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You won't stop the news of clot deaths getting out in the EU, kelvin. Ignore/rubbish the news and claim everyhting is fine and people will know you're lying. People have a healthy suspicion and bullshitting will exacerbate that.
If you want to persuade people to get vaccinated you need to be cautious, methodical and transparent. That strategy has worked very well so far with an ever increasing proportion of the population saying they'll get vaccinated. Now is not the time to be dismissive and undermine trust.
France 3 is curently going through all the numbers:
.66% of vacinated have an undesirable reaction, of which 32% "serious". The whole system of side effect recording is being presented.
That's the kind of information that people need to be given if you want them to turn up.
No one said it wasn’t. I was talking about the effect of suspending distribution, not data reviewing and transparency. Being over cautious with this delay could well have a positive effect on uptake long term, and I hope it does. It’s not certain that people will respond that way to it though, is it?
Just a thought, could a vaccine be made lawfully mandatory? I realise that smacks of 1984 and state power, but...
As I said to Mefty you'l get a few more deaths short term. You can work that out: 300 000 delayed for a week in a country of 66 million with 25 000 new cases per day says that in a week you might prevent about 1000 cases and maybe 5 deaths. Seen like that I reckon it's worth delaying if it means millions more will accept vaccination.
Edit: my numbers are pesimistic, it's less deaths than that but I'm not going to correct.
In France no chance, Kryton. Other countries no idea. You can't even suspend doctors for not getting vaccinated here because the law says there's no way of knowing if they've been vaccinated, medical secret it is.
Seen like that I reckon it’s worth delaying if it means millions more will accept vaccination.
I agree. But “if” is the key word there.
Edukator - 32% of people having serious side effects? No chance - that’s BS.
Read again, .66% have side affects of which 32% "serious". That means about 1 in 400 get "serious" side effects.
I don't do bullshit and nor does France 3. 🙂
You need to write your posts better in that case!
Nah, you just need to read all the words and engage your brain
And 1 in 10 for long Covid, that needs referencing too.
https://www.bbc.co.uk/news/health-55331166
The ONS said one in 10 people it surveyed who tested positive for Covid-19, still had symptoms 12 weeks later.
One in five had symptoms for five weeks or more.
I've also seen suggestions that those figures may underestimate the incidence of long covid. Fwiw, I've had 12 months of it and know four other people, all men, all very fit, aged from early 20s through to 50s with it.
For me it's been massively debilitating, I can't work, can't ride a bike, if I do too much I'm crushed by a horrible, shaking fatigue for several days. For months I was sleeping two or three hours a night. My autonomic nervous system was shot. I have measured sensory nerve changes in both hands, and lots more etc.
Anyway, my point is that it's very unpleasant and not exactly rare even if exact figures are hard to find. The idea that if you're not old, fat, or without co-morbities you will simply feel crap for a few days then get on with your life is an attractive, reassuring safety blanket, but not accurate I'm afraid. And just because experts aren't sure whether there are 150,000 people with long covid in the UK or twice that, doesn't change the general point that it's happened to a lot of people.
You won’t stop the news of clot deaths getting out in the EU, kelvin. Ignore/rubbish the news and claim everyhting is fine and people will know you’re lying. People have a healthy suspicion and bullshitting will exacerbate that
You're probably right. So where are these are effects in the UK?
Just a thought, could a vaccine be made lawfully mandatory? I realise that smacks of 1984 and state power, but…
But what?
I think the immediate worry is that vaccine take-up is statistically lower in deprived and minority neighbourhoods, so you potentially end up with pockets where fewer people are vaccinated and covid has the potential to spread and fester.
Also, although take-up has been high in older age groups, you have to wonder whether it'll fall off among younger people who perceive themselves as being at little or no risk from the virus.
And if that means not enough people are vaccinated to achieve some sort of herd immunity, then that conversation will probably be had. I also suspect the government is hoping they won't reach that point, but...
It wouldn't be a good look would it.
