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Misslee

Are Pfizer's And Moderna's Covid Vaccine Really Safe?

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I've watched this video and it has been a revelation and it has been exactly my experience that a vaccine gave me celiac disease I had the first symptoms within 6 months after getting one.

It isn't genetics for me. 

I also got eczema in 2012, 4 months after an another vaccine I had to take against yellow fever. No eczema either in my family's history.

What do you think and what about you?

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Misslee,

Celiac Disease is genetic.  You have to have the genes for it to get it.

Thiamine deficiency can cause  that thiamine transporter gene (read about it below) to turn off which triggers the Celiac Disease gene to turn on.  

Eczema is definitely a manifestation of Celiac Disease.  

 

And now....

I'm reposting what I wrote from the other thread about vaccines......

 

Dr. Berg didn't research deep enough.

The adjuvant to which Dr. Berg  refers is aluminum hydroxide. 

Here's an article on aluminum hydroxide....

https://www.hormonesmatter.com/injecting-aluminum-new-documentary-questioning-vaccine-safety/

Aluminum hydroxide prevents the absorption of thiamine, Vitamin B1.

Thiamine is needed to provide energy to every cell in the body.  Under conditions of stress, the body's demand for thiamine increases.  Without enough thiamine, the body can't function properly and symptoms of thiamine deficiency become more prominent.

Another article explains this...

"Vaccination as a Stressor"

https://www.hormonesmatter.com/vaccination-stressor/

"Injection of the vaccine, acting as a stressor, simply precipitated an increased energy demand that caused an increase in thiamine consumption that was already in short supply."

 

Illness, stress (either physical or emotional), carbohydrate-heavy diets and some medications (see linked article below) can lower thiamine levels.  

"Drug–nutrient interactions: discovering prescription drug inhibitors of the thiamine" transporter ThTR-2 (SLC19A3)

https://academic.oup.com/ajcn/article/111/1/110/5637679

Metformin is a thiamine depleting medication. 

 

Those thiamine transporters allow thiamine to enter cells.  During thiamine deficiency, these transporters shut down.  In order to get the transporters working again, high dose thiamine supplementation is required.  

"Thiamine supplementation facilitates thiamine transporter expression in the rumen epithelium and attenuates high-grain-induced inflammation in low-yielding dairy cows"

https://www.sciencedirect.com/science/article/pii/S0022030217304071

It's interesting to note those thiamine transporter genes are located in the same area as the gene for Celiac Disease and diabetes and other autoimmune diseases.  

 

Yes, Thiamine can help alleviate inflammation.  

Inflammation and thiamine deficiency can have detrimental effects on the gastrointestinal tract as well as other systems in the body.

 

 

The cascade of health problems in thiamine deficiency is discussed in this article....

"Neurological, Psychiatric, and Biochemical Aspects of Thiamine Deficiency in Children and Adults"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6459027/

 

Thiamine is used in the treatment of Covid patients in ICUs along with vitamins C and D, and zinc....

"Be well: A potential role for vitamin B in COVID-19"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7428453/#!po=40.3846

"Thiamine is able to improve immune system function and has been shown to reduce the risk of type-2 diabetes, cardiovascular disease, aging-related disorders, kidney disease, cancer, mental disorders and neurodegenerative disorders [6]. Thiamine deficiency affects the cardiovascular system, causes neuroinflammation, increases inflammation and leads to aberrant antibody responses [6]. As antibodies, and importantly T-cells, are required to eliminate the SARS-CoV-2 virus, thiamine deficiency can potentially result in inadequate antibody responses, and subsequently more severe symptoms. Hence, adequate thiamine levels are likely to aid in the proper immune responses during SARS-CoV-2 infection. In addition, the symptoms of COVID-19 are very similar to altitude sickness and high-altitude pulmonary edema. Acetazolamide is commonly prescribed to prevent high-altitude sickness and pulmonary edema through inhibition of the carbonic anhydrase isoenzymes and subsequently increases oxygen levels. Thiamine also functions as a carbonic anhydrase isoenzyme inhibitor [9]; hence, high-doses of thiamine given to people at early stages of COVID-19 could potentially limit hypoxia and decrease hospitalization."

Before anyone gets the Covid vaccine, consideration of thiamine supplementation is warranted.

 

Oh, the increase in autoimmune diseases are increasing globally, but especially in countries that switch from traditional diets to high calorie, high carbohydrate Western fast food diets.

https://www.sciencedirect.com/book/9780128103876/thiamine-deficiency-disease-dysautonomia-and-high-calorie-malnutrition

 

Do your own research.  Don't stop digging for answers.  

 

Hope this helps.  

 

 

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It might be genetics but triggered by the vaccine I took. None of these diseases would have woke up in my body without the vaccines. We don't have any diseases in my family my grand parents my great grand parents my parents my brothers sisters cousins aunties everyone is perfectly healthy. 

To accuse our genetics is an easy way to omit truth from public it's very obvious to me. Who is gonna dig deeper when people hear oh its genetics.

Anyway

I'm glad to know the mechanism of vaccines with that thiamine etc I'll read more about it and all the links you have provided.

thanks for sharing.

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Vaccines do not trigger autoimmune diseases, and no studies I've seen (I've summarized and read every study on celiac disease done since 1994), have indicated that vaccines have been linked in any way as a trigger of celiac disease. You claim that your celiac disease is not related to your genetics, but have you had a genetic test done? If so, what are the results? I doubt you have celiac disease if you are not positive for the DQ2 and/or DQ8 genetic markers for it. Please don't make unsupported scientific claims without support.


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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I am concerned about these mRNA transgenic vaccines because 

1) They have never been used before as a vaccine

2) The safety tests were just short term 

3) You can only scientifically state that a vaccine or any medicine is safe, when it at least had two years of long term safety tests were done.

4) mRNA, the main active ingredient on these covid vaccines of Pfizer and Moderna, was always known to be very unstable and highly toxic. You would apply these molecules on animals and it would provoke a severe inflammatory reaction, which led to death afterwards.

5) Tal Brosh, head of the Infectious Disease Unit at Samson Assuta Ashdod Hospital, acknowledged that there are unique and unknown risks to messenger RNA vaccines, including local and systemic inflammatory responses, that could lead to autoimmune conditions.

6) I suffer from celiac disease. I worry that it can lead to other autoimmune disease or make my disease more sensible to gluten. I read another scientific blog a while ago, which the article mentioned several researchers discussing the safety of mRNA in these vaccines. One acknowledged that mRNA can amplify an immune response. The article then went on discussing if mRNA can led to autoimmune diseases. Although the researchers asked about this topic, stated there was no evidence, the truth is, they don't know. If there is currently no scientific evidence, it does not mean it does not have. It is still unknown. Long term safety tests done with mRNA are still little or non-existent. Something not known scientifically, doesn't mean it doesn't exist. The other point, no matter the opinions of these researchers, as just by the article bringing this point, it is something being discussed. 

Celiac disease is caused be two auto-immune genes. A percentage of the public has it. But, it is just activated in a small percentage of people who have one or both of these genes (1%-5%). However, the activation of these genes can come through eating too much gluten along someone's lifetime or the body suffering some physical stress, such as taking strong medications, a body injury, a woman having a hard pregnancy, etc. Thus, someone who has these autoimmune genes, if his body feels considerable stress when taking this vaccine, can theoretically activate these genes and become a celiac patient. It can't be discarded, as pointed out by Tal Brosh, item 5 above.  

7) An article published by the National Center for Biotechnology Information, a division of the National Institutes of Health, said other risks include the bio-distribution and persistence of the induced immunogen expression; possible development of auto-reactive antibodies; and toxic effects of any non-native nucleotides and delivery system components.

8. The CEO of Merck, several months ago, gave an interview to the Financial Times, and indirectly criticized these companies that were doing these covid vaccines in a rush. He stated they needed to have long term safety studies and that the number of people in the trial were small. It needed to have many more people. He said his company would develop a vaccine for covid, but  which would pass through all the years of safety test and more people on the trial for his vaccine.

