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QUESTION ON NOTICE

Question:

128. Has the TGA assessed the risk of, and presence of micro-RNA sequences comprised within the Pfizer vaccine? 129. Has the TGA assessed the risk of and or presence of Stop Codon read- through arising as a result of the use pseudouridine in the Pfizer miRNA active ingredient? 130. Do the mRNA strands have stop codons embedded in them? If not, how will the cell stop producing spike proteins? 131. Has the TGA tested the quality of the mRNA strands in the vaccine to determine how many are mal-coded or damaged for every given inoculation? 132. Can the TGA guarantee that no other protein is transcribed by the mRNA vaccine other the purported Covid-19 spike protein? If not why not? 133. How many mRNA strands are in one dose of the Pfizer vaccine? 134. How can Pfizer/TGA guarantee that each does of the Pfizer vaccine will have the same number of mRNA strands?

Answer:

Question Number: 189
PDR Number: SQ22-000133
Date Submitted: 24/02/2022
Department or Body: Department of Health

Question 128

There is no evidence that the Pfizer COVID-19 mRNA vaccine COMIRNATY contains MicroRNAs (miRNA) or oncogenic miRNA. miRNAs are short RNAs of around 22 nucleotides. They exist naturally in animals and humans, and thousands of miRNA genes have been discovered in humans. The main function of miRNA is to downregulate gene expression by translational repression, mRNA cleavage and deadenylation. There is no evidence of a positive association of miRNA with adverse effects of COVID-19 vaccination.

Questions 129 & 130

The developers of Covid mRNA vaccines analysed the products of translation of the artificial mRNAs very carefully. They have introduced multiple stop codons in the vaccines to prevent readthrough of the termination codon. The COMIRNATY vaccine consisted of N1-methyl-pseudouridine (Ψ) modified (N1-methyl-Ψ) mRNA encoding the SARS-COVID-19 Spike protein featuring two consecutive UGA stop codons. These were included to minimise the risk the vaccine uses consecutive stop codons as a fail-safe mechanism, so that no frameshifting occurs when the first stop codon fails given an additional in-frame stop codon is expected to prevent the production of unintended proteins.

Pseudouridine has been used in the development of mRNA therapeutics including mRNA vaccines for many years with an aim to enhance RNA stability, antigen expression and adaptive immune responses and to reduce cytotoxicity of modified mRNA. For identical reasons, pseudouridine was used in the COMIRNATY mRNA vaccine to ensure translation efficiency, stability and safety of the vaccine. It has also been reported that N1-Methyl-Pseudouridine-modified mRNA exhibits higher efficacy as compared to the unmodified mRNA vaccines encoding the SARS-COVID-19 spike protein.

The probability of misreading of the vaccine mRNA is very low. Any unintended protein that might be produced would be eliminated from the body. Repeat dose toxicity studies in animal species with the vaccine at doses many times the human dose have indicated no vaccine-related safety risks except for local inflammatory reactions.

Question 131

The Therapeutic Goods Administration (TGA) undertakes laboratory testing on every batch of COVID vaccine, including mRNA vaccines, as part of the batch release assessment process. This includes testing for RNA integrity and identity which involves quantifying the amount of RNA ‘strands’ that are of correct length and sequence to be made into spike protein. A minimum amount of full-length RNA must be present in each batch to pass this test, additionally, the amount of fragment forms of RNA must be below a set specification. The specification limits set for these tests have been established as safe during the clinical development of the vaccine.

Question 132

The mRNA sequence in the mRNA vaccine encodes the spike protein only. There is no evidence of proteins, other than the spike protein being expressed from the vaccine mRNA.

See also response to Q129.

Question 133

Contained in the final vaccine product is the drug substance/active ingredient [mRNA], which is a synthesized, single-stranded, 5′-capped RNA based on the DNA sequence template (www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html and www.ncbi.nlm.nih.gov/pmc/articles/PMC8110223/pdf/jocmr-13-204.pdf). The amount of mRNA per dose is measured in weight rather than strands of mRNA. Each dose of COMIRNATY contains:

• 12 years and over: 30 μg of RNA in 0.3 mL.
• 5 to under 12 years: 10 μg of RNA in 0.2 mL.

Question 134

Each vaccine multi-dose vial contains an overfill to ensure that there is at least one to 1.5 extra doses in the vial to ensure that the end user is able to withdraw the appropriate amount for each dose.

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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.

29/11/2022

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.

28/11/2022

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?

28/11/2022

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?

23/11/2022

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?

21/11/2022

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