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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.👍
A supposedly reputable source is reporting 1/500 serious side effects.
11 million and counting given AstraZeneca vaccine in the UK. If that source is really reputable then we should have 22,000 "serious" side effects in the UK alone and the media, never mind the MHRA, would be all over it.
So what does serious mean then in this context? Others have linked to FDA or other definitions of serious, but we aren't seeing that in the UK. Unless there's a different definition of serious in the FR3 data? Or unless you go all conspiracy, and that's not me.
@poopscoop; if it was shrinkingly small, I agree. 1/500 is not. It's similar odds to death from covid, order of magnitude. It's better than long covid at 1/10. I don't dispute those, the choice isn't whether or not I think vaccines are the answer, they are. It's whether the AZ vaccine has a problem that is just starting to surface. But AZ is not the only choice. Whatiffery, but would you take 1/500 vs maybe waiting a bit longer for a different vaccine with much lower.
And again, for avoidance of doubt, I'm suspicious of that 1/500 number because it doesn't match my understanding or observation. But as a scientist, it could be my understanding that's at fault, not the number.
But as a scientist, it could be my understanding that’s at fault,
What's being a scientist got to do with thinking you might be misunderstanding what serious means? TiRed spelled it out above that in this context its hospitalisation or worse. I'm not observing any reports of 22,000 people being hospitalised by vaccination. These people that had the clotting problem exhibited it more or less straight after being vaccinated. The AZ vaccine has been in people for more than two months now so I think a 1/500 problem would have surfaced well before now.
@ theotherjon I can't say as I've heard anything of the 1 in 500 fugure to be honest mate?
Please don't take my thoughts as my attempt to convince you either way, I'm neither qualified to do so or would wish to try. It's just the thought process I went through and helped me weigh up my concerns, particularly in view of my mum sho has, had thrombosis in her lungs in the past.
Anyway.
If that figure is correct I suspect my decision on whether to have risked the vaccine would have been taken out of my hands to be honest as it would have been suspended from use over hear.
I think this and many other issues will get clearer as time continues but to me I am beginning to see catching Covid as inevitable. If not this month or this year, then next, or the year after it etc. I was fearful that if I held out for the "perfect" vaccine, if you see what I mean, I/ we could get hit with Covid, potentially long Covid or worse that would make a "safer" vaccine a mute point as the damage will have been done.
It's good to think it through though, whatever your conclusions, I see nothing wrong with that.
Unless there’s a different definition of serious in the FR3 data?
Thats my opinion. As others have stated "serious" has a very specific definition in the context of Adverse events:
Results in death
Is life-threatening
Requires hospitalisation or prolongation of existing hospitalisation
Results in persistent or significant disability or incapacity
Is a birth defect.
I think they mean "severe" rather than "serious". If they do mean "serious" which category are we imagining this many people fall in to?
Hospitalization means overnight, which I can't believe is happening given the pressure on hospitals. The most misreported SAEs we see is around "life threatening" and "Results in persistent or significant disability or incapacity" - and usually this is because the doctor casts forward to some theoretical possibility that if the aliment isn't treated, the patients leg could fall off and they could die etc etc. There is obviously interpretation of what "significant incapacity" means - felt like crap and so had to spend the day in bed at home? Is that significant incapacity? No, but it may be being reported as such - so that's a possible explanation.
I suspect that people are using the term "serious" instead of "severe", and then calling the patient's flu like symptoms/muscle aches "severe", because they are in the context of those ailments. That's not how you are supposed to code severity - but is a common mistake amongst doctors who perhaps are not used to doing it.
However, that's all just a guess.
Usually in a trial there is a whole team of people checking in real time how you are coding this stuff - and asking doctors to amend if necessary (I used to do that many moons ago).
The incidence of CVT is very interesting. As Tired says above - with the huge numbers of people getting vaccinated, this kind of rare event are going to become evident much more quickly than it usually would, so it's perfectly possible that this is a real side effect, and the label updated accordingly.
The Times reporting that France and Italy about to resume AZ vaccinations.
As we all argue about this, how many people are dying of Covid?
How many are being hospitalised?
Are we not approaching where we want to be?
How we manage next Autumn is what we need to start talking about, yes?
Is it worth taking an aspirin beforehand? Or perhaps some warfarin from the rat poison bottle?
(Let's not get into the ecological damage that stuff does).
My appointment is on Friday but now I'm tempted to see if they have any spare slots going.
