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QUESTION ON NOTICE

Question:

21 November 2022

8. Has any safety testing been carried out in either humans or animals to determine the side effects of receiving 5 mRNA vaccines? 9. How is it that any deaths with a positive covid test is classed as a Covid death regardless of cause while any death after a vaccine isn’t classed as a vaccine death? Given the vaccine is still only provisionally approved shouldn’t all deaths with 6-8 weeks of receiving a vaccine be treated as a vaccine death until proven otherwise? 10. What are the criteria for a death to be linked to a vaccine? 11. Health advice says the benefits outweigh the risks on having 3 jabs as a 16+ year old person who is otherwise healthy? Where are the trials/numbers that support this statement and how can the TGA/ATAGI say this when longitudinal, carcinogenic, genotoxicity and numerous other tests were not carried out? 12. Severe adverse injuries were only counted by Pfizer in their Covid-19 trial up to 1 month after 2nd jab leading to the number of vaccine injuries being understated. “Limitations of our study include that Pfizer’s SAE table did not include SAEs occurring past 1 month after dose 2. This reporting threshold may have led to an undercounting of serious AE’ in the Pfizer study” – Why does the TGA believe this is acceptable Quality Assurance when Professor Skerritt said on the Today show in early 2021 that serious injuries could occur up to 8 weeks after the vaccine? 13. What is the adverse injury run rate that the TGA considers acceptable for a safe vaccine/drug? What are the benchmarks for proving it was safe? 14. I note that the 6-month data from the Pfizer trials 20 people died in the inoculation group while 15 died in the placebo group. 5,241 had related adverse events in the vaccination group against 1,311 in the placebo group – 300% more, 262 had severe adverse events (interferes significantly with normal function) in the vaccination group v 150 in the placebo group – 75% more and 127 had a serious adverse event (hospitalisation or visit to ER) v 116 in the placebo group which is 10% more – so where exactly does the TGA and other health authorities come up with the statement that the vaccine was actually proven to be safe and effective?

Answer:

Question Number: 155
PDR Number: SQ22-000524
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 8 As previously stated in SQ22-000146, animal toxicity studies were conducted on the mRNA vaccines and reviewed in detail by the Therapeutic Goods Administration (TGA) before approval for human use. After up to four doses of the vaccines were administered there was no evidence of damage to the immune system or other organ systems. A recent UK study of the safety and efficacy of a fifth COVID-19 vaccine dose (available at: https://academic.oup.com/rheumatology/article/61/12/e360/6618544) showed that the fifth dose was safe and well tolerated, and increased neutralising antibodies in immunocompromised individuals. While ongoing safety continues to be closely monitored by the TGA, there is no credible evidence to suggest that subsequent booster doses carry any more risk than the primary dose series (first and second dose). Question 9 Response previously provided in SQ22-000108. Question 10 Response previously provided in SQ21-001136. Question 11 Prevention of severe illness from COVID-19 remains the primary goal of Australia’s ongoing COVID-19 vaccination program. Australian Technical Advisory Group on Immunisation (ATAGI) advises that booster doses of COVID-19 vaccines maintain optimal protection against infection with SARS CoV-2 as protection against SARS CoV-2 wanes over time. In making its recommendations and to ensure the benefits outweigh the risks, ATAGI draws on and considers information from a range of credible sources in relation to COVID-19 and vaccines.

All ATAGI statements include links to the best available medical evidence used to inform ATAGI’s booster advice:
• ATAGI statement about the need for additional doses of COVID-19 vaccines | Australian Government Department of Health and Aged Care (the department), available at: www.health.gov.au/news/atagi-statement-about-the-need-for-additional-doses-ofcovid-19-vaccines#_blank.
• www.health.gov.au/news/atagi-recommendations-for-use-of-pfizer-covid-19-vaccineas-a-booster-dose-in-adolescents-aged-16-17-years.
• www.health.gov.au/news/atagi-statement-on-the-omicron-variant-and-the-timing-ofcovid-19-booster-vaccination.

Question 12 This assertion is incorrect. Safety data for the Pfizer BNT162b2 (mRNA) COVID-19 vaccine has been collected well beyond one month after dose two. Details of the clinical trial data used to inform the decision to provisionally approve the Pfizer BNT162b2 (mRNA) COVID-19 vaccine are detailed in the Australian Public Assessment Report published on the TGA website, available at: www.tga.gov.au/sites/default/files/auspar-bnt162b2-mrna210125.pdf. In addition to the clinical trial data evaluated by the TGA, conditions of provisional registration for all new COVID-19 vaccines in Australia include submission of monthly safety summary reports for the first six months, and thereafter at the TGA specified interval, and six-monthly periodic safety update reports. These reports include summaries of global post-market safety data as summary of interval and cumulative data. In addition, the first people vaccinated in trials of the mRNA vaccines were vaccinated two ½ year ago, and the rollout commenced two years ago. There have been a number of longer-term real-world efficacy and safety studies now published covering very large groups of immunised people.

Question 13 Decisions to register a vaccine on the Australian Register of Therapeutic Goods (ARTG), and keep that product on the ARTG, are based on whether the overall benefit of the medicine is considered to outweigh the potential risks of its use. This acceptable rate of side effects for a product will depend on considerations such as the nature of the condition the product is used to prevent or treat, its effectiveness in preventing or treating the condition, the severity of the side effects, and whether the side effects can be minimised or avoided. Therefore, there is no predetermined rate of adverse effects that is used as a benchmark for determining the safety of vaccines.

Question 14 Response previously provided in SQ22-000015.