U.S. Calls for Pause on Johnson & Johnson Vaccine After Clotting Cases

[PA Democrat]

WASHINGTON — Federal health agencies on Tuesday will call for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination, officials briefed on the decision said.

All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition, the officials said.


Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.

While the move is framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.

https://www.msn.com/en-us/news/us/u-s-calls-for-pause-on-johnson-johnson-vaccine-after-clotting-cases/ar-BB1fB8wg?ocid=msedgntp

[appalachiablue]

1. K/R

The CVS pharmacies in our area are offering the J & J vaccine today, a first here that I know of. Interesting timing.

[SheltieLover]

2. K&R!

[bearsfootball516]

4. It's 6 people out of 7 million.

Not exactly terrifying numbers.

[Victor_c3]

30. Versus 16% of people hospitalized with Covid having clotting issues

https://www.beckershospitalreview.com/cardiology/blood-clots-formed-in-16-of-covid-19-patients-in-nyc-health-system-study-finds.html

This is a nasty virus and it takes a nasty shot to offer protection against it. I’ll roll the dice and risk dangerous possible side effects with a vaccine before I risk seemingly more common severe reactions from an actual Covid infection.

Actually, I already rolled the dice with the vaccine. I received my second dose about a month ago.

... just further illustrating your point

[DenaliDemocrat]

44. 1 in a million

Sounds like random chance to me. No control arm for evaluation. Color me skeptical.

[Ms. Toad]

63. If it is like Astra Zeneca,

The other vaccine that uses the same process, it is a very specific and rare clotting issue, which kills 1/3 odd the people who get it. They are in the process of trying to figure out who is at risk, so they can make specific recommendations about who might want to get a different vaccine.

The initial reports were that the AS clots had a lower occurrence them the general population, which was true, until they got more specific information about the disorder people were developing.

[Celerity]

76. The blood clot issue was never the main issue for me with the AstraZeneca vax it was the

massive fail (only 10.4% efficacy) against the B.1.351 South African variant (the variant that I am in the Moderna tweaked vax trial for here at Karolinska universitetssjukhuset), which is running riot over here in some parts of the EU and is present in the US as well. I am also waiting for further data on the AZ vax's efficacy against the P.1 Brasilian variant.

[Ms. Toad]

81. Since I didn't have the option of Astra Zeneca,

I hadn't spent much time looking at it. But when the information about clots started developing, I followed it enough to see that they had moved past the "it's just random" stage to narrow it to a specific disorder.

Since I've had significant DVT (mechanical, rather than a clotting disorder), I do pay attention to concerns about clotting.

[Celerity]

83. Did you get your desired Pfizer vax yet?

[Ms. Toad]

85. I had my first shot two days after my group was eligible -

I could have had it the day after I was eligible, but since they had appointments a day later, on the weekend, I delayed a for a day. So now I'm fully vaccinated (and past the 2-week post-vax period).

My daughter got her first Pfizer he day after she was eligible - she's got about a week to go until her second. Then our entire family will be fully vaccinated!

[Celerity]

86. Nice. I was appalled at some of the stick you got for simply exercising your

autonomy over your own body as it was clear you were getting vaccinated. There is a real authoritarian streak with some here that I find extremely problematic.

So happy to hear your family is soon fully vaxxed up!

[Ms. Toad]

98. I've never been good at black and white (or sound byte) thinking

And, unfortunately, the inability to think in shades of gray is not exclusively a right-wing deficiency.

[barbtries]

56. all 6 females with a top age of 48.

still not terrifying, but if you are in that demographic, clearly concerning, or they wouldn't be pausing the vaccine.

[Arazi]

84. I'm not sure about that. 18 year old stroke victim. The oldest was 48

These are very young women.

They're probably now on Coumadin or other blood thinner for the rest of their lives which would be pretty tough.

That's a very bad vaccine injury

🙁

[NurseJackie]

3. Anticoagulants such as heparin or warfarin slow down your body's process of making clots.

Anticoagulants such as heparin or warfarin (also called Coumadin) slow down your body's process of making clots. Antiplatelet drugs, such as aspirin, prevent blood cells called platelets from clumping together to form a clot.

Warfarin is taken once a day, usually in the evening. It's important to take your dose at the same time each day, before, during or after a meal. The aim of warfarin therapy is to decrease the blood's tendency to clot, but not stop it clotting completely.

Could the solution be as simple as a short-term Rx for Warfarin, or instructions to take aspirin every day for a week?

[Hugin]

7. I am no expert...

On anything, really.

But, I've been wondering if even taking a low dose aspirin for awhile could mitigate the clotting issue. It seems to me the people at risk have some easily identifiable marker.

[LisaL]

18. Those are not regular blood clots.

It seems to do with immune system turning on it's own platelets.

[Hugin]

25. Interesting...

And, possibly long term, if a change to the immune system is involved.

Since there are currently only six cases identified, I'm hoping a commonality can quickly be isolated and others with that trait can be steered to one of the other vaccines or ultimately (and this is partly why the rest of us should be vaccinated, to shield them) they should forego the vaccinations.

[LisaL]

28. Apparently, in case of J&J, all persons developing blood clots were females under age of 50.

I wonder if it's caused by some weird interactions with birth control pills? Or hormones?

[Hugin]

35. What bothers me...

Is what you say down thread that the J&J is a more traditional vaccine vehicle than the others. There may be a wider problem with vaccines which has gone unnoticed until the world's largest in history clinical trial in progress.

I guess it's a time to learn and make better.

Yeah, hormones or pills? Maybe, both. It's a Sherlock Holmsian scale question.

[Ms. Toad]

88. It's more traditional, in that it uses weakened virus as a delivery mechanism

But it's not really traditional, since what the virus (an adenovirus, not a coronoavirus) is delivering is DNA which tricks the cells into making mRNA, which then works the same was as the mRNA delivered directly via Pfizer and Moderna.

