CDZ Immune Response May Explain Rare Clots After AstraZeneca Vaccine | Medscape

Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

I think you're agreeing with me :p.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
I got my first shot a couple weeks ago and I still have this joyful euphoria of life.

Glad to hear it. Your joy may not last though. You may want to take a look at the following threads here at USMB, which suggest that dark times may be ahead for those who have taken Covid vaccines and so far not had any serious side effects:

Ok..........I'm life/ health underwriter qualified which means I don't do it but can if asked. Been doing it a long time.

A vaccine simply gives you antibodies to fight off a continuing wave of infection especially in peak flu seasons.

You still get it, but it will probably be be minor or just sniffles. All it is, is just dead or nearly dead Covid if you can even call a virus, living.

I read the original article. Can you even understand any of it in a complex way? Even I never herd of a third of the words...lol
Yes, but the covid vaccines aren't vaccines...they are genetic modifiers/mrna inhibitors. The NAME in itself is actually a lie.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

I think you're agreeing with me :p.
Yes...I am....

My point was that these were obvious issues, but the government medical keeps acting like they are a surprise. Sorry, I sound grumpy----didn't get much sleep again.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
I got my first shot a couple weeks ago and I still have this joyful euphoria of life.

Glad to hear it. Your joy may not last though. You may want to take a look at the following threads here at USMB, which suggest that dark times may be ahead for those who have taken Covid vaccines and so far not had any serious side effects:

Ok..........I'm life/ health underwriter qualified which means I don't do it but can if asked. Been doing it a long time.

A vaccine simply gives you antibodies to fight off a continuing wave of infection especially in peak flu seasons.

You still get it, but it will probably be be minor or just sniffles. All it is, is just dead or nearly dead Covid if you can even call a virus, living.

I read the original article. Can you even understand any of it in a complex way? Even I never herd of a third of the words...lol
Yes, but the covid vaccines aren't vaccines...they are genetic modifiers/mrna inhibitors. The NAME in itself is actually a lie.

I have read somewhere that they changed the definition of vaccines in order to accommodate these new RNA vaccines.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

I think you're agreeing with me :p.
Yes...I am....

My point was that these were obvious issues, but the government medical keeps acting like they are a surprise. Sorry, I sound grumpy----didn't get much sleep again.

Nah it's fine, just wanted to make sure we were on the same page, lol :p.
 
#38: “the animal most like human beings” is a biased statement because it is referring to a non-natural host and thus giving the audience what it wants to hear. Any affects of the vaccine on a non-natural host (Homo sapiens) will automatically leave out the model that would answer many more questions than ferrets as a model. If the definition of vaccine has been redefined, so too the medical classification of COVID-19, its coagulation and thrombotic parameters already include hantavirus links to factor XII and the cardiopulmonary aspects already implicate links to Alzheimer’s. The Alzheimer’s link to hantavirus/COVID-19 is based on the Alzheimer’s-like mutations of COVID-19: N501Y and A653V.

Neither reification of portal vein thrombosis nor ferrets as lung sentinels (cherry-picking models for ACE2 receptors will suffice in the long run. Other mistakes will be to continue to disregard the evolutionary history and biology of COVID-19 in natural hosts, what is occurring in nature, because without it, it’s not true science, only speculative yellow journalism, a kind of dairy farming as COVID-19 comes to take on its more lasting namesake. What’s being left out in the media represents a second, separate population of COVID-19.
 
#38: “the animal most like human beings” is a biased statement because it is referring to a non-natural host and thus giving the audience what it wants to hear. Any affects of the vaccine on a non-natural host (Homo sapiens) will automatically leave out the model that would answer many more questions than ferrets as a model. If the definition of vaccine has been redefined, so too the medical classification of COVID-19, its coagulation and thrombotic parameters already include hantavirus links to factor XII and the cardiopulmonary aspects already implicate links to Alzheimer’s. The Alzheimer’s link to hantavirus/COVID-19 is based on the Alzheimer’s-like mutations of COVID-19: N501Y and A653V.