Australia cracking on with the AZ vaccine
John Skerritt, the head of Australia’s Therapeutic Goods Administration, said he held talks with more than a dozen European countries overnight and current evidence suggested there were no reasons to halt the immunisation drive.
The Times reporting that France and Italy about to resume AZ vaccinations.
Theres some suggestion that France never wanted to stop in the first place but needed to fall in line with other EU countries. But as far as I’ve seen, they’re just waiting for the EMA before restarting.
In fact, it was under pressure from its neighbors that France was forced to take this turn. After Denmark, Norway, the Netherlands or Iceland, the decision taken by Germany on Monday afternoon to in turn suspend the use of this vaccine took everything in its path. Forcing the President of the Republic to align himself with this position a few minutes later. "We had agreed to wait for the opinion of the EAJ [initially scheduled for Tuesday], but Berlin fired first under internal pressure," sighs a minister.
My hunch is this will damage some EU countries vaccine drives with an increase in vaccine rejection if it’s the wrong one.
Right; much to address so this could get a bit long, I'll try and be short.
As a scientist.... that has been my whole life. I gather data, weigh it up and decide. Now as a manager of scientists I have to go with instinct as well, not every decision lends to data - a digression I'll come back to.
I used to generate my own data by experiment and have my own confidence in it. I'm not generating Covid data, I rely on it 2nd or 3rd hand. My confidence in that data depends where it comes from. I'll be blunt, some posters on here I accept more or less what they say. Some I am extremely sceptical of (no, call it as it is - they're crackpots, dangerous anti-vaxxers, etc.). In the middle, others post things here and I like to know where that has come from before believing it.
Once I have weighed the evidence and credibility of it from its sources, I draw a conclusion. Most of the time I'm with consensus, more or less. Hence, I'm pro-lockdown, while also suggesting that the long term health and M Health issues will be severe. I'm pro-vaccination, but also wary that some of these vaccines are new tech. I'm pro schools opening, but think teachers should have been offered vacc in advance (yet third also understand why the Gov feels it isn't necessary). etc. I include these not to start arguing their merits, only to try to show I am a rational thinker on this, not one of my barmpots.
Last night Edukator posted that (paraphrase) "0.66% of AZ vaccers had a reaction, and 32% of those were 'serious' " (his speechmarks, not mine)
My maths says that means 0.21% had a "serious" reaction, hence 1/500. That's where that number comes from, poopscoop.
SEVERAL THOUGHTS COMBINE AND COLLIDE
- can that be right?
- what does serious mean?
- if it's right, why isn't it clearly visible / being reported elsewhere?
Add to that - Edukator's not on my crackpot list but that still doesn't seem right. If TiRed told me that I'd still scratch my head? This is where my instinct comes in, if it doesn't seem right go back and check. From my experience as a scientist, it's either the data that's wrong or I've screwed up the interpretation (there could be a third way, that you've just discovered something no-one else has but again my instinct says that I'm not that good a scientist!)
So - weigh up the evidence and address the thoughts.
1. Can that be right?
So, after some googling, turns out that he is right - sort of. I don't have the report but FR news sites have reported ANSM, the French medicines agency's bulletin.
Refusals to use AstraZeneca’s Covid-19 vaccine are on the rise in several European countries after reported cases of blood clots, but no proven link has yet been proven at this stage For its part, the National Medicines Safety Agency (ANSM) only revealed 0.66% of adverse reactions
Conducted by the Amiens and Rouen CRVPs, the British-Swedish vaccine pharmacovigilance survey covers the 454545 people who received their first dose from the start of the vaccination campaign until March 4 Of these, 3013 had side effects for a total of 6362 events Two-thirds of the cases were judged to be temporary and mild (2048)
So correlation of the 0.66% and also 'two thirds....were temporary and mild', which i think extrapolates OK to 1/3 were NOT temporary or mild. Edukator said serious, I haven't read the ANSM report to know what phrase they used.
2. What does serious mean
So I asked on here what serious means and got a definition of serious from FDA etc. I don't know if what ANSM are reporting is using the same criteria, I suspect not....but I don't know, hence I asked.
3. Why aren't we seeing it from the 11M doses we've given.
Very good question. An explanation could be that it hasn't been observed here. I asked if it could be batch specific? Another could be that it has been but it has been hushed up - but I'm not into conspiracies. It could be that i just don't understand the data and facts properly yet - my theory currently, which I why I am asking.
