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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

#371

Post by rgbrenner »

symlinkk wrote: post #118
ceejayoz wrote: post #117

Earlier quoted context omitted.

> Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated. Per https://vaccinetracker.ecdc.europa.eu/public/extensions/COVI... , that's 30M AZ doses. You're still talking about one in a million chance of death here. > And if you compare that to CFR from COVID for person Add a few…

The point he’s trying to make is that if you’re in a low risk group (let’s say under 30 for example) maybe it’s a better idea to just skip the vaccine.

1 in a million chance of vaccine death for AZ. Maybe 1 in 10m for JJ. 0 in 10 for the mrna vaccines.

10 in a million chance of death from covid in the 5-9 age group (the lowest risk group)

This is the perfect example of anti-vacc logic. They pick the latter because they heighten the risk of the former in their mind, while ignoring or downplaying the risk of the latter. Looking at the actual numbers, it makes no sense for anyone at any age to take their chances with covid over the vaccine.

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

#372

Post by laplacesdemon48 »

chaorace wrote: post #111
laplacesdemon48 wrote: post #103

Both the AstraZeneca and J&J vaccines use an adenovirus to deliver DNA instead of mRNA wrapped in lipid (like Moderna & Pfizer). Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up? As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vecto…

I think the argument hinges on the technicality that it's not splicing itself into the host genome, so no chance of it becoming a retrovirus or something like that (in the event that the cell's lineage is not extinguished by the immune system). I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risk…

I didn't want to put this into the parent comment because I didn't want to get just shoved into the "vax" vs. "anti-vax" bucket by the replies.

But there's a very well known case where DNA delivered via an adenovirus killed a teenager during a genetic engineering study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/

>> "No one realized that the vector itself might pose a risk"

I'm sure the dosage, type of adenovirus, and modifications to the adenovirus are different. But there are obviously still risks we don't know about.

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

#373

Post by BurningFrog »

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 the problem with the FDA system.

If thousands are dying for lack of a drug or not has, at best, very little impact on the decisions.

The job of the FDA is to enforce regulations, not to save lives.

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

#374

Post by robbiep »

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 form in your venous sinus.

But there were also reports of more typical blood clots (ie DVTs), the first European Medicines Agency advisory (0) said that this was within the level of noise (im now talking AstraZeneca, so apologies for shifting vaccine as generally they should be considered separately until the evidence catches up, although everyone is quickly drawing parallels between them)

(0) https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene...

Ps apologies for not referencing around HITTs and theories around antibody-mediation for CVT. Basically it’s all pretty noisy anyway at the moment and so my here-say from the medical tea rooms is as good a gossip as any, as long as everyone is aware that no one really has any definitive idea what may be going on yet

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

#375

Post by GavinMcG »

viklove wrote: post #317
Moto7451 wrote: post #287

Earlier quoted context omitted.

That’s not the difference the parent is asking about. He’s asking if the adenovirus based vaccines available are meaningfully different. Reaching beyond the parent’s words, both AstraZeneca and J&J have now had issues with blood clots. If it’s a similar formulation then perhaps you’ve found something and Adenovirus vaccines with a different formulation are unaffected. If they’re very different then perhaps other vari…

The mechanism of delivery isn't a meaningful difference? Okay, if you just want to ignore half of the equation be my guest.

The parent comment wondered

> whether Johnson & Johnson and AstraZeneca are meaningfully different

Grammatically, that asks about the difference between J&J & AZ. Your response instead compared them collectively to the mRNA vaccines, rather than comparing them to each other. Thus the response saying "[t]hat’s not the difference the parent is asking about."

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

#376

Post by nend »

splithalf wrote: post #280
carnivalWilson wrote: post #246

Earlier quoted context omitted.

I'm a bioengineer. Everyone that gives an answer mostly ignores epigenetics and the fact that RNA can permanently alter the _shape_ (or conformation) of how your DNA is tightly wound up. For example, RNA can direct methylation of DNA and alter histones, which can lead to transgenerational epigenetic effects on gene expression and phenotype [1]. The fact is, molecular cell biology is incredibly complex and the models…

Everything in life has potential epigenetic effects! Not sure what you are trying to communicate with your comment but it sounds like you are saying people should avoid the mRNA vax but then you also say “almost certainly no long term effects.” Your thesis seems to be that 10 years is enough time to know for sure that they are safe. Why is 10 years the right amount of time? Why not 50 years or 5? In other words what’…

You seem to be putting a lot of words in OPs mouth. I didn't see OP making any sort of suggestion about whether to avoid the vaccine or not. It looked like they were simply explaining some possible outcomes of the vaccine that are unknown.

OP also didn't say 10 years is enough time to know the long-term effects of these vaccines, just that it's traditionally been the minimum amount of time needed for some other drugs.

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

#377

Post by vincentmarle »

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]…

> While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time.

Except to the general public this overcautious behavior and resulting media hype raises vaccine suspicions, and will decrease public trust in J&J (and even vaccines in general) as a result. It’s already happening.

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

#378

Post by dokem »

cogman10 wrote: post #335
jdminhbg wrote: post #284

Earlier quoted context omitted.

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 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…

You blame the anti-vaxxers for the vaccine not being up to spec? Isn't this what they were saying the whole time?

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

#379

Post by whymauri »

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.

>The rules are not some holy writ handed down from above

I'm sorry, but when dealing with healthcare organizations and policy-makers, it's more like the "holy writ" than the idealized system you describe later.

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

#380

Post by UncleOxidant »

yboris wrote: post #312

Relevant tweet: https://twitter.com/robertwiblin/status/1381967753234411530 J&J doses delivered: 7 million. Reported blood clotting events: 6. Daily risk of dying of COVID19 in the US: 1 in 330,000. CDC and FDA: Pause the J&J vaccine. Draw your own conclusion on how aligned these folks are with your interests.

But there are 2 other vaccines that are still available so it's not like they're stopping all vaccinations. Another consideraton: J&J was/is having production problems so deliveries have been cut considerably - as such this probably won't be a very significant change to vaccination rates. I suspect the FDA will allow J&J vaccinations to resume in a couple of weeks. Maybe they'll recommend it not be used in women under 60 as has been done with the AZ vaccine in Europe. Even if they do that there would still be plenty of men eligible to get the J&J.
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