What exactly is happening with AstraZeneca?

drunkmonkey · 14-03-2021 11:30PM

This is from November but may be relevant...

"A new study shows that the novel coronavirus can trigger the production of clot-causing autoantibodies. This finding may explain the high rate of blood clots among COVID-19 patients."
https://www.medicalnewstoday.com/articles/autoimmune-antibodies-may-cause-blood-clots-in-covid-19

Would it stand to reason that some vaccines by their very nature could trigger those clot-causing antibodies?

I'm no doctor so don't take this as medical advice, aspirin has been shown to reduce the chances of getting Covid by 29%
Aspirin also has another feature, it thins your blood to reduce the chances of clotting. May it help if you're getting the AZ vaccine to take some asprin beforehand.

Wolf359f · 14-03-2021 11:33PM

radiotrickster wrote: »

This is what I don't understand. It seems like a lot of people are unhappy with how long the vaccine rollout is taking because the UK are 'doing better,' even though we all know they're delaying the second Pfizer dose. If Ireland decided to go against clinical advice like that, people would give out about that instead.

Any time I've checked, we've been ahead of the EU average in terms of the percentage of the population vaccinated. There are 16 countries on the Our World In Data table with a similar-ish population to us (3m - 6.5m). Out of all those, we rank third in terms of percentage done, only behind Denmark and Norway (and Denmark also delayed second doses of Pfizer).

They're the types of countries we should be comparing ourselves to, not the UK who started vaccinating weeks before us and aren't reliant on the EU for supply.

They are heavily reliant on EU plants as EU plants make up 60% of their vaccines. But if you mean the EU procurement deal, then yes, you're right.

radiotrickster · 14-03-2021 11:35PM

Wolf359f wrote: »

They are heavily reliant on EU plants as EU plants make up 60% of their vaccines. But if you mean the EU procurement deal, then yes, you're right.

That's what I meant exactly, thanks for clarifying it!

Wolf359f · 14-03-2021 11:37PM

drunkmonkey wrote: »

This is from November but may be relevant...

"A new study shows that the novel coronavirus can trigger the production of clot-causing autoantibodies. This finding may explain the high rate of blood clots among COVID-19 patients."
https://www.medicalnewstoday.com/articles/autoimmune-antibodies-may-cause-blood-clots-in-covid-19

Would it stand to reason that some vaccines by their very nature could trigger those clot-causing antibodies?

I'm no doctor so don't take this as medical advice, aspirin has been shown to reduce the chances of getting Covid by 29%
Aspirin also has another feature, it thins your blood to reduce the chances of clotting. May it help if you're getting the AZ vaccine to take some asprin beforehand.

I think ACE on the vaccine thread made the point, as the issues in Norway were in HCW's, they could have had Covid19 before and the AZ dose could have triggered an over reaction. It could be 1 piece in the puzzle. I;m sure every option is being investigated.

AngeloArgue · 15-03-2021 12:21AM

Danzy wrote: »

No, the damage won't be rectified.
It will be reversed quickly and with a full vote of confidence from the EMA, it will however damage the uptake of all vaccines and Continental European societies and politics is very vaccine skeptical as it is and as we have seen.

What exactly is the purpose of the European Medicines Agency now?

National authorities have usurped their expertise and guidance.

first with the age restrictions on AZ vaccines and now with adverse events of those vaccinated.

This agency recently had to relocate from Britain to the Netherlands due to Brexit.

It seems that national organisations are deciding to ignore their guidance.

Given this new reality why are we waiting on the EMA for approval of such vaccines as J&J, novavax and sputnik V?

Why follow their guidance on approval when ignoring their guidance on use?

Danno · 15-03-2021 12:32AM

MrMusician18 wrote: »

Hard to take your seriously Danno, when you're previously suggested way or of this was for people to not present for testing.

Thanks for your contribution. I am of the firm belief that healthy people should not be wasting the resources of the state by presenting for Covid testing and instead protect others by not mixing until any symptoms have passed. It just adds noise to the actual impact of the virus and heightens scaremongering. There are enough headless chickens running amok without the need for more.

