Translated from Hebrew and slightly abridged with the permission of the author.
On December 12, the FDA granted authorization to the corona vaccine developed by the Pfizer pharmaceutical company and its German affiliate BioNTech after it checked the results of the third stage of the vaccine trials.
This is an event of historic importance in the battle against the corona pandemic that has, in less than a year, killed close to two million people (1.7 m. so far) the world over and left millions of others with psychological and physical damage To that must be added the economic havoc the pandemic has caused.
This official authorization allows the vaccine to be given all over the world and with its 95% effectivity (as authorized by a specially augmented group of FDA scientists), there is no doubt it will cause a massive reversal of pandemic's spread and possibly even stop it completely.
The FDA check effectively erases all the arguments against the virus. The 92 page detailed and explanatory summary by Pfizer-BioNTech passed FDA muster on every facet of the third stage tests, including the efficacy of the vaccine and mainly in its description of the minor side effects to those vaccinated during the trial.
The FDA wrote: "The data provided by the Pfizer company passed our critical examination. The efforts to speed up the development of a vaccine did not negatively affect the scientific standards or trustworthiness of our investigative process." The FDA added that the vaccine may be administered to those over the age of 16. In Israel and the US, medical personnel and the elderly in nursing homes will be the first to receive the vaccine.
The FDA added that "the decision to authorize the vaccine was reached after an open and transparent process that included opinions of independent experts in health sciences, as well as a thorough in-depth evaluation of FDA scientists in order to ensure that this vaccination meets the strict and scientific standards of the FDA in anything connected to security, efficacy and quality of manufacture necessary to support it for emergency use."
On December 13, the New England Journal of Medicine published an applied science article by tens of the best scientists and doctors worldwide who took part in the third stage trials of the vaccine (no. BNT162b2 in the listing of clinical research trials). The article puts paid to the false attacks against the mRNA vaccines produced by Pfizer-BioNTech.
Part I: Questions and answers on the vaccine, explaining the facts in layman's terms:
Q. We are surrounded by all kinds of sources telling us how the vaccine works. How is it different from other vaccines?
Answer Many of us are familiar with the concept of chromosomes within cell nuclei which are made up of coils of genetic matter called DNA. This genetic matter is the "operating system" of every cell. For example, in an insulin-producing cell, the "program" for produing insulin is in a special part of the DNA of that cell. Special nuclear enzymes prepare the "program" and send it outside the nucleus to a part of the cell that contains ribosomes, organelles which know how to read the "program" and create the required insulin protein (it is the description of this ribosomal process that made Israel's Prof. Ada Yona a Nobel Prize Laureate)
What did the vaccine researchers do? In a brilliant scientific process they created a copy of the program (mRNA) that can produce one special coronavirus protein. That is why, when that mRNA compound is injected into someone, the muscle cells of the person inoculated know how to read the program and create one protein of the virus. This is identified by the immune system of that person as a foreign factor that has entered his body and its reaction is to activate immune system cells (T cells) to fight the invading virus protein and to create antibodies in large amounts against the virus protein. This alone turns the vaccinated person into someone protected against any virus whose outside membrane contains said protein.
The mRNA segment of "programming" cannot endanger cells because it cannot penetrate the nucleus to get near the cell's DNA. Since the original programmed segment disintegrates rapidly in the body, it is wrapped in liiposomes or micelles (fatty bubbles) which extend its life for 48 hours because although that is not much time, it is enough to trigger the immune system to produce antibodies. This process is nothing new, the liposome\micelles method to enhance absorption of various medicines\vitamins in our body both orally and intravenously has been in use for decades.
Once again, in contrast to those spreading false information, there is no new element here that can endanger those vaccinated.
Q. What does the vaccination package contain? Aren't there dangerous chemical substances in it?
Answer: In contrast to other vaccines, which are also found to be entirely safe, this vaccine has none of the adjuvant material added to vaccines for other diseases to enhance the immune response. It also has no preservatives. The solution has only a miniscule amount (30 micrograms) of mRNA wrapped in fat particles (those liposomes/ micelles) made of harmless inert fats to be found in injections and intravenous solutions for decades. Actually, the flu vaccine has adjuvants or preservatives - and there is no danger to anyone who is vaccinated against flu – while the corona vaccine does not have these additives or any others.
There is no justification for saying that it has foreign elements that endanger the body. Period.
Q. Why do we need to be given the vaccine in two stages?
Answer: The advantage of mRNA vaccines is that are not made of the virus itself or of particles of it and do not require growing the virus in the laboratory in order to manufacture them. This is the reason we can produce millions of vaccinations in a short time, as opposed to the time needed to create a vaccine containing weakened or dead viruses. That is also the reason there is no way the vaccine can infect anyone with the coronavirus.
