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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

#631

Post by ryankemper »

tharne wrote: post #614
heywherelogingo wrote: post #582

Earlier quoted context omitted.

Agreed, I've had all other vaccines, but this batch is rushed, experimental, and not necessary for me - labelling people such as myself "anti-vaxers" is just dishonest, bitter, childish, name calling. Very few people in my area of London have bothered with the so-called lockdown (too much was open to be called a lockdown), masks, etc - I expect I've had all variants, and apparently my immune system is on top of it, i…

The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".

I hear this line being trotted out all over - especially from the "experts" - and I find it nothing short of enraging. There is a difference between saying "an mRNA platform in general might not be safe" and the actual claim real people make which is "this specific vaccine has not existed for more than a year and is being hastily rolled out on the world population via implicit or explicit coercion". The mRNA platform in general can be safe and, say, the Moderna vax could still have a poor safety profile. This is why we perform rigorous long-term testing and why most vaccine approvals (not that these are FDA approved of course) take several years.

If you can't be intellectually honest enough to admit that there is a difference between "we've used this platform in theoretical research in small numbers" to "we mass-market and roll out this novel vaccine to billions of humans worldwide", you shouldn't be in the discussion, IMO.

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

#632

Post by theptip »

doikor wrote: post #430
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…

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.

> an unknown side effect that did not come up in the original studies.

You shouldn't expect side-effects this rare to show up in the trials. The AZ trial was based on ~32k participants (https://www.astrazeneca.com/media-centre/press-releases/2021...). Your probability of observing a 1/1,000,000 occurrence in 32k observations is something like 3%.

It's impossible to uncover (with statistical significance) 1/1,000,000 side effects without giving millions of doses.

The fact that a rare side-effect has (maybe!) shown up should not negatively impact your priors for how safe the vaccine is. If anything, the fact that we're talking about 7 / 7,000,000 cases should reassure you that we're catching extremely rare stuff, which means we would have caught anything more serious too.

A more general way of putting this is that, by doing a trial you don't prove there are _no_ side-effects, you just put an upper bound on how common they can be. This is the best that science can do! Epistemologically speaking, you can never prove the non-existence of something, you can just show that it doesn't occur in the places you've taken measurements, at a frequency that your experiments would detect. (This is the "black swan fallacy", as John Stuart Mill originally formulated it.)

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

#633

Post by 8note »

ryankemper wrote: post #631
tharne wrote: post #614

Earlier quoted context omitted.

The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".

I hear this line being trotted out all over - especially from the "experts" - and I find it nothing short of enraging. There is a difference between saying "an mRNA platform in general might not be safe" and the actual claim real people make which is "this specific vaccine has not existed for more than a year and is being hastily rolled out on the world population via implicit or explicit coercion". The mRNA platform…

It's the same thing with flu vaccines, mind you. They only get a few months testing before entering mass use

The speed of access for these vaccines is that they started mass production while testing was ongoing, rather than waiting until after testing to start production

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

#634

Post by bcrosby95 »

fastball wrote: post #529
throwaway8581 wrote: post #479

Earlier quoted context omitted.

Young people shouldn't be getting the vaccine period. There is no reason to give every single person who will have children in the future an experimental vaccine for a virus they are at no serious risk from. The long tail risk on that is absolutely insane.

Not exactly sure what procreation has to do with anything. Also pretty sure risk of death outweighs literally any possible long-tail risk, so still seems sensible for the young to get the vax. Also don't think the long-tail risk of an mRNA vaccine can be worse then COVID's long-tail risk.

Total COVID deaths for people aged 0-17 in the USA are 246 so far.

That's not that many. Despite my wife and I getting vaccinated, I'm not completely sure what the correct answer is for our kids.

To put those numbers into perspective, more kids die from the flu in any given year (despite vaccination!). And far more kids die from car related accidents, and cars are a daily fact of life here.

I'm also interested in the other longer term effects of COVID on kids, but there doesn't seem to be a lot of information out there about it.

You talk as if it's a clear cut answer. Given the numbers involved I don't see how it can be.

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

#635

Post by pyronik19 »

tharne wrote: post #614
heywherelogingo wrote: post #582

Earlier quoted context omitted.

Agreed, I've had all other vaccines, but this batch is rushed, experimental, and not necessary for me - labelling people such as myself "anti-vaxers" is just dishonest, bitter, childish, name calling. Very few people in my area of London have bothered with the so-called lockdown (too much was open to be called a lockdown), masks, etc - I expect I've had all variants, and apparently my immune system is on top of it, i…

The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".

They slapped the word "experimental" on the disclosure form and waived liability to the manufacturer... it was rushed... as it should be. I took it. But the reason people don't "trust the science" is that its obvious people are lied to on a regular basis around covid and trust has flatlined.

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

#636

Post by maxerickson »

throwaway8581 wrote: post #536
fastball wrote: post #529

Earlier quoted context omitted.

Not exactly sure what procreation has to do with anything. Also pretty sure risk of death outweighs literally any possible long-tail risk, so still seems sensible for the young to get the vax. Also don't think the long-tail risk of an mRNA vaccine can be worse then COVID's long-tail risk.

We have never deployed an mRNA vaccine before. We don't know what effect it might have on gametes.

I doubt they have, but plenty enough time has passed to evaluate your concern by examining trial participants.

The mRNA in the vaccine lasts a matter hours.

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

#637

Post by caddemon »

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.

They might also add additional guidelines for who is eligible for J&J. A bunch of countries have set a minimum age for AZ vaccine, I could see something similar happening here with J&J. Perhaps excluding women under 50 for example.

But I agree J&J will definitely resume in some capacity in the near-ish future.

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

#638

Post by seoaeu »

barsonme wrote: post #243
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…

I don’t understand why you have to pause then restart. Just update the side effects as you go. Or pause for the affected groups.

The pause is to figure out exactly which groups are affected, and to decide if/how to update guidance. They are presumably working as fast as possible on that. Don't forget that the doses aren't going to go bad, so it is just a short delay in administering them

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

#639

Post by dev_tty01 »

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.

Agreed. Another unknown is how many people may have had some clotting issues that were mild and unreported. As you note, even though the 7/7M odds are compelling, the effect is still unexpected and there are two other vaccine alternatives. Taking a pause to consider the issues and perhaps make adjustments in suitable patient profiles and/or adjust follow up observation and early intervention treatment protocols for the issue makes sense.

Don't know if it matters to anyone, but the "FDA has suggested that health care providers pause the use of the vaccine while the side effects are being studied. However, providers are not prohibited from using the vaccine if they feel the benefits to an individual patient outweigh the risks." [1]

1. https://www.npr.org/sections/health-shots/2021/04/13/9867670...

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

#640

Post by clcaev »

ryankemper wrote: post #631
tharne wrote: post #614

Earlier quoted context omitted.

The technology behind this vaccine has been actively worked on for over a decade. Yes, these vaccines have been sent to market faster than normal, but they certainly have not been "rushed".

I hear this line being trotted out all over - especially from the "experts" - and I find it nothing short of enraging. There is a difference between saying "an mRNA platform in general might not be safe" and the actual claim real people make which is "this specific vaccine has not existed for more than a year and is being hastily rolled out on the world population via implicit or explicit coercion". The mRNA platform…

J&J is not mRNA platform, it uses an adenovirus platform.
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