A consensus is deveoping that the clots are related to the adenovirus delivery mechanism.

[LisaL]

11. Heparin, despite being anti-coagulant, can lead to a similar

clotting problem in rare case. Co I certainly wouldn't pump those people full of anti-coagulants.

[Buckeye_Democrat]

39. Heparin was indeed mentioned as a potential danger...

... in this Chicago Tribune article:

CDC, FDA recommend ‘pause’ for Johnson & Johnson COVID-19 vaccine to investigate reports of blood clots
https://www.chicagotribune.com/coronavirus/vaccine/ct-aud-nw-johnson-and-johnson-coronavirus-vaccine-blood-clots-20210413-iagzysugkvgjvidwega4625bly-story.html?outputType=amp
----------
WASHINGTON — The U.S. is recommending a “pause” in administration of the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots.
In a joint statement Tuesday, the Centers for Disease Control and Prevention and the Food and Drug Administration said they were investigating clots in six women that occurred 6 to 13 days after vaccination. The clots were observed in the sinuses of the brain along with reduced platelet counts — making the usual treatment for blood clots, the blood thinner heparin, potentially “dangerous.”
----------

[barbtries]

59. No.

These clots are different and heparin can do more harm than good.

https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html

[WhiskeyGrinder]

5. 6 people out of 7 million who got the shot? Wait till they hear about birth control pills.

[NurseJackie]

8. Boom!

Thank you.

[Hugin]

9. In a society where people inject botulism toxin under their skin to get rid of wrinkles...

This stuff boggles my mind.

[NurseJackie]

32. You make a valid point!

[Hugin]

36. Are my lips poofy enough?

Seriously, though. Those same toxins are used to treat migraines. When I don't have one, I'm total caution.

However, when in full migraine. I'm GIVE.IT.TO.ME.NOW.DAMMIT!

So, caution is relative.

[They_Live]

14. exactly!

or baby powder.

[Ilsa]

41. Yeah, only women of childbearing years were affected.

I wonder if they are all on the same (generically) medication, either for prophylaxis or hormone therapy?

[spinbaby]

6. Is this immediate?

I have a friend scheduled for the J&J vaccine today.

[appalachiablue]

13. NYT in Latest Breaking News, good luck

https://www.democraticunderground.com/10142728106

[janterry]

50. I was scheduled for mine 15 minutes ago

I called and it was cancelled.

I'm going to wait a week for the dust to settle and then think about rescheduling.

[dalton99a]

10. "Cerebral venous sinus thrombosis is extremely rare"

Federal officials are concerned that doctors may not be trained to look for the rare disorder if recipients of the vaccine develop symptoms of it. The federal health agencies said Tuesday morning that “treatment of this specific type of blood clot is different from the treatment that might typically be administered” for blood clots.

“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the statement said.

In a news release, Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.” Janssen is the name of Johnson & Johnson’s division that developed the vaccine.

In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare.

All of the women developed the condition within about two weeks of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause.

[Hugin]

17. So, they haven't established a causal link, yet.

If there's up to 600,000 Americans getting clots annually, it very well could be coincidence that six would get clots within two weeks of a vaccination.

Say, what I'm thinking is true. Then the other vaccinations would show similar rates of clotting.

Really, this right now falls under 'an abundance of caution'.

[LisaL]

19. Other vaccinations (Pfizer and Moderna) do not show similar rate of clotting.

We already gotten hundreds of millions of people vaccinated with Pfizer and Moderna. I think somebody would have noticed by now.

[barbtries]

66. if anything, it seems to have to do with the adenovirus that J&J's jab uses.

Pfizer and Moderna use MRNA (think that's correct?).

clearly a lot of investigation into this still to be done.

[Ms. Toad]

70. This particular kind of clotting is specific to Astra Zeneca

And J&J.

So yes, same rate of development of clots as other vaccines (and the general unvaccinated population), but a higher rate for this very deadly form of clotting disorder.

[JT45242]

33. Let's think through some statistics...

300-600,000 people a year is approximately 100 per day. And since we'll make it simple math it is about 1 out if every thousand people per year.

They have given 9,000,000 doses to people. You would expect that 9,000 of them would get this clotting disorder this year.

Given that people getting vaccinated, so far at least, tend to be older with comorbidities like high bmi, asthma, diabetes, etc, it is not surprising that some of them would have gotten these blood clots.

Seems like we are willing to use statistical modelling to approve vaccines but not willing to use it to show that the risk over baseline is not statistically significant.

[LisaL]

34. 300-600,000 people per year develop regular blood clots.

Not the type observed after J&J vaccine.

[Ms. Toad]

73. This is not the ordinary clots that anyone can develops.

This is a rare, and deadly (30% mortality rate) specific disorder, that seems to be associated with the two vaccines that use RNA, rather than mRNA.

[littlemissmartypants]

12. Dammit, I have my JJ shot scheduled for Thursday.

I wanted to be one an done. Now it looks like I will be getting the Moderna, if they have any left when I get there.

[Johnny2X2X]

15. This is sooo dumb!

So say there's a 2 week pause for women under 50 on J&J. The instance of blood clots in people with Covid is was higher than less than 1 in a million. This will cost lives. Why are they doing this?

[LisaL]

16. Those are not regular blood clots.

They are quite unusual blood clots.
My guess it is probably going to be common to all adenovirus based vaccines, since AstraZeneca is having the same issue as J&J.

[Johnny2X2X]

21. Blood clots from Covid is 165,000 out of a million

6 out of 6.8 million vs 165,000 out of a million. And the death rate from Covid is 18,000 out of a million. So you're stopping thousands of people from not dying from Covid because 6 in 6.8 million got severe blood clots...but didn't die.

