Dr. Gil Yosef Shachar
The following is a translation of Dr. Shachar’s article on his website חיסון לקורונה האם אפשר להיות רגועים שהוא באמת בטוח?
Vaccine for corona – Is it possible to claim that it is really safe?
By Dr. Gil Yosef Shachar (M.D.)
Before we talk about the safety of the vaccine, a few words about its effectiveness.
The companies that developed the vaccines, Pfizer and Moderna, reported 90-95% efficacy rates for their vaccine.
This is an effectiveness in preventing illness in the vaccinated person himself.
These companies do not yet have any information on whether the vaccine also prevents the vaccinated person from infecting others. The chief scientist of the Moderna company said this himself.
Theoretically there may be a situation where the vaccinated person is exposed to the virus, but does not feel any sign of illness and therefore does not maintain social distance, etc., he meets people, including people at risk, such as the elderly and may infect them, while the unvaccinated person will experience signs of illness. As such, they will stay at home until the end of the disease and will not infect people in risk groups!
Perhaps the unvaccinated can actually protect the population at risk, more than the vaccinated! This is of course a hypothesis. We do not yet have data to answer the question of effectiveness in preventing infection.
We also do not know whether the vaccine will reduce severe morbidity and mortality in the elderly (who are the most important and most vulnerable population to the coronavirus), as these companies did not release accurate data on how many people over 80 participated in the study (average corona mortality is around 80 and they are the population most susceptible to the virus). Corona vaccine manufacturers have not released any specific information on the effectiveness of the vaccine among this age group.
But suppose the vaccine is indeed very effective for all age groups.
And suppose it also prevents infection.
It is quite possible that this will become clear.
Let’s talk for a moment about its safety.
Although the vaccine has not been tested on breastfeeding women and the companies that develop the vaccine explicitly state that they do not know whether the vaccine components pass through breast milk, the director general of the Israeli Ministry of Health has already issued a puzzling statement that there is no problem vaccinating breastfeeding women!
No one in the world knows what effect the vaccine components have on a baby at two days, two weeks, or two months old and whether it causes them such and such side effects, since the vaccine has not been tested on infants and newborns.
(We also do not know what the ingredients of the vaccine are, which is an issue in itself … Pfizer and Moderna did not specify the full list of ingredients of their vaccines)
So to make a statement that there is no problem in vaccinating breastfeeding women, in my opinion it is really irresponsible.
This statement by the Israeli Ministry of Health raises the concern that the Ministry of Health does not have a “responsible adult” who really examines the data carefully, considers them carefully and tries to observe the most basic rule in medicine: “First, do no harm.”
The feeling is that there is a gallop forward here, without looking right and left and who knows, maybe out of a conscious decision to absorb victims who might be trampled from the wild gallop to the finish line.
This is doubly puzzling, when reading that the British Ministry of Health explicitly writes that in light of the lack of information on the safety of vaccines for infants and newborns and in light of the lack of information on whether the vaccines pass through breast milk, breastfeeding women should not be vaccinated.
You can read the guidelines of the British Ministry of Health for the Corona vaccine at this link REG 174 Information for UK Health Professionals (On page 6, in section 4.6 you can see the guideline regarding breastfeeding women).
Regarding vaccine safety in general and not just for babies, there are some questions we do not have unequivocal answers for now:
Some of the questions are relevant to each vaccine and some are unique to the Corona vaccine.
First question:
The vaccine causes our body cells to produce one of the corona virus proteins.
Immune cells recognize the foreign protein and develop antibodies against it.
Here the question arises, can we be sure that there is no protein in the human body that is similar to this protein?
That is, there may be a condition called cross-reactivity in medicine – a condition in which the antibodies created against the corona virus protein will also attack body proteins that are sufficiently similar to the virus protein.
The antibodies will not differentiate between the foreign protein and our protein, a part of which may be very similar to the virus protein.
That is, there is a concern here about the formation of an autoimmune disease.
It is enough that only a section of the corona virus protein be similar (and does not even need a full identity) to a section of any protein in our body, for such a reaction to be generated.
If such a thing happens, the autoimmune disease, in which the immune system attacks tissues in our body, can appear even after many months and even years after the first exposure.
As is well known, the decision to approve the corona vaccines for mass vaccination of the population was following a study of a few months, so at this stage there is no way to know whether autoimmune diseases may develop.
It is important to note that this question is relevant not only to the corona vaccine, but in fact to any vaccine.
Indeed, a significant number of scientific studies have found an association between vaccines and autoimmune diseases. In some consumer leaflets of certain vaccines, it is even listed as a possible side effect that has been found and reported following the vaccine.
It is also worth noting that sometimes a virus or bacterium (not a vaccine) causes the body to produce antibodies, which attack not only the foreign invader, but also cells in our body and cause autoimmune disease.
This is the case for example in Rheumatic Fever disease in which in some people, probably with an early genetic predisposition to it and a specific mutation in DNA, the body produces autoantibodies in response to exposure to the streptococcal bacterium.
This is also what probably occurs in Gillian Barre syndrome and autoimmune thrombocytopenia (ITP) and there are other examples of this mechanism of autoimmune disease formation.
