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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

#461

Post by vibesngrooves »

jonplackett wrote: post #424
jaegerpicker wrote: post #406

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

Love this work!

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

#462

Post by jghn »

DennisP wrote: post #209
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 saying this will add to vaccine hesitancy but I'm not convinced. The vaccine-hesitant are already skeptical of authorities and aren't going to be especially reassured just because US agencies say it's fine, when it's already hit the news that European agencies have halted J&J. Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are…

What we've seen in the US is that the J&J was the choice of people who legitimately wanted a vaccine but were leery of the novelty of the mRNA vaccines. This is going to crush that group of candidates and some non-zero number of them will wind up in the camp of people who don't get vaccinated at all.

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

#463

Post by bluGill »

josephcsible wrote: post #429
fastball wrote: post #362

Earlier quoted context omitted.

Yeah, the problem though is that we have a Tragedy of the Commons situation on our hands. There is a non-negligible portion of the population that wants to have its cake and eat it too – reduce the risk that they will suffer health consequences from COVID-19 by letting everyone else get the vaccine, but not getting the vax themselves, therefore putting their risk from vax at zero.

That seems like it'd be easy to fix: the government just needs to say "as soon as you're fully vaccinated, you don't need to social distance or wear a mask in public anymore". Since that isn't their position, there's basically zero incentive for young, healthy people to risk the vaccine side effects.

That is one option. Which is why so many anti-vac people have jumped on the no vaccine passport bandwagon. If there is no way to prove you have been vaccinated, then they can lie about it and take part in non-masked public activity (I'm not sure why they are against the mask).

There are other options. Give everyone who has got the vaccine some money is one I've heard more than once. Maybe someone else has a different idea.

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

#464

Post by oneepic »

baggy_trough wrote: post #412
jaegerpicker wrote: post #406

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…

An utterly appalling decision by CYA bureaucrats or innumerate idiots. The leadership of the CDC and FDA must be replaced.

You'd replace an entire team due to one decision you didn't like?

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

#465

Post by theptip »

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 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.

> The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.

Or, more generally, in the emergency-order regime, all decisions that can demonstrate a clear 10:1 improvement in expected deaths should be taken, regardless of regulatory red tape.

The FDA and other regulators have over-fitted their process for "minimize likelihood of another Thalidomide, for drugs which have a small chance of saving a life, and a very small chance of causing harm". This is defensible for testing a new statin, where we have existing safe drugs to choose from, and we're looking for incremental improvements. But it's shockingly harmful in an emergency.

One thing that has become very clear is that the FDA and other regulators are structurally incapable of making even rudimentary risk-based tradeoffs in emergency situations, and we need to fix this.

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

#466

Post by kokx »

greenwich26 wrote: post #401
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

The source you mention does not explicitly give a one in 30.000 figure, and it is not something that can be safely concluded from the data in the paper. The authors state that at the time 132,686 people had received their first AZ shot in Norway, of which five had developed thrombosis.

This is definitely not enough data to conclude a 1 in 30,000 figure. And neither does the cited paper conclude this.

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

#467

Post by xiphias2 »

Baeocystin wrote: post #368
xiphias2 wrote: post #352

Earlier quoted context omitted.

They are not alleged at this point, they are real, and we have enough data that proves it. Using a language that pretends that vaccines can't have lethal side effects is just dividing people farther. It's all about the risk-reward calculation, which is still on the vaccine's side for most people. For a 18 year girl though it may be better to wait 2 weeks more for the Moderna / Pfizer vaccine in lockdown at home than…

From what I understand, we have data that shows a few people per million have a serious health condition that appears to be similar in order of magnitude as the normal background rate of the same condition without the vaccine. As someone else in this thread said, isn't that (potentially) like someone getting hit by a car, then calling that a side-effect? When dealing with very large numbers of people, there's going t…

What is the background rate of CVST / 2 weeks? I think it's significantky less that 1/million people

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

#468

Post by lamontcg »

FunnyLookinHat wrote: post #459
doikor wrote: 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.

Yeah and we only just started to roll this vaccine out - so it's fair to say that the risk will likely grow beyond that. You're right that 7 / 7,000,000 are good odds, and most people would likely take them - but it would be unwise to not give people an educated choice between vaccines if there are known risks.

> so it's fair to say that the risk will likely grow beyond that.

not really. that's not how statistics work. it could grow, it could shrink.

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

#469

Post by vmception »

sp332 wrote: post #448
jaegerpicker wrote: post #406

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…

They didn't pause it because they're considering cancelling it. They're pausing it so they can communicate to patients and providers what to look out for after they take it. Once processes are in place to handle future blood clot events, they will resume vaccinations.

I’ve been thinking about this, the communication has been so bad from public and private health officials for 15 months straight.

When not considering any externalities, anti-vaxxers and everyone that comes up with anti-industry and anti-establishment conclusions is rational, but inaccurate only because they dont consider what was not said.

Even with regard to COVID itself, most of the official communication is about avoiding death when the reality is that its not about only avoiding death its about all the additional debilitating effects in the vast “recovered” statistic, so it is rational to decide to ignore that once you do your own math and noticing who is actually dying. But it is not accurate because it doesn't factor in the unsaid aspect.

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

#470

Post by lsllc »

ridethebike wrote: post #449
jaegerpicker wrote: post #406

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 wonder if we randomly select 7 million people (without vaccine) and observe them for couple of months - how many of them will get the blood cloths

According to this BBC News article, it's 4 per 1M:

https://www.bbc.com/news/health-55302595

Quote:

"The MHRA said about four people in a million would normally be expected to develop this particular kind of blood clot - though the fact they are so rare makes the usual rate hard to estimate."

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