6 in 6.8 Million is not statistically relevant. It is one of those things you should monitor, but the CDC shuts it all down and now the vaccine effort will slow and this will dissuade people from getting vaccinated all together. People will die because of this decision.

[LisaL]

24. I am not stopping anybody from anything.

Does it say anywhere I personally recommended a pause on J&J?

[Johnny2X2X]

26. You're in this case meant the CDC

This is a really dumb decision by them.

[LisaL]

27. I don't think so.

We have two other vaccines that don't cause the clotting issue.

[Treefrog]

77. I think I'll trust the CDC on this.

Not someone on a message board. No dog in this fight because I got the Pfizer, but I find this quite alarming.

[Celerity]

79. Wise words.

[hamsterjill]

108. +1

I especially discount the posters who are so insistent that there is nothing to worry about.

A little skepticism might bring a better result. Let’s see if the authorities can learn what’s causing this. It might be something beneficial to the whole campaign.

[mucifer]

29. Seriously, everyone is an epidemiologist these days. You are just passing info.

[barbtries]

68. what you can do though

is mitigate your risk from COVID in other ways or use an alternative vaccine, especially if you are a woman between 18 and 50. There is a reason they're pulling the vaccine; it doesn't mean it will never be seen or used again, but there may ultimately be a labeling change, for instance, or recommendation about who should get it.

it's a rock and a hard place. There's an emergency advisory board on Wednesday and I may try to watch it though Wednesday is my busy work day.

[Johnny2X2X]

80. Agree

The supply chain was beefed up for exactly this type of disruption. The biggest worry I have is the message this will send to the vaccine hesitant portion of the population which we need to convince a portion of to get vaccinated to get to herd immunity.

The CDC probably had no choice, there are probably protocols to be followed.

I am disappointed and it seems dumb, but I doubt they had any other options.

[alittlelark]

20. I got the J&J March 29th

For some odd reason I have felt the need to take aspirin for the last 4 days. I rarely take advil, tylenol or aspirin, all are in the medicine cabinet. I generally think that pain is there for a reason, and taking painkillers dull the messages your body is sending.

I am moving large rocks on my property as part of a landscaping project. Hard work, but I am pretty good at pivoting weight carefully and have had few problems.

For the last 4-5 days I have felt compelled to take aspirin in the AM. I did kinda torque my back 5 days ago when a delivery driver showed up as I was moving a large rock. Normally If I felt the need for pain relief it would be Advil. But no, I felt compelled to take aspirin. Perhaps the body KNOWS things and we should listen.

[Johnny2X2X]

22. Your pain likely has zero to do with the J&J vaccine

Less than 1 in a million got rare forms of blood clots, and only women between a certain age group. How do you equate that to you taking aspirin?

[alittlelark]

31. My pain has to do with twisting my back the wrong way at the wrong time

If I felt the need for pain relief I would normally take advil - a superior painkiller. My point is that instead my body told me to take aspirin. I generally only use aspirin as a tomato fertilizer.

I am 56 and have a family history of pulmonary diseases. I think my body told me to take aspirin.

I am still thrilled to be vaccinated.

[bbgrunt]

65. Well, I got the J&J 3 weeks ago and 2 weeks ago

I developed a very severe case of sciatica. My body told me to go to the emergency ward--screaming all the way in the ambulance. None of the usual treatments seemed to help, although some minimal positive improvement is developing with an ultra sound deep heating treatment.

So my question is whether it is possible that there are other side effects of the vaccine that are non lethal and are not being reported because people are not making the connection. (although the non lethal designation is yet to be seen--I sure felt like I was going to die)

Other than a sore lump on my arm for about 3 weeks, I don't think I've had any other effects.......but in these times of rushing the vaccines without full testing one always has to question if and for how long one should look for such side effects to report.

[barbtries]

72. It's hard to envision how the vaccine would screw with your back.

at any rate, after many years of chronic pain, I manage my back with acupuncture. I always recommend it to people because it truly changed my life. My back still goes out from time to time - just last week in fact - but I manage the episodes with ibuprofen and muscle relaxers, and if they persist I go see my acupuncturist. If you're in NC it's Carolina Acupuncture in Chapel Hill, Dr Chen. He's really good. Good luck! been there done that. Again I don't know but can't see the connection between sciatica and the vaccine, unless you were moving in a way that precipitated the episode.

[bbgrunt]

91. thanks for the suggestion

I know it's hard to understand how it might be connected to the vaccine, but I think most of us do not have the tech expertise to know or even suspect what kind of side effects may occur with such drugs.

Anyway, if this treatment doesn't help, I will seek out an acupuncturist--if I can get there.....I'm willing to try anything.

[Klaralven]

23. Cerebral sinus venous thrombosis

Cerebral sinus venous thrombosis (CSVT) is a rare form of venous thromboembolism (VTE).[1] CSVT represents almost 0.5%[2] -3%[2] of all the types of stroke, affecting predominantly younger people,[3] with an estimated incidence for adults of 3-4 per million, and for children 7 per million.[4]

In the pre-antibiotics era, the leading cause of CSVT were the septic processes, currently the aseptic form of CSVT is the most common cause.[5] An autopsy finding can represent 10% of death causes from cerebrovascular diseases.[6]

CSVT is characterized by a highly variable clinical spectra, difficult diagnosis, variable etiologies and prognosis. Of interest, in poor countries, there is an association with the puerperium, with no clear arguments, but probably related to factors such as inappropriate perinatal care, metabolic derangements, and infections associated to childbirth.[5] The peripartum-associated CSVT has been established to be of 11.6 cases per 100 000 deliveries.[7] There is sex predominance (hormonal?); 75% of all CSVT patients are women, with a 3:1 ratio compared to men.[8]

This work aims to review current knowledge about CSVT including its pathogenesis, etiology, clinical manifestations, diagnosis, and treatment.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3858762/

[joetheman]

37. Wonder if there is any relation to birth control pills taken my young women?

[Marigold]

38. Just got the J & J yesterday

Timing is everything in life. My husband and I went to Walgreen's yesterday and assumed we'd be getting the Pfizer. We were surprised they were administering the J & J. But everyone said how lucky we were to be one and done. Now today I wake up to this news. I am a woman of a certain age, 64, so worried due to my gender but hoping my age might mitigate this effect. Fingers crossed that this continues to be a very rare complication. Kind of upset that apparently J & J was aware of this problem, and are
using the same platform as Astra Zeneca, so there has to be a correlation there somewhere.