Neither reification of portal vein thrombosis nor ferrets as lung sentinels (cherry-picking models for ACE2 receptors will suffice in the long run. Other mistakes will be to continue to disregard the evolutionary history and biology of COVID-19 in natural hosts, what is occurring in nature, because without it, it’s not true science, only speculative yellow journalism, a kind of dairy farming as COVID-19 comes to take on its more lasting namesake. What’s being left out in the media represents a second, separate population of COVID-19.

I have a question for you- why don't you just quote posts? Would make it easier to see what you're referring to. Anyway, not only does your not quoting what you're responding to make it difficult, but I find the way you respond also doesn't seem to really address the points I'm making. Anyway, I'll try to sumarize what I think we agree on and then bring up a point of my own.

Anyway, we can agree that the best way to know what will happen to humans with any drug or vaccine is to test it on humans. Due to the dangers of doing so, this is generally frowned upon. Because of the alleged pandemic, however, they let it happen. I think we're currently seeing the results of this experiment and we will see more of this soon enough.
 
A ferret’s ACE2 receptors is the only thing this writer can agree on as far as similarities with humans, and even that comes with caveats.. Yes, ferrets are used as air quality sentinels. As we all can see in the news, variants are arising in the RBD (receptor binding domain), and 90 cases of the Brazilian variant just occurred in southern Illinois.

Post #1 deals with heparin and clotting, though other things than heparin can be inserted here, which is the point. taking a broader view when we track the variants for any resonance to coagulation, or thrombocytopenia, we find them. It is difficult to align a certain vaccine with certain side-effects, because genomes will respond very differently. In addition, it is impossible for science to precisely state which mutations are most responsible for concern, though the E484K mutation currently has our vote, because it has already been described well in mice (Siena, Italy study).

We think that what the variants do will influence future vaccine design and as well, influence the host’s immune reaction. The latest clotting/thrombo news have gone beyond ACE2 and air-quality ferrets. Now we have hantavirus and Alzheimer’s connections that should not be ignored.
 
By not using the quote function, the reader should claim the right to contradict themselves and boycott it. If one can’t remember what was said, go back and read it again.
 
You lose it at the point where you split the biology and science. No. The best way to know what will happen to humans with any drug or vaccine is to test it on humans (and[italics]) the host that COVID-19 evolved with in nature. Forget the lab theory.
 
You’re right about this: as long as COVID-19’s biology and evolution remain esoteric hostage to elite groups, the experiment can And will be perpetuated.
 
moderna has more blood clot victims than all of them put together. the media is not reporting it.

Moderna Wins Initial $20M Grant from Gates Foundation :stir:

 
A ferret’s ACE2 receptors is the only thing this writer can agree on as far as similarities with humans, and even that comes with caveats.. Yes, ferrets are used as air quality sentinels. As we all can see in the news, variants are arising in the RBD (receptor binding domain), and 90 cases of the Brazilian variant just occurred in southern Illinois.

Post #1 deals with heparin and clotting, though other things than heparin can be inserted here, which is the point. taking a broader view when we track the variants for any resonance to coagulation, or thrombocytopenia, we find them. It is difficult to align a certain vaccine with certain side-effects, because genomes will respond very differently. In addition, it is impossible for science to precisely state which mutations are most responsible for concern, though the E484K mutation currently has our vote, because it has already been described well in mice (Siena, Italy study).

We think that what the variants do will influence future vaccine design and as well, influence the host’s immune reaction. The latest clotting/thrombo news have gone beyond ACE2 and air-quality ferrets. Now we have hantavirus and Alzheimer’s connections that should not be ignored.

You're hard to understand, probably because you are more familiar with a lot of stuff here. Do you have expertise in the field of virology and/or vaccines?
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

in order to stabilize the vaccine, they added PEG which we are exposed to regularly. it prevents the body from breaking down the vaccine's properties. that glycol is partly responsible for many of the anaphylactic reactions.

btw, the PEG is what is going to keep the components in your cells for a very long time. your body will never be the same and literally take over your immune system.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

in order to stabilize the vaccine, they added PEG which we are exposed to regularly. it prevents the body from breaking down the vaccine's properties. that glycol is partly responsible for many of the anaphylactic reactions.

btw, the PEG is what is going to keep the components in your cells for a very long time. your body will never be the same and literally take over your immune system.