I'm not telling anyone that I'm right. In fact I'm asking you to show me why I'm wrong (but with kindness and evidence, not condescension or scorn). I'm not suggesting anyone makes their decisions based on my confusion or wavering. Also I'm still pro-vaccination, I'm just now unsure about AZ.
I want to be able to roll up on Sunday to the booking I leapt on as soon as it opened, and roll up my sleeve with confidence. I can't right now....
Looks like the general public have a big appetite for an inquiry into what the government has been up to this last year with regards the whole topic of this thread.
Unsurprisingly the Conservative voters are the least keen, it's almost like they've been brainwashed.
I can’t right now….
Then cancel now, and let someone else take your slot. Don’t just do a no show.
11 million and counting given AstraZeneca vaccine in the UK. If that source is really reputable then we should have 22,000 “serious” side effects in the UK alone and the media, never mind the MHRA, would be all over it.
That is my logical, non-scientific take on it. We are getting severity levels mixed up somewhere. We've done more vaccination than any other EU country but no sign of such large numbers of problems. Even our Tory biased media couldn't keep that quiet.
As ever, thanks to batfink and TiRed for their contributions.
That number of serious events would have triggered a pause in the uk.
I have no doubt that the pharmacovigilance groups at all the vaccine companies are busy as hell now. If that incidence was occurring anywhere the vaccines would be pulled from use by both the companies and the regulators.
My comment on geographical issues is exactly that. The who has said they haven't received any notifications of the issues, currently it is confined to a small number in western Europe which just seems odd. Admittedly that is where the majority of az vaccinations have occurred so far but it is still odd that none have been reported in the uk
Then cancel now, and let someone else take your slot. Don’t just do a no show.
I wouldn't no show. I will make a decision latest tomorrow, maybe someone on here can answer my concerns or the EMA response will answer it.
I'm not anti-vacc. If I knew I was getting Pfizer, or Moderna, I wouldn't be wavering. Daft as it sounds, because they are both new tech mRNA, the AZ type has more in common with traditional. But they don't have a 1/500 'serious' adverse effects report to be explained right now.
We are getting severity levels mixed up somewhere.
That's what my instinct tells me too.
no sign of such large numbers of problems
Correct. But there could be explanations eg: a batch or plant specific issue?
There’s some media undercurrents that this is France and Germany playing politics with Astrazenica, with added reports of Merkels waining popularity with the German public. Now, my faith in politicians morals is very low, and even then I’d find it hard to believe that they’d really damage their country’s vaccine program and confidence for a political spat.
Part of me is worried that this is individual governments trying to stay ahead of the media. I hope it isn't true but i have a horrible suspicion about it.
sorry graham, not sure what that means? Can you explain?
Re the report; ANSM info is available if you google, but in French and so I don't trust google translate to accurately define what may be technical terms - when we need exactness, not a thesarus version.
https://www.ansm.sante.fr/S-informer/Actualite
You keep saying 11 million. The actual number is, from https://coronavirus.data.gov.uk/
People vaccinated up to and including 15 March 2021
First dose: 24,839,906
And yet still no widespread reports of AEs in categories 3-5 on TiRed's scale. Makes you think...
Essentially are the media forcing the governments to react much more cautiously than they would normally.
Basically the governments are worried that the media will go after them demanding to know why az vaccinations haven't been paused while there are 'all these horrible reactions'.
So as a result the governments have paused to stop the media being seen to be leading policy.
Hope that makes sense
The concern / discussion is around AZ, not vaccines in general. We've done 11M AZ doses. The rest are others.
But I agree. Why is FR reporting 1/500 when we don't see it. We could just assume it's a translation error or a misunderstanding of what is meant by 'not mild or temporary' (extrapolation of the report 2/3 of 0.66% were mild/temporary) or we could try and understand it just a bit better.
I don't do conspiracy (wrt your 'makes you think' dig) but I do like to understand the facts. I don't yet understand these.
