CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns

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CDC and FDA recommend US pause use of Johnson & Johnson's Covid-19 vaccine over blood clot concerns

The US Centers for Disease Control and Prevention and the US Food and Drug Administration are recommending that the United States pause the use of Johnson & Johnson's Covid-19 vaccine over six reported US cases of a "rare and severe" type of blood clot.

The six reported cases were among more than 6.8 million doses of the Johnson & Johnson vaccine administered in the United States. All six cases occurred among women ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination, according to a joint statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research.
 

pattismith

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very similarly, blood clots with the astrazeneca vaccine is mainly a concern for women under 50.

I am 53 old, so I may not be at risk for this rare cloting effect, but my doc gave me a prescription for covid vaccine for "very high risk patient" to help me get an RNA vaccine..

In France, Astrazeneca is currently for people older than 55 now, so the J and J vaccine may be as well...
 
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Booble

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Don't bank on the under 50 thing. That's primarily because older people received vaccines earlier before J&J was approved.
 

Booble

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I've been studying this issue like crazy since I got large amounts of petechiae and pupura blood spots as part of my bad virus in Dec/January2020.

Edited to add, I've printed out the recommended protocol for treatment since I'm assuming doctors in my area may not be up on the latest.
 

Gingergrrl

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I received an e-mail today from TMS (the mastocytosis society) re: the CDC & FDA pausing the J&J vaccine. I wanted to add it to this thread in case it is helpful for anyone:

Johnson & Johnson Vaccine Paused
According to the CDC and FDA live report this am, the recommended pause was made out of an abundance of caution to review data. Six patients out of 7 million doses administered have experienced a thrombosis (blood clot) and/or thrombocytopenia (low platelet count). Due to a type of thrombosis called cerebral venous sinus thrombosis, it is not treated with the typical anticoagulation of heparin, which can actually be harmful in this scenario.

This very rare adverse reaction has occurred 6-13 days after the vaccine, in women under 50. The symptoms are not the same as vaccine side effects. It typically presents as severe headache, abdominal pain, leg cramps or stroke-like symptoms. The reactions and presentation are very similar to the ones that have occurred in Europe with the Astra Zeneca vaccine and a common mechanism is being investigated since it also affects middle age women. The CDC and FDA made the announcement to notify all health care professionals so they could assess any patient and treat appropriately as well as be transparent with patients. This is a temporary pause until more data is collected.
 

Booble

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I agree and I also suspect there are people who experienced these blood clots and it never got reported by the individual or their doctor.
There are some good webinars and whatnot out there from doctors who are helping manage this condition and each one of them have multiple cases in their practices in their individual hospitals. So there MUST be more.
 

Gingergrrl

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There are some good webinars and whatnot out there from doctors who are helping manage this condition and each one of them have multiple cases in their practices in their individual hospitals. So there MUST be more.
In addition, there are cases like this (specific type of blood clots combined with low platelets) from BOTH the AZ vaccine in Europe/UK and the J&J vaccine in the US. Both are adenovirus vector vaccines and both seem to be causing this issue around the globe. There is no possible way that between the AZ cases and the J&J cases that there are only six.
 

Booble

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In addition, there are cases like this (specific type of blood clots combined with low platelets) from BOTH the AZ vaccine in Europe/UK and the J&J vaccine in the US. Both are adenovirus vector vaccines and both seem to be causing this issue around the globe. There is no possible way that between the AZ cases and the J&J cases that there are only six.
I have a theory that they picked the wrong "cold" virus to use as the vector and that the adenoviruses today cause very strong immune reactions.

One of the doctors handling these cases was asked which vaccine should you take if you have a blood disorder. She said we really don't know but one thought is that immunes systems react to the proteins. The Pfizer and Moderna have one protein. The Astra Zeneca and the J&J have the one protein from the spike protein PLUS the proteins from the adenovirus. So your body has more things to potentially react to.
 

Gemini

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In addition, there are cases like this (specific type of blood clots combined with low platelets) from BOTH the AZ vaccine in Europe/UK and the J&J vaccine in the US. Both are adenovirus vector vaccines and both seem to be causing this issue around the globe. There is no possible way that between the AZ cases and the J&J cases that there are only six.
To your point @Gingergrrl today's New York Times reports:

"Dr. Marks of the FDA said the clots 'appear to be extremely rare' and occurred in tandem with a disorder involving low counts of platelets, the cell fragments in blood that form clots."

