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1 vote
tchakpoum 3 janvier 2022 20:59


causant des effets secondaires fréquents car leur méthode génère la production de spike dans les organes comme le cerveau, les ovaires ou le cœur au lieu de rester dans la zone d’injection

Sources ?

https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf page 54
Biodistribution : Several literature reports indicate that LNP-formulated RNAs can distribute rather nonspecifically to several organs such as spleen, heart, kidney, lung and brain. In line with this, results from the newly transmitted study 185350, indicate a broader biodistribution pattern with low and measurable radioactivity in the ovaries and testes. Given the current absence of toxicity in the DART data, the absence of toxicological findings in gonads in the repeat-dose studies and that the radioactivity in the gonads were low (below 0,1% of total dose), the current data does not indicate it to be a safety concern. The relative high dose used in the rats (500x margin to human dose based on weight) also supports a low risk from distribution to the gonads in humans.
https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf  page 52
The evaluation of mRNA-1273 tissue distribution was based on a rat biodistribution study using a similar mRNA-based vaccine encoding CMV antigens (mRNA-1647). The non-GLP status and no inclusion of female rats do not qualify this study as pivotal, which is not considered critical, given the general acceptance of platform approach for evaluating the toxicology profile of mRNA-1273.
Following single IM injection at 100 µg mRNA-1647, the plasma and tissue pharmacokinetics and tissue distribution were assessed in blood and a pre-specified set of organs/tissues for a period of 120 hours. A qualified branched DNA (bDNA) multiplex method was used.
As expected, mRNA-1647 were distributed throughout the body (including brain, heart, lung, eye, testis), and were rapidly cleared from plasma during the first 24 hours, with the T1/2 estimated in a range from 2.7 to 3.8 hours. The highest mRNA-1647 concentrations were at the injection site.
Following plasma clearance, proximal and distal lymph nodes and spleen are the major distant organs to which mRNA-1647 distributes. For these highly exposed tissues, Cmax was between 2 and 24 hours post-dose, and T1/2 was 14.9 hours for muscle of site of injection, 34.8 hours for proximal lymph nodes, 31.1 hours for distal lymph nodes, and 63.0 hours for spleen. Liver distribution of mRNA-1647 was also evident, consistent with the recognised LNP distribution pattern.
Même document, page 47
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

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