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QUESTION ON NOTICE

Question:

49. The use of pseudouridine in mRNA vaccines was developed as a very recent concept and its long-term effects are unknown. It has however been known for 10 years that the use of pseudo-U causes the stop codons (required to stop adding amino acids to a protein chain) to misfunction, thereby elongating the protein chain and risking translation of the next segment (the 3’UTR) (Karijolich 2011). The effects of this are unknown and cannot be known without specific experiments to address the issue. When did the TGA become aware that the synthetic nucleotide pseudouridine was being used rather than the natural uridine and what testing did it undertake to ensure that it was safe to use? 50. Studies have shown the psuedouridine has a higher translation error rate than uridine. Wasn’t it reckless to roll out the vaccine knowing that? Improving the fidelity of uridine analog incorporation during in vitro transcription | bioRxiv (available at: www.biorxiv.org/content/10.1101/2022.04.12.488100v1)

Answer:

Question Number: 169
PDR Number: SQ22-000538
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 49 Both Therapeutic Goods Administration (TGA) provisionally approved Pfizer (COMIRNATY), and Moderna (SPIKEVAX) vaccines consist of N1-methyl-pseudouridine(Ψ) modified (N1- methyl-Ψ) mRNA encoding the SARS-COVID-19 spike protein. N1-methylpseudouridine is a naturally occurring modified nucleotide, that is highly abundant and naturally widespread in cells and its use does not change the features of the mRNA. Pseudouridine or N1-Methyl-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, available at:(https://pubmed.ncbi.nlm.nih.gov/30135514/, https://pubmed.ncbi.nlm.nih.gov/28251988/, https://pubmed.ncbi.nlm.nih.gov/34805188/ and https://pubmed.ncbi.nlm.nih.gov/34075344/). For identical reasons, N1-Methyl-Pseudouridine was used in the Pfizer (COMIRNATY) and Moderna (SPIKEVAX) mRNA vaccines to ensure translation efficiency, stability and safety of the mRNA vaccines. It has also been reported that N1-Methyl-Pseudouridine modified mRNA exhibits higher efficacy (more than 90% of efficacy against COVID-19 symptoms) as compared to the unmodified mRNA vaccines (lower than 50%) encoding the SARS-COVID-19 spike protein (available at: https://pubmed.ncbi.nlm.nih.gov/34145413/). To minimise any misreading risks associated with stop signals (ΨGAΨGA in Pfizer/BioNTech’s vaccine, and ΨGAΨAAΨAG in the Moderna’s vaccine), both mRNA vaccines use consecutive stop codons as a fail-safe mechanism, so that no frameshifting occurs if the first stop codon fails (available at: https://pubmed.ncbi.nlm.nih.gov/34805188/). Based on the knowledge and experience from decades of research and trials with mRNA therapeutics, the COVID-19 vaccine manufacturers were able to design an appropriate dosing regimen and threshold of doses ensuring the proper balance between immune responses and safety of these vaccines. Animal toxicology studies of the Pfizer and Moderna mRNA vaccines at doses 200-times higher than the human dose on a dose/body weight basis have not shown any safety concerns. Question 50 See response to Question 49.

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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.

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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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