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Why did the U.K. regulator not know of these issues sooner?

144 replies

Roonerspismed · 08/04/2021 08:55

Look, I get that medicines all have rare side effects. I get that.

But why did our regulator seem completely ignorant on the numbers? They said we had what - 5 cases - and it wasn’t the same issue here. For weeks.

Various EU and non EU countries had already picked up on it - weeks in advance.

We still said we didn’t have the numbers. Then it seems like last week they did more diligence and checked and we found lots more.

So - assuming the MHRA hasn’t deliberately hidden matters which I don’t think they have - then how is our data assessed? If we had 65 cases of this rare clotting issue in various U.K. hospitals shortly after a vaccine, why wasn’t this picked up/recorded/asked/reported? How are doctors and hospitals advised on this?

Why isn’t this being asked in the media? Isn’t this an absolutely massive deal? How can we have trust in the system?

There are now lots of women alleging menstrual changes. A lesser issue perhaps but still a big deal for those TTC or not - what is happening to those cases?

How can I gain trust in the system?

OP posts:
Quartz2208 · 12/04/2021 08:49

confuseddotcom90 there is exactly the same document for Pfizer from the UK government (look for Case Series Drug Analysis Print Pfizer it goes straight to a pdf)

Pfizer has:

TOTAL REACTIONS FOR DRUG 124371
TOTAL REPORTS 43491
TOTAL FATAL OUTCOME REPORTS 302

Astrazeneca has

TOTAL REACTIONS FOR DRUG 440871
TOTAL REPORTS 116162
TOTAL FATAL OUTCOME REPORTS 472

These then usually are not linked - the CDC has had similar numbers for Pfizer and Moderna

The bloodclot effects of AZ are there though

This is a risk - we havent done anything like this since the Smallpox vaccine (which I as I said earlier did indeed CAUSE death at a rate of 1 to 2 per million given).

Its a balance exercise - what causes the most harm, what has the potential to do more to you COVID or the vaccine, and then society as a whole.

No one should take the vaccine thinking that there are no risks attached to it because that simply isnt true. And I certainly would not be giving my children it until there is a lot more data because the risks to them (and it becoming rife again once adults are done) are low. But I will get it myself within the next month when it opens up because I have analysed it and in MY belief there are more risks involved longer term in not having it than having it.

For those healthy under the age of 30 I think it is a more difficult choice

MackenCheese · 12/04/2021 09:09

There is no point in complaining on MN. Every single one of you with reactions/haemorrhage/menstrual change needs to go to the MHRA website and yellow card it yourself if you can remember the date of your jab.

Others waiting for their jabs are depending on this info to make informed decisions.

Do it now!

FloraFauna27 · 12/04/2021 09:42

Thank you @btwwhichonespink. Those stats are eye opening!

Quartz2208 · 12/04/2021 10:04

You can only look at the Astrazeneca stats as being useful when comparing them to other vaccines. People should make an informed decision but that means looking at all the data and all of the risks

Ontopofthesunset · 12/04/2021 13:34

I know someone posted this earlier but those deaths are not necessarily (and very probably mostly not at all) because of the AZ vaccine - they are deaths/incidents that occurred within a timeframe that could suggest they are linked. As someone upthread said, if you looked at the incidence of, say, stroke and cardiac event in the general population of the same age, unvaccinated, you would find similar numbers.

SempreSuiGeneris · 12/04/2021 16:35

That is not correct. As you would expect deaths within 28 days are far higher than the yellow card levels given the age profile of the vaccinated (espec Pfizer). The yellow card events are only those where vaccination is a suspected proximate cause.

SempreSuiGeneris · 12/04/2021 16:38

Should clarify that I agree it is not necessarily the case that all yellow carded events are in fact as a result of vaccination.

btwwhichonespink · 12/04/2021 16:45

It is definitely the case that not all yellow carded events are as a result of vaccination. Just like not all deaths within 28 days of a positive test are related to covid. Until both are counted the same way we can't take the figures seriously.

Imagine the vaccination death rate if we counted all deaths within 28 days of a vaccine as vaccine deaths. We wouldn't do that because we don't want to artificially inflate the numbers which would scare people into thinking the vaccine was much, much more deadly than it is. Now, why wouldn't we take that approach with recording the deaths from covid?

CuriousaboutSamphire · 12/04/2021 16:49

@Quartz2208

You can only look at the Astrazeneca stats as being useful when comparing them to other vaccines. People should make an informed decision but that means looking at all the data and all of the risks
And remember those stats are absolute numbers, not percentages.

We have used more AZ than Pfizer, though exact numbers are hard to get (for obvious reasons).

Quartz2208 · 12/04/2021 19:13

I agree - from what I can see in terms of AZ Pfizer the last figures I saw was roughly 30% more AZ than Pfizer which actually means the deaths recorded on both arent actually that far apart.

