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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

#661
post #346

Earlier quoted context omitted.

> Personally, I lay the blame primarily on anti-vaxxers. They've made us far too cautious around vaccinations. It has screwed up our risk management rules. I've no doubt that this pull back will result in anti-vaxxers publishing BS about the safety of J&J vaccinations to try and scare people away from it. This has nothing to do with "anti-vaxxers". Vaccines usually take years to develop precisely because we give them…

The only part of the safety process we bypassed was 6 moths of phase-3 data, we decided 2 was good enough. Everything else was just bypassing all the time where we were doing nothing at all because there wasn't money to run the next study.

That's not really true. The phase 1 trials were a good bit faster than they'd normally be. Also, even if you ignore that, having years of phase 2 and phase 3 trials gives you a lot of additional safety data, in the form of larger trials with longer duration. Also, better cross-tabs, so that it's possible to assess safety by age, gender, race, pregnancy, etc.

The vaccine trials were limited in their power to detect rare events. The Pfizer trial [1], for example, explicitly said that events rarer than 0.01% are less likely to be detected:

> This trial and its preliminary report have several limitations. With approximately 19,000 participants per group in the subset of participants with a median follow-up time of 2 months after the second dose, the study has more than 83% probability of detecting at least one adverse event, if the true incidence is 0.01%, but it is not large enough to detect less common adverse events reliably. This report includes 2 months of follow-up after the second dose of vaccine for half the trial participants and up to 14 weeks’ maximum follow-up for a smaller subset. Therefore, both the occurrence of adverse events more than 2 to 3.5 months after the second dose and more comprehensive information on the duration of protection remain to be determined. Although the study was designed to follow participants for safety and efficacy for 2 years after the second dose, given the high vaccine efficacy, ethical and practical barriers prevent following placebo recipients for 2 years without offering active immunization, once the vaccine is approved by regulators and recommended by public health authorities. Assessment of long-term safety and efficacy for this vaccine will occur, but it cannot be in the context of maintaining a placebo group for the planned follow-up period of 2 years after the second dose.

Even a 0.001% risk is not small, when you're talking about giving the vaccines to billions of people.

(I don't mean to single out Pfizer here. It's just the one I've read most recently.)

[1] https://www.nejm.org/doi/full/10.1056/nejmoa2034577

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

#662

Earlier quoted context omitted.

Careful to not play the appeal to authority. Anyone can understand anything, regardless of their so-called qualifications. Are they likely to? No, and that’s why someone’s qualifications are purely a heuristic, not a prerequisite.

I'm not insisting that a claim is true just because an authority says it is. You can't just bring up "appeal to authority" and call it a day. I'm insisting that the average unqualified individual should not think they have a better chance of being correct over the authorities in question. There's no other rational option for unqualified individuals than to listen to medical authorities unless you have a medical degre…

How does authorities being wrong / changing their recommendations factor in to what your consider a rational option? If you were a high risk individual back in January 2020 who ignored their advice and quarantined + wore a mask (an effective mask, i.e N-95), you made the right choice.

Despite how much smarter and informed humanity is, we still make decisions based on trust. Science can only explain so much and runs out of answers eventually.

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

#663

Earlier quoted context omitted.

Your chance of dying from COVID is heavily dependent on your age and any preexisting conditions, so any comparison that uses a single probability for everyone is totally wrong for a very large number of people.

The exact same caveat can be made for people who are vulnerable to the extreme side effects of the J&J vaccine. It depends on specific characteristics of the person taking the vaccine. “any comparison that uses a single probability for everyone is totally wrong for a very large number of people.”

Yes, with the key point that the people who are most at risk of dying from the vaccine are a different set of people than those most at risk of dying from COVID.

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

#664

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 believe their concern is more of long term effects and not short term. A vaccine isn't meant to cause blood clotting, unless we know the specific mechanism of how that's happening it could be much more dangerous.

Most immune reactions will cause blood thickening. If your arteries are already full of crap they will clot, this is why if you are at risk of blood clots you need to be careful even when you get the common cold.

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

#665
post #490

Earlier quoted context omitted.

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…

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…

> 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.

No, it's not. That's a misunderstanding of how the vaccine development process works and what takes time.

What takes time in the normal course of development is testing the vaccine, yes. Specifically, determining how effective it is. The reason that takes so long is that in general there are very, very few cases of most of the diseases vaccines are developed to prevent -- and you can't just go giving people Ebola to check how many of them catch it.

It's fearmongering, plain and simple.

There's mountains of data for your perusal online explaining how and why it got done fast -- here's one example. [1]

[1] https://www.immunology.org/coronavirus/connect-coronavirus-p...

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

#666

Earlier quoted context omitted.

Careful to not play the appeal to authority. Anyone can understand anything, regardless of their so-called qualifications. Are they likely to? No, and that’s why someone’s qualifications are purely a heuristic, not a prerequisite.