9) People who took the Pfizer test, even the ones who didn't have a history of allergy, had to be rushed at an ICU bed, fifteen minutes after taking the Pfizer vaccine. One of them from Alaska, which was reported in the New York Times, even developed cardiac problems. 

10) The flaws of  Pfizer's trials is evident, as no volunteer on the vaccine trial, developed the types of reactions, nor rushed to an ICU, after taking the vaccine, as the public now taking it.  This shows that the number of people on Pfizer's trials were small, as pointed out by the CEO of Merck, in the interview with the Financial Times. 

11) All the researchers developing these RNA therapies used by the biotechnology industry, still lack a good understanding of the health risks that these new treatments can cause. Merck, for instance,  is developing a drug called EIDD-2801, which places molecules in a virus’s RNA genetic material, that then trigger a cascade of mutations-- which ultimately kill it. According to the Financial Times, tests done on bacteria show that it could cause mutations in the DNA of human patients--though Dr Perlmutter, head of research of Merck, said he did not expect this to be a safety issue in practice and noted that other so-called mutagenic drugs had reached the market. “You would prefer not to bring forward a drug that is positive on the Ames test [for mutagenicity], but it’s not necessarily a showstopper,” he said.

All these biotechnological therapies are promising. But, the scientific community still lacks a proper comprehension and knowledge of how these treatments can affect other parts of the organism or it can cause new diseases on the patients. This also goes for gene editing, which if done wrongly, can lead to cancer and other health risks. There are already lots of medical studies showing all sorts of dna mutations on rats, when gene editing was applied. 

This lead to my question:

Although researchers in the 2000, such as Katalin Karikó and  Drew Weissman, found out which nucleotide (set of RNA molecules) caused the exaggerated inflammatory reaction and replaced it with a synthetic molecule without the same toxic potential, and that In animal testing, there was no significant inflammatory reaction, which didn't kill the rats anymore, are there any short and long term, peer reviewed studies done with these genetically altered mRNA molecules used in these covid vaccines? It doesn't mean that the rat don't die any longer, due to inflammatory reactions, that there is no other toxicological effects of this molecule. As item 5 and 7 above mentioned, there are health risks to mRNA. 

Another point of safety risk is the anti-freeze used in Pfizer's vaccine. This is also another point, mentioned to me, by lots of people I know in the scientific community. 

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On 12/18/2020 at 6:02 AM, Misslee said:

It might be genetics but triggered by the vaccine I took. None of these diseases would have woke up in my body without the vaccines. We don't have any diseases in my family my grand parents my great grand parents my parents my brothers sisters cousins aunties everyone is perfectly healthy. 

To accuse our genetics is an easy way to omit truth from public it's very obvious to me. Who is gonna dig deeper when people hear oh its genetics.

Anyway

I'm glad to know the mechanism of vaccines with that thiamine etc I'll read more about it and all the links you have provided.

thanks for sharing.

Hi Mislee, You need to do a genetic test to see if you have one or both of these celiac disease genes. You could also have developed an allergy or intolerance for gluten, even though not having celiac disease, coincidentally during the period you had that vaccine shot you have mentioned. I remember taking the yellow fever vaccine a few years ago and right before the shot, the nurse handed me a paper, warning of severe health problems that someone could develop, by taking that shot, per every million of people, who took it. I am happy I didn't develop any health problem taking that vaccine. I just took because I had to take, due to circumstances. But, I avoid at all cost to take any vaccine. They are not vitamins, that you can take, as much as you want. There are risks. I just take when the benefits outweight the risks and the vaccine at least passed by 2 years safety tests.

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@marc9803 I've merged your new topic with an existing one, since it covers the same ongoing discussion here. There is also another similar topic here, but I consider this different so I'm not merging them:

From what I've read the development and research into RNA vaccines has been ongoing since the 1970's:

https://www.cnn.com/2020/12/16/us/katalin-kariko-covid-19-vaccine-scientist-trnd/index.html

Although the clinical trials for these vaccines were rushed faster than ever, there isn't any convincing evidence that I've read to indicate that this means that corners were cut, nor have the trials indicated that they are not safe in humans. 

So far millions of people have received them, and only rare allergic reactions have been reported, and I believe this has been isolated to the polyethylene glycol in Moderna's vaccine "Six severe allergic reactions to the vaccine have been reported in the U.S., according to the Centers for Disease Control and Prevention, out of 272,001 doses administered through Dec. 19":

https://www.wsj.com/articles/scientists-eye-potential-culprit-for-covid-19-vaccine-allergic-reactions-11608901200

Allergic reactions do happen from vaccines, so this isn't unusual, and the rate is quite low, thus, even Moderna's vaccine is still considered safe.

I hope @RMJ can also weigh in here, but many of your points made above lack links and support. 

Also, we are dealing with a novel virus that has a known death rate of 1-3%, and has killed more than 300K Americans to date. Any talk of this vaccine being more dangerous than the virus that is designed to stop must explain why we'd be better off without these vaccines. Are people dying or getting sick now from the vaccine? Please provide evidence of this.


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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@marc9803 I will go though each of the points you made, but ultimately the FDA has a rigorous process that all drugs must pass in order to be allowed on the market. In this case the process was expedited, however, it is my understanding that none of the normal safety procedures were skipped or excluded, including the 30,000 person trial for safety and efficacy. 

1) True, mRNA vaccines haven't been used, but this fact alone does not mean that they are not safe, or are more dangerous than any other type of vaccine. mRNA was used in this case, I believe, because it would make it more likely to cover future mutations of covid, thus making the vaccine more effective.

2) The safety tests were done according to the FDA's requirements, so they are not "short term" when compared to any other vaccine that has been given a green light by the FDA.

3) Please provide some support for your statement regarding a 2 year requirement before you can call a vaccine or medicine safe. You make this statement as if it is a fact, however, you do not back it up with anything. Please provide an FDA link to this requirement. It's my understanding that all safety and efficacy criteria were met for both vaccines. If we waited two more years millions more would die of covid-19 who could otherwise be saved.

4) You make the claim that mRNA has always been known to be toxic. I'm sure that during the 50 years of research there are examples of studies where toxicity was experienced, but this does not mean that the current vaccines are somehow toxic, does it? Please provide links or data to show us that the current two approved covid vaccines are toxic. Just saying that there is some past research where mRNA toxicity was observed does not make either of these vaccines toxic.

5) For #5 I think you refer to this article:
https://www.jpost.com/health-science/could-an-mrna-vaccine-be-dangerous-in-the-long-term-649253
where they discuss theoretical risks, but the very same article goes on to say:

Quote

BUT MICHAL LINIAL, a professor of biological chemistry at the Hebrew University of Jerusalem, told the Post that she believes there is no cause for concern. Linial explained that “mRNA is a very fragile molecule, meaning it can be destroyed very easily... If you put mRNA on the table, for example, in a minute there will not be any mRNA leftover. This is as opposed to DNA, which is as stable as you get.” She said that this fragility is true of the mRNA of any living thing, whether it belongs to a plant, bacteria, virus or human. As such, she said the worry should not be that the mRNA won’t get into the cells and instead will stay outside, floating in the body and causing some kind of reaction. Rather the concern should be that if it doesn’t enter the cells, it will disintegrate and therefore be ineffective. She said that while Moderna and Pfizer are based on new vaccine technologies, they are asking our bodies to do something they do every day: protein synthesis, the process where cells make proteins. Moderna and Pfizer are simply delivering a specific mRNA sequence to our cells. Once the mRNA is in the cell, human biology takes over. Ribosomes read the code and build the protein, and the cells express the protein in the body.