I am totally convinced that the issue here with the 1/500 stat and the definition of serious is entirely a consequence of imprecise use of terms (sorry again for my contribution to that!) and translation errors. For context that same French website ( https://fr.ebeneinfo.com/news/news-en-astrazeneca-vaccine-causes-more-side-effects-than-pfizer-and-moderna-according-to-ansm/) has the following:
In its investigation, the ANSM informed of 8487 cases of adverse reactions (0.19%) out of more than 4566000 vaccinations made with the Pfizer / BioNTech vaccine, 22% of which are serious
22% (Pfizer), a third (AZ) of recorded side effects being 'serious' simply cannot mean serious in the sense of the specific definitions used in these trials. Absolutely no way, it's not even a case of 'could there be a cover-up?' - out of all the people who got a headache or slightly sore arm, a fifth or a third ended up hospitalised or with permanent consequences? No way, that wouldn't have made it very far into a Phase 3 trial never mind out into public use. Much, MUCH more likely that this is a case of linguistics / semantics.
That's not to say that there might not be a small blood clotting risk, and like others I'm inclined to think that the agencies who are pausing are not incompetent, so there is indeed a chance. But I predict / guess that they'll all end up resuming use on the basis that there's no evidence of a risk that's anywhere near as high as the benefit. I'm booked in for a jab on Monday, and I'll definitely be saying yes please to it!
anecdote of one here (so take it for what its worth - not much) , but a colleagues wife had the az vaccine a few weeks ago, and 36 hours later suffered a blood clot, went to hospital, was treated, no harm done, came back home. I was on a conf call with him yesterday, when he suddenly had to rush off. I've just spoken to him this morning, she's had another clot, she's ok again, trip to hospital, but they dont know whats causing it. No history of clots prior to this.
I'll repeat that I've put "serious" in inverted commas from the the first time I quoted it because it is unusual and vague. It's not a problem of translation, there isn't a definition in terms of symptoms to accompany its use. Numbers don't tally either between sources but are in the same ball park.
I don’t trust google translate to accurately define what may be technical terms
You can trust the Google translation, it's perfect to me on the ansm document.
It is abundantly clear that the probability of experiencing a serious adverse event (i.e. hospitalisation or worse) is not 1/500. This would have been obvious at the clinical trial phase, let alone now that millions have been dosed.
If you want to avail yourself of some facts about side effects of the AZ vaccine, read the SmPC (section 4.8, table 1):
It tells you that an event with 1/500 occurrence is 'uncommon'. To put that in to context, dizziness and swollen glands fall in to that category.
This is the official label for the Ox/AZ vaccine, as published by the EMA. It's a summary of the known properties for healthcare providers. There are no details of rare and very rare events, but this may be updated with clinical experience. Section 4.8 if interested.
EDIT: I see TallPaul has published the UK version - you'll find they are the same - Brexit or not 😉 . Phase3 studies, even in vaccines, will not find very rare events as I alluded to above.
@edukator - I know, hence I've always credited your use of the "serious" inverted commas too.
So how are ANSM defining 'not mild or temporary' (trying to avoid using 'serious' at all now)
What sort of symptoms are 1/500 people getting, that meet this definition?
@julians anecdote (which is what it is albeit one that mirrors other events and which are significant enough that the EMA is reviewing)
- TBH that doesn't bother me, it's a clearly defined effect and it's numerically at a very very small level and one that I can compare rationally against the benefit of having the AZ vaccine.
It's the 1/500 chance of a 'not mild or temporary' effect of the AZ, and it's not a comparison of 1/500 vs the issue of Covid, it's the comparison of a 1/500 chance vs a smaller (22% of 0.19% = 1/2500 approx) chance from the Pfizer.
As we all argue about this, how many people are dying of Covid?
How many are being hospitalised?
Are we not approaching where we want to be?
There are currently still 10 times more in hospital than there were last summer.
Theotherjonv - that french link said 1/3 Side effects were mild and temporary. They seem to have extrapolated that to say “not mild/temporary = serious” The reality is there are many more levels before we get to “serious”
Once we start looking at events in a large population, numbers which are actually statistically insignificant, look large.
If yesterday it turned out that 10 people died in car crashes in the U.K. , and a further 10,000 people had serious incidents or near misses, that sounds scary as hell! Do you think getting in your car will likely kill you or lead to a crash? Will it stop you driving?
Also - from a link TiRed shared in an earlier post, there were blood clotting issues in the mRNA vaccines too. It also seems to be a big issue with actual COVID sufferers.
Other experts have suggested there is always some events of clotting and platelet issues both in viruses and vaccines.
Do you think getting in your car will likely kill you or lead to a crash? Will it stop you driving?
