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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

#691

Earlier quoted context omitted.

Deaths of despair increased though: https://www.marketwatch.com/story/deaths-of-despair-during-c...

As did unintentional injury, which was due to overdoses.

Alcohol and drug abuse is way up as well, that will have long term ramifications.

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

#692

Earlier quoted context omitted.

That's interesting to know. When I got my Pfizer jab, the lady said "oops, I did it wrong" and blood came out. She didn't jab me again though and I just assumed it was good to go. Should she have done it again at a different site? I was told elsewhere that it doesn't make the vaccine any less effective, but I'm curious what others on here think now...

As I understand it the concern isn't effectiveness so much as potential for side effects. An intramuscular injection is meant to stay pretty much in a small area of muscle tissue. If it goes into the vein the vaccine then travels into tissues all over the body.

That makes no sense of course. You’re innoculating the whole body, especially bone marrow and lymph nodes, not a small area of muscle.

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

#693

"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…

Agreed, I don't think anyone knows clearly what is happening. Some additional points that are related.

Thrombocytopenia has been a known complication of adenovirus vectors that researchers have worked to overcome in recent decades.

These incidents mirror HITT (women are at higher risk for HITT) and seem to be happening in the timeperiod where IgG titers spike post vaccination.

To me this indicates it's not unlikely something with the adenovirus vectored vaccines (J&J, AZ) is causing this issue. And because this thread seems to have gone to hell, I'll add that I support doing subgroup specific risk calculations and allowing vaccinations to proceed where it makes sense.

https://jvi.asm.org/content/81/9/4866 https://ashpublications.org/blood/article/109/7/2832/125650/... https://pubmed.ncbi.nlm.nih.gov/17148587/

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

#694

Earlier quoted context omitted.

This comment is a prime example of why we’re in this mess with vaccine denial in the first place. You’re either not allowed to say anything negative about vaccines, or you’re an anti-vaxxer who thinks your kids will get autism and 5G chips. It’s so cult-like. We should be honest about the (low) risks and benefits of vaccination without turning it into a political campaign of shame and bullying, and trust people to ma…

IMO, no - I'm saying that folks risk management is completely out of wack. The chance the disease kills you is 1 in 100. The chance that the vaccine kills you is 1 in 7 000 000. One is bigger than the other. By, like, a lot. The government's response is to pacify anti-vaxxers.

Again with the made up numbers that erode trust.

I’m 25 and I’m relatively healthy. The risk that the disease kills me is significantly less than 1 in 100; it’s hard to find numbers but one chart had the hospitalization rate for me at 1%, and the death rate 0.01% (edit: though the death rate only covered age and didn’t divide by other factors such as obesity). The “chance” the vaccine kills you is currently zero as there have been no recorded deaths that have been linked to a COVID vaccine. The blood clotting risk has been cited as 1 in a million, but we’re working with limited data. This is the problem with making such extrapolations.

I write all of this as I’m on day 2 of dealing with the side effects of J&J.

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

#695
post #558

Earlier quoted context omitted.

Of course the cases are shortly after vaccination, the data is symptoms reported shortly after vaccination which might be side effects. You're not going to have anyone who got a clot before the vaccine or long afterwards in the dataset, but those cases still did/will exist. There is no evidence yet of a correlation in timing.

The background rate you quoted are expected to be spread out independent of vaccination. If you pick a two-week window after vaccination you should only expect 1/6 of the cases that are expected in 3 month, which is the number you calculated.

But we're not observing people for 3 months and picking an arbitrary two week window. People do not get added to the population until they have taken the vaccine, and they are all observed for different lengths of time. We did not hypothesize a 2 week period beforehand and compare how many landed within to how many were outside that range, the 2 weeks is just a circle drawn around the datapoints after the fact.

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

#696

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 drug was approved under an emergency order and this side effect was not listed. Sadly, this is the case. The German regulator's FAQ explicitly called this out; they are not interested in determining the path that saves the most lives, they are simply following the process that checks all of the boxes that the regulations require. In the EU this regulatory pause of AZ has likely killed thousands of people. > Th…

Why is the correct solution not to support people enough that the only reason anyone has to interact is to do "essential" work--for which the they should be paid hazard-level pay--and then do this slowly and carefully? We can offer the vaccine to people who would then feel better taking it--particularly if it means they get to make hazard-level pay--but it wouldn't matter if people didn't: the main risk of getting covid should be "I decided to interact with people, knowing the risks", and it isn't our job to prevent them from getting ill any more than it is our job to police peoples' home lives. This whole "the sky is falling" emergency scenario is a false dichotomy we have constructed to avoid actually staring at the problem of wage slavery :(.

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

#697

Earlier quoted context omitted.

IMO, no - I'm saying that folks risk management is completely out of wack. The chance the disease kills you is 1 in 100. The chance that the vaccine kills you is 1 in 7 000 000. One is bigger than the other. By, like, a lot. The government's response is to pacify anti-vaxxers.

Again with the made up numbers that erode trust. I’m 25 and I’m relatively healthy. The risk that the disease kills me is significantly less than 1 in 100; it’s hard to find numbers but one chart had the hospitalization rate for me at 1%, and the death rate 0.01% (edit: though the death rate only covered age and didn’t divide by other factors such as obesity). The “chance” the vaccine kills you is currently zero as t…

Yep, I used averages not made-up numbers.

The reason everyone has to get it is so that the average goes down to 0, for everyone.

7 million trials is not limited data. It's dramatically, and I do mean dramatically more data than basically any other clinical trial for any other drug you've ever heard of. By probably 2 orders of magnitude. It's simply not limited data.

The average phase 3 trial has 300-3000 participants [1]. Not seven million.

Also a week in after J&J.

[1] https://en.wikipedia.org/wiki/Phases_of_clinical_research

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

#698
post #310

Earlier quoted context omitted.

Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop. The ideal strategy without hindsight was conventional wisdom: Pro…

CDC data shows that more like 25% of Americans have antibodies to COVID, so your number is off by a factor of two. [ https://covid.cdc.gov/covid-data-tracker/#national-lab ] Additionally, you make a few glib statements that don’t really check out - you say give hospitals three weeks to prepare - how? There’s been a lot made of hospitals getting ready, but for the most part, the limiting factor for covid treatment has…

Like a while bunch of places did in March and April last year: build emergency capacity during what was supposed to be only a short several-week lockdown. Instead, when the capacity went mostly unused during the lockdown, it was quietly dismantled and lockdowns continued.

Also, we knew by April last year that ventilators were a bad choice: Doctors were jumping to it because of a specific weird symptom (blood oxygen levels impossibly low), but they had to keep turning the ventilators to higher settings to get an effect - to the point it was causing further lung damage. There's a bunch of less damaging ways to get more oxygen into a patient they'd been shifting to: https://www.statnews.com/2020/04/08/doctors-say-ventilators-...

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

#699

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…

Injecting IM solution into a blood vessel is excruciating and you and the provider would notice it immediately if it happened. It is likely to cause an embolism and possibly kill you, but I don't think it would be unnoticeable and then cause a thrombus multiple days later.

There are also not a lot of major vessels near common injection sites, for this reason. It's possible and rather common to nick a surface capillary or something, and those can bleed quite a lot, but a vein or artery would be totally different. Swelling, horrible pain, likely a cough.

Source: inject myself with intramuscular estrogen every week.

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

#700

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:/…

Still, even if it gets close to a small vessel it might be problematic

Maybe we'll need to do it for AZ. Or maybe subcutaneous?

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