"He also said that the Astra Zeneca cases in Europe and the Johnson & Johnson cases in this country [US] were very, very similar."


My question to the FDA & CDC is should patients with pre-existing platelet disorders like ITP be alerted/screened before taking these vaccines?
 

Booble

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To your point @Gingergrrl today's New York Times reports:

"Dr. Marks of the FDA said the clots 'appear to be extremely rare' and occurred in tandem with a disorder involving low counts of platelets, the cell fragments in blood that form clots."

"He also said that the Astra Zeneca cases in Europe and the Johnson & Johnson cases in this country [US] were very, very similar."

My question to the FDA & CDC is should patients with pre-existing platelet disorders like ITP be alerted/screened before taking these vaccines?

The ITP experts are suggesting that their patients DO get vaccinated.
At this time they are not suggesting screening for all with ITP but are measuring pre-vaccine platelet counts as baselines more for research purposes (according to them).

That said, we are learning more as the New England Journal of Medicine describes that there is an actual blood testing methodology that can ascertain the immunity/platelet thingamabob factors. At this time they are not suggesting screening for that (probably because too many millions of people) but are mentioning it for post vaccine symptomatic testing.

I was going to get J&J but since I had platelet problems after a bad (likely adenovirus) infection, I think I'm going to go for Pfizer. I was hoping for 1 and done to lessen the risk and worry but I think I'll take my chances with the allergic response to PEG instead.

The other option is the upcoming Novavax.
 

Gingergrrl

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One of the doctors handling these cases was asked which vaccine should you take if you have a blood disorder. She said we really don't know but one thought is that immunes systems react to the proteins. The Pfizer and Moderna have one protein. The Astra Zeneca and the J&J have the one protein from the spike protein PLUS the proteins from the adenovirus. So your body has more things to potentially react to.
That is very interesting and it makes sense (especially for women who have a history of autoimmunity) that there is a greater chance of having a rare autoimmune reaction when there are TWO variables to potentially react to vs. just one!

New England Journal of Medicine research paper on this topic out today.
https://www.nejm.org/doi/full/10.1056/NEJMoa2104840?query=TOC

Very interesting. And CDC treatment guidance:
https://emergency.cdc.gov/han/2021/han00442.asp
Thank you for posting these links and they are extremely helpful! I'm going to quote a few things from your links in a new post right after this one (so it is easier to read and reply to).

This situation re: the autoimmune reaction to the AZ & J&J vaccines (causing blood clots & low platelets) has given me absolute 100% confirmation that if I ever did decide to get a COVID vaccine within my lifetime, it will NOT be AZ or J&J.

I had eleven different autoantibodies prior to starting the treatments that led to my remission. Any time that my immune system encountered something foreign (like a virus, mycotoxins, etc), it flipped into overdrive and started creating autoantibodies until the point that I was completely disabled. Now that there is irrefutable evidence that the AZ & J&J vaccines are causing this autoimmune attack on platelets (in women who did not even have a history of severe autoimmunity like me!) it confirms my choice.

I was not certain which type of COVID vaccine might be safer for women with autoimmunity (between the mRNA vaccines and adenovirus vector vaccines) and now it appears to be the mRNA vaccines are safer. I will still be declining the vaccine altogether but this info has been extremely helpful.

Edited to Add: I am going to ask my doctor to see if he shares my interpretation of this new info (re: the adenovirus vaccines being more dangerous than the mRNA vaccines in women with a history of severe autoimmunity).

"Dr. Marks of the FDA said the clots 'appear to be extremely rare' and occurred in tandem with a disorder involving low counts of platelets, the cell fragments in blood that form clots."

"He also said that the Astra Zeneca cases in Europe and the Johnson & Johnson cases in this country [US] were very, very similar."

My question to the FDA & CDC is should patients with pre-existing platelet disorders like ITP be alerted/screened before taking these vaccines?
I agree with your question and my personal feeling is that I would be extremely careful of the adenovirus vector vaccines if I had ITP. I would choose to avoid them.

