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To: RideForever

Your statement is inaccurate. The amount of spike protein produced by the vaccine is short lived and negligible in quantity in comparison to the actual virus which is pumping out live virus covered in spike proteins.

The vaccine mrna has a 10 hour average half-life and and produces isolated spike proteins that can’t replicate on their own.


18 posted on 05/06/2021 12:34:36 PM PDT by Valpal1
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To: Valpal1
The vaccine mrna has a 10 hour average half-life and and produces isolated spike proteins that can’t replicate on their own.

It sounds like the isolated spike proteins are produced for 10+ hours by the vaccine, and the Salk report is showing that those may account for new diabetes cases and vascular disease symptoms. How long it takes to be 100% effective is how long the isolated spike proteins are produced.

19 posted on 05/06/2021 1:07:54 PM PDT by RideForever (One of the 'control group' ...)
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To: Valpal1

Here is Moderna’s findings on mRNA vaccine tissue distribution

2.3.3. Pharmacokinetics No dedicated ADME studies with mRNA-1273 were conducted, which is acceptable as generally nonclinical PK studies are not relevant to support the development and licensure of vaccine for infectious diseases. However, distribution studies should be conducted in the case of new formulations or novel excipients used. Accordingly, the biodistribution of the vaccine platform was evaluated with mRNA-1647 in a non-GLP, single-dose, intramuscular injection study in Sprague Dawley rats.

The objectives of this study were to determine the tissue distribution and pharmacokinetic characteristics of mRNA-1647 constructs following IM administration. mRNA-1647 contains 6 mRNAs, which encode the full length CMV glycoprotein B (gB), and the pentameric glycoprotein H (gH)/glycoprotein L (gL)/UL128/UL130/UL131A glycoprotein complex (Pentamer). The 6 mRNA are formulated at a target mass ratio of 1:1:1:1:1:1 in the Sponsor’s standard proprietary SM-102–containing LNPs. It is biologically plausible that the distribution of the mRNA vaccine is determined by the lipid nanoparticle content, whereas the influence of the mRNA itself is considered very limited. Therefore, it is acceptable that the biodistribution study was performed with the same lipid nanoparticles containing another mRNA (i.e. mRNA-1647). The amount of the LNPs in the test material differed slightly in particle size from the final vaccine formulation of mRNA-1273.

Even though it is not straightforward to understand the impact that the different particle size might have on mRNA tissue distribution, if any, nevertheless the liver distribution is not affected because the average diameter of endothelial fenestrae in the liver sinusoids in the test system (Sprague–Dawley rats) is 161 nm. The observed biodistribution with smaller LNP particle size should thus represent a worst-case scenario. A qualified multiplex branched DNA (bDNA) assay was used for determination of mRNA in various tissues in the biodistribution study conducted with mRNA-1647. The LLOQ of the method were set at 0.05 ng/mL for the gB mRNA and UL130 mRNA, and 0.01 ng/mL for the gH, gL, UL128 and UL131A mRNAs.

Following single IM injection at 100 µg mRNA-1647, subgroups of 5 rats were sequentially sacrificed pre-dose and 2, 8, 24, 48, 72, and 120 hours after dosing, for quantitation of 6 mRNA constructs in blood and a pre-specified set of organs/tissues. Concentrations of mRNA-1647 were quantifiable in the majority of tissues examined at the first time point collected (2 hours post-dose) and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma. Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye. Both tissues were examined in the frame of the toxicological studies conducted with mRNA-1273 final vaccine formulation. Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although to very low levels (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that liver is a common target organ of LNPs.

The T1/2 of mRNA-1647 was reliably estimated in muscle (site of injection), proximal popliteal and axillary distal lymph nodes and spleen with average T1/2 values for all vaccine components of 14.9, 34.8, 31.1 and 63.0 hours, respectively. mRNA-1647 was rapidly cleared from plasma during the first 24 hours with the T1/2 estimated in a range of 2.7 - 3.8 hours. The mean concentrations of all vaccine components became undetectable after 24 hours, except for gH, which was detectable up to the last time point of 120 hours but which was also detectable in 2 pre-dose plasma samples. The mRNA constructs were not measurable after maximum 3 days in tissues other than the muscle, lymph nodes, and spleen (~25 hours in brain). Reference with regards to the mRNA biodistribution is made to the respective adverse findings observed in rat spleens in toxicological studies. No adverse findings were detected in the ophthalmological examinations or the brain/CNS. No dedicated studies on absorption, metabolism, and excretion for mRNA-1273 have been submitted. This is generally acceptable with regards to the nature of the vaccine product.


20 posted on 05/06/2021 1:23:30 PM PDT by Cathi
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