Jones, Sander Greenland, Patrick Whelan, Robert M. Kaplan, Peter Doshi :: SSRN 219. In a previous QON the TGA stated “Since these vaccines were granted provisional approval, more than 11 billion people have received doses of COVID-19 vaccines worldwide. Data on real-world use of the COVID-19 vaccines approved in Australia provides reassurance about their safety and that the trials were carried out correctly. This is supported by reviews of safety data by international medicines regulators in countries with extensive COVID-19 vaccine experience who have found no new safety concerns associated with the use of COVID-19 vaccines. In addition, the TGA’s monitoring program has not detected any new safety signals in relation to COVID-19 vaccines to date?” This reply is a blatant lie that will be reported for contempt. A number of side effects have been reported such as myocarditis and heavy menstrual bleeding. Why is the TGA covering up serious side effects from the mRNA Covid vaccines? 280. Given the Covid vaccine trials were so short in duration why does the TGA take the sponsors word as to what side effects are and ignore real world data being reported

Answer:

Question Number: 208
PDR Number: SQ22-000578
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 203 It is incorrect and misleading to infer that the paper by Fraiman et al ‘highlights the risk of vaccine injuries at 11 in 10000”. This paper was not designed to confirm vaccine-related harm and is not a formal harm-benefit analysis. The authors confirm that this preliminary analysis cannot be used to compare benefits and harms of vaccination programs for several reasons. The authors state that they only compared the number of individuals hospitalized for COVID-19 against the number of serious events. Some individuals experienced multiple events whereas hospitalised COVID-19 participants were likely only hospitalised once, biasing the analysis towards exhibiting net harm (or excess harm). Furthermore, most serious adverse events that contributed to the results in the paper are relatively common events in the background population and no individual patient data (or causality) assessments are completed as part of this analysis. The primary conclusion of the paper is the need for further analysis due to the limitations of the paper.

Question 219 This previous Therapeutic Goods Administration (TGA) statement is out of date and has been grossly misrepresented in the current question. Since 3 March 2021, the TGA has consistently published a vaccine safety report (previously published weekly and currently published fortnightly) for the Australian public which outlines current rates of adverse event reporting and identifies new safety issues identified by the TGA. This includes regular reporting on the rates of myocarditis and articles on emerging issues including menstrual disorders. The latest safety report can be found here: www.tga.gov.au/news/covid-19- vaccine-safety-reports/covid-19-vaccine-safety-report-17-11-2022#myocarditis-andpericarditis-with-mrna-vaccines

Question 280 The TGA’s vaccine safety monitoring system is rapidly detecting, investigating, and responding to emerging safety issues identified for COVID-19 vaccines. Health professionals and consumers form a key part of this system through the reporting of their experiences to the TGA. The TGA uses this data to look for patterns that may indicate an emerging safety issue for a vaccine. If a new issue is identified, the TGA undertakes appropriate regulatory action which may include updating the known adverse effects in the Product Information document for that vaccine. In addition, we agree that there is massive and global real world safety and effectiveness data on the vaccines now available, subject of a large number of publications in top-tier medical journals, which accurately depict the nature of and rates of serious adverse events. Outcomes of the TGA’s COVID-19 vaccine safety monitoring system are published fortnightly and are available at the link noted in response to question 219 above.