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US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

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Re: US agencies call for pause in Johnson & Johnson vaccine

#401

Post by greenwich26 »

jjk166 wrote: post #331

6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time. > Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]…

Over the past 2 weeks, the reported rate of these events associated with the AZ vaccine has gone from 1 in a million, to 1 in 30,000 [0].

[0] https://www.nejm.org/doi/full/10.1056/NEJMoa2104882

Re: US agencies call for pause in Johnson & Johnson vaccine

#402

Post by AlimJaffer »

UncleOxidant wrote: post #309

John Campbell suggested on his video the other day that perhaps this is happening because some injectors are not aspirating. What that means is that when an intramuscular injection is given you want to ensure that it goes into the muscle and not into a vein. So the proper way to do this is for the person doing the injection to first pull out the syringe (after it's been stuck into the arm) a bit to make sure there's…

Medical professionals are often taught these days that aspiration is not necessary for IM injections, particularly in commonly used sites such as the delts.

From the CDC [1]: Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites

[1] https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/admi...

Re: US agencies call for pause in Johnson & Johnson vaccine

#403

Post by MuffinFlavored »

jdminhbg wrote: post #284
myrandomcomment wrote: post #230

Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are usi…

This is a vaccine for a disease that has killed over half a million people in the US over the past year, not a new breast implant. The rules are not some holy writ handed down from above, they are our way of trying to properly manage risk. When the situation changes, the rules can also change.

> This is a vaccine for a disease that has killed over half a million people in the US over the past year

Serious question, how many of those people would have died in the past 12 months if they didn't get COVID? The number is most likely not 500,000, but it also probably isn't 0.

Is it most likely something insignificant like 5,000?

Re: US agencies call for pause in Johnson & Johnson vaccine

#404

Post by lisper »

_ea1k wrote: post #344
lisper wrote: post #207

Earlier quoted context omitted.

What part of the country are you in? And what counts as "pretty easy to get"? In California, the most populous state, people under 50 are not generally even eligible to try to get an appointment for another two days. I don't know how it is in other states, but I don't think this is unusual. That the vaccination rate is supply-limited is manifest in the fact that less than a third of the U.S. population has been vacci…

South Carolina -- availability varies, but most parts of the state have at least some appointments and they seem to be becoming more readily available. > there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses. The people that do not want the vaccine are a part of why. There are different reasons for this, with some just wanting others to g…

> We have urban areas with vaccines available

Really? Where?

Re: US agencies call for pause in Johnson & Johnson vaccine

#405

Post by wallacoloo »

jjk166 wrote: post #331

6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time. > Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]…

> All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination.

All the observed cases occurred shortly after vaccination, so I’m not sure 3 months is the right divisor to use in your comparison.

Re: US agencies call for pause in Johnson & Johnson vaccine

#406

Post by jaegerpicker »

7 people out of 7 million dose's. That's why they stopped. My wife and I got the J&J shot on Saturday so I'm directly at risk and I'd take it everytime even if the risk was 10 times what it currently is. I've already seen a bunch of anit-vaxers referring to this in new articles this morning. So let's see, 1 in a million chance that the vaccine will make you sick (only 1 person has died so far, which is terrible but it's 1 out of 7 million) vs a worldwide pandemic that has killed millions. All these anti-vaxers talking about living in fear of a virus that has 98% survival rate are AFRAID of a vaccine that has a 99.999998% ( 7/7,000,000 == 0.000001) survival rate, oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19. The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.

Re: US agencies call for pause in Johnson & Johnson vaccine

#407

Post by 13415 »

woofie11 wrote: post #364
cogman10 wrote: post #335

Earlier quoted context omitted.

This is what's been frustrating for me with world health organizations. I get the need to make sure medicine is safe and effective, and we absolutely should follow those to a T when it comes to new medicines on the market in non-emergency situations. However, that's not the case here. vaccines are well studied in general and J&J is one of the more "normally developed" vaccines on the market. After generally ensuring…

Here, risk management should be a personal decision. In this case, the right set of actions might be to grant people freedom, and let market forces rule. I think some people would choose the J&J vaccine if it meant getting vaccinated faster. Some people would choose Moderna / Pfizer, later. It really depends on things like whether or not you can work from home, how depressing it is not interacting with people, or how…

> risk management should be a personal decision

I think this is unrealistic for medical application, not only for vaccinations but in general for anything related to side effects of drugs.

First of all, most people don't have the data and in this case part of the risk management is to get more data or consolidate and evaluate existing data more thoroughly. Second, while you might be an exception, the vast majority of people do not have the knowledge and skills to properly assess risks or perform multiattribute cost-benefit analyses. Layman cannot even compare small probabilities correctly and frequently mix up risks that differ from each other by multiple orders of magnitude. Even people with fairly good knowledge of probability theory will have a hard time judging small risks without extensive comparison data and maybe some didactic tools like "micromort" comparisons.

Re: US agencies call for pause in Johnson & Johnson vaccine

#408

Post by davak »

robbiep wrote: post #374
textman wrote: post #322

"The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence." https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0... So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J…

If you’re doing the calf exercises to ward off a DVT, (and not to just stretch your strained calf!) you may be barking up the wrong tree. The preliminary theories (backed by the thrombocytopaenia) are that, if there’s a vaccine induced thrombosis with thrombocytopenia, it is probably immune-mediated (similar to HITT - heparin induced thrombocytopenia and thrombosis). And then there’s some weird thing that makes them…

Good take.

Arterial clots with thrombocytopenia is incredibly rare. Additionally the PF4 activity in these patients is very abnormal and appears to be to immune mediated. Lots of science and focus going into the mechanism around this now. The other recent NEJM articles around clots associated with the other adenovirus COVID vaccines are likely a similar phenomena.

Re: US agencies call for pause in Johnson & Johnson vaccine

#409

Post by birken »

AlimJaffer wrote: post #402
UncleOxidant wrote: post #309

John Campbell suggested on his video the other day that perhaps this is happening because some injectors are not aspirating. What that means is that when an intramuscular injection is given you want to ensure that it goes into the muscle and not into a vein. So the proper way to do this is for the person doing the injection to first pull out the syringe (after it's been stuck into the arm) a bit to make sure there's…

Medical professionals are often taught these days that aspiration is not necessary for IM injections, particularly in commonly used sites such as the delts. From the CDC [1]: Aspiration before injection of vaccines or toxoids (i.e., pulling back on the syringe plunger after needle insertion but before injection) is not necessary because no large blood vessels are present at the recommended injection sites [1] https:/…

This lines up exactly with what Dr. Daniel Griffin talked about in the most recent clinical update podcast for TWIV [1]. Apparently aspirating makes the shot more painful, because the needle is in the body longer, and serves no benefit as long as the vaccinator is putting it in the right location.

1: https://www.microbe.tv/twiv/twiv-741/ (towards the end)

Re: US agencies call for pause in Johnson & Johnson vaccine

#410

Post by benchaney »

paulcole wrote: post #383

Everyone posting here confidently saying that the FDA is clearly wrong is pretty disappointing to me. I think of all the comments about how "MBAs" and "marketing people" just don't get software development. And then I look at software development people who seem to think they clearly get medical research and regulation.

The problem is with how they are handling their data. You don’t have to know anything about biology per se to see the issue. It is entirely mathematical. By the way, the medical establishment has a terrible track record surround use of and understanding of statistics. I don’t think it’s right to suggest that self described experts are somehow infallible.
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