Wolf359f · 15-03-2021 12:34AM

AngeloArgue wrote: »

What exactly is the purpose of the European Medicines Agency now?

National authorities have usurped their expertise and guidance.

first with the age restrictions on AZ vaccines and now with adverse events of those vaccinated.

This agency recently had to relocate from Britain to the Netherlands due to Brexit.

It seems that national organisations are deciding to ignore their guidance.

Given this new reality why are we waiting on the EMA for approval of such vaccines as J&J, novavax and sputnik V?

Why follow their guidance on approval when ignoring their guidance on use?

Just because the EMA approves a vaccine, it does not force a country to administer it. If we went down that road, Jesus it would be a slippery slope.

The EMA approved various vaccines for general use, it's up to each countries to decide to take onboard that or make changes. mRNA for elderly people being one example. The EMA never stated the most efficient vaccine should be given to the elderly, they never stated to vaccinate the elderly and HCW's first either.

The EMA has approved J&J. They are still reviewing Sputnik.
The point of the EMA is to approve vaccines and medicine. We can't just have, say a president suggest we inject beach into us to kill covid.

The DayDream · 15-03-2021 12:35AM

Roger_007 wrote: »

Possibly never.
Once a safety concern has been officially raised about the vaccine, public confidence has been lost and people will simply refuse to take it and wait until some other vaccine is available.

Well I had my first dose last week and while I had a bad reaction to it (sick 2 days straight) I absolutely want to have the 2nd dose and I would bet my left arm (which is still sore) Astrazenica will be back in action here.

Yes some will refuse to take it, but the show will be back on the road. These pharma companies make products that kill a few people each year all the time, they rarely stop the product being sold and used.

I'm imagining that even if there was some extended stoppage that there would be arrangements made for those that got the first dose to still get their 2nd as planned after 12 weeks. That's plenty of time to sort it out, it would be common sense, as long as the patient still wants it.

Wolf359f · 15-03-2021 12:38AM

Danno wrote: »

Thanks for your contribution. I am of the firm belief that healthy people should not be wasting the resources of the state by presenting for Covid testing and instead protect others by not mixing until any symptoms have passed. It just adds noise to the actual impact of the virus and heightens scaremongering. There are enough headless chickens running amok without the need for more.

Trump would be proud of you.
If we all followed your lead, we would have had 80% less covid cases, yet the same hospital and death figures. It's people not going to testing that adds the noise.
The big bump from lack of testing over the weekends creates noise.
People having symptoms and not being tested until they reach the hospital created noise.

Not getting tested is the most irresponsible thing you can do.

AngeloArgue · 15-03-2021 12:39AM

Wolf359f wrote: »

Just because the EMA approves a vaccine, it does not force a country to administer it. If we went down that road, Jesus it would be a slippery slope.

The EMA approved various vaccines for general use, it's up to each countries to decide to take onboard that or make changes. mRNA for elderly people being one example. The EMA never stated the most efficient vaccine should be given to the elderly, they never stated to vaccinate the elderly and HCW's first either.

The EMA has approved J&J. They are still reviewing Sputnik.
The point of the EMA is to approve vaccines and medicine. We can't just have, say a president suggest we inject beach into us to kill covid.

The EMA is seems to be effectively finished as an authority on vaccines in Europe.

Why are we awaiting on their approval and not authorising nationally?

Wolf359f · 15-03-2021 12:40AM

The DayDream wrote: »

Well I had my first dose last week and while I had a bad reaction to it (sick 2 days straight) I absolutely want to have the 2nd dose and I would bet my left arm (which is still sore) Astrazenica will be back in action here.

Yes some will refuse to take it, but the show will be back on the road. These pharma companies make products that kill a few people each year all the time, they rarely stop the product being sold and used.

I'm imagining that even if there was some extended stoppage that there would be arrangements made for those that got the first dose to still get their 2nd as planned after 12 weeks. That's plenty of time to sort it out, it would be common sense, as long as the patient still wants it.