6-7) There are people who claim they got their celiac disease from current childhood vaccinations. You can make up all sorts of hypothetical risks and run with them, but you need to provide some evidence beyond just stating the possible risks. I've seen no studies to date that link any vaccines as the cause of celiac disease, yet people do make the claims. It's up to the person making such a claim to produce the evidence, and not the other way around. You can make all sorts of hypothetical claims about what these new vaccines might cause, and it is not up to Pfizer or Moderna to disprove all of these claims.

Got a link for you claim in #7?

8. The CEO of Merck is behind and has no approved vaccine. His company competes with both Pfizer and Moderna in this space, thus, he is financially motivated to cast a cloud on his competitors' success in beating Merck in this race.

9-10) What "people" do you mean? How many compared to the number of people inoculated?  Every vaccine has a certain threshold of people who have an allergic or negative reaction to it. There is no talk of the rate of issues causing the withdrawal of either vaccine because the rate of reactions is very small, thus the risk is very small. The known death risk of covid-19 certainly outweighs the risks associated with these new vaccines.

The number of people in the trials was not reduced, and met all FDA requirements. 30,000 people were required to be inoculated in the last test, which is the standard requirement for vaccines.

11) See my answers to 4, 6 & 7. Again, you can make lots of vague scary claims about mRNA vaccines and what they COULD do to you, but you need to provide the evidence to back those claims. You can't just throw out lots of scary "what ifs" as an argument against these vaccines. The world's leading experts believe them to be safe, and nearly all countries are adopting and using them. 

We now know the real risk of death when we don't use them, and how society can be shut down without a vaccine, so the real risk here is that not enough people will get vaccinated to reach herd immunity.


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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2 hours ago, marc9803 said:

I remember taking the yellow fever vaccine a few years ago and right before the shot, the nurse handed me a paper, warning of severe health problems that someone could develop, by taking that shot, per every million of people, who took it. I am happy I didn't develop any health problem taking that vaccine. I just took because I had to take, due to circumstances. But, I avoid at all cost to take any vaccine. They are not vitamins, that you can take, as much as you want. There are risks. I just take when the benefits outweight the risks and the vaccine at least passed by 2 years safety tests.

Over 400K still die of malaria each year, and millions more have to suffer serious chronic illness due to it:
https://www.who.int/news-room/fact-sheets/detail/malaria

How many people died or got seriously ill from the malaria vaccine? It's possible that you didn't get it due to the vaccine you received. That's the real problem with vaccines, people no longer get the disease, forget about them, believe the diseases are no longer scary or even exist, then start questioning why they need to take them, and/or start believing that vaccines are the cause of other issues they or their kids might have.

Do some internet searching on polio and small pox to see exactly what you don't need to worry about anymore due to vaccines.

44 minutes ago, DJFL77I said:

the flu kills a lot of people too..   

It took me one very bad bout with the flu when I was about 28 to start getting a vaccine each year. I don't worry about the vaccines, but do still worry about getting the flu again.


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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I’d be glad to add some information, with references.

Item 1: mRNA vaccines have not been authorized by FDA before, but have been developed and studied for other coronaviruses, such as MERS.  They were never approved because the need for a MERS vaccine went away. That is why development was able to proceed so quickly for COVID-19.     https://www.nature.com/articles/s41586-020-2622-0

Item 2: The number and length of nonclinical (prior to human use) safety studies depends on the drug/vaccine being developed.  A drug that is intended to be taken every day for a lifetime needs longer studies than one that will be taken once.  See section (a)(8) of 21CFR312.23.  

Item 3: I don’t know where you got two years.  Two year studies for drugs taken chronically are done in rats because that is their average lifespan.  The FDA guidance on COVID vaccines explains the specific requirements that they developed for these vaccines.

Item 4: Please provide a link to a peer-reviewed journal for your claim of mRNA toxicity.  mRNA is in every cell in our bodies.  It is unstable and is expected to be degraded relatively rapidly after injection (information from Moderna during FDA vaccine advisory committee meeting).

Items 9 and 10: The rate of severe allergic reactions to the vaccine is less than 1 in 40,000 based on what has been reported.  In the Pfizer clinical studies, which were large for clinical studies, about 18,000 people received the vaccine. Therefore a 1 in 40,000 reaction could be missed.  No reference because this is simple mathematics.  It is not a flaw in the study. It is very common for additional side effects to be seen once a drug is approved and used by many more people than were in the clinical trials.

Item antifreeze:  Antifreeze is ethylene glycol and is toxic. The Pfizer and Moderna vaccines include polyethylene glycol (PEG) which is a different molecule and not toxic.  It is not a new ingredient in drugs. It is the active ingredient in the laxative Miralax and in even larger amounts in some colonoscopy preps such as Golytely. PEG is attached to a number of lifesaving drugs.  In the Pfizer and Moderna vaccines it is attached to one of the lipids. It might be what is causing the rare allergic reactions but that has not yet been proven or disproven.

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22 hours ago, Scott Adams said:

@marc9803 I will go though each of the points you made, but ultimately the FDA has a rigorous process that all drugs must pass in order to be allowed on the market. In this case the process was expedited, however, it is my understanding that none of the normal safety procedures were skipped or excluded, including the 30,000 person trial for safety and efficacy. 

1) True, mRNA vaccines haven't been used, but this fact alone does not mean that they are not safe, or are more dangerous than any other type of vaccine. mRNA was used in this case, I believe, because it would make it more likely to cover future mutations of covid, thus making the vaccine more effective.

2) The safety tests were done according to the FDA's requirements, so they are not "short term" when compared to any other vaccine that has been given a green light by the FDA.

3) Please provide some support for your statement regarding a 2 year requirement before you can call a vaccine or medicine safe. You make this statement as if it is a fact, however, you do not back it up with anything. Please provide an FDA link to this requirement. It's my understanding that all safety and efficacy criteria were met for both vaccines. If we waited two more years millions more would die of covid-19 who could otherwise be saved.

4) You make the claim that mRNA has always been known to be toxic. I'm sure that during the 50 years of research there are examples of studies where toxicity was experienced, but this does not mean that the current vaccines are somehow toxic, does it? Please provide links or data to show us that the current two approved covid vaccines are toxic. Just saying that there is some past research where mRNA toxicity was observed does not make either of these vaccines toxic.

5) For #5 I think you refer to this article:
https://www.jpost.com/health-science/could-an-mrna-vaccine-be-dangerous-in-the-long-term-649253
where they discuss theoretical risks, but the very same article goes on to say:

6-7) There are people who claim they got their celiac disease from current childhood vaccinations. You can make up all sorts of hypothetical risks and run with them, but you need to provide some evidence beyond just stating the possible risks. I've seen no studies to date that link any vaccines as the cause of celiac disease, yet people do make the claims. It's up to the person making such a claim to produce the evidence, and not the other way around. You can make all sorts of hypothetical claims about what these new vaccines might cause, and it is not up to Pfizer or Moderna to disprove all of these claims.

Got a link for you claim in #7?

8. The CEO of Merck is behind and has no approved vaccine. His company competes with both Pfizer and Moderna in this space, thus, he is financially motivated to cast a cloud on his competitors' success in beating Merck in this race.

9-10) What "people" do you mean? How many compared to the number of people inoculated?  Every vaccine has a certain threshold of people who have an allergic or negative reaction to it. There is no talk of the rate of issues causing the withdrawal of either vaccine because the rate of reactions is very small, thus the risk is very small. The known death risk of covid-19 certainly outweighs the risks associated with these new vaccines.

The number of people in the trials was not reduced, and met all FDA requirements. 30,000 people were required to be inoculated in the last test, which is the standard requirement for vaccines.

11) See my answers to 4, 6 & 7. Again, you can make lots of vague scary claims about mRNA vaccines and what they COULD do to you, but you need to provide the evidence to back those claims. You can't just throw out lots of scary "what ifs" as an argument against these vaccines. The world's leading experts believe them to be safe, and nearly all countries are adopting and using them. 

We now know the real risk of death when we don't use them, and how society can be shut down without a vaccine, so the real risk here is that not enough people will get vaccinated to reach herd immunity.