[LisaL]

40. All the women who got the clots with J&J were under the age of 50,

so you should likely be fine.

[PCIntern]

42. In my office the other day

A woman who is a basic scientist investigating the mechanism of blood clotting and Covid attempted to explain the complication to me. It was so esoteric that I could not follow her past the first sentence and a half. Apparently, this is an extremely complex situation and God only knows what’s really going on on a biochemical level.

[sheilahi]

43. well isn't this a fine how do you do.

Well, this is just great. Had my J&J vaccine a week ago and was feeling pretty relieved.........until now. Was feeling pretty good about having practically zero side effects but now I'm just wondering how long it will be before we find out the stuff isn't even effective against the virus. Can we expect to see a class action lawsuit coming up? I've always felt pretty good about not working around asbestos and getting Mesothelioma and now this. Crap.

[LisaL]

45. It's 72 % effective against the virus (in the US), as shown in clinical trial.

Nobody promised you it was a 100 % effective.

[sheilahi]

47. right

Yeah, well nobody promised me a rose garden either but at least a rose garden wouldn't have caused blood clots.

[LisaL]

51. And what does that have to do with a price of tea in China?

[dalton99a]

49. They can only be sued if there's willful misconduct in the production of their vaccine

Otherwise they are protected from lawsuits until 2024 under a 2005 federal law which Trump invoked

[Sgent]

104. True

but if you have injury you can still get compensation from the vaccine court, so I recommend you talk to an attorney if this is the case.

[womanofthehills]

126. You cannot go to vaccine court with experimental vaccines

Only with vaccines that have final FDA approval. So NO vaccine court for Covid vaccine injuries. You can apply to a countermeasure agency that rarely pays out

[womanofthehills]

125. You cannot sue pharma for vaccine injury -

In the US, Pharma has immunity from liability if something unintentionally goes wrong with their vaccines. For vaccine injury, not connected to an “experimental” vaccine, you can apply for compensation to the US government’s “Vaccine Injury Compensation Program” where you will be given a free lawyer and will able take your case to a judge but NOT with the Covid vaccines as long as they are experimental. The governor set up an alternative Counterfund office with no lawyers, judges -this office rarely pays out claims - 6%.

[Drunken Irishman]

46. This is terrible optics.

Frankly, this could be a disaster. There's already enough skepticism about the vaccine without one of the major three being paused weeks into its usage for something like this.

It would not surprise me if this really impacts the consistency at which we're vaccinating people now. It absolutely adds credence to the concerns of many anti-vaccers, even if superficially.

I really hope the pausing of this vaccine, due to a very small amount of those negatively impacted, is worth the potential of millions now stepping back and refusing to get vaccinated after fears that something will come out about the other two vaccines like this one.

[LisaL]

48. I don't think anybody is saying this is good news.

Especially considering the other two vaccines (Pfizer and Moderna) are not going to be easy to administer in under developed nations. Especially Pfizer, due to ultra cold storage requirements.

[Drunken Irishman]

52. I didn't say anyone was.

Only saying I hope the pause is worth potentially undermining the entire vaccine rollout now. This has the potential to be devastating considering a huge chunk of the country haven't even received their first, let alone second doses of the other two. I could absolutely see this pause stopping people dead in their tracks from getting either the first dose or the second and then we are fucked.

After all, the government loses credibility here by telling us for weeks we're okay to get the vaccine:

https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/janssen.html

And other places telling us it's safe https://www.dukehealth.org/blog/what-you-need-know-about-johnson-johnson-vaccine

Now we're to trust that there won't be a similar pause on the two major vaccines, especially with so many people now receiving their second dose where maybe there's a larger chance at having a reaction.

So many people are already refusing the vaccine. This is going to make it much worse. I really hope we didn't just end the impressive push we've seen to get people vaccinated out of a reaction that seems to effect so few people.

[LisaL]

54. I kind of got a feeling government was over-selling J&J.

It's efficacy was lower, compared to the other two. As for telling us it's safe, with such a rare adverse effects, millions need to be vaccinated to make a connection.

[Drunken Irishman]

71. The problem now is that people may doubt their views on the other two.

And that's a concern. If people start questioning the safety of the other two, even if irrationally, that will undermine the whole endeavor.

[Ms. Toad]

75. The other two are not associated with this very rare disorder.

Only the two that use the adenovirus as a delivery mechanism.

[hamsterjill]

89. Except that they could be.

My daughter had ITP as an adolescent and we became aware of the possibility (stressing that word because there is one poster who will be on my ass for posting this, of course) that there was an effect on platelets.

Her doctor advised that she get vaccinated but they monitored her platelet level as a precaution. The knowledge and discussions with her doctor gave me comfort. But the issue is a real one. One male doctor in Florida who had ITP died after receiving the Pfizer vaccine. They are still saying “they can’t confirm that it was related to the vaccine”.

While my post will be viewed as negative, I honestly think it’s very positive that more is being learned so that vaccines can be improved. No one wants to die of COVID. But that should not stop discussion and improvement.




https://www.health.com/condition/infectious-diseases/coronavirus/rare-blood-disorder-covid-vaccine-thrombocytopenia?amp=true

[Ms. Toad]

94. A specific mechanism has been proposed

that is directly related to the difference between Astra Zeneca, J&J, and Sputnik & the mRNA vaccines.