By all accounts your second dose reactions shouldn't be as bad as the first dose. So the worst is over in a way. Just need to wait a few weeks and you can be confident you're pretty well protected.

Strazdas · 15-03-2021 12:42AM

AngeloArgue wrote: »

What exactly is the purpose of the European Medicines Agency now?

National authorities have usurped their expertise and guidance.

first with the age restrictions on AZ vaccines and now with adverse events of those vaccinated.

This agency recently had to relocate from Britain to the Netherlands due to Brexit.

It seems that national organisations are deciding to ignore their guidance.

Given this new reality why are we waiting on the EMA for approval of such vaccines as J&J, novavax and sputnik V?

Why follow their guidance on approval when ignoring their guidance on use?

No country in the EU (bar Hungary I think) is taking a vaccine that the EMA hasn't authorised.

You're mixing this up with their regulators unilaterally suspending use of a vaccine which has already been authorised by the EMA - which they are perfectly free to do.

Wolf359f · 15-03-2021 12:44AM

AngeloArgue wrote: »

The EMA is seems to be effectively finished as an authority on vaccines in Europe.

Why are we awaiting on their approval and not authorising nationally?

Why is the EMA finished in Europe as an authority on vaccines?

You need to direct that question to the Minister of Health.
Maybe he would like an agency far superior than what we have to crunch the data?

AngeloArgue · 15-03-2021 12:49AM

Strazdas wrote: »

No country in the EU (bar Hungary I think) is taking a vaccine that the EMA hasn't authorised.

You're mixing this up with their regulators unilaterally suspending use of a vaccine which has already been authorised by the EMA - which they are perfectly free to do.

The EMA authorised AZ for all adult ages. Many European countries that come under their remit unilaterally acted against this guidance. Many countries have subsequently reversed their age restrictions.

Likewise the EMA guidance is to continue using AZ while adverse events are investigated. Again many European countries choose to not follow this guidance.

Why are we rigidly following guidance on approvals while diverging on guidance for use?

AngeloArgue · 15-03-2021 12:55AM

Strazdas wrote: »

No country in the EU (bar Hungary I think) is taking a vaccine that the EMA hasn't authorised.

You're mixing this up with their regulators unilaterally suspending use of a vaccine which has already been authorised by the EMA - which they are perfectly free to do.

Are national authorities such as Ireland then free to approve vaccines that the EMA has not yet approved? just like Hungary.

The point I'm getting at is that the EMA has been denigrated by the age restriction guidance and now the suspension of programs for investigations of potential adverse reactions both of which just happen to involve the AstraZeneca vaccine

Wolf359f · 15-03-2021 01:02AM

AngeloArgue wrote: »

Are national authorities such as Ireland then free to approve vaccines that the EMA has not yet approved? just like Hungary.

Yes they are, they can approve tic-tacs as a vaccine to covid if they wish.
(I'm not comparing Sputnik to tic-tacs. I think it looks like a viable vaccine.)

MrMusician18 · 15-03-2021 02:22AM

Danno wrote: »

Thanks for your contribution. I am of the firm belief that healthy people should not be wasting the resources of the state by presenting for Covid testing and instead protect others by not mixing until any symptoms have passed. It just adds noise to the actual impact of the virus and heightens scaremongering. There are enough headless chickens running amok without the need for more.

Bull****. You don't want people to get tested because you believe it keeps the positivity number up and creates an "excuse" for the government to continue restrictions.

It's an awfully shame that irresponsible thread you opened was deleted.

Diarmuid · 15-03-2021 06:13AM

Kermit.de.frog wrote: »

Public confidence is really important. I expect this to be reversed really quickly and it may actually boost confidence when it is.

The doubt has been seeded in peoples mind, this is not going to boost public confidence just like the previous poor communication and doubts over the efficacy has had a negative impact on the roll out.