 

 

Regarding your point 4, there is still no toxicological assessment about the toxicity of the two covid mRNA vaccines, because the tests were poorly done and short term.  We will know in a few years, since no long term tests were done—independently if FDA approved Pfizer’s trials.

Regarding your point 5, which mention Michal Linial, is total nonsense what that person said. Fast degradation, doesn’t mean that it doesn’t have toxicological effects. mRNA has a fast degradation, yet it still killed in a short period the lab rats. This problem was just resolved when two researchers, beginning of 2000, Katalin Karikó and  Drew Weissman, found out which nucleotide (set of RNA molecules) caused the exaggerated inflammatory reaction and replaced it with a synthetic molecule ,without the same toxic potential.

BT proteins produced in gmo plants also degradate fast when digested. However, countries that have follow the precautionary principle, asks the company who owns the gmo seed, which it wants to be approved for commercialization, to provide an allergenicity test with the time it takes to degrade, as well as lab tests with rats eating it, through a water solution or put on food. The results shows fast degradation, but all sorts of toxicological problems with animals fed with it, which there are dozens of peer reviews about this subject.

Anyway, it doesn’t make sense that Michal Linial say that it degrades fast, as an excuse of not being harmful, when the lab rats were dying, just by being in contact with this molecule.

Michal lineal is just another of these dishonest researchers, who omits parts of the story, in order to try to make an argument. This is the most I see among these researchers, nowadays. It is also funny that when the reporter asks him, if he will take these mRNA vaccines, he declines.

Regarding your point 6 and 7, there are literature about the risks of mRNA, which is even discussed in scientific magazines like Nature. See below

Norbert Pardi, Michael J. Hogan, Frederick W. Porter & Drew Weissman
Nature Reviews Drug Discovery volume 17, pages261–279(2018)

Potential safety concerns that are likely to be evaluated in future preclinical and clinical studies include local and systemic inflammation, the biodistribution and persistence of expressed immunogen, stimulation of auto-reactive antibodies and potential toxic effects of any non-native nucleotides and delivery system components. A possible concern could be that some mRNA-based vaccine platforms induce potent type I interferon responses, which have been associated not only with inflammation but also potentially with autoimmunity. Another potential safety issue could derive from the presence of extracellular RNA during mRNA vaccination. Another study showed that extracellular RNA promoted blood coagulation and pathological thrombus formation.

https://www.nature.com/articles/nrd.2017.243?fbclid=IwAR1p3QOffnNXnnekqiKV30pFMmT3TK0bEySSBcQfrl_EUe4fSsTPqIYjb5Q#Tab1

Anyway, as mentioned on my original post, something can’t be assumed to be safe, just because the problems still haven’t been found—especially with a new technology, which scientists are aware of risks and are doing ongoing safety tests to find out .

The other day, I read an article on CNBC, which an U.S govt agency was going to do their own research, with new vaccine trials of the Pfizer vaccine, with  people with allergic reactions, to find out why this group of people had such adverse side effects when taking Pfizer’s vaccine. They are also thinking of doing with another group, which don’t have allergic reactions. It makes sense if they do with these two group of people, since there were also lots who don’t have allergic reactions, but ended up in an ICU, fifteen minutes after taking the vaccine.

Regarding your point 8, it doesn’t matter if Pfizer and Moderna are Merck’s competitors. If Merck wanted, they could develop a vaccine as fast as these other companies. Merck has the know how and a track record of developing, all sorts of vaccines. Merck preferred to take another approach and the method of taking time to develop one for covid.

Regarding your point 9 and 10, the number of severe adverse effects, should be 1 per every 1,000,000 or more. Instead, the Pfizer’s vaccine was literally several every 50,000 to 100,000. I remember that when several severe cases were started to appear in the U.S, the number of people who took that vaccine, was still under 100,000. The funny thing, these severe cases appeared already in the first three days of vaccination. In England, it was literally the first day, several people had severe reaction to Pfizer’s vaccine. I saw several virologists on the news talk about these severe reactions to Pfizer’s vaccine and they said it was rare to happen in a vaccine—especially the large number of people, who had these severe reactions, vs. the small number of people who actually took that vaccine.

If the reporting of new severe reactions to that vaccine slowed, it was simply because in the U.S and Great Britain, doctors are advising to nobody take it, if the person has a history of allergies or other health issues, that might give these adverse side effects.

 You mention that FDA let do trials with 30,000. Well, I can tell you that the FDA has loosened the requirement for volunteers on these trials and that in the past, it was way many more and many years, before a vaccine was put in the market. This also goes around the world. You also need to do long term tests with rats, before going for human trials. I read that Pfizer did tests with rats before testing people. But, they were only short term tests.

The reason why you need years of safety tests with medications and vaccines is to know if the person might develop a disease or other health problems, in the long term, after taking the vaccine. This is a scientific dogma and which makes sense.

There can be cases where FDA or other regulatory agencies, might shortened the safety tests, as the ingredients or methods used in the vaccine, has a history of safety. But, this is not the case for these mRNA covid vaccines. In fact, it is the first going to be used for the public.

Regarding your note 11, there is no consensus by “ leading experts” that this vaccine is safe. In fact, it is divided in the scientific community. But, the govt and media are throwing, at least at a minimum, a misleading narrative.  It would even be irresponsible to make such a claim, when it was never used before. If a few individuals made such a claim, they are at least irresponsible and have a bad character. See also  Norbert Pardi, Michael J. Hogan, Frederick W. Porter & Drew Weissman Nature Reviews Drug Discovery volume 17, pages261–279(2018), as mentioned above.

Regarding your point 11 still, there will be no herd immunity, in a good portion of countries in the world, because people don’t want to take the vaccine, as the safety trials were short.  Everybody knows that. In Germany, 30%, don’t want to take it In France, 50%. In Spain, also between 40% to 50%. In Italy, similar figures as Spain. In the U.S, 50%. In Brazil, 30% and growing. In Russia, 50%

In fact, even the countries which had the greater acceptance to take these covid vaccines, like Great Britain, there are still 20%, who have doubts if they will take that vaccine.

You will only get heard immunity, if the govt start to force people to take it. This is being discussed by the Italian and Spanish govts. 

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Regarding your point 5, which mention Michal Linial, is total nonsense what that person said. Fast degradation, doesn’t mean that it doesn’t have toxicological effects. mRNA has a fast degradation, yet it still killed in a short period the lab rats. This problem was just resolved when two researchers, beginning of 2000, Katalin Karikó and  Drew Weissman, found out which nucleotide (set of RNA molecules) caused the exaggerated inflammatory reaction and replaced it with a synthetic molecule ,without the same toxic potential.

So it has only been 20 years now since they have resolved the inflammation issues with mRNA that you seem so concerned about, yet you are still so focused on this issue with this vaccine? Clearly they have worked this out, and I am not hearing of any issues with inflammation in those who are taking the vaccine (I personally know 3 people who have had it, and two are infectious disease doctors).

Regarding the rate of people having negative reactions, you can see data here that shows only a few Grade 4 reactions, ones that required emergency room visits, were recorded here for the Moderna vaccine:

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html

Quote

Among vaccine recipients, the median onset of systemic reactions was 1 to 2 days after either dose, with a median duration of 2 days. Grade 4 fever (>40.0°C) was reported by four vaccine recipients after dose 1 and 11 vaccine recipients after dose 2. There was one report of grade 4 fatigue and one report of grade 4 arthralgia, both in the younger age group after dose 1. In the older age group, there was one report of grade 4 nausea or vomiting after dose 2. No other systemic grade 4 reactions were reported.

You will also notice that due to the placebo effect, many who got a placebo, probably saline solution, instead of the actual vaccine reported similar issues as those who go the real one.