That's the way almost everybody I know sees Covid. Madame goes to school, I went swimming this morning, we meet up in the numbers allowed to MTB. We take the equivalent precautions to checking the tyres, putting on a seat belt and driving to conditions but no, it hasn't stopped us, we only stop doing stuff when banned.
10 deaths a day is almost exactly what we get on the roads this side of the channel, back when I was first on the French roads it was 40. Covid is only four times that, and less than that if you are under 60, slim and otherwise healthy.
Covid isn't sufficiently threatening for most people to worry about, but they're being very good and wearing their masks and putting on seat belt all the same. Watching German TV yesterday some poor sod had been given an 80e fine for wearing a mask in the car whilst transporting a vulnerable person - a few weeks later a mask in that situation became obligatory but the fine stands.
IGNORE
If the vaccine is effective we should see a decline in the percentage of older age groups being hospitalised due to Covid ?
That does not appear to be happening...
I would expect the older age groups to make up a smaller ratio of hospital admissions due to the vaccine.
What am I missing ?
Source data: https://coronavirus.data.gov.uk/details/healthcare?areaType=nhsregion&areaName=London
The graph is plotting new admissions by day.
Dantsw13
I sort of agree, except actually it was Ed that extrapolated to 'serious' which created an undesired effect for me - I think because serious is a proper definition when looking at Adverse Effect terminology. Hence I'm trying not to use 'serious' any more. Instead I'm interested to understand what a 'NOT mild and/or temporary effect' means. I'm working through the info Tallpaul and Tired referenced (thanks BTW!) to try to sort that out in my confused head.
I'm more (and increasingly) to the "1/500 - can't be right, why aren't we seeing that in the UK" camp but for the time being (my appt is not till Sunday) I don't need to make a decision. I'd like to understand what that 'not mild or temporary' means while there is still time to find out and then decide. If I have to delay my vaccination to do that I will, I won't just not turn up.
Your car analogy misses the point.
We don't have the data to say 10 people died and 10,000 others had near misses. We have a (reliable - albeit needs interpreting and is somewhat unclear) report saying that if you drive your AZcar there's a 1/500 chance something will happen to you that has a non mild / temporary effect from it. What that is - well, dying in a massive fireball could be one outcome, it could be that you end up being fat and unfit because you could have walked. Both could be described as not mild / temporary, but would affect my likelihood of choosing to drive by a different amount.
Ah - you say - but you have to drive to get to work, because of all the positive benefits of going to work. True. The benefits do outweigh a 1/500 chance.
But my counter is not that I'm choosing not to go to work. I could instead go by Pfizertrain which has a 1/2500 chance of a long lasting / non-mild effect instead. Is that irrational?
Hypothesis; a month or so ago the hospitals were close to overrun. Only the most serious got in, there wasn't space for the 'not seriously at risk of dying immediately but would still benefit' tier of patients.
As the number in the first category reduces, and space becomes available, those spaces are taken up by 2nd tier.
The age demographic would I think remain the same. What would be interesting is to see if the 'illness factor' of the hospital population has changed. I don't know if that data is gathered / available. BUT - as a proxy, can we estimate the 'illness factor' of the hospital population by the number that are dying?
What is death rate doing over the same period?
It's just a thought.....
I think my argument would be the 1/500 “serious” is wrong. The stats for car incidents would definitely be available, it was just illustrative numbers.
The numbers in 80+ are definitely coming down.
Let’s also remember the % risk from Covid is with a lockdown and social distancing. Without closing our country the numbers would be 😳😳😳
I think my argument would be the 1/500 “serious” is wrong
Me too, if we define serious by the official Adverse Effect definition of serious. I'm just not sure what 'not mild / temporary' means.
The graph above is of new daily hospital admissions.
Looking at deaths, I have plotted for London...
I am not clear on how accurate the data is in recent days. There might be reporting delays.
% is misleading. As the absolute number of over 85's decreases due to vaccination, the others will increase as a % even if they don't change (or even decrease) in absolute terms.
This is deaths for the UK, using ONS data. I have used female data as there are a higher proportion of old females so the trend should be clearer.
Again, I would have expected to see the percentages dropping in the older age groups due to vaccination.
The reason I first looked at hospitalisations is that the impact of vaccination on deaths would take longer to come through in the data.
theotherjonv
% is misleading. As the absolute number of over 85’s decreases due to vaccination, the others will increase as a % even if they don’t change (or even decrease) in absolute terms.