If this decision is reversed quickly, then it shouldn't have been taken in the first place. 17m doses have been administered already. The regulators have all the data in the world needed to review this risk. So do that and then make a decision. Throwing this level of doubt into the public and then reversing it a few days later is incredibly poor judgement and decision making and will have a lasting negative effect. It reeks of "covering my ass" attitude.

Dempo1 · 15-03-2021 06:34AM

Diarmuid wrote: »

The doubt has been seeded in peoples mind, this is not going to boost public confidence just like the previous poor communication and doubts over the efficacy has had a negative impact on the roll out.

If this decision is reversed quickly, then it shouldn't have been taken in the first place. 17m doses have been administered already. The regulators have all the data in the world needed to review this risk. So do that and then make a decision. Throwing this level of doubt into the public and then reversing it a few days later is incredibly poor judgement and decision making and will have a lasting negative effect. It reeks of "covering my ass" attitude.

Have to agree, I believe irreversible damage has been done already, I get the decision but there's been so much doubt swirling around AZ for the past few months, wether it be supply, contracts, efficacy and now this. Personally I'd now have doubts and I'm most definitely pro vacinne. Government strategy has become very dependent on the AZ vacinne and rightly or wrongly (I make no judgement), I'd be shocked if people are now going to question or refuse this vacinne and if enough do, the entire Roll out plan compromised. Yesterday's PR scramble to limit the damage has just made things worse.

Danzy · 15-03-2021 08:36AM

eoinbn wrote: »

If we had to drop AZ it might not make a huge difference ......... ....

Everyone, except for the over 70s, would be pushed out a few weeks. It would mean that more people would have to wait until July. We are talking a delay of weeks, not months.
...

s.

The biggest issue you are not mentioning is that it closes the Idea of a normalish summer for most of Europe.

Many countries in Europe have about 10% of GDP and/or employment in that sector.

That's just for starters. 2 seasons on the floor.

Talk has turned in Europe to vaccines not yet approved as being the ones that will be rapidly rolled out to catch up.

Much of Europe will be at risk of another wave in the Autumn if things don't rapidly change.

is_that_so · 15-03-2021 08:38AM

Diarmuid wrote: »

The doubt has been seeded in peoples mind, this is not going to boost public confidence just like the previous poor communication and doubts over the efficacy has had a negative impact on the roll out.

If this decision is reversed quickly, then it shouldn't have been taken in the first place. 17m doses have been administered already. The regulators have all the data in the world needed to review this risk. So do that and then make a decision. Throwing this level of doubt into the public and then reversing it a few days later is incredibly poor judgement and decision making and will have a lasting negative effect. It reeks of "covering my ass" attitude.

Covering your ass is what you do with a brand new vaccine that is either emergency or conditional use and this is not a new development with vaccines. They've acknowledged they may get blamed for overreaction but it really is a very good idea to investigate a very rare occurrence. At most it may add extra advice to vaccination protocols but it is a fully transparent and cautious approach.

Danzy · 15-03-2021 08:39AM

Diarmuid wrote: »

The doubt has been seeded in peoples mind, this is not going to boost public confidence just like the previous poor communication and doubts over the efficacy has had a negative impact on the roll out.

If this decision is reversed quickly, then it shouldn't have been taken in the first place. 17m doses have been administered already. The regulators have all the data in the world needed to review this risk. So do that and then make a decision. Throwing this level of doubt into the public and then reversing it a few days later is incredibly poor judgement and decision making and will have a lasting negative effect. It reeks of "covering my ass" attitude.

The infuriating thing is that the AZ vaccine is one of the most observed vaccines in existence.

Same with the Pfizer one.

Danzy · 15-03-2021 08:48AM

is_that_so wrote: »

Covering your ass is what you do with a brand new vaccine that is either emergency or conditional use and this is not a new development with vaccines. They've acknowledged they may get blamed for overreaction but it really is a very good idea to investigate a very rare occurrence. At most it may add extra advice to vaccination protocols but it is a fully transparent and cautious approach.

