73. Given Pfizer understated the injuries of Maddie De Garay in the initial Pfizer trial why does the TGA believe that Pfizer won’t understate the injuries incurred by children in the childhood vaccine rollout? 211. Given Pfizer classified Maddie De Gary as stomach issues how does the TGA know other severe reactions from the initial Pfizer trial weren’t understated?
Question Number: 170 PDR Number: SQ22-000125 Date Submitted: 24/02/2022 Department or Body: Department of Health The Therapeutic Goods Administration (TGA) has comprehensively evaluated each of the provisionally registered COVID-19 vaccines, including Pfizer’s Comirnaty, to ensure that they meet Australia’s high standards of safety, quality, and efficacy. As part of this process, the TGA must first […]
Has the TGA investigated the relationship between adverse events and whether or not aspiration of the needle occurred when the inoculation occurred?
Question Number: 174 PDR Number: SQ22-000137 Date Submitted: 24/02/2022 Department or Body: Department of Health The Therapeutic Goods Administration (TGA) has not investigated whether aspiration of the needle was performed in cases where adverse events were reported. Information about whether immunisers aspirated needles before injection is not usually included in adverse event reports.
Could all the minutes of meetings of the Advisory Committee on Vaccines over the last two years please be provided?
Question Number: 113 PDR Number: SQ22-000185 Date Submitted: 24/02/2022 Department or Body: Department of Health The minutes of meetings of the Advisory Committee on Vaccines (ACV) are not released as they contain commercial-in-confidence information. However, the Therapeutic Goods Administration (TGA) is currently processing an FOI request that will result in the release of some of […]
Does the TGA/ATAGI believe it is necessary to aspirate when inoculating? If not, why not?
Question Number: 196 PDR Number: SQ22-000250 Date Submitted: 24/02/2022 Department or Body: Department of Health Some scientific reports have proposed that inadvertent injection of a COVID-19 vaccine into a blood vessel may be a contributing cause of serious adverse events following immunisation, such as thrombosis with thrombocytopenia syndrome (TTS) and myocarditis. Based on a review […]
The NSW government doesn’t count a person as being vaccinated until 21 days after the receiving the first dose of the vaccine. Is it therefore correct to say it takes three weeks for the vaccine to work against the Covid virus?
Question Number: 123 PDR Number: SQ22-000254 Date Submitted: 24/02/2022 Department or Body: Department of Health The COVID-19 vaccines being administered in Australia require two doses to provide the best immunity. The first dose helps the immune system create a response against SARS-CoV-2, the virus that causes COVID-19, with the second dose boosting the immune response […]
Are there support groups for mothers who had the Covid vaccines and now need additional support for their babies who require additional medical support because their babies have been impacted by the vaccine?
Question Number: 124 PDR Number: SQ22-000255 Date Submitted: 24/02/2022 Department or Body: Department of Health Real-world evidence has shown that the Pfizer and Moderna COVID-19 vaccines are safe for women who are pregnant and breastfeeding. COVID-19 vaccination may provide indirect protection to babies by transferring antibodies through the placenta (during pregnancy) or through breastmilk (during […]
In the Freedom of Information request 3604 the TGA did not examine any documents relating to the composition of the final protein product produced following the injection of the Pfizer vaccine into humans. How can the TGA guarantee the safety of the Pfizer vaccine if no quality assurance has been performed around the composition of the protein that has been programmed to be mass produced by the body on an indeterminate basis?
Question Number: 187 PDR Number: SQ22-000202 Date Submitted: 24/02/2022 Department or Body: Department of Health The safety of a vaccine cannot be assessed by the composition of the protein alone. Safety must be assessed in human clinical trials. The safety of the Pfizer COVID-19 vaccine was assessed through the actual use of the vaccine, first […]
250. Given Pfizer unblinded the Covid-19 vaccine control group after two months, when normally (sic) time frame is closer to three years how can the TGA justify relying on data that has not been genuinely benchmarked against a control group? 251. Given that the control group was unblinded after two months why does the TGA continue to say that the Pfizer trials were the gold standard in clinical testing?
Question Number: 167 PDR Number: SQ22-000194 Date Submitted: 24/02/2022 Department or Body: Department of Health All data from the pivotal trials for each of the provisionally approved COVID-19 vaccines were genuinely benchmarked against a control group. All pivotal studies were conducted with a placebo (or active control) group to determine comparative efficacy and safety. The […]
248. Re the post marketing surveillance data while the total number of injuries is known the total number of people who had been given the vaccine is not? Does the TGA know the population size of the circa 44,000 injuries? If not, why not – shouldn’t have the TGA asked Pfizer for it by now?
Question Number: 177 PDR Number: SQ22-000193 Date Submitted: 24/02/2022 Department or Body: Department of Health This question appears to be referring to the 42,086 case reports in the Pfizer report submitted to the United States Food and Drug administration (US FDA) and released under FOI in the US available at: https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf. The Pfizer report does […]
Why is myocarditis written off (sic) a mild injury that people can recover from when it (sic) fact it can cause sudden death, premature death and permanent damage to the heart muscle thus restricting the victims ability to pump oxygen and other nutrients around their bodies for the rest of their lives?
Question Number: 117 PDR Number: SQ22-000191 Date Submitted: 24/02/2022 Department or Body: Department of Health The Therapeutic Goods Administration (TGA) has, and continues to, provided accurate and balanced information about the seriousness of myocarditis following COVID-19 vaccination. This information is based on the TGA’s analysis of Australian adverse event reports, as well as a growing […]