(Related to the DNA delivered by the adenovirus vector escaping and going places it shouldn't. There are enough Pfizer and Moderna vaccines administered that if it was generically vaccine-related there would have been reports. The reports of this very rare clotting disorder are specific to Pfizer and J&J, which both deliver DNA using an adenovirus vector.)

[hamsterjill]

96. Yes.

But platelets affect clotting. And it is issues with platelets that have been seen RARELY in the Pfeizer and Moderna vacs.

Not arguing. Just stating.

[Ms. Toad]

100. This addresses your specific concern:

In their paper, Greinacher and his colleagues also speculate about a possible mechanism. Vaxzevria consists of an adenovirus engineered to infect cells and prompt them to produce the virus’ spike protein. Among the 50 billion or so virus particles in each dose, some may break apart and release their DNA, Greinacher says. Like heparin, DNA is negatively charged, which would help bind it to PF4, which has a positive charge. The complex might then trigger the production of antibodies, especially when the immune system is already on high alert because of the vaccine. An immune reaction to extracellular DNA is part of an ancient immune defense triggered by severe infection or injury, Greinacher notes, and free DNA itself can signal the body to increase blood coagulation.

Alternatively, the antibodies may already be present in the patients and the vaccine may just boost them. Many healthy people harbor such antibodies against PF4, but they are kept in check by an immune mechanism called peripheral tolerance, says Gowthami Arepally, a hematologist at the Duke University School of Medicine who is working as an external consultant with AstraZeneca on the issue. “When you get vaccinated, sometimes the mechanisms of peripheral tolerance get disrupted,” she says. “When that happens, does that unleash any autoimmune syndromes that you are predisposed to, like HIT?”

Early suggestions that the rare reactions may be the result of a COVID-19 infection before vaccination have not been substantiated. None of the five patients in Norway had been infected, for instance. Others have suggested that antibodies against the virus’ spike protein—which many vaccines seek to elicit—somehow cross-react with PF4. That could spell trouble for nearly all COVID-19 vaccines. But so far, there is no evidence that the messenger RNA–based vaccines made by the Pfizer-BioNtech collaboration and Moderna, which tens of millions of people have received, are causing similar clotting disorders.

Initial studies by Greinacher’s team, posted as a preprint, don’t support that theory either. Among more than 200 patients who had recovered from COVID-19, they found only a few with antibodies that reacted to PF4, and those reacted relatively weakly. More importantly, Greinacher says, the platelet-activating antibodies isolated from VITT patients did not react to the coronavirus spike protein. At a press conference on Friday, Greinacher called the finding “fantastic news for the vaccination program.”

https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

[Drunken Irishman]

92. So?

A week ago, people were saying J&J was safe - if that can change, who's to say another problem won't arise with the other two, even if it's separate of the issue with J&J?

I don't believe there will but it's clear a solid number of Americans are skeptical of the vaccine. This just sows more distrust. I think it's just bad optics and is going to potentially hurt the progress we've seen with vaccinating, especially when they inevitably start up the J&J one again and reassure Americans it's safe.

[hamsterjill]

95. +1

n/t

[Ms. Toad]

97. Remember - all of these vaccines were approved on an emergency basis

By definition, that means we know less about them than we do about vaccines/medicines that go through the normal approval process. There's a reason the approval process takes longer.

It is NEVER a good idea to lie to the people about what we know - remember Fauci misled people about the efficacy of masks in order to make sure that the general population didn't snarf up all of the masks that were needed for medical workers. That pretty directly led to a lot of mask skepticism: First you tell us it didn't work, and now you're telling us it is critical. Fauci has since acknowledged that he knew, at the time he made the misleading statements, that they were effective. (We have since gained more information - but it was known at th time he made the comments.)

Other problems may well arise with the other vaccines. We are being guinea pigs - because the alternative of doing nothing until the vaccines can go through the full approval process is more deadly.

This particular clotting issue - until enough had acquired it to flesh out that it was a specific rare disorder - seemed to be just background noise. (Generally) clotting is no more a risk following vaccines than in the general population. That remains true - and was part of the basis on which the assertion that it was safe is true. Now, with more information, we know it is a very specific (and rare) clotting disorder - AND - as to that specific clotting disorder it is happening more frequently than the general population (and seems to be caused by the vaccines).

That will happen. We may well discover 5 years down the road that there are long-term consequences from the vaccine. There is no way we can know that now - because this is the very first time we are using this mechanism for a vaccine.

So - the choices are - wait for a couple of years for the normal vaccine approval process, or wait even longer to determine long-term consequences - OR - use it on an emergency basis because the (short-term) safety of the vaccine on the millions who have receive it greatly exceeds the risks associated with COVID. The latter choice will ALWAYS come with re-evaluation if/when we discover things it would have been impossible to know at the time the emergency approval was granted.

It would be irresponsible, with what we now know, to continue to administer the J&J vaccine without teasing out (as best we can) who is at risk for developing the deadly disorder, or developing warnings that can help people make better choices as to which vaccine they seek out. Since both J&J and Astra Zeneca have this issue (and Astra Zeneca is pretty well on the way to tracking down the risks/causation), it won't necessarily be a long pause.

BUT - what we need is education, not lies.

[Drunken Irishman]

99. The problem is that we've been told the J&J vaccine is safe.

Just as we've been told these two other vaccines are safe. This undermines all of it. It's a horrifically bad look because now people are going to question whether it's worth taking the other vaccines since they're still finding out potential major side effects.

So, really, you could say they've already lied by pushing a narrative that these vaccines are safe - and pausing the J&J vaccine absolutely undermines that narrative. They clearly don't think it's safe anymore.

[Ms. Toad]

102. You've put your finger on the problem - the problem isn't with this pause -

But with the misleading blanket statement that the vaccines are safe.

