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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:
btwwhichonespink · 08/04/2021 09:10

It's not just that they didn't pick up on it. They supposedly looked into it and dismissed it.

Then the media set about a campaign to blame the EU's bitterness at our success as the root cause of the concerns.

Some serious questions need to be answered about this.

herecomesthsun · 08/04/2021 09:21

Ah.

So, JVT implied in passing that there was an issue about whether clots were due to covid or to the vaccine.

There were scenarios where people got vaccinated but were already carrying covid or became infected within a short period of time, before they could develop immunity.

Bear in mind that many young women will have been HCPs and so exposed to infection in their work to some extent.

I am wondering whether, if these people developed CST, it was initially attributed to covid rather than the vaccine.

It sounds as though a lot of unpicking of data has gone on.

In addition, it may be that people weren't thinking of the vaccine as causing these clots, so didn't report the clots first off. When there was more discussion in the news, the reports linking the situation would then have been made.

These are very rare side effects, so maybe 2 cases per million as opposed to 1 per million normally. The risks are much higher for people in their 40s of getting ill with clots from covid.

As regards menstrual irregularities, I had a very light period and then a bit of a gap after Pfizer. In my case it could however be the menopause, which is fine. There are often multiple explanations for these things.

People under 30 will have the options of other vaccines in any case.

There's an article on fertility and vaccines here : www.bmj.com/content/372/bmj.n509

There are risks to getting covid when actually pregnant, so having had a jab may be avery good thing.

Thepilotlightsgoneout · 08/04/2021 09:23

it may be that people weren't thinking of the vaccine as causing these clots, so didn't report the clots first off. When there was more discussion in the news, the reports linking the situation would then have been made.

This - they’ve gone back over the data, looking for a blood clot-vaccine link.

bongsuhan · 08/04/2021 09:28

One theory I've read is that in the other countries, larger groups of the relevant persons (i.e. younger and possibly female) were vaccinated with AZ earlier while in UK older people were vaccinated first, which would explain why the phenomenon would show up in some countries more than in others.

Roonerspismed · 08/04/2021 09:33

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.

OP posts:
Notoriouslynotnotious · 08/04/2021 09:34

Because they were putting their fingers in their ears. We had the Norwegian CMO on one of our prime time political shows in Ireland explaining their reasons for pausing their use of AZ while this was investigated. They had experienced a not insignificant number of women arriving to a single hospital with the same symptoms of an extremely rare blood clot all after being vaccinated. Meanwhile people were castigating European countries for being cautious with AZ.

I personally would have AZ in the morning if it was offered to me as the risk is still low compared to Covid and particularly long covid for my age group but I still think it was prudent to investigate what was happening re the blood clots.

Roonerspismed · 08/04/2021 09:38

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.

OP posts:
Willyoujustbequiet · 08/04/2021 09:54

My gp flagged my reaction a month ago. I do worry that a lot more will come out

bumbleymummy · 08/04/2021 09:59

We rely on the yellow card system for reporting. Under reporting is a massive issue. It just may not have been flagged because not enough incidents were being reported.

Totallydefeated · 08/04/2021 10:04

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.

newstart1234 · 08/04/2021 10:10

I can only give my perspective from Denmark here but - Denmark has still not resumed az use but it is still part of the vaccine schedule so the assumption is that it will for part of the vaccine program. It was picked up early by the regulator here and stopped immediately I think on the 10th March. It could well have been because the Covid rate was and is low, so the potential for the 2 patients who habe died from the blood clots were not so easily linked to having Covid itself. The Danes also like to work closely with the Norwegians therefore the incidences were probably more closely followed than maybe elsewhere. The risk benefit analysis changes when there is a lot of Covid so in the U.K. in March the jab was clearly preferable but covid mortality here in Denmark was much much lower at that point which makes these patients’ reactions more statistically clear. Maybe. I don’t know.

Boringlynormal · 08/04/2021 11:47

@Willyoujustbequiet What was your reaction?

I think the UK has completely failed us on this one. I had a jab that I should not have been given, in my opinion. I'm really angry about it as I don't feel confident taking the second one so will end up part-vaccinated as a result of coming forward when called and trusting the buggers.

bookworm1632 · 08/04/2021 11:57

Sigh - the UK regulator like every other countrys' regulator, the WHO and the EMA have all been scrutinising the deployment of every vaccine.
It's ALWAYS a risk/reward scenario, with ANY medical intervention.

Even now, the rewards massively outweigh the risks EVEN in the younger groups, because the risks are so incredibly small.

The nations who have stopped using the AZ vaccine have done so because they've got just as much access to alternative vaccines - if the AZ vaccine was the only one, NOBODY would have stopped issuing it. However, the UK having a large supply, would be foolish to slow down the program to wait for other vaccines as that would simply result in far more deaths in the long run.

btwwhichonespink · 08/04/2021 12:13

Even now, the rewards massively outweigh the risks EVEN in the younger groups, because the risks are so incredibly small.

I'm not sure that's true at all. Clots are not the only factor. There are other side effects too.

Alondra · 08/04/2021 12:26

@btwwhichonespink

It's not just that they didn't pick up on it. They supposedly looked into it and dismissed it.

Then the media set about a campaign to blame the EU's bitterness at our success as the root cause of the concerns.