I definitely agree that the issue of PEG in Pfizer and Moderna's vaccines is cause for concern. RFK Jr's Children's Health Defense site came up with 5 questions they'd like Fauci and the FDA to answer. The very first question deals with PEG and how it can cause ADAs (Anti-Drug Antibodies):
**
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?

In January 2019, the U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research issued a document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”

The document, described as providing “recommendations to facilitate industry’s development and validation of essays for the assessment of the immunogenicity of therapeutic protein products during clinical trials,” clearly acknowledges the existence of anti-drug antibodies, such as polyethylene glycol (PEG), in humans. The document states:

  • Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety and efficacy.
  • The clinical effects of immune responses in subjects are highly variable, ranging from no measurable effect to extremely harmful.
  • Detection and analysis of ADA formation is a helpful tool in understanding potential immune responses.
  • Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safet, or efficacy is crucial for any therapeutic protein product development program.
  • Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled Immunogenicity.
However, despite the FDA’s own guidance recommending that information about immunogenicity be included on the vaccine package inserts, no such information is included on either the Pfizer-BioNTech or Moderna COVID-19 vaccine inserts.

Page six of the FDA document cites research that specifically addresses the need to “adequately understand the risk of anti-drug antibodies … in products with modifications such as pegylation.” But without that information provided on package inserts, vaccine recipients can’t understand those risks.

The rapidly developed and currently distributed mRNA vaccines rely on a new nanoparticle-based “carrier system” that utilizes PEG. The lipid nanoparticles (LNPs) carrier system used in the two COVID-19 vaccines to facilitate the delivery of the mRNA into the cell is pegylated — which means, coated with PEG. Coating the lipid nanoparticle with PEG keeps it from degrading.

An article published this year in Advanced Drug Delivery Reviews reported:

“Conjugation of polyethylene glycols (PEGs) to proteins or drug delivery nanosystems is a widely accepted method to increase the therapeutic index of complex nano-biopharmaceuticals. Nevertheless, these drugs and agents are often immunogenic, triggering the rise of anti-drug antibodies (ADAs). Among these ADAs, anti-PEG IgG and IgM were shown to account for efficacy loss due to accelerated blood clearance of the drug (ABC phenomenon) and hypersensitivity reactions (HSRs) entailing severe allergic symptoms with occasionally fatal anaphylaxis.”

It is mystifying how a never-before-utilized vaccine technology that contained a synthetic, nondegradable and increasingly controversial polymer (PEG) — known to be associated with adverse immune responses and the development of anti-drug antibodies — was allowed to bypass the bedrock of pharmaceutical development, which is immunological testing.
**

The other 4 questions can be seen here:
 
You lose it at the point where you split the biology and science. No. The best way to know what will happen to humans with any drug or vaccine is to test it on humans (and[italics]) the host that COVID-19 evolved with in nature. Forget the lab theory.

the problem is, when they do the human trials, they only test healthy individuals, then turn around and administer it to the disabled and those who have immune deficiencies . in many cases they omit the those that had the reactions. additionally, the placebo in the trials could be another vaccine, perhaps one that also entails aluminum.
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

in order to stabilize the vaccine, they added PEG which we are exposed to regularly. it prevents the body from breaking down the vaccine's properties. that glycol is partly responsible for many of the anaphylactic reactions.

btw, the PEG is what is going to keep the components in your cells for a very long time. your body will never be the same and literally take over your immune system.

I definitely agree that the issue of PEG in Pfizer and Moderna's vaccines is cause for concern. RFK Jr's Children's Health Defense site came up with 5 questions they'd like Fauci and the FDA to answer. The very first question deals with PEG and how it can cause ADAs (Anti-Drug Antibodies):
**
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?

