53. Could the bio-distribution data in regard to lipid nanoparticles and spike proteins from Pfizer’s initial trial please be released? 54. If no bio-distribution data is available, then why wasn’t the distribution of these molecules tracked?

Question Number: 153
PDR Number: SQ22-000115
Date Submitted: 24/02/2022
Department or Body: Department of Health

Question 53

There was one study report on the tissue distribution of luciferase (used as a surrogate for spike protein) and one study report on the distribution of lipid nanoparticles provided to the Therapeutic Goods Administration (TGA) by Pfizer. The studies are:

• R&D Study Report No. R-20-0072: Expression of luciferase-encoding modRNA after IM application of GMP-ready ACUITAS lipid nanoparticle formulation.
Note: This study report is already in the public domain, published by the Japanese regulatory agency: www.pmda.go.jp/drugs/2021/P20210212001/672212000_30300AMX00231_I100_1.pdf)
The nonclinical evaluation report (redacted) for BNT162b2 [mRNA] COVID-19 vaccine (COMIRANTY™) – January 2021 from the TGA contains an evaluation of this study report. This evaluation report was published in response to a FOI request to the TGA. www.tga.gov.au/sites/default/files/foi-2389-06.pdf

• A Tissue Distribution Study of a [3H]-Labelled Lipid Nanoparticle-mRNA Formulation Containing ALC-0315 and ALC-0159 Following Intramuscular Administration in Wistar Han Rats.
Note: This study report has not been published by the TGA. However, the nonclinical evaluation report (redacted) for BNT162b2 [mRNA] COVID-19 vaccine (COMIRANTY™) – January 2021 from the TGA contains an evaluation of this study report. This evaluation report was published in response to a FOI request to the TGA: www.tga.gov.au/sites/default/files/foi-2389-06.pdf

Question 54

Studies containing the biodistribution data of the surrogate for the spike protein (luciferase) in mice and a lipid nanoparticle-mMRA formulation in rats are available. As noted in response question 53, an analysis of these studies was undertaken by the TGA. The nonclinical evaluation report (redacted) for BNT162b2 [mRNA] COVID-19 vaccine (COMIRANTY™) – January 2021 contains the TGA’s evaluation of these studies and is already available from the TGA: www.tga.gov.au/sites/default/files/foi-2389-06.pdf