Some serious questions need to be answered about this.

As it is, look at the media in the UK right now. DM doesn't report Australian recommendations unless you click on the Australian edition. Same with The Guardian - it says in the first page that people in their 20s to keep getting the jab, click on the Australian edition and is a different story. Even The Independent has on top of the page "why I would say yes to the AZ vaccine despite blood clots."

I've been seriously questioning the the UK media campaign against the EU but this is becoming jaw dropping.

TinaYouFatLard · 08/04/2021 12:32

How do we report potential issues?

Within two weeks of my AZ jab I was hospitalised with suspected internal bleeding. My haemoglobin level was 55. Endoscopy and colonoscopy revealed nothing. Having done a very rudimentary internet search it seems that internal bleeding may also be an issue and I feel strongly that I need to report this.

Willyoujustbequiet · 08/04/2021 12:38

@Boringlynormal

I had unexplained excessive bleeding - nosebleeds and from my gums. Family history of sudden fatal thrombocytopenia too. Awful flu like symptoms too and in bed for about 4 days .

In my 40s, on no medication and no underlying health conditions. Have my platelets checked once a year and ordinarily fine. I only got it as I'm a carer.

I wish I'd never been given the Oxford one.

Willyoujustbequiet · 08/04/2021 12:40

@TinaYouFatLard

It sounds very similar to my experience. My gp reported it for bleeding

bumbleymummy · 08/04/2021 12:46

@TinaYouFatLard

You can report it yourself here:

yellowcard.mhra.gov.uk/

dementedpixie · 08/04/2021 12:49

@TinaYouFatLard

How do we report potential issues?

Within two weeks of my AZ jab I was hospitalised with suspected internal bleeding. My haemoglobin level was 55. Endoscopy and colonoscopy revealed nothing. Having done a very rudimentary internet search it seems that internal bleeding may also be an issue and I feel strongly that I need to report this.

You report using the yellow card scheme. You can do that yourself, probably online
Witchlight · 08/04/2021 12:53

The vaccine is not a magic wand making everything lovely and rosey. It is a balanced risk. Because it has had to be rolled out in months rather than years, there are bound to be unknown risks of all the vaccines.

  1. The EU have a more risk averse population when it comes to vaccines and they decided to not vaccinate their older populations. This meant the AZ vaccines were give to a younger age group sooner. This proved to be the wrong move and more EU citizens were hurt.
  2. The U.K. gave the vaccine to the older population first, who were less likely to be harmed. Because of this, they were not seeing the same picture as the EU.
  3. even with the risk specified, you are still better off getting the vaccine.
    You are more likely to live if you do.
  4. The decision to vaccinate early, rather than wait for years of testing, has saved tens of thousands of lives already and continues to save more each day than have been killed by it.
  5. we do not have a choice to drop the AZ vaccine in favour of the other types (which may yet have other unknown issues) as there is not enough. It is perfectly reasonable that we aim the other vaccines to the people at greatest risk of the side effects.

Unless you know you are at high risk of clotting, it is by far safer to have the AZ jab than not.
The other jabs should go to the youngest, not those who now don’t want AZ.
The government made the right call to vaccinate the population and if I were making the call, with hindsight, I would do so again.

TinaYouFatLard · 08/04/2021 14:04

Why are some posters insistent that Covid-19 is deadly to all ages. We know this isn’t true.

I had Covid back in November - I barely noticed it apart from flu like aches and sleepiness. I did however, notice a blood Hb level of 55. I thought I was going to die. I needed three blood transfusions and am still under hospital care.

I am 42 and healthy - I didn’t need the bloody vaccine in the first place. If this disgusting government start coercing us into injecting our children with these unknown substances I will not cooperate again.

LaBrujaPiruja · 08/04/2021 14:16

@Witchlight

Re #1
The EU vaccinated the elderly population with Pfizer and ModeRNA. I don’t know where you got that information but it is not correct.

bookworm1632 · 08/04/2021 14:23

@btwwhichonespink

Even now, the rewards massively outweigh the risks EVEN in the younger groups, because the risks are so incredibly small.

I'm not sure that's true at all. Clots are not the only factor. There are other side effects too.

And your qualification is...????

There haven't been any other serious side effects attributed to the vaccines and certainly no other causes of death.

From a vaccine - 1 in a million chance of death, and about 5x that of getting clots.

Set against, for a healthy person mid 20's, the risk of dying from covid is about 10 times higher at 1 in 100,000. PLUS a 13% chance of long-covid - about 1/3 of those are serious long-term issues.

Witchlight · 08/04/2021 14:26

[quote LaBrujaPiruja]@Witchlight

Re #1
The EU vaccinated the elderly population with Pfizer and ModeRNA. I don’t know where you got that information but it is not correct.[/quote]
I probably worded it wrongly.

The EU older population was not given AZ, but given Pfizer. They gave the younger people AZ.

The UK older population were given vaccine (predominantly AZ) oldest first, so other than CEV and healthcare, far fewer of the most at risk population was given AZ.

So as a portion of the population vaccinated with AZ, the EU had very different, higher numbers. The UK had far fewer.

I find the difference in the sex of those who became ill quite intriguing. Are healthcare professionals more gender biased in EU than UK. If more women work in healthcare in EU than Uk, it would explain it.