Thread by @RayArmat

Thread:
Some Phramacokinetics, Geno- & Reprotoxicity highlights, Moderna's report to EMA, mostly animal studies
ema.europa.eu/en/documents/a…
P. 47: "Low levels of #mRNA could be detected in all examined tissues except the #kidney, this included heart, lung, testis & also ..

2./ #brain tissues, indicating mRNA/LNP platform crossed the blood/brain barrier..liver is a common target organ of LNPs.."
P. 49: ".. coagulation changes included increase in fibrinogen, activated partial thromboplastin time .".
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P. 50, Genotoxicity: "significant

3./ increases in micronucleated erythrocytes were reported in both sexes" (Note: chance of genetic chromosomal damage to red blood cells)

P. 51, ReproToxicity: "The mRNA-1273-related non-adverse effects were limited to an increase in the number of foetuses with common skeletal

4. variations of 1 or more rib nodules & 1 or more wavy ribs.. The overall pregnancy index was numerically lower in mRNA1273 vaccinated female rats (84.1%), compared to control animals (93.2%), but remains within the Test Facility’s historical control range (low range being 75%)"

5./P. 53-54: "A decrease of RBC mass.. were noted.. Hepatic alterations.. were frequently observed.. The observed eosinophil increase in rat LNP-mRNA studies could therefore be potentially clinically relevant... Decreasing lymphocyte counts.. decreased lymphoid cellularity..

6./ and/or single cell necrosis of #lymphocytes in the spleen, mesenteric lymph nodes, and in the thymus"

P. 115-116: "2 SAEs of deep vein #thrombosis in the mRNA-1273 group (none in the placebo group). .2 SAEs of embolic stroke (none in placebo)..The Investigator did not ..

7./ consider these events as treatment related.. The other deaths which were reported in
participants who received mRNA-1273 included #suicide, head trauma due to fall, multisystem organ
failure, and death due to unknown causes. None of the deaths were assessed by Investigator ..

8./ as related to study product.

#pandemic #immunology