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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:
NearlyAlwaysInsane · 08/04/2021 16:04

This is getting far beyond what the OP's question was, which is why didn't the UK regulator know of these issues sooner. This is not a thread about what is safer or not.

So getting back to the topic.....yes there are questions that need to be answered. When other European regulators were blowing the whistle weeks earlier and in this country all we heard was the droning of 'there is no link' and a general rubbishing of (otherwise globally impressive) European healthcare, there really are questions to be answered. And the UK media has a part in this too, with all the continuous nationalistic vitriol and foreigner-bashing.

noblegiraffe · 08/04/2021 16:09

That was an illustration of why vaccinating large groups of people can be necessary, Sempre in response to Tina’s lack of understanding of why it might be necessary to vaccinate groups of people against covid who aren’t clearly at serious risk.

in an age stratified situation where benefits accrue disproportionately to one group and harms to the other

Well yes, but the risks of covid to the under 50s as a group still appear to be higher than the risk of the vaccine as a group, until, as I understand it, we look at the under 30s with the AZ vaccine. I’ve not looked at the data though.

No comment on children as the vaccines aren’t licensed for them yet. I do know there’s a long covid kids campaign group who are arguing that covid is not harmless for children, so that would need to be taken into account.

bookworm1632 · 08/04/2021 16:09

@bumbleymummy

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.

I don't think this is correct. The risk of dying from covid for a healthy person in their mid 20s is around 1 in 250,000 or less.

No, you've likely got that from one of these calculators that combines the risk of death from covid AND the chance of contracting imminently contracting covid. They're meant for use by medical professionals NOT the general public, it's not meant to be an absolute measure of risk because that changes over time depending on what happens with infection levels.
bumbleymummy · 08/04/2021 16:14

Yes, and our infection levels are currently incredibly low. :)

FWIW the EMA reported a 1 in 100,000 for the blood clot risk.

bookworm1632 · 08/04/2021 16:14

@NearlyAlwaysInsane

This is getting far beyond what the OP's question was, which is why didn't the UK regulator know of these issues sooner. This is not a thread about what is safer or not.

So getting back to the topic.....yes there are questions that need to be answered. When other European regulators were blowing the whistle weeks earlier and in this country all we heard was the droning of 'there is no link' and a general rubbishing of (otherwise globally impressive) European healthcare, there really are questions to be answered. And the UK media has a part in this too, with all the continuous nationalistic vitriol and foreigner-bashing.

The UK scientists pointed out that the link was unproven BUT significantly also pointed out that even if there was a link it was still better to get the jab on a risk/reward basis. That will have taken into account the ages we were currently vaccinating and the need to prevent a 3rd wave.

Other nations who have taken the decision to suspend the Oxford jab have done so because case levels there were low and/or they could just as easily offer an alternative vaccine.

As for the newspapers' take, well that's a different kettle of fish - I hardly ever see a science/medical article that's remotely accurate in ANY newspaper. Real science is boring - it doesn't make for stories that sell.

bookworm1632 · 08/04/2021 16:17

@bumbleymummy

Yes, and our infection levels are currently incredibly low. :)

FWIW the EMA reported a 1 in 100,000 for the blood clot risk.

They won't stay low forever - and the vaccine is a one time only risk.

The EMA reported that risk for all clots, but only a fraction resulted in deaths.

So unless you're deliberately choosing to be statistically dishonest, if you're using THAT figure, then the risk from covid itself is MUCH MUCH higher. A significant number of 30 yr olds end up hospitalised and/or with long lasting (possibly permanent) serious conditions from covid, but don't die.

MarshaBradyo · 08/04/2021 16:19

Bookworm sums it up

noblegiraffe · 08/04/2021 16:27

When other European regulators were blowing the whistle weeks earlier and in this country all we heard was the droning of 'there is no link' and a general rubbishing of (otherwise globally impressive) European healthcare, there really are questions to be answered

But it was the EMA (the European regulator) who said there was no link, not the U.K. And that was about blood clots in general, not the really rare type.

www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots - 18th March

www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-update-ongoing-evaluation-blood-clot-cases - 25th March

bumbleymummy · 08/04/2021 16:34

@bookworm1632 If you're going to start factoring in other risks from covid then you also need to include the risk of other vaccine side effects.

Tbf, the risk of dying from covid or from a blood clot caused by the vaccine is very low. People should be allowed to make their own decisions when it comes to which risk they are comfortable taking. Some people have already recovered from covid with no long term issues and now have immunity so their cost-benefit ratio irt having the vaccine is going to be different to someone with no previous infection and underlying health issues that make them more likely to have complications from covid.

noblegiraffe · 08/04/2021 16:35

Do we know that people who have recovered from covid have immunity? I think not?

bumbleymummy · 08/04/2021 16:39

Yes, we know that the majority do.

www.nih.gov/news-events/nih-research-matters/lasting-immunity-found-after-recovery-covid-19

MarshaBradyo · 08/04/2021 16:41

[quote bumbleymummy]@bookworm1632 If you're going to start factoring in other risks from covid then you also need to include the risk of other vaccine side effects.

Tbf, the risk of dying from covid or from a blood clot caused by the vaccine is very low. People should be allowed to make their own decisions when it comes to which risk they are comfortable taking. Some people have already recovered from covid with no long term issues and now have immunity so their cost-benefit ratio irt having the vaccine is going to be different to someone with no previous infection and underlying health issues that make them more likely to have complications from covid.[/quote]
If you’ve had a positive Covid test I understand what you’re saying

But wouldn’t it depend when that occurred as at some point that immunity will subside?