With the Pfizer vaccine it looks like the same number of people who got the placebo had Grade 4 reactions as those who got the actual vaccine:

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html

2 Grade 4 reactions to the vaccine vs. 2 Grade 4 who received placebo.

Pfizer vaccine:

Quote

Systemic Reactions

Among all vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 77.4% reported at least one systemic reaction. The frequency of systemic adverse events was higher in the younger than the older age group (82.8% vs 70.6%). Within each age group, the frequency and severity of systemic adverse events was higher after dose 2 than dose 1. Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. For both age groups, fatigue, headache and new or worsened muscle pain were most common. The majority of systemic events were mild or moderate in severity, after both doses and in both age groups. Fever was more common after the second dose and in the younger group (15.8%) compared to the older group (10.9%). Overall, the median onset of systemic adverse events in the vaccine group in general was 1 to 2 days after either dose and lasted a median duration of 1 day. Four grade 4 fevers (>40.0°C) were reported, two in the vaccine group and two in the placebo group. No other systemic grade 4 reactions were reported. Data on systemic reactions were not solicited from persons aged 16-17 years. However, their reactions to vaccination are expected to be similar to those of young adults who were included. In addition, reactogenicity data from adolescents aged 12-15 years were obtained and reviewed, and were similar to those from adults aged 18-55 years.

The take away here is that you can give people water injections and not have the "1 per every 1,000,000 or more" safety level that you claim these vaccines need to reach to be safe. Injecting water in people and telling them that it might be a vaccine will illicit similar severe reactions due to the placebo effect.

Personally I believe that the reason why people may not get vaccinated at higher rates is due to all the fear mongering that has been going on against all vaccines over the past 10-20 years. I also think that is what you may be doing here, fear mongering without looking at the actual safety data. 


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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On 12/30/2020 at 6:32 PM, Scott Adams said:

So it has only been 20 years now since they have resolved the inflammation issues with mRNA that you seem so concerned about, yet you are still so focused on this issue with this vaccine? Clearly they have worked this out, and I am not hearing of any issues with inflammation in those who are taking the vaccine (I personally know 3 people who have had it, and two are infectious disease doctors).

Regarding the rate of people having negative reactions, you can see data here that shows only a few Grade 4 reactions, ones that required emergency room visits, were recorded here for the Moderna vaccine:

https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html

You will also notice that due to the placebo effect, many who got a placebo, probably saline solution, instead of the actual vaccine reported similar issues as those who go the real one.

With the Pfizer vaccine it looks like the same number of people who got the placebo had Grade 4 reactions as those who got the actual vaccine:

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/reactogenicity.html

2 Grade 4 reactions to the vaccine vs. 2 Grade 4 who received placebo.

Pfizer vaccine:

The take away here is that you can give people water injections and not have the "1 per every 1,000,000 or more" safety level that you claim these vaccines need to reach to be safe. Injecting water in people and telling them that it might be a vaccine will illicit similar severe reactions due to the placebo effect.

Personally I believe that the reason why people may not get vaccinated at higher rates is due to all the fear mongering that has been going on against all vaccines over the past 10-20 years. I also think that is what you may be doing here, fear mongering without looking at the actual safety data. 

You put of those links to try to make a point that it's safe. But, there's no long term tests. It is irresponsible to claim a medication or vaccine is safe, if no long term tests were done. This is elementary in science. Nobody can scientifically state that these vaccines are safe if no long term tests were done. 

I used to work in the life sciences field in the past and still have contact with dozens of known researchers around the world-- lots even who publish annually, peer reviewed studies in the most respected scientific magazines. I asked them, in the last month, the following questions:

1) Are they safe, especially mRna vaccines of Moderna and Pfizer? 

2) Will you take it?

Regarding the safety of them, all of them said no, as no long term safety tests were done and even the short term tests were poorly done. They have a similar opinion as the CEO of Merck. 

Regarding if they will take any of those vaccines, independently if it's Moderna's, Pfizer's, Oxford's or any other, one group said that  they will take, not because they thought the vaccines were safe, but because they were emotionally affected by the people they see dying with this virus. Lots even went further about the safety question and said that, " We will only know if we will develop any health related problems in 1-3 years, after taking these Pfizer's or Moderna's vaccines, or any other covid vaccine. By the way they spoke about these mRNA vaccines, they sounded that they will choose the less worse and certainly won't pick mRNA vaccines. I think they are going with Oxford's vaccine or with Janssen.  

There's another group who simply said they are not stupid to take any of those first generation covid vaccines, due to badly done safety tests. They also mentioned problems with the anti-freeze, mRNA molecule and that there's no long term data of the safety of mRNA in literature. One researcher said to me that there's even a  transgenic Chinese covid vaccine being developed, which uses the Ad5 vector, which increases the chance of the person getting the AIDS virus.

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THERE IS NO ANTIFREEZE IN THE PFIZER AND MODERNA COVID VACCINES!  Yes I am yelling. I’ve had to correct this misinformation too many times today.  

The vaccines contain polyethylene glycol. It is used in the over the counter laxative Miralax, as well as other drugs.

Antifreeze contains ethylene glycol. It is toxic.

Polyethylene glycol and ethylene glycol have completely different chemical and toxicological properties.  Saying they are the same is like saying that glucose is the same as starch.  They aren’t.

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The Oxford and Janssen vaccines also use adenovirus vectors. Adenoviruses have been studied as vectors for years.  There is one approved vaccine for tuberculosis using such a vector.

The adenovirus vector only increases the chance of HIV in a particular subset of patients who already have been exposed to HIV (seropositive). Please watch out for making misleading generalizations.

Adenovirus vector vaccines

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There's another group who simply said they are not stupid to take any of those first generation covid vaccines, due to badly done safety tests. They also mentioned problems with the anti-freeze, mRNA molecule and that there's no long term data of the safety of mRNA in literature. One researcher said to me that there's even a  transgenic Chinese covid vaccine being developed, which uses the Ad5 vector, which increases the chance of the person getting the AIDS virus.

@marc9803 your posts, unfortunately, are full of misinformation. As @RMJ has pointed out, there is no antifreeze in the covid-19 vaccine, so please stop spreading misinformation that is clearly designed to make people afraid of it.  You say that "There's another group who simply said they are not stupid to take any of those first generation covid vaccines, due to badly done safety tests," but what does this really mean? Of course there are all sorts of groups that may not take it for all sorts of reasons--perhaps Amish people might not take it because they are Amish and don't believe in science...so what? Please explain your claim here that there were "badly done safety tests." What safety tests were done badly?


Scott Adams

Celiac.com - Celiac Disease Board Moderator

Founder Celiac.com

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2 minutes ago, RMJ said:

THERE IS NO ANTIFREEZE IN THE PFIZER AND MODERNA COVID VACCINES!  Yes I am yelling. I’ve had to correct this misinformation too many times today.  

The vaccines contain polyethylene glycol. It is used in the over the counter laxative Miralax, as well as other drugs.

Antifreeze contains ethylene glycol. It is toxic.

Polyethylene glycol and ethylene glycol have completely different chemical and toxicological properties.  Saying they are the same is like saying that glucose is the same as starch.  They aren’t.

The way you wrote your comment, clearly shows you are confused about this topic. Polyethylene glycol is an antifreeze and is in Pfizer's and Moderna's vaccine and the vaccine industry uses several types. You just need to google about this topic if it's not your field.   Read the article below about how the antifreeze in Pfizer's vaccine (Polyethylene glycol)  is suspected of causing these allergic reactions.

Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions

Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).

PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine. 

Others are skeptical of the link. Still, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) was concerned enough to convene several meetings last week to discuss the allergic reactions with representatives of Pfizer and Moderna, independent scientists and physicians, and the Food and Drug Administration (FDA).

NIAID is also setting up a study in collaboration with FDA to analyze the response to the vaccine in people who have high levels of anti-PEG antibodies or have experienced severe allergic responses to drugs or vaccines before. “Until we know there is truly a PEG story, we need to be very careful in talking about that as a done deal,” says Alkis Togias, branch chief of allergy, asthma, and airway biology at NIAID.

