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QUESTION ON NOTICE

Question:

21 November 2022

229. As per the TGA non-clinical report – “there was very mild inflammation of lung tissues in both the control and vaccinated group 7 or 8 days after challenge with no difference in the inflammation score.” Given these results how can the TGA say the vaccine reduced lung infections from Covid? 234. The non-clinical report noted that the potential of vaccine to induce cytokine release was not adequately assessed in non-clinical trials. Why did the TGA approve the vaccine given such a risk was not properly understood? 235. On page 34 and page 35 pf the TGA non-clinical report the transfection and expression rates of the modified mRNA’s are much higher – isn’t that proof that the vaccine is much more pathogenic and infectious than the virus? 241. Why didn’t the TGA mention the use of methylpseudouridine in the non-clinical report? 245. In Section 2.4 on page 36 of TGA non-clinical report the structure of the spike protein is redacted – why is that?

Answer:

Question Number: 239
PDR Number: SQ22-000609
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 229 The efficacy of the COVID-19 vaccine was determined in several non-clinical and clinical studies by analysing a number of parameters including viral RNA load and radiographic analysis of lungs. In this case, the vaccine protected monkeys from infection when challenged 55 days after the second vaccine dose, based on evidence of decreased viral RNA load and radiographic lung lesions in the immunised animals. Monkeys and other animals do not exhibit exactly the same symptoms and pathology of COVID-19 infections as humans. Animal models develop milder lung diseases than humans from COVID-19 infection. Similar microscopic lung inflammation observed in both challenged control and immunised animals on day seven or eight after virus challenge does not mean that the vaccine was ineffective. The Senator is confusing (mild) inflammation with infection. See also the response to Question 97 (SQ22-000557).

Question 234 It was noted in the non-clinical report that the potential of the vaccine to induce cytokine release was not assessed in these non-clinical trials. This is not a routine requirement in medicine and vaccine non-clinical development, except for certain medicines in drug families that are known to potentially induce cytokine release. However, information obtained from the clinical trials of the vaccine in humans indicated that the risk posed by cytokine induction was not of significance.

Question 235 There is some confusion around the biochemistry and immunology here. Higher translation and expression rate is not associated with pathogenicity, rather it indicates better antigen (spike protein) expression. The expressed spike protein is not a pathogen and is not infectious. The spike protein is only one component of the coronavirus. It serves as an antigen to induce humoral and cellular immune responses against SAS-CoV-2 virus.

Question 241 The Therapeutic Goods Administration mentioned in the report that the Pfizer COVID-19 vaccine is a nucleoside-modified mRNA vaccine. The modification includes introduction of methylpseudouridine into the mRNA sequence, which is noted in multiple published articles.

Question 245 The redacted information is not the spike protein structure but related to other commercially sensitive information.