- metadata:
- source: https://www.youtube.com/watch?v=fVNFFtmb9gA
- people:
- [[Dr. John Campbell]]
- related:
- [[2023-03-25 Senator Rennick full interview - Dr. John Campbell]]
- [[TGA Pfizer - Nonclinical Evaluation Report 2021-01 foi-2389-06.pdf]]
---
<iframe width="560" height="315" src="https://www.youtube.com/embed/fVNFFtmb9gA" title="YouTube video player" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture; web-share" allowfullscreen></iframe>
YOUTUBE
https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4
TGA knew
[03:58](https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4#t=238.117647) systemically distributed throughout the body.
https://youtu.be/fVNFFtmb9gA&t=238
[04:49](https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4#t=289.193395) mainly into the liver, adrenal glands, spleen and ovaries
[06:16](https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4#t=376.771069) spike protein distribution was not studied. they did not study the amount of spike produced throughout the body
[07:39](https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4#t=459.435115) conclusions the TGA drew: *Slow but significant distribution of lipid nanoparticles from the site of injection with **major uptake into liver**.*
[09:45](https://ce32172b.s3.ap-southeast-2.wasabisys.com/Australian%20government%20biodistribution%20data%20-%201080p.mp4#t=585.290713) concentration in various organs, including bone marrow
Tissue distribution (lipid nanoparticles encapsulation RNA)
(Page 44)
Rats after i.m. vaccine injection
The concentration of radioactive lipid marker reached the peak level in plasma (8.9 μg lipid eqv/mL),
between 1 – 4 h post-dose,
and distribution mainly into liver, adrenal glands, spleen and ovaries over 48 h
Concentrations were higher in plasma than in blood, with mean blood: plasma ratios of 0.5 – 0.6.
DISTRIBUTION (page 40)
The distribution of LNP-BNT162b2 (V9) mRNA or expressed S protein was not studied.
Table 4-2. Mean concentration of radioactivity (sexes combined) in tissue and blood following a single IM dose of 50 μg mRNA/rat
(page 45)
Mean total radioactivity was greatest at the injection site followed by the liver,
with much lower total recovery in spleen, adrenal glands and ovaries
The tissue distribution pattern was similar in 100 μg mRNA/animal dose group as noted above for 50 μg mRNA/animal dose,
with highest distribution into liver, adrenal glands and spleen.
Conclusions
Slow but significant distribution of lipid nanoparticles from the site of injection with major uptake into liver.
Minor distribution in spleen, adrenal glands and ovaries over 48 h.
Mean blood:plasma ratios of 0.5-0.6 indicating nanoparticles mainly present in plasma fraction of blood with peak concentrations in plasma at approx. 2 h post-dose.
Liver concentrations over time
25 mins 0.74
1 hour 4.62
2 hours 10.97
4 hours 16.55
8 hours 26.54
24 hours 19.24
48 hours 24.29
METABOLISM
(page 46)
In vitro studies indicated minor metabolism of ALC-0159 and ALC-0315 in liver, with most of the lipids found unchanged at the end of the 2 or 4 h incubation period