Or do what others do, look at the data, which there is an incredible amount of, for AZ.

Don't dress up panic as due diligence.

11 million vaccinated and monitored, as if rare occurences aren't examined as de rigueur.

ebbsy · 15-03-2021 08:51AM

Danzy wrote: »

Or do what others do, look at the data, which there is an incredible amount of, for AZ.

Don't dress up panic as due diligence.

11 million vaccinated and monitored, as if rare occurences aren't examined as de rigueur.

Correct.

fly_agaric · 15-03-2021 08:53AM

Danzy wrote: »

The biggest issue you are not mentioning is that it closes the Idea of a normalish summer for most of Europe.

AZ can never supply the volumes of vaccine needed to deliver this "normalish summer" in the EU, even without this new mess.

Doctors can't inject doses of vaccine that do not exist, no matter how willing the patients might be to take it.

AngeloArgue wrote: »

Why are we rigidly following guidance on approvals while diverging on guidance for use?

I imagine it is a matter of risk and responsibility.

Going against first + plowing your own furrow is very risky (for authorities) and if something goes wrong they will be directly and solely to blame for that.
There's much less risk (for the same authorities) in being even more cautious.
Again, if they do nothing and there is actually some problem there (e.g. a bad batch of vaccine or whatever) blame will fall directly on those national authorities for taking no action rather than on the EMA.

But of course the public trust in the vaccine may be damaged afterwards, which is a different sort of risk.

Also the EMA approving the vaccine for use doesn't mean that countries and their doctors must use it or face some sort of punishment, does it?

Kermit.de.frog · 15-03-2021 08:55AM

Pfizer and Moderna which make up the big majority of vaccinations so far are still being rolled out I take it?

NeuralNetwork · 15-03-2021 08:55AM

I’m actually fed up reading Twitter and forums on this. The Irish authorities are dammed if they do and damned if they don’t.

All I see online is rant, rant, rant and more rant and a good dose of Brexit inspired toxicity thrown in too and armchair experts who suddenly know more about vaccines than teams of virologists and immune experts who’ve spent their entire careers working with vaccines and vaccine safety.

It’s a new vaccine for a new disease and a competent national regulator in Norway has raised a yellow flag alert and that’s being responded to.

If the Irish regulatory agencies didn’t respond to it and carried on regardless and something is wrong, they would be absolutely torn to shreds legally and politically.

Glitches will happen and issues will need to be ironed out as we go along. That’s the nature of where we are right now. These are conditional authorisations with a lot more on going scrutiny as a result.

is_that_so · 15-03-2021 08:58AM

Danzy wrote: »

Or do what others do, look at the data, which there is an incredible amount of, for AZ.

Don't dress up panic as due diligence.

11 million vaccinated and monitored, as if rare occurences aren't examined as de rigueur.

It's not 3 people scattered around the world, it's a possible cluster of an extremely rare occurrence that none of the data so far has shown up. You stop and investigate that one. It could very well be nothing or a freakishly improbable situation.

is_that_so · 15-03-2021 09:00AM

Kermit.de.frog wrote: »

Pfizer and Moderna which make up the big majority of vaccinations so far are still being rolled out I take it?

Pfizer are the biggest one by far, Moderna's contribution is small for now. AZ is currently at 20% or so, at about the level we plan to distribute it.

robinph · 15-03-2021 09:02AM

NeuralNetwork wrote: »

I’m actually fed up reading Twitter and forums on this. The Irish authorities are dammed if they do and damned if they don’t.

What is really needed is some fresh Harry and Megan news to restore the news cycles back to normal. Then the talk of boring regulations being followed with pauses on vaccines for a week here or there for different ones just dissapears off the TV and nobody really cares anything about it until they turn up, get vaccinated, and see the name of some company they had never heard of 6 months ago on their vaccination card and they then go back to getting on with their day.

The problem isn't that use of the vaccines is being paused, its that us who know nothing about such things are being bombarded with news about it and that then causes hesitancy.

What exactly is happening with AstraZeneca?

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