In January 2019, the U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research issued a document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”

The document, described as providing “recommendations to facilitate industry’s development and validation of essays for the assessment of the immunogenicity of therapeutic protein products during clinical trials,” clearly acknowledges the existence of anti-drug antibodies, such as polyethylene glycol (PEG), in humans. The document states:

  • Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety and efficacy.
  • The clinical effects of immune responses in subjects are highly variable, ranging from no measurable effect to extremely harmful.
  • Detection and analysis of ADA formation is a helpful tool in understanding potential immune responses.
  • Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safet, or efficacy is crucial for any therapeutic protein product development program.
  • Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled Immunogenicity.
However, despite the FDA’s own guidance recommending that information about immunogenicity be included on the vaccine package inserts, no such information is included on either the Pfizer-BioNTech or Moderna COVID-19 vaccine inserts.

Page six of the FDA document cites research that specifically addresses the need to “adequately understand the risk of anti-drug antibodies … in products with modifications such as pegylation.” But without that information provided on package inserts, vaccine recipients can’t understand those risks.

The rapidly developed and currently distributed mRNA vaccines rely on a new nanoparticle-based “carrier system” that utilizes PEG. The lipid nanoparticles (LNPs) carrier system used in the two COVID-19 vaccines to facilitate the delivery of the mRNA into the cell is pegylated — which means, coated with PEG. Coating the lipid nanoparticle with PEG keeps it from degrading.

An article published this year in Advanced Drug Delivery Reviews reported:

“Conjugation of polyethylene glycols (PEGs) to proteins or drug delivery nanosystems is a widely accepted method to increase the therapeutic index of complex nano-biopharmaceuticals. Nevertheless, these drugs and agents are often immunogenic, triggering the rise of anti-drug antibodies (ADAs). Among these ADAs, anti-PEG IgG and IgM were shown to account for efficacy loss due to accelerated blood clearance of the drug (ABC phenomenon) and hypersensitivity reactions (HSRs) entailing severe allergic symptoms with occasionally fatal anaphylaxis.”

It is mystifying how a never-before-utilized vaccine technology that contained a synthetic, nondegradable and increasingly controversial polymer (PEG) — known to be associated with adverse immune responses and the development of anti-drug antibodies — was allowed to bypass the bedrock of pharmaceutical development, which is immunological testing.
**

The other 4 questions can be seen here:

making dinner now which is almost ready. will get back to you
 
Found an interesting article published by Medscape today. It was published on March 31. Quoting a portion of it below. Constructive feedback welcome.

**
(Reuters) - Researchers may have found an explanation for the rare but serious blood clots reported among some people who received AstraZeneca's COVID-19 vaccine.

They believe the phenomenon is similar to heparin-induced thrombocytopenia (HIT), in which heparin triggers the immune system to produce antibodies that activate platelets. Drugs other than heparin can cause clotting disorders that strongly resemble HIT, and the researchers suspect that in rare cases, the AstraZeneca vaccine may be another such trigger.

Four previously healthy individuals who got the AstraZeneca shot and developed life-threatening clots had the same kind of antibodies that activate platelets and initiate clotting in HIT, the researchers reported in a paper posted on Research Square ahead of peer review.

Twenty individuals who received the vaccine but did not develop clots did not have these antibodies.


An editorial comment posted with the study noted that drug-induced thrombocytopenia is treatable if identified promptly.
**

Source:

The study they are referring to is here:
A Prothrombotic Thrombocytopenic Disorder Resembling Heparin-Induced Thrombocytopenia Following Coronavirus-19 Vaccination Research Square, online March 29, 2021.
Oh stop it---the vaccines and virus act like an allergic reaction? gee, I wonder how many people have been posting that this is what both the virus and vaccine do---hence why the symptoms are worse with each subsequent exposure. Boosters they think will be needed every 6 months btw---

in order to stabilize the vaccine, they added PEG which we are exposed to regularly. it prevents the body from breaking down the vaccine's properties. that glycol is partly responsible for many of the anaphylactic reactions.

btw, the PEG is what is going to keep the components in your cells for a very long time. your body will never be the same and literally take over your immune system.

