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US agencies call for pause in Johnson & Johnson vaccine

bbc.co.uk

541–550 of 1001 posts

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

#541

Earlier quoted context omitted.

> * Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet. That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.

The clinical trials have been for months on limited numbers of people. Given this seems to be a 1 in a million situation the odds are against those trials discovering them.

Actually they did notice extra blood clots during the trials, but didn't think it was statistically significant [0] (15 blood clots versus 10 in the placebo group, in a trial of 20k people).

[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...

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

#542
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]…

> All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination. All the observed cases occurred shortly after vaccination, so I’m not sure 3 months is the right divisor to use in your comparison.

You are only looking at people a short time after vaccination. Anyone in the population who had a clot prior to being vaccinated or who will get a clot later this year have not been counted.

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

#543
post #430

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.

> side effect

To be clear, we haven't determined that it's actually a side effect. That's why they've stopped, to get a better handle on what actually happened, and what to do about it.

It could be related to the vaccine, it could not be. It could be 1 in a million, it could be 1 in 100k.

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

#544

"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…

seems like they were all young women. so let’s say young women make up 1/4 of those vaccinated.

for them it’s more like 1/250k

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

#545

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.

Yes we do? The mRNA vaccines cause your body to produce the coronavirus spike protein. That is the beauty of an mRNA vaccine – the cure literally cannot be worse than the disease, because the cure is just a subset of the disease. Anything these mRNA vaccines do to your gametes would also be done (and worse) by COVID-19 itself, so... definitely get vaxxed with an mRNA vaccine if you're worried about long-tail risk. Also this is the J&J vaccine which is viral vector, not mRNA (Moderna/Pfizer).

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

#546
post #448

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.

The fatality rate for this adverse event was almost 30% with the similar Astra Zeneca vaccine. Fuck your vaccine propaganda. Nobody in my family will be getting this vaccine.

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

#547
post #430

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.

While I understand this to a degree - this still pretends the long-term risks of covid are zero or less than the Johnson & Johnson vaccine.

It is a two sided equation.

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

#548
post #493

Earlier quoted context omitted.

Multiple advanced health care systems in the world are independently pulling these vaccines. I wouldn’t brush it off as the FDA being overly cautious. None of these vaccines have been tested in humans for more than 12 months. And you’re assuming that health authorities can wave a magic want and instantly know who is having some kind of undetected brain clotting? I think the risks are extremely unclear even though peo…

Not a single one of those health authorities allowed vaccine challenge trials. That tells you how much they care about saving lives versus how much they care about not getting blamed for any deaths.

It does appear that challenge trials are starting, a search easily turned up this UK one: https://ukcovidchallenge.com/covid-19-volunteer-trials/

The main benefit of challenge trials is to speed up development as I understand it not to broaden risk estimates.

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

#549
post #310

Earlier quoted context omitted.

Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop. The ideal strategy without hindsight was conventional wisdom: Pro…

> With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown. Where was this "full shutdown" you speak of? Not anywhere in the US. In Wuhan, and some other Asian countries, sure. Didn't we kind of have the 3 month shutdown-lite you're referring to? Mi…

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

#550

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'm not qualified to comment on whether or not that is a valid concern, but the vaccine we're discussing here (J&J) uses a modified viral vector, as do the AstraZeneca and Gamaleya vaccines.
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