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QUESTION ON NOTICE

Question:

21 November 2022

174. Will the Health department run a study to determine if Covid antibodies are higher in the vaccinated or unvaccinated? If not, why not – isn’t this critical to determine the long term of effects of multiple Covid vaccines on the immune system to find out if repeated vaccine shots lower the body’s immune defences? 201. Has the TGA or the sponsor tested the modifications to the mRNA in the vaccine spike protein to ensure that it is capable of being broken down by the body’s immune system? If so, can studies please be provided and the number of days taken to break down the spike protein be stated? 269. How much confidence is there that the proline insertions keep the spike protein in its prefusion shape? What studies have been completed that demonstrate this? Does the TGA accept that if the spike is not replicated in its prefusion shape then the immune system will recognise it as a different pathogen to the virus spike protein?

Answer:

Question Number: 205
PDR Number: SQ22-000575
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 174 The Therapeutic Goods Administration (TGA) does not conduct clinical trials or serological surveys on any medicine or vaccines, however the TGA is aware that studies to assess immunity derived from both vaccination and natural infection (or a hybrid of both) are ongoing. We refer the Senator to serosurveillance studies conducted by the National Centre for Immunisation Research and Surveillance in Sydney (available at: www.ncirs.org.au/covid-19/serosurveillance-sars-cov-2) which address antibody levels in different cohorts. The TGA is not aware any reputable evidence to support the view that vaccination against COVID-19 lowers the body’s immune response to the virus. On the contrary, there is a large amount of evidence to support the fact that protection against COVID-19 increases with recommended additional doses. In addition, there are a number of published studies which demonstrate that protection against serious infection is greatest in those who have had both a SARS-Cov2 infection and several doses of mRNA vaccines.

Question 201 The degradation of protein in the human body is well understood. Proteins are broken down reasonably rapidly to small peptides and amino acids through proteolysis by proteases. Natural or synthetic proteins (such as therapeutic proteins and vaccine antigens) are metabolised by the same pathways. It is internationally agreed that studies on the degradation of therapeutic proteins such as monocloncal antibodies (e.g. trastuzumab) and vaccine antigens (e.g. flu vaccines) are not required for the registration of therapeutic proteins or vaccine antigens (ICH guideline S6 (R1) – preclinical safety evaluation of biotechnology-derived pharmaceuticals (available at: https://database.ich.org/sites/default/files/S6_R1_Guideline_0.pdf as used by all major medicines regulators). Therefore, no specific studies on the degradation of spike protein synthesised from spike protein mRNA, were required or provided.

Question 269 Numerous published studies and submitted data have shown that the two proline substitutions stabilise the spike protein in its pre-fusion form (for example, Corbett, K.S., et al. (2020). Nature 586: 567). COVID-19 vaccines were designed to induce antibodies targeting the prefusion form of the spike protein to block the virus from attaching to and entering into human cells. Irrespective of whether the spike protein is expressed in the prefusion conformation or post-fusion form, it is only a very small fragment of the virus and it is not a pathogen. The prefusion or post-fusion form of the spike protein remains a protein derived from the coronavirus, not from a different virus.