Kimye4eva · 08/04/2021 16:45

@reformedcharacters

I think the screamingly obvious missed point in all of this is that this situation absolutely demonstrates why there is a need for long term data before vaccinating entire populations although I’m pretty sure that some will be along to tell me that’s how we will get the data Hmm
You made you own point there @reformedcharacters! Trials only give so much data, particular with side effects as rare as this one.

We could have held off, but then we’d be in lockdown for the rest of the year and people would be continuing to die in much greater numbers (as opposed to the 19 or so people who have died of these rare blood clots).

I’m happy to take my chances with AZ. If people don’t want to no one is forcing them.

MarshaBradyo · 08/04/2021 16:49

Also if immunity lasts for so long post Covid do people prefer to get it again each year or wouldn’t having a yearly vaccine just be easier?

noblegiraffe · 08/04/2021 16:51

[quote bumbleymummy]Yes, we know that the majority do.

www.nih.gov/news-events/nih-research-matters/lasting-immunity-found-after-recovery-covid-19[/quote]
A study of 200 people suggests that about half had T cells that kill the virus 6 months after infection.

Is this enough to recommend that people who have had covid shouldn't have the vaccine? And how long previously? Do you want them to hit a cut-off date and then be invited for vaccination or would that hold up the vaccination program by making it really fiddly?

bumbleymummy · 08/04/2021 17:28

@noblegiraffe That was one study of many. You can look for them yourself. There have been several this year showing that immunity lasts for 6-8+ months in the majority of people. It does wane faster in older people, but that's not the group we're talking about here.

I'm not saying that people with immunity after infection shouldn't have the vaccine, I'm pointing out that their cost-benefit ratio when weighing up whether or not to have the vaccine now is going to be different to someone who is in a higher risk group. People tend to make decisions based on their individual risk.

bumbleymummy · 08/04/2021 17:32

@MarshaBradyo

Also if immunity lasts for so long post Covid do people prefer to get it again each year or wouldn’t having a yearly vaccine just be easier?
We don't know how long immunity after infection lasts yet - beyond the studies that show up to 8 months. It is expected to last longer, not just drop off a cliff after 8 months, and it could end up lasting several years. Perhaps if it does become endemic, its natural circulation will provide 'boosters' much in the same way as chickenpox. Time will tell.
btwwhichonespink · 08/04/2021 17:33

I don't get flu every year. In fact I don't think I have ever had it. So yes, I'll take my chances. I certainly won't be getting an annual vaccine!

noblegiraffe · 08/04/2021 17:34

But the problem with individuals weighing up their cost/benefit ratio is that, as I said before, we also need a group effort with vaccination to tackle this pandemic.

If enough individuals decide against vaccination, then other measures will need to be implemented to control covid that may well affect them. So they need to take that into account as well.

MarshaBradyo · 08/04/2021 17:38

@btwwhichonespink

I don't get flu every year. In fact I don't think I have ever had it. So yes, I'll take my chances. I certainly won't be getting an annual vaccine!
No I haven’t either as it’s not necessary for me.

It doesn’t mean it’s the right decision for this pandemic.

btwwhichonespink · 08/04/2021 17:39

Maybe if they had spent time on bringing a conventional vaccine to market instead of trying to mass-test a brand new gene-based vaccine in an emergency then none of this would be happening.

It's all well and good saying everyone needs stand with an apple on their head in front of the archer for the greater good but on a personal level - just no. The vulnerable - it makes sense yes.

bumbleymummy · 08/04/2021 17:42

And I already replied to that. We need a level of immunity, which we're already very close to reaching - the UCL model suggests early next week. That immunity comes from a combination of immunity after vaccination and immunity after infection. Many of the younger, low risk people who decide not to be vaccinated will either already be immune or will have a mild case and develop immunity in the near future. They will all be contributing to herd immunity.

Remember, the restrictions were there to stop the NHS being overwhelmed. The low risk groups are unlikely to need hospital treatment. So even if some of them decide against vaccination, its unlikely that we'll need restrictions to prevent hospitalisations that could overwhelm the NHS.

bumbleymummy · 08/04/2021 17:42

@noblegiraffe

Aloethere · 08/04/2021 17:48

@noblegiraffe

But the problem with individuals weighing up their cost/benefit ratio is that, as I said before, we also need a group effort with vaccination to tackle this pandemic.

If enough individuals decide against vaccination, then other measures will need to be implemented to control covid that may well affect them. So they need to take that into account as well.

There are other vaccines though. It isn't AZ or nothing. If people want to wait for a vaccine they feel more comfortable with then I don't think they should be guilted into it.

People have already made ginormous sacrifices for those more vulnerable than them. There has to be a measured way of dealing with it than that of a lot of people on mumsnet which is to mock and ridicule people with concerns(that is after they mocked and ridiculed various countries for spotting a potential link in the first place). I think it is all starting to feel like a step too far now, people stayed at home, lost jobs and businesses, sacrificed a lot to keep people safe now you want people to inject something which may have a mortality rate no matter how small to keep people safe too.

quiteathome · 08/04/2021 17:50

Pretty sure I had Covid twice, so we can not put all of those eggs in one basket.

Entirely possible they did not find a link because they were not looking.

From 17 million vaccinations you would probably expect some adverse reactions. Our younger people possibly got Pfizer (Just a theory as this seems to be more likely for HCP in a hospital setting) and most of the others have been older and given the Oxford vaccine.