The vaccines are safe, within the testing we were able to do. It is often true that some safety issues don't show up until the vaccines are widely distributed. (Since we are distributing these as a much faster rate than, say, a new medicine we are gaining knowledge that it might take years to develop for medicines. DES for example, was on the market for 31 years before they developed enough information that it was unsafe to pull it. The problem that made it unsafe existed when it was granted regular approval for use - it just took time to determine that the risks outweighed the benefits.

We knew, when the vaccines were approved, that we have ZERO information about long-term benefits. We knew, based on the testing that, with the limited testing they could do prior to seeking approval, that the benefits outweighed the risks (not that there were NO risks, but that - by and large - the risks were lower than the outcome they were testing for: reduction in severe disease and death)

BUT - once we have identified a safety issue, it is utterly irresponsible to ignore that risk becuase the optics look bad.

Pausing vaccination doesn't mean they think it is broadly unsafe, anymore than identifying that Pfizer carries a risk of anaphylzxis not present in the other vaccines means that Pfizer is unsafe. It merely means that certain people should probably seek out a different vaccine.

That will almost certainly happen here - the pause will be temporary until they can sort out the population for which this vaccine is contraindicated. Johnson & Johnson will continue to be safe (within the limits of what we know now) for everyone else.

[Drunken Irishman]

103. And the pause is already going to make a skeptical group more skeptical.

It wasn't that long ago less than half of America said they would not get the vaccine (https://www.nbcnews.com/politics/2020-election/poll-less-half-americans-say-they-ll-get-coronavirus-vaccine-n1236971). This is a very fragile process and this outcome is telling those who have doubts to possibly continue having those doubts until things are fully understood - fair or not.

The government pushed the idea that J&J is safe. Their pause hurts their credibility, not just with J&J but the other vaccines.

If I'm someone who has doubt, my thought process now is why should I trust that there won't be an issue with the other two vaccines that cause a pause in a couple weeks?

[hamsterjill]

105. Exactly.

What would you be thinking if you were a young woman between 18 and 48 who just got the J&J vaccine yesterday only to get up and read the headlines this morning?

Do i feel lucky? Well, do ya punk? (Bad reference, but provided to illustrate my point). Most people will obviously be just fine, but if you are the “one” affected...well, I think there would be a little angst.

And yes, this is absolutely going to undermine confidence in the roll out of all three vaccines. It’s unfortunate, but it will.

[Ms. Toad]

109. Bottom line - lying about the risks is wrong. Period.

Ignoring a now-demonstrated risk is wrong.

How would you feel if, unbeknownst to the public, the vaccines had a deadly side effect & your loved one died from that side effect AFTER the side effect was known (but kept secret), because the government decided that a few deaths was worth not alarming the public. (And if that sounds like how Trump handled the COVID crisis, that is deliberate.)

If people react negatively to a necessary pause, then we have to do a better PR campaign about the need for vaccines, and the balancing act between the risks associated with the vaccine & the risks associated with COVID. Bottom line - getting vaccinated is a choice that we have to convince people to make.

Many are already skeptical of government assertions that steps weren't skipped in developing the vaccine because the prior administration lied to us. Compounding that skepticism must stop.

If other problems develop with the other vaccines, the fact that the government has its finger closely on the pulse of what we are learning about these vaccines - and that it will take appropriate steps to ensure that as we learn more we will use that information to ensure that as little harm is done during this emergency response to a public health crisis as possible.

[Drunken Irishman]

110. I don't know why you keep thinking I'm advocating lying.

But they already have lied. They told us J&J was safe. That is clearly not the case since they paused its usage.

My point is that they better hope the pause is worth the potential damage it's going to cause - as opposed to not pausing but being more transparent with the risks. Because right now, there's a level of doubt that is likely to hit the other two vaccines and if a significant portion of America now takes a wait and see approach with these other two, we're in for a bad time.

We had great momentum getting people vaccinated. I suspect this move is going to halt all of it and really hurt the amount of people who actually get the vaccine.

So, like I said, the pause better be that needed because it's likely to result in much fewer vaccinations across the board.

[Ms. Toad]

113. Lying by omission is still lyng.

And continuing to vaccinate people when there is a known deadly risk associated (and likely caused) by the vaccine is worse.

I believe that they should have been more assertive as to our limited knowledge of vaccine safety (which you can confirm by searching here for my post in threads touting vaccine safety and urging blind obedience to the vaccine mandate), any thinking person knows (or should know) that when you are declaring safety based on limited trials that cannot have addressed long-term safety what you are declaring is "safe to the extent it was possible to obtain safety under the circumstances - i.e. we know nothng about long-term safety, and our safety assertions to short term consequences is limited to what our trials could have shown."

Now that we know more, it is irresponsible to proceed in a manner that is inconsistent with that knowledge - and we need to be transparent about what we know, and how that impacts the vaccinaton program.

[Drunken Irishman]

114. It's not an omission.

You're not omitting anything by staring the risks. And no, I'm trying to figure out if continuing the vaccine, with the stated risks (and the fact we're only looking at 6 noted cases out of 7 million) is better than pausing the vaccine and crippling the whole process because now millions of people will not trust a government that told them the J&J vaccine was safe and now they're telling them, "oops our bad we gotta pause it because it might not be safe at all".

That's the debate here. You are arguing something completely irrelevant because no one is saying omitting or lying to the public.

This decision has the potential of ruining the continued vaccine rollout.

So I hope it's worth the pause knowing the damage it could eventually do.

[Ms. Toad]

115. We're far from the first to pause COVID vaccines using the same mechanism

for the same reason: The countries have completely or partially caused AstraZeneca for the same safety risk: Germany, France, Spain, Italy, Denmark, Norway, Netherlands, Ireland, Iceland, Bulgaria, Democratic Republic of Congo, Indonesia, Cyprus, Portugal, Latvia, Slovenia, Estonia, Sweden, Luxemborg, Thailand, and Austria, Lithuania.