Absolutely BadlyWiredDog. I was an occasional seasonal asthmatic until March last year. Some years I never took a puff on my inhalers and never had effort induced asthma, it was always allergy related. Since March I've used them almost constantly. A year on I'm slowly, slowly improving.
Mine is a mild case of long Covid if that's what it is; I can't say with certainty it's Covid, asthma sometimes just gets worse. I'l find out more when the trees start dowsing me in pollen this weekend.
I'm not rying to minimise how dangerous Covid is, I'm making acase for inciting the highest number of people to get vaccinated even if that means delaying AZ vaccination for a week or two to maintain confidence in the system.
So by your numbers @edukator, there should be 61250 people in the UK with severe side effects of the vaccine. I don't think that's what we are seeing, or do you think that's been hushed up?
I never said "severe" which is a step up from "serious". I wish people would actually quote me if they're going to quote me.
There's a reason I put "serious" in inverted commas, the France 3 report didn't define "serious" and I simply repeated it in inverted commas to make it clear is was the language on the chart not mine. Refer to the appropriate thread for an STW sample in which many people are reporting some side effects but I don't think anyone would class them as "serious" yet. Keep watching.
I don't know if there has been hsushing up, I do know that from a lower number of vaccinations in the EU a higher number of issues have been raised which has led to AZ releasing some numbers of cases with as little complementary information as possible it seems to me. Transparent not.
Edit, and while I'm reminding people what I actually said the term was "undesired rection"
what defines 'serious' side effects?
As per OWG's calc, either serious means 'not really that serious' or those France 3 numbers can't be correct, can they?
South Park Vaccine special is out! 🙂 Its on Amazon
what defines ‘serious’ side effects?
As per OWG’s calc, either serious means ‘not really that serious’ or those France 3 numbers can’t be correct, can they?
Tbh, the EMA are meeting on Thursday I think. And the UN have said this;
WHO has not received reports about “thrombo-embolic events” in other parts of the world, she added.
https://news.un.org/en/story/2021/03/1087362
Id just give it two days and see what comes out. The reports I’m seeing in French news paint this as partly aligning with other EU countries and precautionary measures. Certainly nothing on the sites I looked at to suggest anything other than “following procedures”.
I'm inclined to think "serious" "undesirable reaction" is as you say, 'not really that serious', theotherjonv, they didn't die. But I'm just reporting as it was reported - don't shoot the messenger !
At least France 3 report such information.
FDA definition of serious adverse events
The definition of serious adverse events is clear in all jurisdictions. I have linked the fda terms. The ema and mhra will be very similar.
Anything that falls under that definition will be automatically reported to the regulators.
Quite why the national regulators are acting differently from the ema is strange though. But time will tell if these are vaccine related or not.
It's probably important to note that 'serious adverse event' has a specific meaning. Not everything that counts as an SAE would qualify as sounding 'serious' to most of us. Though obviously some would, so without more info it's very hard to put those figures into proper context. If it's one in 400 have life changing problems that's one thing, but if it's one in 400 feel really crap for a week then it's not the same.
not shooting anyone, just slightly incredulous at the numbers and trying to understand what is actually being reported by FR3, in the context of serious and also that FDA definition linked above.
I'm booked in for Sunday, I'm wondering if I might cancel and rebook after the EMA report. Or wait till then and then decide. I'm a scientist myself and follow the facts, but facts are a little contradictory right now and as said, the Irish Medicines Agency, the French, the Germans - these are not quacks by any measure.
Ema definition of sae
An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.
These are not minor events, by their definition they could result in death or serious consequences
If France 3 been using that category they'd have used the word "grave" not "serious" because the international definition uses "grave". "serious " is pretty vague which is one of the reasons I put it in inverted commas from the outset.
Selon l'article R. 5121-152 du Code de la Santé Publique, un effet indésirable grave est "un effet indésirable létal, ou susceptible de mettre la vie en danger, ou entrainant une invalidité ou une incapacité importantes ou durables, ou provoquant ou prolongeant une hospitalisation, ou se manifestant par une anomalie ou une malformation congénitale".
I've tried to find the origin of the France 3 data on line and failed.
Anyhow there's a thread on side effects now.
