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QUESTION ON NOTICE

Question:

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?

Answer:

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 establish the acceptable safety, quality, and efficacy of the vaccine based on the comprehensive evaluation of a wide range of information. This includes clinical studies, non-clinical toxicological studies, chemistry, risk management and manufacturing information.

Clinical trials are a key part of the scientific evidence that are reviewed during the assessment of a new vaccine. The TGA requires well-designed trials of a sufficient length with a sufficient number of people who represent the people for whom the vaccine is intended. The results must demonstrate that the benefits of the vaccine greatly outweigh the risks. In addition, all clinical trials must comply with the Guideline for Good Clinical Practice to ensure that the results are credible and obtained ethically in the setting of informed consent where the rights of trial subjects are protected.

The decision to provisionally approve a vaccine is also informed by expert advice from the Advisory Committee on Vaccines (ACV), an independent committee with expertise in scientific, medical and clinical fields including consumer representation.

Based on the comprehensive data provided to the TGA, Comirnaty has been evaluated as effective and safe for use in adults, adolescents and children aged five years and above. These decisions were made by senior medical officers on the basis that the benefits of the vaccine outweigh any potential risks and is in keeping with current international data.
Australian Technical Advisory Group on Immunisation has also recommended the use of Comirnaty in these age groups.

The provisional approval of Comirnaty, as with all provisionally approved COVID-19 vaccines, is subject to certain strict conditions, such as the requirement for Pfizer to continue providing information to the TGA on longer term efficacy and safety from ongoing clinical trials and post-market assessment. These studies are ongoing and are continuing to gather data on longer-term safety and effectiveness to complement post-market monitoring and spontaneous adverse event data. It is anticipated that these will be completed between late 2021 and mid-2024. Continued approval of Comirnaty depends on this longer-term efficacy and safety data.

Given the number of vaccines administered to date (and the time that has passed since vaccination began), it is highly likely that serious side-effects would have been detected by now. The TGA continues to closely monitor adverse events reported in Australia, and evidence from the use of the vaccines in young people around the world, to identify and investigate possible emerging safety issues. This is the most comprehensive safety monitoring program of therapeutic goods ever conducted in Australia. Where the TGA confirm a safety concern, the TGA will take action, including informing health professionals and the public. For COVID-19 vaccines, that includes putting the latest information in our weekly safety report at: www.tga.gov.au/periodic/covid-19-vaccine-weekly-safety-report.

In addition, the TGA undertakes an independent assessment of every batch of vaccine supplied in Australia to ensure that it meets the required quality standards and publishes reports of suspected side effects on its website at: www.tga.gov.au/database-adverse-event-notifications-daen.

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HAVE YOUR SAY

LATEST QUESTIONS ON NOTICE

Senator RENNICK: Okay-last question. I had a conversation with Gavin Morris a couple of years ago about the way the ABC reports the increase in temperature from 1910. The ABC, like many other media organisations, reports the homogenised data without actually explaining the difference between the homogenised data and the raw data. Gavin Morris stressed that they reported the raw data. That is incorrect; the ABC reports the homogenised data. So I’ll ask this question again: why won’t the ABC distinguish between the raw data and the homogenised data, which is a different dataset to the actual observations recorded by the bureau? Mr Anderson: I don’t know the answer to that. I will need to take that on notice and provide a response to you. Senator RENNICK: Okay. I would like to point out that Gavin Morris did say last time that they reported the raw data and that they distinguished between raw and homogenised. I’ll stress this again, the ABC doesn’t, but I think in terms of full transparency they should.

Senator RENNICK: Do we have any costings for storage? How much will it cost, in terms of storage, to get to our 2030 target? Mr Duggan: A lot of this is, of course, private provisions. In fact, you’d hope that the vast majority of it was. Government has policies that would assist thatSenator RENNICK: That is fine, but we’re told every day that renewables are cheaper. I want that quote substantiated by proper costings, whether it’s funded publicly or privately, because it’s going to end up either out of the taxpayer’s pocket or on their energy bill. So I’m looking for costings just on storage. I want it on other issues as well, such as transmission, but I’m asking: do you have costings on that storage? Ms Brunoro: We’ll take that on notice. The difficulty with answering that question with any kind of precision is that, in terms of deep storage, it will relate to a number of technologies-it’s the same for deep and shallow. It will ultimately depend on the precise mix of those, but we can do things at a high level with respect to the nature of the type of storage that fits within that and provide some estimates to you. Senator RENNICK: So you don’t have definite figures at the moment? Mr Duggan: What we can do for you-and we’ll have to take this on notice-is look at the existing pipeline of projects that are underway and what the private proponents have told us about the cost of those things. We can add to that: through Rewiring the Nation or other policies that are helping to assist that, we can break down the government contribution to that. But we just don’t have all that detail in front of us. Senator RENNICK: I want government and private, because, ultimately, it going to cost the consumer through taxes or energy bills. But is that fair to say that that’s not completed yet? Mr Duggan: We will take that on notice and we’ll endeavour to do our best to come back to you.