[LisaL]

121. Considering how rare those blood clots are, we were told

vaccine is safe because that's the information they had to the best of their knowledge.
When adverse effects are so rare, clinical trials don't reveal them (not enough people participating).

[Drunken Irishman]

128. Considering how rare it is, I don't think they should have paused it.

The headline today barely touched on the number - 6 out of 7 million - and instead focused on the pause due to blood clots. It's a bad narrative.

[Treefrog]

78. Yes, this is what worries me, but I'm glad they're taking this action.

[barbtries]

53. my son's girlfriend just got the J&J vaccine last Friday. She's 25.

I got a worry curse from my mother. I hope my son doesn't have the same curse, or her mother, or her, and especially i hope she doesn't get a deadly blood clot.

i'm trying to find the rate of these blood clots without any luck. "extremely rare" isn't concrete enough to keep me from worrying. so many questions. why only women? rate for that age range of women? signs that you may be developing these clots? When do you know you are not going to be affected by these clots if you were given the J&J jab?

aargh. this fucking virus. and worry! i don't want to and i do.

[LisaL]

55. About one in a million in the US.

NT

[barbtries]

57. is that for her demographic?

that's what I'm trying to figure out. the phenomenon seems to be limited to young women. of course it's early days. but still. I'm just going to give her a call now. make sure her side effects have resolved. She had a bad headache after the shot.

ETA: her headache lasted only for the first day after the shot, she's at work feeling great. sigh

[LisaL]

58. All the persons developing clots in the US were women under the age of 50.

Clots developed in six persons out of more than six millions administered vaccines, so less than one in a million chance. Here is the article with this information.

"All six cases occurred among women between the 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."

https://www.cnn.com/2021/04/13/health/johnson-vaccine-pause-cdc-fda/index.html

[barbtries]

74. thank you for the link.

it was helpful.

[janterry]

60. is this statistic accurate

given symptoms can develop 2 weeks out?

(perhaps more, for all we know).

but if it is just 2 weeks out - is it 1/million? (just asking as I think all of this through . My dose was to be about 30 minutes ago....now cancelled.

[LisaL]

61. So far nobody in US developed those more than 2 weeks out.

NT

[janterry]

62. ty

n/t

[Buckeye_Democrat]

64. Blood clots are observed in Covid patients.

Far more pervasive clotting than what's been observed with the J&J and AZ vaccines.

Perhaps J&J's penetration into the nucleus of cells, using the DNA there to produce the RNA for later spike protein production, could somehow cause a similar but far less severe clotting reaction?


How J&J works:
https://www.nytimes.com/interactive/2020/health/johnson-johnson-covid-19-vaccine.html
----------
... Once inside, the adenovirus escapes from the bubble and travels to the nucleus, the chamber where the cell’s DNA is stored.
The adenovirus pushes its DNA into the nucleus. The adenovirus is engineered so it can’t make copies of itself, but the gene for the coronavirus spike protein can be read by the cell and copied into a molecule called messenger RNA, or mRNA.
----------

How Moderna and Pfizer works, injecting the RNA directly instead of using the nucleus to create it.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html
----------
They do not affect or interact with our DNA in any way.

mRNA never enters the nucleus of the cell, which is where our DNA (genetic material) is kept.
The cell breaks down and gets rid of the mRNA soon after it is finished using the instructions.
----------

[Ms. Toad]

82. Here's an article that suggests they are a lot closer to establishing causality -

and a mechanism that fits with what you are suggesting:

https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes

In their paper, Greinacher and his colleagues also speculate about a possible mechanism. Vaxzevria consists of an adenovirus engineered to infect cells and prompt them to produce the virus’ spike protein. Among the 50 billion or so virus particles in each dose, some may break apart and release their DNA, Greinacher says. Like heparin, DNA is negatively charged, which would help bind it to PF4, which has a positive charge. The complex might then trigger the production of antibodies, especially when the immune system is already on high alert because of the vaccine. An immune reaction to extracellular DNA is part of an ancient immune defense triggered by severe infection or injury, Greinacher notes, and free DNA itself can signal the body to increase blood coagulation.

[Buckeye_Democrat]

90. Interesting.

Thanks!

Edit:
They might have indeed discovered the mechanism. And obviously there would be far more loose DNA from an actual Covid infection with lots of replication, causing far more severe clotting issues if their idea is correct.

[StarryNite]

101. Yes, I was also thinking of how Covid causes clots and a whole lot of other problems.

I wonder if taking things to reduce clots like aspirin or fish oil might be helpful?

I got my J&J three weeks ago. But I'm not in the age bracket they are talking about. However my daughter and dil both got the J&J. It will be three weeks this Thurs for my dil and it's two weeks today for my daughter. My daughter, even though very careful, had Covid in Nov and we were concerned about the possibility of her having clots then. There's no winning...

[Buckeye_Democrat]

107. The possible explanation shared by "Ms. Toad" above...

... might be correct. The AstraZeneca and J&J vaccines use the same technique to create the spike proteins, which involves DNA.

Moderna and Pfizer skip DNA, injecting the RNA directly. (Which also makes them more fragile and prone to breaking down.)

Hard choices emerge as link between AstraZeneca vaccine and rare clotting disorder becomes clearer
https://www.sciencemag.org/news/2021/04/hard-choices-emerge-link-between-astrazeneca-vaccine-and-rare-clotting-disorder-becomes
----------
In their paper, Greinacher and his colleagues also speculate about a possible mechanism. Vaxzevria consists of an adenovirus engineered to infect cells and prompt them to produce the virus’ spike protein. Among the 50 billion or so virus particles in each dose, some may break apart and release their DNA, Greinacher says. Like heparin, DNA is negatively charged, which would help bind it to PF4, which has a positive charge. The complex might then trigger the production of antibodies, especially when the immune system is already on high alert because of the vaccine. An immune reaction to extracellular DNA is part of an ancient immune defense triggered by severe infection or injury, Greinacher notes, and free DNA itself can signal the body to increase blood coagulation.
----------

If correct, it could help explain the more severe clotting observed among Covid patients.