I'm not insisting that a claim is true just because an authority says it is. You can't just bring up "appeal to authority" and call it a day. I'm insisting that the average unqualified individual should not think they have a better chance of being correct over the authorities in question. There's no other rational option for unqualified individuals than to listen to medical authorities unless you have a medical degre…

There are actually a lot of reasons to be skeptical of experts — the same as why you should be skeptical of anyone. Appeal to authority has a contrapositive: the disappeal to lack of authority. The arbitrary person can be right just as much as the expert can. The whole point of logic and reason is that it’s about facts, not the people.

Critically the problem with your reasoning is the last sentence. No, you do not need to have a medical degree to be right when a doctor is wrong; ask anyone who’s had a medical issue that all doctors agree does not exist.

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

#668

Earlier quoted context omitted.

We will ask if the vaccine somehow cause those 6 people to be hit by a car, if we decide the vaccine caused that would be listed. (I don't see how a vaccine could cause people to be hit by a car, but I'm open to suggestions)

could cause some sort of mental change that causes one to be drawn towards fast-moving objects?

That would probably be listed as drowsiness, depression, dementia or something like that. They already tell you not to drive heavy manchinery after the J&J vaccine though.

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

#669
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 not dishonest. It's a very adequate answer to the over-simplifying claim above. I.e. there is a difference between a newer and an older platform and there is a difference between an experimental platform and a new platform (that's not experimental but has been in development for a long time).

You can always argue for making things slower and experiments longer, the problem is, that there is a pandemic going on with 3M deaths in the past year. Actually people seem to think that you can develop vaccines without being rushed, but it doesn't seem to be the case. There are several reasons why other vaccines took years:

- it was a long time ago and scientists had a lot less knowledge, experience and older technology. (Think e.g. the mRNA vaccines, which J&J is not one of, where the first candidate could be completed in something like 2 weeks after the isolation and sequencing of the virus.) - they had to start from 0 for a new virus (because they new less, etc.). Like for the polio, or HIV. In the case of SARS-CoV2, they could build a lot on the experiments from SARS-CoV1. As far as I know, there was a vaccine candidate back in 2003, but by the time it would go into phase-3, the epidemic was over. Also, it seems that research never stopped about the coronavirus vaccines, so there were new results between 2003 and 2020 that the mRNA vaccines built on. - some viruses are easier to develop a vaccine for. (E.g. the HIV is not one of them, because it's very good at evading the immune system) - I've already mentioned this, but if the vaccine candidate doesn't get ready on time because of the above reasons, then you may have to wait for years before you can do a phase3 trial because there will be no people getting infected, so you won't be able to measure the effectiveness. This is what happened with the ebola vaccine in 2014. Now the vaccine is 7 years old, but it doesn't make it any safer, because there weren't people who could be vaccinated. (Well, of course, you could vaccinate them and wait for any long term side effect, just in case, that would show up without being infected, but that doesn't seem like a very important data point.)

But again: why would you want to wait for several years in a situation like this when we do have a pretty clear picture of both the worst case risks of the vaccines and the risks of the disease (which are higher than the worst case risks of the vaccines).

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

#670
post #486

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've already seen a bunch of anit-vaxers referring to this in new articles this morning. So, take pause and examine the situation. Are these people actually anti-vaxxers, ie they oppose all vaccination due to weird paranoia about autism due to a discredited "study". OR are they against this one vaccine because of political affiliation. I'm really concerned that if we call out the people who are afraid of this one v…

It goes beyond "radicalizing" potential anti-vaxxers IMO, because at this point it's become like its own religion, where every vaccine must be equally good and questioning a vaccine is somehow outrageous.

US agencies are the ones recommending a halt. US refused to approve AZ, and Europe halted it, in many countries imposing additional restrictions when resumed. Doctors specializing in the field agree these are legitimate concerns.

If people want to argue cost/benefit tradeoffs, or speculate on things we aren't sure about yet that's totally cool, as long as they are upfront about it. And I understand if someone still wants to get J&J and is upset or just generally disagrees with the total/forceful pause.

But I don't understand treating anyone that has a concern about J&J like a brainwashed neanderthal, when literally the actual medical community has reservations about this particular vaccine. As a young woman I would not get J&J right now. Luckily I was able to get Pfizer instead.

Anyway, I agree there is a problem more generally with scientific education that can push "moderately misinformed" people into much deeper rabbit holes instead of working to educate them. I guess my point is just that I think this is a good example of how people have gotten so entrenched in the issue that it has reached a new level. There will be cases when the science is legitimately unclear, but the popular sentiment will all of a suddenly decide "science says X" and then the internet runs with it.

Another example - there was an ~2 week period last March where I had multiple educated/"science supporting" friends talk down to anyone considering a mask. No it was not coming from a hoarding perspective and it had 0 sense of uncertainty about it. These were strongly worded statements about how "masks don't do anything for COVID, the science is pretty clear".

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