Question Number: 167
PDR Number: SQ22-000536
Date Submitted: 21/11/2022
Department or Body: Department of Health
Question 45 Based on the currently available literature on mRNA-based vaccines and studies with the Pfizer COVID-19 vaccine, vaccine mRNA and antigen protein are expected to be degraded by multiple endogenous pathways. A whole-body imaging study with a surrogate, luciferase expressing mRNA indicated that the mRNA and translated antigen protein were mainly localised at the injection site, distributed in liver, and nearly completely degraded in nine days. In mice injected with the luciferase mRNA, the absence of expressed protein by nine days after dosing indicates that mRNA has been degraded. Safety of the vaccines was demonstrated by animal toxicity studies at very high vaccine doses, in clinical trials in human subjects, and from worldwide vaccination programs.
Question 46 See response to question 45.
Question 47 In regard to the persistence of the spike protein – See response to question 45. N1-methylpseudouridine is a naturally occurring modified nucleotide, highly abundant and naturally widespread in cells. The fate of N1-methylpseudouridine in the mRNA vaccines should be the same as the natural methylpseudouridine. See also response to question 49, SQ22-000538. N protein is not expressed by COVID-19 mRNA vaccines. Further, clinical trials and post-market surveillance showed no evidence of long COVID from vaccination. Importantly, vaccination reduces the incidence and severity of COVID infection and of long COVID.