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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

#11

Post by [deleted] »

Daho0n wrote: post #9
ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

People keep repeating this myth of birth control. I don't know how doctors do their job in other countries but if they look at the patients health history this number is a myth. Luckily health officials here (ETA: Denmark) inform about these myths on television whenever the government holds a press conference about new Covid-19 measures but this isn't so everywhere so please stop spreading FUD. ETA: I see you made ni…

[deleted]

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

#12

Post by Eduard »

ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

This is kneejerk statistics 101 reaction.

* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.

* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.

I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.

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

#13

Post by jMyles »

ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

This take seems a little short-shrift to me.

This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.

So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.

But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.

A pause to assess the data and allow any lag to resolve seems prudent.

And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.

For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.

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

#14

Post by jMyles »

bognition wrote: post #7
ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

I agree that on the surface these numbers are not alarming. That said I trust that the government agencies know what they are doing here. If anything there is tremendous political pressure to NOT scrutinize the vaccines. There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.

I generally agree with your comment, but

> That said I trust that the government agencies know what they are doing here.

If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.

For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.

By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.

It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.

0: https://www.bmj.com/content/372/bmj.n627

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

#15

Post by temp8964 »

ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

Seriously I can't believe this is that simple. There is no way public health bureaucrats don't understand this common sense logic. Otherwise they would all become vaccine deniers.

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

#16

Post by ceejayoz »

Daho0n wrote: post #9
ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

People keep repeating this myth of birth control. I don't know how doctors do their job in other countries but if they look at the patients health history this number is a myth. Luckily health officials here (ETA: Denmark) inform about these myths on television whenever the government holds a press conference about new Covid-19 measures but this isn't so everywhere so please stop spreading FUD. ETA: I see you made ni…

Yes, I realized I'd edited to add the quote. Retracted my comment.

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

#17

Post by refurb »

roenxi wrote: post #8
ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

Possibly they are nervous because it could signal deeper problems. If there is anything people should have learned from the pandemic is that it takes a few months for the medical profession to sort themselves out when new data appears on the scene.

This is the thing. A similar issue was seen with heparin a decade or so back. Basically the heparin molecule (an impurity I believe) was causing an immune reaction that cross reacted with a protein that activates platelets. Not a minor side effect and until the full extent of the issue is known (who is at high risk? How do we treat if it happens) I don’t blame them for being cautious.

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

#18

Post by jonplackett »

I just made this website to show you how really, really small the risks are, and how they compare to risks we happily take every single day.

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.

This vaccine seems to have about the same rate, which makes sense as I think it uses the same technology.

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

#19

Post by ceejayoz »

jMyles wrote: post #13
ceejayoz wrote: post #2

Six cases in seven million administered doses. One death. Meanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye. The vaccine hesitancy this engenders is likely gonna kill more than that one person. https://twitter.com/NateSilver538/status/1381936112311148548 > Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. I…

This take seems a little short-shrift to me. This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects. So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply. But given what we kno…

> A pause to assess the data and allow any lag to resolve seems prudent.

I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.

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

#20

Post by School-Cotton »

We’ve completely transformed human civilization in a desperate attempt to slow down the spread of this virus that kills 1 in 200 people, and now we don’t want to use one of the miracle cures because of a literal one in a million chance of issues.

People are absolute garbage at thinking about scale.

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