15. The TGA/ Prof Skerritt has previously said the mRNA breaks down in minutes to hours yet they quote the International Coalition Medicines of Regulatory Agencies in FOI 3220 which says mRNA can break down in weeks after vaccination – so which is it and why is there such variation in understanding? 16. When does the mRNA actually break down – it’s been shown to hang around for 60 days and when does the spike protein break down – and when do the lipids break down- is there a definite end date – if not why not? 17. When do the spike proteins created by vaccine mRNA break down – studies have shown they remain in the body up to 15 months after the shot?

Question Number: 156
PDR Number: SQ22-000525
Date Submitted: 21/11/2022
Department or Body: Department of Health

Question 15 The half-lives of native mRNA in mammalian cells range from minutes to hours, depending on many factors such as transcript function and cell type. Due to the rapid degradation of mRNA, vaccine mRNAs are delivered in lipid nanoparticles, which protect the mRNA from being broken down by nucleases and which help to deliver the mRNA into cells. Thus, the degradation of vaccine mRNA is slightly slower than the decay of some native mRNAs (see information on COVID-19 vaccine RNA breakdown in the response to Question 16 below).

Question 16 There are no data specifically on the degradation of COVID-19 vaccine mRNAs in laboratory animals or humans. The mRNA of an experimental flu vaccine has an elimination half-life of 19 hours at the intramuscular injection site and 25 h in draining lymph nodes in mice (Bahl K.J. et al. (2017) Mol. Ther. 25: 1316). The mRNAs in an mRNA-based cytomegalovirus vaccine developed using the same platform as for the Moderna COVID-19 vaccine was rapidly eliminated from tissues with half-lives of 15-60 h in rats. The vaccine mRNAs were mainly retained at the injection site, with moderate distribution to local lymph nodes and spleen; only a relatively small fraction of the administered mRNA dose was distributed to distant tissues. The mRNA constructs did not persist beyond one to three days in tissues except for the injection site muscle, lymph nodes and spleen (where very small amounts were detectable at five days). Spike protein breakdown was discussed in the response to Question 17. Lipid nanoparticles (LNP) are broken down just like any other lipids in the human body. Animal studies showed that ALC-0159 (PEG-lipid, one component of LNPs in the Pfizer vaccine) was completely eliminated in 14 days, while ALC-0315 (another lipid component) was still detectable in the liver but the level was significantly lower within 24 hours of dosing, indicating elimination from the body. Repeat dose toxicity studies in rats with the Pfizer vaccine formulation with the LNP doses approximately 100 times the human clinical dose, showed no systemic toxicity.

Question 17 There are no distribution and degradation data on the spike protein synthesised from COVID-19 vaccine mRNA. A whole-body imaging study with a surrogate, luciferase expressing mRNA in mice indicates that the mRNA and translated antigen protein are nearly completely degraded in nine days. The Infectious Disease Society of America estimates that the spike protein generated by COVID-19 vaccines last up to a few weeks maximum, like other proteins made by the body (available at: www.idsociety.org/globalassets/idsa/publichealth/covid-19/real-time-learning-network-vaccines-faq.pdf, page 12). We do not believe there are credible studies showing protein persistence for 15 months.