Wpis z mikrobloga

Szczepionki użyte do badań kliniczny miały lepszą jakość, niż te komercyjne.

We cannot assume the results of the clinical trials apply to the products used in the general

population. To rapidly produce sufficient doses and to decrease production costs, the

manufacturing process used for the commercial roll-out of the vaccines is quite different than the

manufacturing process used for the clinical trials. In its rolling review in November 2020, the

EMA notes that there was a decrease in the purity of the mRNA. In the clinical trial batches, the

> intact mRNA was 78-83% pure, which was much higher than in the commercial batches at 60%.3

This difference is may be large enough to normally require confirmatory clinical trials. These

impurities included fragmented mRNA, and it is not yet known what effects these smaller mRNA

fragments (impurities) have in the body, since shorter spike protein fragments may be produced,

which may be release more readily into the circulation from vaccine transfected cells. Such

truncated fragments may lack the transmembrane domain at the back end of the spike protein,

which would normally anchor them to the cell membrane. At the time of conditional approval, the

allowable limits for fragmented mRNA was up to 50% in the final product.


We have little data on whether these fragmented mRNA result in harmful proteins or peptides

(small proteins) or if they induce autoimmunity (cause the body to attack itself). For example,

there can be as much as a 30% amino acids similarity between the spike protein and a human

protein called Syncytin-1, and although cross-reactivity of spike protein antibodies produced in

vaccinated individuals have not yet been directed towards Syncytin-1,11,12 autoimmunity often

takes years before they manifest in people.


https://www.canadiancovidcarealliance.org/wp-content/uploads/2022/11/22OC29_EMA-Analysis-of-BNT162b-Manufacture.pdf

#koronawirus #szczepienia
  • 1
  • Odpowiedz