Edit: have a look at Mildred's post, that looks pretty undesirable effect to me, not sure I'd give it serious though, one of the 1 in 200 rather than the 1 in 400 "serious".
about the safety of a vaccine tested so briefly
You can expect to be torn a new one when coming out with such arrant nonsense.
Prof Van Tam "Within that time*, in the UK, one million ordinary people have volunteered and then taken part in COVID-19 research studies. At a time that is tough for all people, and in some cases tragic, those people have put this aside and selflessly volunteered, in huge numbers, to provide vital information to help others. I have been humbled by the scale of this volunteering, and wish to thank everyone who has taken part, or intends to take part now."
*Since 11 March 2020
From this article here. I'm not a researcher but those that are can probably let us know how many volunteers a 'normal' drug-testing study will have. I expect it is tens of thousands worldwide for a well-funded one. This was 1 million in the UK!
EDIT was called in early today for Astra Zeneca, only 90 minutes but every little helps. Herself was 8 hours early.
1000-2000 for phase 2, upwards of 3000 for phase 3.
Trials cost a fortune and normally don't need the speed required now.
There is no question that short term effects should be well covered by the size of the studies so far.
Longer term we will have to wait and see but i would be amazed if they are near the severity or frequency of anything derived from the covid infections
Me too..... but there are some big and well respected authorities calling time out to review, and can we easily just assume the UK's right and they are all just over cautious.
Ema definition of sae
An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.
These are not minor events, by their definition they could result in death or serious consequences
Sorry, looks like I got that wrong - I think I was thinking of 'severe' which can mean e.g. a severe headache. Should have checked before writing, soz!
Does seem somewhat implausible that 1 in 400 have adverse events *that* bad though. Where by 'implausible' I mean 'definitely no way'. So in a roundabout way I stand by my point - the figure of 1 in 400 is only meaningful if it's attached to a definition of WHAT falls into that category.
It does seem strange that these events are only being reported in specific geographical areas.
But if there is a signal there then it needs reviewing to confirm one way or the other no question
only being reported in specific geographical areas
sorry, have not been following closely, what does 'specific geographical areas' mean? Country or more localised - could it be batch specific / plant specific for example?
Chance of serious reaction to vaccine = 1 in 225,000
Where does that come from? That’s supposed to be the number we don’t know yet.
From the article posted higher up with the numbers from Germany. BWD referenced the long Covid figure. The 1 in 1000 for Covid deaths, well, I'm not young or skinny, so my odds are probably worse
Just had a chat with my mum on the phone- the rumour going round Doom Monger Close where she lives is that there has been a big increase in people not turning up for the jabs since this clotting story broke at the weekend.
Anyone on the front line seen that happening?
MCTD
Your 1/225,000 is not chances of a serious reaction, that is I think your calc based on the specific CVT reaction.
The 1 in 1000 for Covid deaths, well, I’m not young or skinny, so my odds are probably worse
And if you're grappling with variant P1, young and skinny don't matter.
Adverse events have five grades
1) mild
2) moderate
3) serious - needs hospitalisation
4) life threatening
5) death related to AE
https://en.m.wikipedia.org/wiki/Adverse_event
You don’t want a Grade 5 AE. Typically vaccines will induce grade 1/2 and you’ll see these in the phase 1 studies as bar charts. Grade 3 are rare. They’ve noted grades 3-5.
But the numbers treated is enormous. Very rare events will not manifest in Phase 3 studies. But very rare events unrelated to treatment will occur by chance at the time of treatment for some unfortunate people. And then on top of all that, there may also be an underlying tiny signal. Welcome to Pharmacovigilence. There are a lot of Bayesian statistics underlying basal event rates and likely causality.
Like any highly regulated setting, definitions are clear for recording purposes with standardised terms. This is not just made up as we go along. There are complex decision-making processes even for seemingly rare events.
Your 1/225,000 is not chances of a serious reaction, that is I think your calc based on the specific CVT reaction.
I need to stop trying to be clever with stuff I don't understand.....🤦♂️
I'm really confused and conflicted.