AZ does appear to have more reactions - and antedoctally that appears to be true much more fever/fatigue/nausea from it

FatCatThinCat · 19/04/2021 09:21

According to the Torygraph, the delay was largely down to brexit and leaving EudraVigilance, which meant that the MHRA didn't have quick access to the EU data on adverse reactions.

www.telegraph.co.uk/global-health/science-and-disease/revealed-britains-regulator-missed-link-astrazeneca-jab-rare/

jasjas1973 · 19/04/2021 09:32

[quote FatCatThinCat]According to the Torygraph, the delay was largely down to brexit and leaving EudraVigilance, which meant that the MHRA didn't have quick access to the EU data on adverse reactions.

www.telegraph.co.uk/global-health/science-and-disease/revealed-britains-regulator-missed-link-astrazeneca-jab-rare/[/quote]
Yet another benefit of Brexit.

Roonerspismed · 19/04/2021 10:07

To be fair to the torygraph, it painted a fair picture here and said it was due to the “algorithms” used for the yellow card system, which weren’t sensitive enough to pick up on it.

The countries that did said they magnified their inspection of data given the vaccine is new. The MHRA didn’t and applied algorithms that seem pretty broad brush.

So if the MHRA couldn’t unpick its own data properly, I don’t know how it would be able to unpick another’s data any better.

What I find remarkable is that we managed to vaccinate 30 million people whilst not finding these cases. Lucky or just incompetent?

OP posts:
SempreSuiGeneris · 19/04/2021 11:43

Sounds like complete fantasy. European press were full of detailed analysis for weeks before the MHRA finally decided they couldn't pretend any longer. Not great for confidence going forward tbh.

Schulte · 19/04/2021 13:25

It does look a lot like they just don’t want anything to slow down the vaccination programme. The 30 year age limit is a joke, it’s either safe or it isn’t. I don’t buy the risk benefit argument. Interesting that Canada is now lowering the age limit to 40, citing stats from the UK.

Willow2017 · 19/04/2021 13:36

There haven't been any other serious side effects attributed to the vaccines and certainly no other causes of death.
Have you looked at the Yellow card website?
There are a hell of a lot of worrying side effects.

exiledfromcornwall · 19/04/2021 13:48

@Totallydefeated

I’m not surprised at all, I’ve been concerned for years that reactions to all vaccines are largely under-reported, as there’s usually a swift move to dismissal by HCPs if you ever mention any sort of reaction or unusual event after a vaccine. The prevailing mindset seems to be that it couldn’t possibly the vaccine, so let’s not even bother to consider it. I suspect the amount of yellow cards that go in is way lower than the possible reactions.

DH had the Astra Zeneca and subsequently developed confusion and amnesia, such that he couldn’t remember what had been said to him a minute earlier - total loss of short term memory. When I mentioned to the Dr treating him at hospital that he’d had the jab a few days earlier it was completely glossed over. I very much doubt a yellow card was put in.

Of course, we don’t know this episode was definitely linked to the vaccine - it may just have been a very unusual coincidence. But the authorities won’t be able to spot any trends if data doesn’t go to them. I hope with these cases the incidents are sufficiently serious that data is properly reported and we get a true picture of the risks, which currently seem statistically very low.

That's interesting because my DH had a seizure 10 hours after his first ever flu jab, and he was rushed to hospital and diagnosed with autoimmune encephalitis. When we mentioned the jab to the neurologist she said it was unlikely to have been that as the attack occurred so soon after, but it just seems too much of a coincidence to me. Did the doctor consider encephalitis as a possibility, because confusion and short term memory loss are classic symptoms (not that I want to scare you or anything).
Moondust001 · 19/04/2021 13:49

@Roonerspismed

But why did regulators elsewhere at least have this data? Arguably we should have had it even sooner given the issue isn’t restricted to the young.

Why did we have actively have to search for the data? Other regulators didn’t.

They did, and they didn't. That's the problem. Even now, nobody - and I mean nobody can say for certain that the clots are caused by the vaccine(s) - AZ is not the only one where this effect has been observed - a combination of the vaccine(s) and something else, or something else entirely and nothing to do with the vaccines. With such incredibly low numbers to work with out of millions, and absolutely no evidence, it's a judgement call as to whether you think they are linked or not. It still is - there is absolutely no evidence to prove a link to the vaccine(s) and so the link is "presumed" to exist in the absence of any better explanation (and there may actually be much better explanations that we simply don't know about yet). If there were hundreds or thousands of deaths / clots per million, the link would be kind of obvious, even if you couldn't say why it was happening. But for small numbers, and not understanding causality, people are guessing. And the threshold for guessing in lower for some people than others. It's that simple.

And @TinaYouFatLard "Why are some posters insistent that Covid-19 is deadly to all ages. We know this isn’t true."
We don't know that at all. The risk for those in lower age groups is less. But there is more than enough evidence that the virus may be deadly in any age group and for people who are perfectly healthy. Saying that there is no risk and that Covid is not deadly to all ages is just as bad as saying that it is deadly to nobody. I am, however, astounded that you claim to have had side-effects serious enough to hospitalise you and you were neither told how to, nor capable of finding out how to, use the yellow card system (which was on the leaflet accompanying your vaccine) yet you could self-diagnose using Google.

Devlesko · 19/04/2021 13:54

@Roonerspismed

I would actually prefer the AZ vaccine even though I’m a covid vaccine hesitant.

At least there has been more diligence on it

Gawd knows what shit is lurking in the others.

God Knows what's lurking in any of them. It's fair enough, they are still being trialled, as more gineau pigs come forward, they'll be more side effects noted.
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