Will the specific protein chosen by corona vaccine manufacturers (out of so many proteins to choose from) cause such a cross-reactivity response and autoimmune disease?
For now we have no answer to that.
The second question for which we do not have an answer for now is: do the vaccine components penetrate our brain?
The blood vessels that feed the brain are made up of another layer in the artery wall, called the blood brain barrier – or in Hebrew ‘the cerebral blood barrier’.
The body wanted to protect the most sensitive and important organ and prevent the passage of substances that could damage the brain cells, so the blood vessels that supply the brain have an additional protective layer, which other blood vessels in the body do not have to prevent substances that can damage the brain from penetrating.
Do the vaccine components penetrate the cerebral blood barrier?
Have they checked it out at all?
We do not know. Corona vaccine manufacturers have not released any data on this.
The third question is unique to corona virus vaccines: mRNA vaccines
A brief background to understand the question:
All the vaccines we know to this day are vaccines that contain the virus / killed bacterium, or the attenuated one, or parts of it (for example only its shell and the like).
That is, the foreign protein, against which the body is supposed to produce antibodies, is found in the bloodstream and not inside our healthy cell.
Immune system cells that are designed for this exact function, reach the same foreign protein that is in the bloodstream, assimilate it into their shell and present it to the white cells that are responsible for the production of antibodies.
In the case of an mRNA vaccine, this is a completely different mechanism.
A molecule that is not a protein (but a genetic code) is injected into the blood, which enters a body cell.
Because mRNA is not a protein, no antibodies are produced against it at all. (Antibodies are produced only against proteins).
The mRNA that has penetrated a cell in our body uses our healthy cell to produce the protein it encodes. In the case of the corona vaccine, it is one of the corona envelope virus proteins.
Now the same cell, displays this foreign protein on its cell envelope.
White cells recognize a foreign protein on our cell envelope and produce antibodies against it.
Here the question arises, do the white cells really know that it is our body’s cell and that they should produce antibodies only against the foreign protein presented to them or, G-d forbid, they will treat the presenting cell as a foreign cell and also produce antibodies against other proteins on the cell envelope.
It is honest to ask, why do I not ask this question about the cells of the immune system that display foreign protein, something that happens every day?
How can the immune system not see the cells that display the foreign protein as an invader that must be destroyed in its entirety?
The answer is that when there is a foreign protein in the bloodstream, the cells that will assimilate it into their shell, are the cells of the immune system that is the job assigned to them: introducing foreign proteins into the antibody-producing cells.
The cells that produce the antibodies know that it is “in our power” and do not produce antibodies against all the proteins that display the cell, but only against the foreign protein that is presented to them.
But here, in the new vaccine for corona, the mRNA vaccine, for the first time in the history of vaccines, the one that is introducing the foreign protein is a different cell! A normal cell from our body and not a specific cell that the cells of the immune system know is its function!
That is, the immune system may think it is an invader and attack the entire cell and not just the foreign protein.
Here, too, the result may be an autoimmune disease.
Is this a real concern or is it part of a conspiracy theory of “vaccine opponents”?
The answer to this question was written by Dr. Michal Haran, a senior hematologist at Kaplan Hospital.
She wrote this in a post she posted on her Facebook page and it is available to the public.
She phrased it in a clear and understandable way to all.
I have brought here her words, as they say. Word for word.
Every other word is unnecessary.
Dr. Michal Haran’s reference to the uncertainty regarding the safety of mRNA vaccines and the possibility of developing autoimmune diseases following the corona vaccine:
Today, I finished writing (together with other doctors and experts) a stand paper that addresses the possible risks of the new vaccines in technology that has not been tested so far in humans. In the days when they were corrected this discussion would have stayed between doctors, there were committees and there were decisions that take into account all the considerations.
Except that these are not days as their repair and we have already been informed that they started providing these vaccines in other places in the world and very soon probably here too.
The newspapers and social media are full of explanations about the safety of vaccines compared to the serious disease caused by the coronavirus. They say loosely that there may be some unreasonable risks, but these are null in compared to the dangers expected from infection with the virus.
So, my opinion is different and I think that the risk of the virus for most of the population is much smaller than the risk of providing a cure that has not passed the acceptable stages. The claim that vaccines are very likely to be effective in preventing serious illness or contagion and that there is no proof (yet) of possible damages are valid for any experimental medication and anyone involved in clinical trials knows how few medicines go through the bar of effectiveness and safety required, not to mention those that even the normal stages don’t Ensuring their safety and they are off the shelves within a year or two from the moment they started to be given to everyone.
Since most of the public doesn’t understand medicine or biology and it’s required to decide, when it’s pressure to get the vaccine I decided to explain the important things that are written in the paper of the stand in an understandable language to those who don’t have a medical background and I’d also be be happy to answer and explain things that are not clear enough.
The idea behind the technology of the new vaccines is a brilliant idea that wasn’t easy to implement either and I’m definitely taking my hat off to whoever managed to do it.
You need to understand that the immune system is built so that it knows how to differentiate between the cells of the body itself and foreign cells, so that it normally will not attack the body’s cells, but once there is a foreign cell (for example a bacteria or virus that is not really a cell) it will attack it.