The vaccine is given in two stages intramuscularly. The first portion (Prime) begins the process of stimulating an immune reaction (cell and antibody) against the corona virus protein and the second (Boost) given 21 days after the first, is intended to enhance the immune response and cause the production of a large store of antibodies in the body of the person vaccinated as well as to build a longterm immune "memory" that will cause the antibody producing cells to continue producing them the minute the vaccinated person is exposed to the real virus once again.
Q. Why be vaccinated, if the vaccine does not completely prevent contagion?
Answer: Vaccines are not administered to completely prevent contagion, because that is impossible unless a person is in an enclosed space cut off from the world That is why it must be made clear that even after vaccination, viruses may continue to infect those who are vaccinated if they are exposed to them, but with one major difference – someone who has been vaccinated will have an initial light and possibly unnoticed case, while his immune system will react immediately and powerfully, preventing the development of complications, because it has already practiced doing so due to the administration of the vaccine. It is comparable to an elite army unit practicing before it meets the enemy!
Part II The scientifically observed true facts regarding the vaccine and everything connected to preventing coronavirus and its resulting complications:
In the first stages of research, there was a controlled experiment with remarkable results using monkeys which were given live corona virus nasally – the vaccine prevented the virus from multiplying in their bodies almost entirely and prevented the development of complications such as pneumonia.
As far as humans are concerned, data collected up to now shows that after two vaccinations the efficacy of the vaccine is the highest ever discovered by scientists (an average of 95%!) and the vaccine prevented recurrent infection and complications. If we expect the vaccine to be the "Iron Dome" against corona virus, we can say that it deflected the virus, even if it cannot prevent its launching attempts
Who can and should receive the new anti-corona vaccination:
It is important to keep updated regarding the Israeli Health Ministry directives once they are published. For now, here is a summary of FDA and other health organization directives:
The results of research studies done so far on varied young and adult population groups have enabled professionals to recommend vaccinating securely most young people over 16 and adults of any age with slight background diseases. However:
Allergies: Those with a background of severe allergic reactions to any vaccinations, medicines or food and anyone who carries a prepared syringe with him for that reason must not be vaccinated for fear of developing an allergic reaction.
Young people under 16: There is not yet enough information for that age group so the vaccination is not given to them.
People with weakened immune systems: Because the vaccine is not made from live viruses, there is o fear of it multiplying in the body, therefore it can be given to those with weakened immune systems, if authorized by their doctor. Those with weak immune systems are in danger of dying if they contract the coronavirus, which is why vaccinating them is recommended. However, it is possible that their weak immune system will fail to produce enough antibodies, and the vaccine's efficacy in that case is lowered.
Pregnant and nursing mothers: Although there are no data showing that the vaccine affects pregnant and nursing women (and the foetus or nursing infants) in any negative way, until there is more data it is not recommended to be vaccinated while pregnant or nursing. It is recommended that vaccination be delayed until that period is over, as an extra precaution, as is done with any new medication or vaccine. Pregnant and nursing women are always the last to be allowed to receive new vaccines.
Part III Scientific responses to the lies filling the web.
Lie:The vaccination method (using mRNA segments) is new, experimental, insufficiently researched and dangerous.
The opposite is true. This is an old tried and true method, in use for over 30 years, and is also being used in the hopes of helping destroy cancer. The first publications of mRNA injection techniques were in the 1980s. My cancer research (Biotherapy) used the mRNA method.
Lie: The vaccine damages those vaccinated, causing fertility problems, miscarriages and other reactions, including death.
The vaccine does not harm those vaccinated, nor does it cause fertility problems or death. Those are total fabrications. On the contrary, this type of vaccination is as safe or safer than injecting weakened or dead viruses.
Lie: There is a claim circulating on the web saying that the vaccine can cause 22 kinds of diseases and syndromes.
The truth, once again, is just the opposite. The vaccine causes none of those 22 side effects. The fear mongers took the FDA list of side effects that the FDA looks for – but they did not publicize the fact that the FDA found no traces of them. The existence of the list is the little bit of truth on which they based their lies, but as I wrote here, this is what the researchers looked for, but the FDA repoorted unequivocally that none of the problems\diseases listed was found in those who received the vaccine as a result of vaccination.
The scientists who checked the third stage of the trials of the Pfizer vaccine reported that any side effects found in those vaccinated of all ages were relatively light and disappeared after several days (a reaction at the vaccination spot, tiredness, headaches, muscle and joint pain, shakes or fever)
Lie:Two people died of the Pfizer vaccine.
The two people who died and were mentioned over and over on the media were proven without a doubt to have died of heart attacks that had no connection with the vaccination.