I suspect this clotting issue isn't very prevalent with the vaccines, and it's also not something to worry about long-term -- i.e., like it's going to suddenly worsen months after the vaccination.

It's still far better than an actual infection, with much more severe clotting issues that can accompany it.

[Johnny2X2X]

67. Biden planned for this, Trump wouldn't have.

Agree or disagree with the FDA's decision, but know that Biden led on this when he cut POs for more vaccines than the US would need. And I remember him being criticized for it on Right Wing media, and even here by some. Biden and his team managed the risk of something going wrong with 1 of the vaccines by overbuying. This as life and death, so he hedged, because we would need the backup vaccines if anything went wrong. This is risk management 101, in any manufacturing business you do this all the time as a project manager, you have a long lead time part and you need 100 parts, you order 110 because you know there's a small chance a few of the parts will be bad and you cannot afford to carry that risk.

And it's not elementary, Trump had the same exact chance to hedge when we were developing a test formula for Covid-19. The WHO offered their formula and Trump refused because he was told that the US CDC usually develops the best tests. And I have zero doubt that he had people around him saying, "Mr. President, we will likely develop our own test that is better, but accept this anyway just in case." But Trump said no because he doesn't like the WHO and wanted to be able to brag about our own "beautiful" tests. Well, our tests were faulty and lives were lost because it was rolled out and then had to be reformulated and rolled out again.

[Buckeye_Democrat]

69. I have FAR more trust in the Biden administration...

... to resolve it, and to do so HONESTLY.

That was an impossible expectation from the Trump administration, which seemed to respect lies more than the truth!

[Johonny]

87. So much for opening by July 4th

[Drunken Irishman]

93. Yup. Wouldn't be surprised if the amount vaccinated plummets now.

[Sgent]

106. ZDogMD did a great layman review

of the issues surrounding both this and the AstraZenica vaccine.

[Buckeye_Democrat]

111. Fantastic video about it!

Thank you for sharing it!


The policies in Australia and Europe that he mentioned, generally avoiding those one-dose vaccines among younger people due to risk comparisons, is something the USA might need to consider doing in the future too.

[LisaL]

122. Except we already vaccinated most of the oldies.

The plan for J&J was to vaccinate younger people, including students, since only one dose is necessary.
Whom are they going to vaccinate with it now?

[Buckeye_Democrat]

127. Yeah, it's unfortunate timing of the emergency approvals.

It still seems wise to pause J&J for now, until this clotting issue is further investigated.

The USA might decide to move full-speed ahead later.

[crickets]

119. Excellent video. Thanks, Sgent. nt

[Vinca]

112. I wonder how many women of this age would have had blood clots anyway given birth control

pills and hormone therapy later on. It seems like kind of a drastic measure to do this since it's feeding ammunition to the anti-vaxxers and will ultimately result in less people getting vaccinated and more deaths.

[Calculating]

116. This is completely absurd

We'll probably lose a huge amount more people to covid now just because this will encourage more antivax lunacy. 6 out of 7 million people developed clotting problems, and for that we're crippling the vaccination effort? Total joke

[liberal_mama]

117. It is so absurd to me too. It makes me wonder if there is something else that concerns them.

It seems like a huge overreaction for 6 people with blood clots out of 7 million doses. I know they recently had to throw out 15 million doses of the J&J vaccine due to issues at the factory.

[LisaL]

120. Those are not usual blood clots. They are very rare blood clots.

It would appear J&J has a similar issue to AstraZeneca.

[Ms. Toad]

123. This is a very specific - and deadly - clotting issue.

In one report of it it I read, it is deadly for 30% of the people who develop it.

15 countries have paused the AstraZeneca vaccine (which uses the same mechanism) for the same reason. They are close to establishng causation (as opposed to correlation) and have theorized a plausible mechansm that is limted to the adenovirus delivery mechanism.

You would not find it a joke if your relative was one of those stricken with a known deadly condition caused by the vaccine. That is not antivax - it is the kind of thing that (but for emergency authorization) might have prevented approval.

This is not a halt - it is a pause to do one, or both, of two things: Develop warnings that include this risk (not dissimilar to the Pfizer warning about anaphylaxis), and identify those most at risk (so they can make a better choice). They initially believed it might be limited to those who had previously had COVID (and might apply to all COVID 19 vaccines). That is pretty much ruled out now - and the working theory is that it is the use of DNA (in and adenovirus vector), rather than mRNA - which is used in which in Pfizer and Moderna. Five

Far from being ridiculous, this is a responsble response to to learning about a specific dangersous side effect that was unknown at the time of the emergency approval.

[beaglelover]

118. This is so ridiculous. A handful of people got blood clots out of millions who have received

the J&J vaccine and they can't prove that the clots were related to the vaccine. We need all vaccines in arms asap so we can get to herd immunity and get back to normal!

[Ms. Toad]

124. They are very close to establishing causation

for the AstraZeneca vaccine (which uses the same mechanism - using an adenovirus to delvier DNA). They are about a month ahead in that research, since 15 countries paused the administration of AstraZeneca for the same reason around mid-March.

This particular clotting disorder is very rare, very deadly, and the normal treatment for blood clots may actually trigger the disorder.

There are two vaccines that use a different mechanism, and pose no risk as to this particular disorder. So the march to herd immunity can still go forward during what will likely be a short pause to make sure that (1) the J&J warnings include a warning about this rare and deadly side effect and (2) to the extent possible they identify who might be most at risk.