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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

#501

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 i…

By not stopping it will forever by 7 out of 7 million.

By stopping they can at least find out if it's 5000 out of 7 million (and more deaths).

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

#502
post #430

Earlier quoted context omitted.

The problem isn't 7 out of 7 million odds. It is that it is an unknown side effect that did not come up in the original studies. We have approved vaccines with worse side effects before. The difference is that we knew what those side effects were and weighed the risk vs reward and made the call to use it.

> It is that it is an unknown side effect that did not come up in the original studies. Well, obviously it didn't. Exactly because it is so rare A clinical study with (I think) 30k people can't detect something that's 1 in a million case

Yes. And that is why when something like this pops up we stop giving out the treatment while we look at the new data and make the decision.

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

#503

6 cases doesn't seem high enough to rise above the baseline incidence rate that I would expect for a population of millions that have received the vaccine. The reported data simply doesn't explain stopping use of this vaccine. It seems like either: 1) They are overreacting based on sparse data, which will cast doubt on the validity of their actions. 2) There is information being withheld that implicates, though perha…

This vaccine is similar to the AZ one which seems to have an elevated rate over a much larger sample size. Thus a pattern here that matches patterns we expect of the AZ vaccine suggests this has the same problem even though if we take the data alone it is still within the range of normal.

As such 1 is no longer correct, if we didn't have a compare these numbers are high but within expected chance. However these numbers are looking like within the range of the compare even more than normal.

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

#505

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'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…

Everyone is the world is either going to be exposed to the spike mRNA from the vaccines or the virus.

Pointless FUD to worry about that or even bring it up.

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

#506

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:/…

"no large blood vessels are present at the recommended injection sites"

That's a bold statement. Sure, no large blood vessels may be present at the recommended injection site on an average human, but it's well known there is more divergence in anatomy than they necessarily teach about in primary school, and vaccines are supposed to go in basically everyone.

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

#507

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 i…

> The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.

The CDC and FDA both agree that use of the J&J vaccine should be paused so they can further study this previously unknown side effect.

Maybe someone here could help you get in touch with them since you clearly know something they don't?

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

#508
post #490

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 i…

I think it is a disservice to outright label people as anti-vaxers simply for questioning the risk-calculus of vaccines. The (1/7 million) is the current, unconditional and empirically observed adverse effect of the vaccine - this is a somewhat noisy measure of the true prevalence of this issue. It is okay to be cautious and there are legitimate concerns, and quite frankly, I trust the FDA have good reason to pause t…

> I've already seen a bunch of anit-vaxers referring to this

It's not only a disservice, it's a biased way of thinking which only serves the one making the statement, given it allows them a way to alleviate their concerns about having received a level of uncertainty from their actions. I get them them because I also got that shot!

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

#509
post #303

Earlier quoted context omitted.

The rules do not exist to manage risk. They exist to strike a balance between ethics and risk in emergency situations. If you’d like to change them going forward, feel free to advocate. I think it’s best we stick with our current rules this round.

We've changed the rules for every single part of life and society because of this massive emergency, with no idea what the long-term consequences of doing so might be. I'm not sure why the FDA should be excluded.

The FDA has a process in place as per the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013. If you find that legislation inadequate in some way, I think following due process to change it is the way to go. If how we handle pandemics should be more agile, let’s get legislation behind that.

I don’t think jerking our knees over an ethics safeguard that led to a pause in administration of a vaccine that soon won’t be widely available anyway is a great habit to get into.

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

#510

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 i…

I just made this website to show you how really, really small the risks are for the AstraZeneca vaccine which also has this ‘issue’. It compares the risks of dying from a blood clot after the AZ vaccine (about 1 in a million) to the risks we happily take every single day. http://whatoneinamillionmeans.com If you're not willing to take 1 in a million chances, it's gonna be pretty hard for you to get out of bed today

I’d probably be careful using this as a public health communication tool; you’re comparing these risks to things like flying, which people are viscerally afraid of. Not to mention that the CVST issue is a poorly understood and evolving picture, so it’s hard to confidently assert that the risk is actually a micromort.

The perceptive gap between zero risk and extremely small risk is enormous. If I’m young and healthy, I can easily avoid the additional 1 micromort risk of taking the vaccine by simply not taking it. Now what?

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