Senator RENNICK: Thanks very much. Yet again, in terms of the overall modelling, have you got a breakout of how many turbines you need, how many solar panels you need to get to 82 per cent renewables? Ms Brunoro: Again, the Integrated System Plan does provide an indication of the type of the level of renewable energy, so just bear with us a second. Mr Peisley: Sorry, I don’t think we do have that figure in front of us. We’re happy to take it on notice and get it to you. Ms Brunoro: But if it gives you a sense of it, it’s nine times the amount of the existing variable renewable energy that currently is-well, as of when the last Integrated System Plan came out, it was operating in the NEM at that point. So that gives you the quantum ofSenator RENNICK: So nine times what? Ms Brunoro: Nine times. Senator RENNICK: Yes, but what? Ms Brunoro: The variable renewable energy that is currently in the National Electricity Market. Senator RENNICK: So what’s the cost of that? Ms Brunoro: Again, Senator, it depends on the mix of technologies that you’re going to deploy. There are some figures that we can pull out for you around what they roughly think around different-solar versus wind for instance. We can actually seek to provideSenator RENNICK: So can you give me some definite costings on that? Not now, but on notice?

1. According to the December 2020 update, Australia emitted 499 million tonnes of carbon dioxide equivalent to a 5 per cent decrease on 2019. Australia’s grasslands are estimated to be 440 million hectares and native forest 147 million hectares, a total of approximately 587 hectares. It is estimated forest and grasslands absorb between 0.5 and 2 tonnes of carbon per hectare. Assuming an average of 1 tonne of CO2 absorbed by these landscapes then isn’t Australia already at net zero? 2. Can the CSIRO provide a comprehensive roadmap of the work required for Australia to meet a 43% reduction in CO2 by 2030? This roadmap should set out the length of transmission lines, the number of transmission towers, the number of solar panels (for a given wattage), the number of wind turbines (for a given wattage), the number of batteries (for a given storage), the amount of lithium, copper, cobalt, nickel, concrete, and steel etc. needed to build the aforesaid generators and storage. It will need to include the amount of land needed for solar, wind, transmission, and storage products and the biodiversity offsets. Could the amount of CO2 required to build, recycle, or dispose of the aforementioned items also be included. Likewise, could the cost of building, recycling, and disposing of the aforementioned items also be clearly outlined. Biodiversity impacts such as increased tyre wear due to heavier batteries in cars, increased breaking distance on roadkill, impact on bats and birds from transmission lines and wind turbines, and removal of native flora and fauna due to land use should also be clearly outlined. 3. If the CSIRO cannot provide, can it state which department is responsible for maintaining and tracking the roadmap and refer the question onto them? 4. Could the change in Earth’s temperature as a result of Australia undertaking the 43% reduction in CO2 measures please be stated in order to ensure appropriate benchmarking and accountability if targets are not met? 5. Could the CSIRO confirm if every country uses the same methods to calculate CO2 emission and reductions? If not, why not? What guarantees are there under the Net Zero that Australia won’t be disadvantaged as a result of signing up to the Net Zero pledge?

1. Can the Department of Climate Change, Energy, the Environment and Water provide a comprehensive roadmap of the work required for Australia to meet a 43% reduction in CO2 by 2030. This roadmap should set out the length of transmission lines, the number of transmission towers, the number of solar panels (for a give wattage), the number of wind turbines (for a given wattage), the number of batteries (for a given storage), the amount of lithium, copper, cobalt, nickel, concrete, and steel etc. needed to build the aforesaid generators and storage. It will need to include the amount of land needed for solar, wind, transmission and storage products, and the biodiversity offsets. Could the amount of CO2 required to build, recycle, or dispose of the aforementioned items also be included? Likewise, could the cost of building, recycling, and disposing of the aforementioned items also be clearly outlined? Biodiversity impacts such as increased tyre wear due to heavier batteries in cars, increased breaking distance on roadkill, impact on bats and birds from transmission lines and wind turbines, and removal of native flora and fauna due to land use should also be clearly outlined. 2. If the Department cannot provide, can it state which department is responsible for maintaining and tracking the roadmap and refer the question onto them?

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