(I'm just watching the TV news as well)
So the EMA is going to give their verdict on Thursday but Emer Cooke is saying tonight that the benefits outweigh the risks. So what are they verdicting on?
In the meantime, despite the EMA boss saying the benefits are clear, half the countries in Europe have paused pending the review.
We're pushing on regardless.
I'm a scientist trying to follow the facts but how do I pick the facts out of that ^
Assume an event occurs in 1/250000, then treating 25 million people means the expected number of events is on average 100 events, with some associated distribution. The probability of not seeing an event is effectively nil.
Now suppose you tested your vaccine in 15,000 subjects in a Phase 3 trial. Then the probability of seeing at least one event is actually only 5.8%. You might see one case if you ran 20 Phase 3 trials! It’s the coupon collectors problem if interested.
P = 1 - (249999/250000)^15000 = 0.058
This assumes zero background events. That just makes life even harder!
Very rare events are hard to find in clinical trials. In fact most drugs for chronic conditions only have 1000 patient years of data at approval. The exception is cardiovascular disease, where large trials are needed for prevention. Then it’s about 10,000 patient years. That’s why regulators and pharma take post-marketing vigilance so seriously.
But I'm not talking about the CVT reaction; the 1/225000 or 1/250000 event. Edukator was saying the French media was reporting 1/500 for serious events.
"0.66% side effects of which 32% serious"
= 0,21%
I can't rationalise those numbers against the lack of serious effects being reported in the millions we've vaccinated. Hence asking again what serious means..... if that's a sore arm or flu symptoms for a day or two then maybe but why are respected agencies calling time out?
Answer - because the EMA is reviewing and will report on Thursday. But reporting on what - a 1/250K event, that the EMA is saying is pretty much in line with population level occurrence? Why would half of Europe be stopping if that's all they're waiting for? Or are these other agencies aware of something we are not, more in line with the FR3 incidence level......
I don't want to sound all conspiracy but I can't get these various bits of fact/data to fall into the right places in my mind. I hope I'm misunderstanding or misinterpreting but at this point I can't see what.
The German perspective is quite interesting and it seems that there is a flaw in how they are approaching it. This is an extract from what the Department of Health published.
They seem to worried about legal consequences of any harm done as a result of the vaccine, but there does not seem to be any mitigation for the overall public good that vaccination does i.e. they seem to have difficulty with a utilitarian trade-off.
Anyway I am due for mine on Friday and I will take whatever I am given.
If you are so worried about risk and are going to let any of this stop you getting vaccinated against what is around the third leading cause of death in developed nations today then I suggest you never travel in a car, ride a bike, cross a road or walk down stairs or have unprotected sex ever again.
Is that aimed at me, uponthedowns?
Go back and read what I've said, in particular earlier, as soon as the opportunity came up I booked but I am now wavering because something - probably misunderstanding - is confusing me about the safety, and consequently I'm trying to understand what. Not compare it to various other things that I may or may not do.
A supposedly reputable source is reporting 1/500 serious side effects. I don't see that can be right but just because it doesn't fit my understanding doesn't mean it's wrong, it might be my understanding that's wrong.
Maybe try and help the understanding instead of being condescending because you assume you are right.
^^ This isn't meant to sound negative towards you mate (genuinely the opposite) im really just outlining the thought process I went through in deciding if the vaccine was a good idea for me and my 91 year old mother.
I think the problem is there is always going to be a shrinkingly small risk with any vaccine. Remembering most people will probably end up having a Covid jab yearly in the future we all need to come to terms with this.
Im 52 and not in massively good health. Very important to me, I want to remain as active as I can over the decades (I hope) to come and I didn't want to risk long Covid which is only just beginning to be understood. It's also worth noting that one of the common issues Covid itself causes is...blood clots.
Long Covid has the potential to be horrific and the odds on that are around 1 in 10. Those are not odds I'm willing to risk.
Long term heart defects, neurological damage, lung damage... they make what we know about the vaccines seem like absolute certainties in comparison.
Just my take and my thought process anyway.👍