I definitely agree that the issue of PEG in Pfizer and Moderna's vaccines is cause for concern. RFK Jr's Children's Health Defense site came up with 5 questions they'd like Fauci and the FDA to answer. The very first question deals with PEG and how it can cause ADAs (Anti-Drug Antibodies):
**
1. Why didn’t the FDA’s Center for Biological Evaluation and Research require Moderna and Pfizer-BioNTech to conduct immunogenicity testing on their COVID-19 vaccines for anti-drug antibodies as recommended in the agencies’ own guidelines for drug development during clinical trials?

In January 2019, the U.S. Department of Health and Human Services, FDA, Center for Drug Evaluation and Research, and Center for Biologics Evaluation and Research issued a document, “Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody (ADA) Detection: Guidance for Industry.”

The document, described as providing “recommendations to facilitate industry’s development and validation of essays for the assessment of the immunogenicity of therapeutic protein products during clinical trials,” clearly acknowledges the existence of anti-drug antibodies, such as polyethylene glycol (PEG), in humans. The document states:

  • Immune responses to therapeutic protein products have the potential to affect product pharmacokinetics, pharmacodynamics, safety and efficacy.
  • The clinical effects of immune responses in subjects are highly variable, ranging from no measurable effect to extremely harmful.
  • Detection and analysis of ADA formation is a helpful tool in understanding potential immune responses.
  • Information on immune responses observed during clinical trials, particularly the incidence of ADA induction or any implications of ADA responses affecting pharmacokinetics, pharmacodynamics, safet, or efficacy is crucial for any therapeutic protein product development program.
  • Accordingly, such information, if applicable, should be included in the prescribing information as a subsection of the ADVERSE REACTIONS section entitled Immunogenicity.
However, despite the FDA’s own guidance recommending that information about immunogenicity be included on the vaccine package inserts, no such information is included on either the Pfizer-BioNTech or Moderna COVID-19 vaccine inserts.

Page six of the FDA document cites research that specifically addresses the need to “adequately understand the risk of anti-drug antibodies … in products with modifications such as pegylation.” But without that information provided on package inserts, vaccine recipients can’t understand those risks.

The rapidly developed and currently distributed mRNA vaccines rely on a new nanoparticle-based “carrier system” that utilizes PEG. The lipid nanoparticles (LNPs) carrier system used in the two COVID-19 vaccines to facilitate the delivery of the mRNA into the cell is pegylated — which means, coated with PEG. Coating the lipid nanoparticle with PEG keeps it from degrading.

An article published this year in Advanced Drug Delivery Reviews reported:

“Conjugation of polyethylene glycols (PEGs) to proteins or drug delivery nanosystems is a widely accepted method to increase the therapeutic index of complex nano-biopharmaceuticals. Nevertheless, these drugs and agents are often immunogenic, triggering the rise of anti-drug antibodies (ADAs). Among these ADAs, anti-PEG IgG and IgM were shown to account for efficacy loss due to accelerated blood clearance of the drug (ABC phenomenon) and hypersensitivity reactions (HSRs) entailing severe allergic symptoms with occasionally fatal anaphylaxis.”

It is mystifying how a never-before-utilized vaccine technology that contained a synthetic, nondegradable and increasingly controversial polymer (PEG) — known to be associated with adverse immune responses and the development of anti-drug antibodies — was allowed to bypass the bedrock of pharmaceutical development, which is immunological testing.
**

The other 4 questions can be seen here:

all of them knew what PEG would do. PEG was even forbidden in birth control for that reason.

however, the ferret lungs and PEG are not the elephant in the room. as time goes on, we will see the vaccinated develop dementia, Parkinson's, autoimmune diseases, an acceleration of cancer, cardiac arrhythmias, strokes, and even AIDS. yes a component of HIV is in there. We are already seeing these illnesses pop up.

in one video I can no longer locate, a Dr. proclaimed that we will have to bury our dead and continue our DNA for future generations. that Dr. is one of many who predict the vaccinated will die by the millions.

I am not trying to scare you, just relaying what I am hearing.

so back to the topic: when my daughter and I heard the victims were 6 women of childbearing age or possibly or sexually active, we wondered if it had to do with birth control which can cause blood clots.
 
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#54: Hi Phoenyx, don’t worry about it, we are making progress on this thread, which is a timely thread. Some experience in virology but not profesionally.
 

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