Pfizer, too, says it is “actively seeking follow-up.” A statement emailed to Science noted it already recommends that “appropriate medical treatment and supervision should always be readily available” in case a vaccinee develops anaphylaxis.

Anaphylactic reactions can occur with any vaccine, but are usually extremely rare—about one per 1 million doses. As of 19 December, the United States had seen six cases of anaphylaxis among 272,001 people who received the COVID-19 vaccine, according to a recent presentation by Thomas Clark of the U.S. Centers for Disease Control and Prevention (CDC); the United Kingdom has recorded two. Because the Pfizer and Moderna mRNA vaccines use a new platform, the reactions call for careful scrutiny, says Elizabeth Phillips, a drug hypersensitivity researcher at Vanderbilt University Medical Center who attended an NIAID meeting on 16 December. “This is new.” 

News reports about the allergic reactions have already created anxiety. “Patients with severe allergies in the US are getting nervous about the possibility that they may not be able to get vaccinated, at least with those two vaccines,” Togias wrote in an invitation to meeting participants. “Allergies in general are so common in the population that this could create a resistance against the vaccines in the population,” adds Janos Szebeni, an immunologist at Semmelweis University in Budapest, Hungary, who has long studied hypersensitivity reactions to PEG and who also attended the 16 December gathering.

Scientists who believe PEG may be the culprit stress that vaccination should continue. “We need to get vaccinated,” Phillips says. “We need to try and curtail this pandemic.” But more data are urgently needed, she adds: “These next couple of weeks in the U.S. are going to be extremely important for defining what to do next.”

Toothpaste and shampoo

Pfizer’s and Moderna’s clinical trials of the vaccines, which involved tens of thousands of people, did not find serious adverse events caused by the vaccine. But both studies excluded people with a history of allergies to components of the COVID-19 vaccines; Pfizer also excluded those who previously had a severe adverse reaction from any vaccine. People with previous allergic reactions to food or drugs were not excluded, but may have been underrepresented.

The two vaccines both contain mRNA wrapped in lipid nanoparticles (LNPs) that help carry it to human cells but also act as an adjuvant, a vaccine ingredient that bolsters the immune response. The LNPs are “PEGylated”—chemically attached to PEG molecules that cover the outside of the particles and increase their stability and life span.

PEGs are also used in everyday products such as toothpaste and shampoo as thickeners, solvents, softeners, and moisture carriers, and they’ve been used as a laxative for decades. An increasing number of biopharmaceuticals include PEGylated compounds as well.

PEGs were long thought to be biologically inert, but a growing body of evidence suggests they are not. As much as 72% of people have at least some antibodies against PEGs, according to a 2016 study led by Samuel Lai, a pharmaco-engineer at the University of North Carolina, Chapel Hill, presumably as a result of exposure to cosmetics and pharmaceuticals. About 7% have a level that may be high enough to predispose them to anaphylactic reactions, he found. Other studies have also found antibodies against PEG, but at lower levels.

“Some companies have dropped PEGylated products from their pipeline as a result,” Lai says. But he notes that the safety record of many PEGylated drugs has persuaded others that “concerns about anti-PEG antibodies are overstated.”

Szebeni says the mechanism behind PEG-conjugated anaphylaxis is relatively unknown because it does not involve immunoglobulin E (IgE), the antibody type that causes classical allergic reactions. (That’s why he prefers to call them “anaphylactoid” reactions.) Instead, PEG triggers two other classes of antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG), involved in a branch of the body’s innate immunity called the complement system, which Szebeni has spent decades studying in a pig model he developed.

In 1999, while working at the Walter Reed Army Institute of Research, Szebeni described a new type of drug-induced reaction he dubbed complement activation-related pseudoallergy (CARPA), a nonspecific immune response to nanoparticle-based medicines, often PEGylated, that are mistakenly recognized by the immune system as viruses.

Szebeni believes CARPA explains the severe anaphylactoid reactions some PEGylated drugs are occasionally known to cause, including cancer blockbuster Doxil. A team assembled by Bruce Sullenger, a surgeon at Duke University, experienced similar issues with an experimental anticoagulant containing PEGylated RNA. The team had to halt a phase III trial in 2014 after about 0.6% of 1600 people who received the drug had severe allergic responses and one participant died. “That stopped the trial,” Sullenger says. The team found that every participant with an anaphylaxis had high levels of anti-PEG IgG. But some with no adverse reaction had high levels as well, Sullenger adds. “So, it is not sufficient to just have these antibodies.”

At the NIAID meeting, several attendees stressed that PEGylated nanoparticles may cause problems through a mechanism other than CARPA. Just last month, Phillips and scientists at FDA and other institutions published a paper showing patients who suffered an anaphylactic reaction to PEGylated drugs did have IgE antibodies to PEG after all, suggesting those may be involved, rather than IgG and IgM.

Other scientists, meanwhile, are not convinced PEG is involved at all. “There is a lot of exaggeration when it comes to the risk of PEGs and CARPA,” says Moein Moghimi, a nanomedicine researcher at Newcastle University who suspects a more conventional mechanism is causing the reactions. “You are technically delivering an adjuvant at the injection site to excite the local immune system. It happens that some people get too much excitement, because they have a relatively high number of local immune cells.”

Others note the amount of PEG in the mRNA vaccines is orders of magnitude lower than in most PEGylated drugs. And whereas those drugs are often given intravenously, the two COVID-19 vaccines are injected into a muscle, which leads to a delayed exposure and a much lower level of PEG in the blood, where most anti-PEG antibodies are.

Nevertheless, the companies were aware of the risk. In a stock market prospectus filed on 6 December 2018, Moderna acknowledged the possibility of “reactions to the PEG from some lipids or PEG otherwise associated with the LNP.” And in a September paper, BioNTech researchers proposed an alternative to PEG for therapeutic mRNA delivery, noting: “The PEGylation of nanoparticles can also have substantial disadvantages concerning activity and safety.’”

Katalin Karikó, a senior vice president at BioNTech who co-invented the mRNA technology underlying both vaccines, says she discussed with Szebeni whether PEG in the vaccine could be an issue. (The two know each other well; both are Hungarian and in the 1980s, Karikó taught Szebeni how to make liposomes in her lab.) They agreed that given the low amount of lipid and the intramuscular administration, the risk was negligible.

Karikó emphasizes that based on what we know so far, the risk is still low. “All vaccines carry some risk. But the benefit of the vaccine outweighs the risk,” she says.

Szebeni agrees, but says he hopes that’s also true in the long run. He notes that both mRNA vaccines require two shots, and he worries anti-PEG antibodies triggered by the first shot could increase the risk of an allergic reaction to the second or to PEGylated drugs.

Stay for 30 minutes.

To understand the risk, Phillips says, it’s crucial to unravel the mechanisms underlying the immune reactions and find out how often they are likely to occur. The known U.S. cases are currently under study, but key clues may have vanished: Anaphylactic reactions produce biomarkers that only remain in the blood for a few hours. At the NIAID meeting, participants discussed ways to ensure that blood samples from future cases are taken immediately and tested for those markers.

If PEG does turn out to be the culprit, the question is, what can be done? Screening millions of people for anti-PEG antibodies before they are vaccinated is not feasible. Instead, CDC guidelines recommend not giving the Pfizer or Moderna vaccines to anyone with a history of severe allergic reaction to any component of the vaccine. For people who have had a severe reaction to another vaccine or injectable medication, the risks and benefits of vaccination should be carefully weighed, CDC says. And people who might be at high risk of an anaphylactic reaction should stay at the vaccination site for 30 minutes after their shot so they can be treated if necessary.

“At least [anaphylaxis] is something that happens quickly,” Philips says. “So, it’s something that you can be very much alerted to, prepared to recognize early and be prepared to treat early.”

https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions

 

 

3 minutes ago, Scott Adams said:

@marc9803 your posts, unfortunately, are full of misinformation. As @RMJ has pointed out, there is no antifreeze in the covid-19 vaccine, so please stop spreading misinformation that is clearly designed to make people afraid of it.  You say that "There's another group who simply said they are not stupid to take any of those first generation covid vaccines, due to badly done safety tests," but what does this really mean? Of course there are all sorts of groups that may not take it for all sorts of reasons--perhaps Amish people might not take it because they are Amish and don't believe in science...so what? Please explain your claim here that there were "badly done safety tests." What safety tests were done badly?

Polyethylene glycol is an antifreeze and is in Pfizer's and Moderna's vaccine and the vaccine industry uses several types. You just need to google about this topic if it's not your field.   Read the article below about how the antifreeze in Pfizer's vaccine (Polyethylene glycol)  is suspected of causing these allergic reactions.

Suspicions grow that nanoparticles in Pfizer’s COVID-19 vaccine trigger rare allergic reactions

Severe allergy-like reactions in at least eight people who received the COVID-19 vaccine produced by Pfizer and BioNTech over the past 2 weeks may be due to a compound in the packaging of the messenger RNA (mRNA) that forms the vaccine’s main ingredient, scientists say. A similar mRNA vaccine developed by Moderna, which was authorized for emergency use in the United States on Friday, also contains the compound, polyethylene glycol (PEG).

PEG has never been used before in an approved vaccine, but it is found in many drugs that have occasionally triggered anaphylaxis—a potentially life-threatening reaction that can cause rashes, a plummeting blood pressure, shortness of breath, and a fast heartbeat. Some allergists and immunologists believe a small number of people previously exposed to PEG may have high levels of antibodies against PEG, putting them at risk of an anaphylactic reaction to the vaccine. 

Others are skeptical of the link. Still, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) was concerned enough to convene several meetings last week to discuss the allergic reactions with representatives of Pfizer and Moderna, independent scientists and physicians, and the Food and Drug Administration (FDA).

NIAID is also setting up a study in collaboration with FDA to analyze the response to the vaccine in people who have high levels of anti-PEG antibodies or have experienced severe allergic responses to drugs or vaccines before. “Until we know there is truly a PEG story, we need to be very careful in talking about that as a done deal,” says Alkis Togias, branch chief of allergy, asthma, and airway biology at NIAID.

Pfizer, too, says it is “actively seeking follow-up.” A statement emailed to Science noted it already recommends that “appropriate medical treatment and supervision should always be readily available” in case a vaccinee develops anaphylaxis.

Anaphylactic reactions can occur with any vaccine, but are usually extremely rare—about one per 1 million doses. As of 19 December, the United States had seen six cases of anaphylaxis among 272,001 people who received the COVID-19 vaccine, according to a recent presentation by Thomas Clark of the U.S. Centers for Disease Control and Prevention (CDC); the United Kingdom has recorded two. Because the Pfizer and Moderna mRNA vaccines use a new platform, the reactions call for careful scrutiny, says Elizabeth Phillips, a drug hypersensitivity researcher at Vanderbilt University Medical Center who attended an NIAID meeting on 16 December. “This is new.” 

News reports about the allergic reactions have already created anxiety. “Patients with severe allergies in the US are getting nervous about the possibility that they may not be able to get vaccinated, at least with those two vaccines,” Togias wrote in an invitation to meeting participants. “Allergies in general are so common in the population that this could create a resistance against the vaccines in the population,” adds Janos Szebeni, an immunologist at Semmelweis University in Budapest, Hungary, who has long studied hypersensitivity reactions to PEG and who also attended the 16 December gathering.

Scientists who believe PEG may be the culprit stress that vaccination should continue. “We need to get vaccinated,” Phillips says. “We need to try and curtail this pandemic.” But more data are urgently needed, she adds: “These next couple of weeks in the U.S. are going to be extremely important for defining what to do next.”

Toothpaste and shampoo

Pfizer’s and Moderna’s clinical trials of the vaccines, which involved tens of thousands of people, did not find serious adverse events caused by the vaccine. But both studies excluded people with a history of allergies to components of the COVID-19 vaccines; Pfizer also excluded those who previously had a severe adverse reaction from any vaccine. People with previous allergic reactions to food or drugs were not excluded, but may have been underrepresented.

The two vaccines both contain mRNA wrapped in lipid nanoparticles (LNPs) that help carry it to human cells but also act as an adjuvant, a vaccine ingredient that bolsters the immune response. The LNPs are “PEGylated”—chemically attached to PEG molecules that cover the outside of the particles and increase their stability and life span.

PEGs are also used in everyday products such as toothpaste and shampoo as thickeners, solvents, softeners, and moisture carriers, and they’ve been used as a laxative for decades. An increasing number of biopharmaceuticals include PEGylated compounds as well.

PEGs were long thought to be biologically inert, but a growing body of evidence suggests they are not. As much as 72% of people have at least some antibodies against PEGs, according to a 2016 study led by Samuel Lai, a pharmaco-engineer at the University of North Carolina, Chapel Hill, presumably as a result of exposure to cosmetics and pharmaceuticals. About 7% have a level that may be high enough to predispose them to anaphylactic reactions, he found. Other studies have also found antibodies against PEG, but at lower levels.

“Some companies have dropped PEGylated products from their pipeline as a result,” Lai says. But he notes that the safety record of many PEGylated drugs has persuaded others that “concerns about anti-PEG antibodies are overstated.”

Szebeni says the mechanism behind PEG-conjugated anaphylaxis is relatively unknown because it does not involve immunoglobulin E (IgE), the antibody type that causes classical allergic reactions. (That’s why he prefers to call them “anaphylactoid” reactions.) Instead, PEG triggers two other classes of antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG), involved in a branch of the body’s innate immunity called the complement system, which Szebeni has spent decades studying in a pig model he developed.

In 1999, while working at the Walter Reed Army Institute of Research, Szebeni described a new type of drug-induced reaction he dubbed complement activation-related pseudoallergy (CARPA), a nonspecific immune response to nanoparticle-based medicines, often PEGylated, that are mistakenly recognized by the immune system as viruses.

Szebeni believes CARPA explains the severe anaphylactoid reactions some PEGylated drugs are occasionally known to cause, including cancer blockbuster Doxil. A team assembled by Bruce Sullenger, a surgeon at Duke University, experienced similar issues with an experimental anticoagulant containing PEGylated RNA. The team had to halt a phase III trial in 2014 after about 0.6% of 1600 people who received the drug had severe allergic responses and one participant died. “That stopped the trial,” Sullenger says. The team found that every participant with an anaphylaxis had high levels of anti-PEG IgG. But some with no adverse reaction had high levels as well, Sullenger adds. “So, it is not sufficient to just have these antibodies.”

At the NIAID meeting, several attendees stressed that PEGylated nanoparticles may cause problems through a mechanism other than CARPA. Just last month, Phillips and scientists at FDA and other institutions published a paper showing patients who suffered an anaphylactic reaction to PEGylated drugs did have IgE antibodies to PEG after all, suggesting those may be involved, rather than IgG and IgM.

Other scientists, meanwhile, are not convinced PEG is involved at all. “There is a lot of exaggeration when it comes to the risk of PEGs and CARPA,” says Moein Moghimi, a nanomedicine researcher at Newcastle University who suspects a more conventional mechanism is causing the reactions. “You are technically delivering an adjuvant at the injection site to excite the local immune system. It happens that some people get too much excitement, because they have a relatively high number of local immune cells.”

Others note the amount of PEG in the mRNA vaccines is orders of magnitude lower than in most PEGylated drugs. And whereas those drugs are often given intravenously, the two COVID-19 vaccines are injected into a muscle, which leads to a delayed exposure and a much lower level of PEG in the blood, where most anti-PEG antibodies are.

Nevertheless, the companies were aware of the risk. In a stock market prospectus filed on 6 December 2018, Moderna acknowledged the possibility of “reactions to the PEG from some lipids or PEG otherwise associated with the LNP.” And in a September paper, BioNTech researchers proposed an alternative to PEG for therapeutic mRNA delivery, noting: “The PEGylation of nanoparticles can also have substantial disadvantages concerning activity and safety.’”

Katalin Karikó, a senior vice president at BioNTech who co-invented the mRNA technology underlying both vaccines, says she discussed with Szebeni whether PEG in the vaccine could be an issue. (The two know each other well; both are Hungarian and in the 1980s, Karikó taught Szebeni how to make liposomes in her lab.) They agreed that given the low amount of lipid and the intramuscular administration, the risk was negligible.

Karikó emphasizes that based on what we know so far, the risk is still low. “All vaccines carry some risk. But the benefit of the vaccine outweighs the risk,” she says.

Szebeni agrees, but says he hopes that’s also true in the long run. He notes that both mRNA vaccines require two shots, and he worries anti-PEG antibodies triggered by the first shot could increase the risk of an allergic reaction to the second or to PEGylated drugs.

Stay for 30 minutes.

To understand the risk, Phillips says, it’s crucial to unravel the mechanisms underlying the immune reactions and find out how often they are likely to occur. The known U.S. cases are currently under study, but key clues may have vanished: Anaphylactic reactions produce biomarkers that only remain in the blood for a few hours. At the NIAID meeting, participants discussed ways to ensure that blood samples from future cases are taken immediately and tested for those markers.

If PEG does turn out to be the culprit, the question is, what can be done? Screening millions of people for anti-PEG antibodies before they are vaccinated is not feasible. Instead, CDC guidelines recommend not giving the Pfizer or Moderna vaccines to anyone with a history of severe allergic reaction to any component of the vaccine. For people who have had a severe reaction to another vaccine or injectable medication, the risks and benefits of vaccination should be carefully weighed, CDC says. And people who might be at high risk of an anaphylactic reaction should stay at the vaccination site for 30 minutes after their shot so they can be treated if necessary.

“At least [anaphylaxis] is something that happens quickly,” Philips says. “So, it’s something that you can be very much alerted to, prepared to recognize early and be prepared to treat early.”

https://www.sciencemag.org/news/2020/12/suspicions-grow-nanoparticles-pfizer-s-covid-19-vaccine-trigger-rare-allergic-reactions

 

 

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12 minutes ago, Scott Adams said:

@marc9803 your posts, unfortunately, are full of misinformation. As @RMJ has pointed out, there is no antifreeze in the covid-19 vaccine, so please stop spreading misinformation that is clearly designed to make people afraid of it.  You say that "There's another group who simply said they are not stupid to take any of those first generation covid vaccines, due to badly done safety tests," but what does this really mean? Of course there are all sorts of groups that may not take it for all sorts of reasons--perhaps Amish people might not take it because they are Amish and don't believe in science...so what? Please explain your claim here that there were "badly done safety tests." What safety tests were done badly?

Nothing personal and don't mean to be disrespectful. Instead of accusing people of misinformation, please do some research, before accepting face value, misinformed statements of others.  

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I agree that polyethylene glycol MIGHT be the cause of the anaphylactic reactions - more research needed to confirm. That does not mean that it is the molecule that is in antifreeze.

Usually when people say that the vaccine contains antifreeze they’re trying to scare people into thinking it contains the toxic molecule, ethylene glycol, used in car radiators.

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10 minutes ago, RMJ said:

I agree that polyethylene glycol MIGHT be the cause of the anaphylactic reactions - more research needed to confirm. That does not mean that it is the molecule that is in antifreeze.

Usually when people say that the vaccine contains antifreeze they’re trying to scare people into thinking it contains the toxic molecule, ethylene glycol, used in car radiators.

The point made is not if polyethylene glycol MIGHT or not have caused these allergic reactions. The point I MADE is that polyethylene glycol is the antifreeze ingredient on this vaccine. If you are still confused about this topic, do a google, " polyethylene glycol and antifreeze". Anyway, the first time I heard about the antifreeze on mRNA vaccines were from researchers I have contact. They also clearly stated to me antifreeze (polyethylene glycol). 2) The second time I heard researchers talk about the antifreeze was in a scientific platform, which has hundreds of thousands of researchers from all over the world, which I am a member of that platform, and the topic was about the antifreeze and polyethylene glycol in Pfizer's vaccine. The thread had more than 50 comments as of yesterday and the people commenting were all post doctor's from Yale, Harvard, John Hopkins, etc. 

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The question the FDA asked the advisory committees for Pfizer and Moderna was not: Is the vaccine 100% safe in all circumstances.  The question was: Do the benefits outweigh the risks. They authorized the vaccines because they felt the benefit DOES outweigh the risks.  It is not at all uncommon for additional side effects to be seen after a drug is commercially available.

There is a worldwide pandemic.  Hospitals are full.  Healthcare workers are stressed beyond belief. The more contagious variant has been found in my county. People are dying from COVID-19.

Due to those circumstances, I feel the benefits of the vaccine for me, in the 65 and older age group, clearly outweigh the risks. No drug or molecule is 100% guaranteed safe.  People have even died from drinking too much water.

Avoid the vaccines if you feel the risk to you is greater than the benefit.  Or choose the one you feel is least risky. But please stop trying to scare others into avoiding a potentially life-saving vaccine.

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13 minutes ago, RMJ said:

The question the FDA asked the advisory committees for Pfizer and Moderna was not: Is the vaccine 100% safe in all circumstances.  The question was: Do the benefits outweigh the risks. They authorized the vaccines because they felt the benefit DOES outweigh the risks.  It is not at all uncommon for additional side effects to be seen after a drug is commercially available.

There is a worldwide pandemic.  Hospitals are full.  Healthcare workers are stressed beyond belief. The more contagious variant has been found in my county. People are dying from COVID-19.

Due to those circumstances, I feel the benefits of the vaccine for me, in the 65 and older age group, clearly outweigh the risks. No drug or molecule is 100% guaranteed safe.  People have even died from drinking too much water.

Avoid the vaccines if you feel the risk to you is greater than the benefit.  Or choose the one you feel is least risky. But please stop trying to scare others into avoiding a potentially life-saving vaccine.

I'm not trying to scare anyone. I just think there is a false narrative in the media, stating that these vaccines are safe and brainwashing people. I am in favor of scientific transparency and an honest debate about the safety of these covid vaccines in society. However, this has not happened. There is like a witch hunt, any person who question the safety of them. Regarding your point on why you want to take it, If I were in the vulnerable group, I would probably take that vaccine. The risk benefit would outweigh the risk. I have no problem with this analysis.  But, if the person is healthy, non-smoker, I wouldn't take it. The issue I have is this narrative from the media, govts, saying that the vaccine is safe.   

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RMJ and  Marc9803,

I don't know how to follow a thread without making a comment.

So I have a few questions as follow up. Fascinating and excellent conversation BTW. I have really enjoyed reading it....the back and forth.

I have really learned a lot from this thread.

1) So the two approved US vaccines use PEG as carrier. Is that correct??

2) does the Johnson and Johnson vaccine due for approval in January/February time rame also use PEG as a carrier?

3) If they both (Pfizer and Moderna) vaccine both use PEG as a carrier.....why does one have to be "SUPER COLD" and the other one can be stored in a regular refrigerator.

4) IF you have had a reaction to PEG before.....I Have had a terrible reaction to Miralax (PEG) before and won't touch the stuff.....does that mean I should stay away from the Morderna and Pfizer vaccine and wait instead on a Adenovirus carrier vaccine??

5) do either of you know when the Oxford Vaccine (Adenovirus carrier) is expected to be approved in the USA?

6) I have not heard of the Janssen virus yet? How close is it to being approved in the USA?

Thank you both for your great insight and wealth of knowledge on this topic.

Posterboy,

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