I was going to get J&J but since I had platelet problems after a bad (likely adenovirus) infection, I think I'm going to go for Pfizer. I was hoping for 1 and done to lessen the risk and worry but I think I'll take my chances with the allergic response to PEG instead.
I thought that Moderna contained PEG but Pfizer did not. This is what I am remembering from my research but now I need to confirm it in case I am remembering wrong. I am actually (shockingly!) not allergic to PEG.
 
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Booble

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To be clear, I'm not sure that it's actually an auto-immune response per se but a blood response that activates platelets. Or at least that's how it is described. But I'm not a doctor, epidemiologist, or hematologist so I'm interpreting from having read multiple medical journals, papers, etc.

Pfizer is the one with PEG.

The other thing is that we could take one dose of Pfizer which seems to provide as strong coverage as J&J.
 

Gingergrrl

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To be clear, I'm not sure that it's actually an auto-immune response per se but a blood response that activates platelets. Or at least that's how it is described. But I'm not a doctor, epidemiologist, or hematologist so I'm interpreting from having read multiple medical journals, papers, etc.
I just re-read the links (and several other links) and they seem to state that the adenovirus vaccines (AZ and J&J) are triggering an autoimmune attack on platelets. This seems to be why doctors are saying NOT to use heparin in these cases (which would often be the standard treatment with normal blood clots) b/c in these cases, there is also an attack on the platelets and heparin could cause the person to bleed to death. I will find the exact quotes from the doctors in case I am understanding it wrong.

Pfizer is the one with PEG.
I just Googled the ingredient lists and they say that both Pfizer and Moderna contain PEG. Does this match with what you are finding?

The other thing is that we could take one dose of Pfizer which seems to provide as strong coverage as J&J.
This is one of the questions that I plan to ask my doctor (re: his thoughts re: having just one dose of Pfizer or Moderna vs. two doses).
 

Booble

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I just re-read the links (and several other links) and they seem to state that the adenovirus vaccines (AZ and J&J) are triggering an autoimmune attack on platelets. This seems to be why doctors are saying NOT to use heparin in these cases (which would often be the standard treatment with normal blood clots) b/c in these cases, there is also an attack on the platelets and heparin could cause the person to bleed to death. I will find the exact quotes from the doctors in case I am understanding it wrong.



I just Googled the ingredient lists and they say that both Pfizer and Moderna contain PEG. Does this match with what you are finding?



This is one of the questions that I plan to ask my doctor (re: his thoughts re: having just one dose of Pfizer or Moderna vs. two doses).
Good conversation!
Heparin can also "activate" the platelets and people who have this blood disorder.

You're correct. Pfizer and Modern both have PEG.


You should not receive the Pfizer-BioNTech COVID-19 vaccine if you have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including:

  • Polyethylene glycol (PEG)
  • Lipids
  • Potassium chloride or potassium phosphate
  • Sodium chloride or sodium phosphate
  • Sucrose


You should not receive the Moderna COVID-19 vaccine if you have a history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine including:

  • Polyethylene glycol (PEG)
  • Lipids
  • Tromethamine or Tromethamine hydrochloride
  • Acetic acid
  • Sodium acetate
  • Sucrose
 

Booble

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I'm tempted to ingest something with PEG to see what happens, but that's probably not a great idea!
I think my only reactions have been when applied to the skin.
I'm also trying to be certain on what ingredients of CT Contrast dye I'm allergic too. They only told me I'm allergic but not which ingredient. Presumably the iodine.
 

pattismith

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I just re-read the links (and several other links) and they seem to state that the adenovirus vaccines (AZ and J&J) are triggering an autoimmune attack on platelets. This seems to be why doctors are saying NOT to use heparin in these cases (which would often be the standard treatment with normal blood clots) b/c in these cases, there is also an attack on the platelets and heparin could cause the person to bleed to death. I will find the exact quotes from the doctors in case I am understanding it wrong.
The question of using heparin (coagulation inhibitor drug) in these cases is double.

-Multiple thrombus + low blood platelets is the usual feature of Disseminated Intravascular Coagulation (DIC)

Like in any DIC case, anticoagulation treatment is warrant only if the platelet count is over a certain level, otherwise bleeding will occur.

-In the particular case of adenovirus vaccine induced DIC, the cause is the induction of PF4 auto-antibody that activates platelet aggregation.
Heparine is a known drug that is involved in a very similar DIC with the same antibodies, so in these cases Heparine should be replaced by another coagulation inhibitor.