Lie:The claim of fertility damage
This is the most unfounced fear of all because
a. there is no resemblance whatsoever between the corona proteins and those of the placenta, so that antibodies against the corona virus cannot affect the placenta and
b. corona itself does not affect fertility so a vaccine aimed against one of the corona proteins certainly won't.
Lie: There are claims that the vaccine changes the cells' genetic material and damages cells, tissues and organs.
This is an infantile claim whose source is people who know nothing of genetics, or of the vast difference between an RNA messenger and the DNA of the cell. (There are also people who know genetics and know they are mistaken, but are spreading the lie anyway)
Very briefly, an mRNA segment is a copy and is outside the cell nucleus, in the cell's liquid, while DNA is in the impenetrable nucleus protected by a membrane and other factors and cannot be affected by mRNA.
The mRNA segment heads for the ribosomes in the cell plasma outside the nucleus where proteins are formed and dies there in a matter of hours. It disintegrates rapidly and the liposome technique described previously keeps it alive for up to 48 hours so it can lead to the production of the antigen against corona.
After those 48 hours, mRNA disintegrates and disappears from the body. That is why the vaccine needs such low temperatures while stored and needs to be given twice.
Lie: A group of doctors filed a request with the EMA to recheck.
Contrary to posts on the web, a group of doctors did not file a request with the EMA (Europe's FDA) to recheck the Pfizer side effects reports. Two doctors, one of whom has been known for spreading disinformation about corona and was called to task for doing so, wrote a request and it was posted on the web before they were to submitt it to the EMA.
The FDA report is the final word on vaccines and the Health Feedback researchers whose job it is to find lies on the web also found all the points in that request to be false.
Lie: They are hiding the bad things from us.
There is no way the pharmaceutical companies can hide negative side effects from us as the trials are taking place in different locations, with unconnected researchers doing them who are closely monitored.
Note: tens of medical centers worldwide are doing clinical trials in inoculating people with the vaccine in the same time period, so that over a million people have been vaccinated. This is the largest number of people ever vaccinated in trials of a new vaccine. The labs in the West are under strict supervision which obligates them to report on each step before doing it, show complete results, their control, and then and only then, will they obtain permission for the next step. As we saw, Pfizer prepared a thorough wide-ranging report to the committee of world renowned scientists, statistic experts and physicians with much experience in vaccine research. It would not have been authorized had any of the stringent criteria not met their standards.
More lies and facts:
-The vaccine has no possibility of injecting dangerous viruses or other substances into our bodies, even theoretically. The fatty bubbles were authorized decades ago by the most strict research bodies.
-The vaccine has a 95% success rate if both injections are taken, while flu vaccine is at most 50-70% successful
-Results of vaccination trials usually depend on self-written reports from those vaccinated, which are often not accurate because by the time they report, they have forgotten details of any reactions.. In the corona vaccine trials, the reasearchers approached each person who was vaccinated, asking them detailed questions over and over and still found no side effects worthy of mention. Anything that came up was gone long before the second shot was to be administered.
-We are not vaccinating children now, but that is not because they do not suffer from after effects of the disease. There are long term effects, such as lack of concentration, in children who recovered from corona, as well as chronic breathing problems, aching muscles and more.
-And last but not least, as far as the imaginary science fiction-like scenario in which electronic chips are in the vaccine and will inform whoever wishes to know of our every move, control us and change our genetic makeup, I suggest sticking to reading science fiction. Man is as yet unable to do anything of the sort even if he wished to. Do not let these delusionary ideas affect your judgment.
An entire litany of lies has evolved about the corona vaccine, but an analysis of the practical scientific facts and the clear knowledge of the safety of this kind of vaccination, there is no doubt that the new vaccine exhibits high and impressive levels of efficacy and security. Only systematic vaccinations, organized and wide-ranging, of our population will bring this pandemic and the mad conditions under which we now live to an end. Medical history shows that 14 of the different plagues and diseases that killed a quarter of the world population were defeated only by vaccinations.
Run to be vaccinated (after your doctor clearly authorizes you do so) and make sure to keep to the guidelines and regulations from the Health Ministry and other official agencies which deal with the issue. I hope to be one of the first vaccinated – as a child I missed the polio vaccine because of my birth date and have suffered from it all my life.
Please send to everyone you know.
*Prof. Cham Gamliel heads the Rotem Medical Research Institute in Jerusalem today, as well as teaching at Bar Ilan University. He is a well-known professor of cancer research who taught at Chicago University and received international prizes for this work on microscope scanning of viruses as possible factors in developing cancer, especially blood cancers such as leukemia, as well as his work on oncologic nutrition. He authored an encyclopedic work on modern applications of Maimonides medical methods and chairs the Maimonides Research Institute in Kiryat Ono.
*Translated by Rochel Sylvetsky, Arutz Sheva Op-ed Editor
Partial list of sources: