Question Number: 175
PDR Number: SQ22-000544
Date Submitted: 21/11/2022
Department or Body: Department of Health
Question 155 We are unclear about the source of the Senator’s claim that there have 20,000 serious injuries as it does not align with data held by states and territories of the Commonwealth (including the Therapeutic Goods Administration (TGA)). So we believe the assertion that there is a serious rate of one in 1000 is wildly inaccurate and a very significant overestimation. Note that injury rates cannot be calculated from spontaneous adverse event report numbers, and it is incorrect to use these data in this way. Publication of an adverse event report in the Database of Adverse Event Notifications does not mean that the vaccine caused the event. Prof Skerritt’s response in an interview with John Laws in June 2021 was in response to an assertion by Mr Laws that Mr Clive Palmer “really did represent misrepresent the facts and the figures” regarding deaths from the COVID vaccines. Mt Palmer had asserted that there had been 210 deaths caused by the vaccines whereas at the time of the interview of a few million people vaccinated there had been only one death associated with vaccination and small number of serious adverse events – hence a “few in a million”. The Department of Health and Aged Care (the department) stands by this statement as accurate at the time it was made.
Question 156 A Danish prospective cohort study (Nygaard et al) published in May 2022 in one of the world’s top medical journals, The Lancet estimated the incidence of multi-system inflammatory syndrome in children (MIS-C) at one in 3400 unvaccinated individuals after SARS-CoV-2 infection and 1 in 9900 vaccinated individuals. The estimated vaccine effectiveness against MIS-C after the delta variant was 94% in children aged five–17 years. Question 192 The study cited shows that adverse events seen in children aged six months to five years were mild-moderate, self-limiting and included irritability/crying, redness and/or swelling at injection site, fatigue, fever and muscle pain. Although eight serious adverse events occurred in the six-23 month vaccinated group, only one event was considered to be potentially vaccine-related by study investigators. Therefore, we do not agree with the inference from the Senator’s question that the rate was one in 200. This participant experienced fever and febrile convulsion and was also subsequently found to have a concomitant viral illness. Both fever and febrile convulsion are known adverse effects that are included in the Product Information for this age group. No participants in this age group discontinued the study due to adverse events. This study certainly does not alter the conclusion that the benefits of vaccination continue to greatly outweigh the risk of side effects.