The method developed causes muscle cells to produce protein belonging to the virus and present it on the cell envelope. Meaning that turns muscle cells into foreign cells, temporarily, only until the immune system cells realize that they need to produce antibodies against them.
The problem is that I don’t know how we will explain to the cells of the immune system that the foreign cell they need to attack is not really a foreign cell, but a normal and healthy muscle cell and that they need to produce antibodies only against the protein of the virus and not against other protein that are next to it It’s not just a theoretical concern, but a familiar phenomenon from the field called cancer immunotherapy. One of the dangers in patients with advanced cancer receiving medications designed to activate the immune system against cancer cells is the development of self-antibodies to the point of serious and dangerous autoimmune diseases.
We need to understand that once antibodies are created against the muscle cells that are in the arm (the place of injection) they will also act against the same protein in other muscles. The skeleton muscles are an important and essential system without which there is no life. Each of the protein found on the membrane of the muscle cell (which is some of them and the complex relationship you can see in the attached fig) is essential and injury to it will bring a disease that can be difficult and deadly.
A lot of these diseases won’t manifest immediately, but only after a few years.
It is possible that now, in a patient who will receive the vaccine there will only be very light and not alarming signs: a little muscle pain, a light weakness, difficulty in breathing in an effort (all of them are easy side effects and tolerable in the studies done on these vaccines) and maybe even nothing.
If you want to know what might happen when only one protein is damaged, ask the parents of a child with a disease called Duchene muscular dystrophy. They will tell you that their child was born healthy and evolved as usual until the age of a year and then there were very small things that triggered a bit of concern until at the age of 4-5 he started slowly losing abilities like getting up from the floor, jumping, later also walking and within about ten years he was confined to a wheelchair Respiratory. https://www.littlesteps.org.il/%D7%A2%D7%9C-%D7%94%D7%9E…/
Ask, rightly, why if this is such a significant problem, you thought about it and not any of the other doctors (including those who planned the experiments in the pharmaceutical company). Maybe the reason for this is because unfortunately I personally knew a charming and dedicated doctor to patients who due to a much more familiar vaccine and considered safe, developed a serious and progressive muscle disease that resulted in his death within 10 years. He may have received financial compensation for it, but how can you really compensate a person for the destruction of life?
Maybe this is because I also have a rare autoimmune muscle disease whose first episode was several months after I got the same vaccine. Although, in my case the connection is much less clear, but naturally when you’ve been dealing with this kind of disease for years, you know firsthand what it is all about.
Maybe the reason for this is because of the (somewhat unusual) combination of being a hematologist, who also deals with research (and I have quite a few publications on the subject) of these two systems (the muscle system and the immune system) I understand that it is two most complex systems that today we know about 10 times [more]. From what they knew when I was a medical student 30 years ago, and it’s pretty clear to me that in 30 years we’ll know 10 times more than we know and maybe then we won’t be able to understand and know everything.
I also know from past experience how brilliant people are looking for solutions to difficult problems, not always in the enthusiasm that floods them are able to think about the difficult and unexpected results that may be the result of their interference in complex biological systems that none of us really understand about Borane. And this is an unfortunate example from my field of expertise. Genetic therapy designed to cause bone marrow cells to produce a protein that is lacking in a disease called SCID (which is known in the general public as a disease of bubble children, because these are children with severe immune lacks that may die from any banal infection), caused some of the children who received it to get severe blood cancer after 3-6 years. Fortunately this treatment was only given to a very small number of patients while being followed over a number of years. When it comes to a small number of patients, you can learn from the mistakes and fix. But how will it be possible to learn from the mistakes when treatment is given to millions around the world? Why Gene Therapy Caused Leukemia In Some ‘Boy In The Bubble Syndrome’ Patients
Source: Michal Haran’s Facebook post on December 6, 2020
So far, the words of Dr. Michal Haran, a senior hematologist at Kaplan Hospital.
And finally – a point to think about:
The degree of caution and certainty regarding the safety of a medical procedure must be very great, especially when it comes to a procedure designed for healthy people.
When a person is ill with a life-threatening illness, we often give up clear evidence of safety and settle for the chances of success, because in any case there is nothing to lose.
But this is not the case when it comes to the procedure for healthy people.
For them there is a lot to lose.
In such a case, we need a very high certainty that the procedure will not harm them.
We can compromise on efficiency, but not on safety (if it does not help, at least it will not hurt).
Do we have enough data to say with confidence that corona vaccines meet the required safety threshold of a medical procedure designed for healthy people?
your,
Dr. Gil Yosef Shachar (M.D.)
Important clarification: This article should not be seen as a recommendation not to get vaccinated against corona. It is certainly possible that in certain risk groups, where there are high mortality rates, or severe morbidity in the case of corona infection, the benefit of the vaccine is worth the risk of side effects that may or may not occur.
The purpose of this article is to stimulate a legitimate and desirable discussion on the safety of the corona vaccine and to raise questions that are worth considering and present the essential question marks that exist regarding mRNA vaccines.
