Why are pharmaceutical companies not responsible for manufacturers, have never been approved by clinical trials, and are not guaranteed or compensated?

Ari Shika 2021/08/10 15:25

The core of the problem (why pharmaceutical companies take no manufacturer responsibility, have never been approved by clinical trials, and are not guaranteed or compensated),
ADE (Anti-Body Dependent Enhancement).

This is the most important point from the beginning, but let's repost what is well known in the field. And the latest information from Israel and the United Kingdom is exactly that (vaccination is causing a new pandemic).

"Discovery of antibody that enhances infection with new coronavirus-may be involved in the aggravation of COVID-19-"
Osaka University, Japan Agency for Medical Research and Development
【point】
㋐ It was discovered that when infected with the new coronavirus, not only neutralizing antibodies that prevent infection but also antibodies that enhance infection (infection-enhancing antibodies) are produced.
㋑ It was found that when the infection-enhancing antibody binds to a specific site of the peplomer of the new coronavirus, the antibody directly causes a structural change of the peplomer, and as a result, the infectivity of the new coronavirus becomes high.
㋒ Infection-enhancing antibodies have been found to diminish the protective effect of neutralizing antibodies.
㋓ High production of infection-enhancing antibody was observed in severely ill patients with new coronavirus infection (COVID-19). It was also found that even non-infected persons may have a small amount of infection-enhancing antibody.
㋔ By analyzing the production of infection-enhancing antibodies, it may be possible to test people who are prone to aggravation. The results of this research are also important for the development of vaccines that do not induce the production of infection-enhancing antibodies.

Source URL:

https://www.amed.go.jp/news/release_20210525-02.html

"We have discovered that when infected with the new coronavirus, not only neutralizing antibodies that prevent infection but also antibodies that enhance infection (infection-enhancing antibodies) are produced. 』\
In other words, even if the COVID-19 vaccine is inoculated, in some cases, an antibody (infection enhancement antibody) ADE = antibody dependent enhancement that does not weaken the activity of the COVID-19 virus and enhances infection can be produced.

It is hoped that a vaccine that cannot enhance infection (infection-enhancing antibody) ADE = antibody dependent enhancement can be developed.

* 1: RBD (Receptor Binding Domain)
The Receptor Binding Domain is the region where the spike protein (Spike) of the new coronavirus binds to ACE2, which is a cell receptor. RBDs with closed structures have low binding to ACE2, but more RBDs with open structures have higher binding to ACE2 and become more infectious.

* 2: ACE2
Cell surface receptors when the new coronavirus infects cells.

* 3: NTD (N-Terminal Domain)
The N-Terminal Domain is the N-terminal region of the amino acid of the spike protein (Spike), and its function is not well understood.

* 4: Antibody-dependent enhancement of infection (ADE)
A phenomenon in which infection is enhanced by the binding of antibodies to virus particles. Until now, it was thought that when an antibody binds to virus particles, the virus easily infects certain immune cells expressing the Fc receptor * 5, which is the receptor for the antibody. The antibody-dependent enhancement of antibody-dependent enhancement seen in dengue virus and the like is mediated by the Fc receptor, but this study clarified for the first time the mechanism of Fc receptor-independent antibody-dependent enhancement of infection.

* 5: Fc receptor
It is a receptor expressed on the surface of some immune cells, binds to antibodies attached to pathogens such as viruses, and is involved in the activation of immune cells.

<< Summary >>
"
While antibodies play an important role in virus infection protection, it is known that antibodies against viruses exacerbate infection, and this phenomenon is said to be antibody-dependent enhancement (ADE) * 4. ADE is known as dengue virus, etc., and once infected with dengue virus, if infected with a different type of dengue virus, it may be aggravated by the antibody produced by the initial infection. It has also been reported that an antibody against the virus is an exacerbating factor in feline infectious peritonitis virus, which is one of the coronaviruses. It has been thought that the Fc receptor expressed by certain immune cells is involved in the enhancement of infection by these antibodies. That is, when an antibody bound to a virus particle binds to a cell's Fc receptor, virus infection is triggered via the Fc receptor. However, since infection via these Fc receptors is limited to specific immune cells expressing the Fc receptor, it has been considered that they are not significantly involved in the infection of many cells in the body. ..

Therefore, in this study, in order to elucidate the function of antibodies produced in COVID-19 patients, 76 types were prepared by expressing antibody genes against spike proteins cloned from immune cells of COVID-19 patients in human cells. The function of the antibody against the peaplomer was analyzed in detail. As a result, there are antibodies that increase infectivity to Fc receptor-independent simply by binding to virus particles, unlike the previously known enhancement of antibody-dependent infection via Fc receptors * 5. It became clear.
"

<< Photo >> You can think that it is a deception to hit the vaccine without touching ADE. Ask the following basic questions. (I can't answer. The answer is ADE. The story of the toxicity of the spike protein itself (which creates blood clots) is different.)
・ Why pharmaceutical companies do not take manufacturer responsibility
・ Why hasn't mRNA been approved for clinical trials (over 20 years) even though it is not a new technology?
・ Why no one gives any guarantee or compensation? (Causality is not proven, insurers will not compensate once the causality is clear. That's why clinical trials and approvals aren't approved.)