243. Luciferase and the covid spike protein are completely different – what evidence do you have that just because Luciferase breaks down in 9 days the same goes for the spike proteins? 252. How heavy should the vaccine spike protein be? Was it tested for quality control and if so, what was the acceptable margin of error – if not, why not?

Question Number: 242
PDR Number: SQ22-000612
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 243 Luciferase protein and Pfizer’s COMIRNATY expressed spike protein are both protein macromolecules with large 3-dimensional molecular structures. The viral spike (S) protein of SARS-CoV-2 is reported in the literature as having a molecular weight of 143 kDa (deglycosylated form). The degradation of proteins is well characterised and understood. Proteins are broken down 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 monoclonal 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, available at: https://database.ich.org/sites/default/files/S6_R1_Guideline_0.pdf). The recommended dosing regimen for Pfizer mRNA vaccination in humans is two doses at least 21 days apart and a booster dose at least six months after the completion of a COVID-19 vaccine primary series. Given the recommended vaccination doses are so far apart, it is highly expected that the expressed spike protein from one vaccination will not be present at the site of injection in any significant quantity when next dose of vaccine is administered. See also response to question 204 in SQ22-000580.

Question 252 See response to question 243. Pfizer COVID-19 BNT162b2 vaccine express modified spike protein in vivo after intramuscular administration of vaccine. The quality control of mRNA encoding for the spike protein is controlled by drug substance specifications. The quality attributes included in drug substance specifications are clarity, coloration, pH, RNA concentration, identity of encoded RNA sequence, RNA integrity, 5’-Cap, poly(A) tail, residual DNA template, dsRNA, bacterial endotoxin and bioburden. Similarly, the quality of drug product (i.e. COMIRNATY vaccine) is controlled by various attributes included in specifications. All the vaccine batches to be released in Australian market are tested for compliance with approved specifications ensuring quality of every batch. See also responses to questions 204 in SQ22-000580 and 243 in SQ22-000612.