The others should indeed increase as a percentage and the older age group should decrease. However they are not ?
I am looking at the percentage to try to measure the impact of vaccination on older age groups.
The reason there are less over 85 dying in absolute terms is due to lockdown in my opinion, not vaccine.
@neiloxford the proportion of COVID deaths by age group has changed. the 85+ and 75-84 groups have fallen considerably since December vaccine rollout and the 65-74 have risen to take their place (it's a proportion after all). They will fall too as the middle age proportion rises.
Hospital admissions are confounded by usage patterns. Not all the cases in 85+ will make it to hospital, the gender breakdown will be important too.
Below is relative risk of dying of COVID19 compared to historic risk of death (any cause) = (COVID deaths in age grp/total COVID deaths)/(historic deaths in age group/historic total deaths). Spot the decline in the oldest groups. I've been debating with David Spiegelhalter whether this constitutes evidence of vaccinal effect. Draw your own conclusions 😉 I think males show a solid effect, and males have been disproportionately affected by COVID.
Week 50 vertical line is date of vaccine rollout.
is there also an effect that the next age group bands (75+ and 65+) that were more susceptible to dying because of other health issues etc. will also have been vaccinated early because of that combined risk. So while TiRed says the number is increasing as a proportion, that effect is not as stark as if we only vaccinated over 85's and didn't do the unders.
The further down the age groups we come, the lesser the impact of vaccination (if we're only using not dying as the measure)
If you look at the Cases to Death rates by age you can see the effect of the vaccine:
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The rate for those over 90 has dropped from 30% on the 1st of Feb to 17% as of the 11th March, and continues to reduce.
Other age groups are similar, just offset due to when they were eligible for the vaccine.
Looking at % of deaths is confusing, as it contains too many variables, but here it is for England:
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You can see the 90+ group start to fall, while the "younger" age groups rise, as the effects of the vaccine wont be apparent yet.
3 things:
Hasnt London the lowest uptake on vaccines?
Hasnt London a lower average age than other regions?
% deaths isnt a great way of measuring things.
The effect in London could be less due to the demographics.
@Tired Thank you for those graphs. It is good to see some other analysis on the issue.
I also see a clearer trend with males when comparing Male and Female death data as per these two graphs.
Cases to Death rates
Also known as the CFR is falling, but there may also be confounding effects - case acquisition for example, not to mention lag (you need to plot cases to deaths two weeks later). Dying is an unequivocal endpoint that is internally consistent.
There is an effect, but also remember there is already increasing population immunity which may (big may) have an effect on the faster recorded rate of epidemic decline in this lockdown.
For all those males out there, some cold hard facts on mortality. The proportion who die in the 75-84 age range is about the same as that for 85+ (30% in each group). For females i am afraid that about 28% are in the 75-84 group and 47% in the 85+ group. It's tough being male and there is a reason why the nursing homes are full of old ladies.
Well I’m off to a buy a shotgun, 1000 rounds of buckshot and a house in the middle of nowhere.
What is needed is a graph for each age group plotting vaccinated people vs unvaccinated.
We will have to wait for somebody in government to create the analysis...
Well at least there's someone in Europe who can't get enough AZ vaccine. She really doesn't do irony does she.
not to mention lag (you need to plot cases to deaths two weeks later)
Yep, those figures have a 2 week lag between cases and deaths
There is an effect, but also remember there is already increasing population immunity which may (big may) have an effect on the faster recorded rate of epidemic decline in this lockdown.
Fair point.
Its been decreasing across all age groups over that period, but its more pronounced in the 90+ age group.
Lots of variables to consider, but all of the numbers are going in the right direction at the moment.
It'll be interesting to see the effects of Schools going back over the next week or so.
We will have to wait for somebody in government to create the analysis…
They have:
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https://www.england.nhs.uk/statistics/statistical-work-areas/covid-19-vaccinations/
Ah, I was not clear.
Using the headings from that table and just looking at total.
For example, one analysis is:
Of the 94.8% of the population aged over 80 who HAD the vaccine, what % have died of covid in March
Of the 5.2% of the population aged over 80 who DID NOT HAVE the vaccine, what % have died of covid in March
The expection is that a much lower % of people died of covid in March who had the vaccine.
In order to do this, it might need a team working across departments to pull all the raw data together and merge it. This team might not exist.
I found this BBC article on vaccine side effects interesting
https://www.bbc.co.uk/news/health-56375307