What exactly is happening with AstraZeneca?

08-04-2021 07:25PM

LLMMLL wrote: »

Earlier you were talking about not being sent to the back of the queue but just being able to “wait” for your preferred vaccine.

You still haven’t explained how this would work in practice, even if an age restriction is put in place.

Say AZ is limited to over 60s. Once we vaccinate them with AZ we then have to do everyone else in order of age. When your age group is being vaccinated there will not be an unlimited supply of Pfizer. There is likely to be 1/4 AZ.

If you are assigned AZ it seems likely you will refuse. Can you specify exactly what should happen in this case?

It's 2021, we have pretty sophisticated IT systems that can handle bookings.

On the portal, a simple "are you willing to accept an Astrazeneca vaccine?" with a Yes/No option and a link to information about the blood clot risks would suffice. Some will accept it if it means getting vaccinated quicker. Those who don't will be allocated the next available slot for one of the other vaccines.

It really doesn't need to be as difficult as you're making out.

LLMMLL · 08-04-2021 07:28PM

Flying Fox wrote: »

It's 2021, we have pretty sophisticated IT systems that can handle bookings.

On the portal, a simple "are you willing to accept an Astrazeneca vaccine?" with a Yes/No option and a link to information about the blood clot risks would suffice. Some will accept it if it means getting vaccinated quicker. Those who don't will be allocated the next available slot for one of the other vaccines.

It really doesn't need to be as difficult as you're making out.

And for those that choose no what happens? Where does their vaccine come from?

astrofool · 08-04-2021 07:28PM

stefanovich wrote: »

https://www.rai.it/dl/doc/2021/02/19/1613725900577_AZ_FIRMATO_REPORT.pdf

Here is the contract in full. Look at section 14.

Miike wrote: »

https://ec.europa.eu/info/sites/info/files/eu_apa_-_executed_-_az_redactions.pdf

Sections 2.2, I draw your attention to (e) and section 14.

Already explained above, AZ could have gone for emergency approval and put liability onto the governments, they chose conditional marketing approval which puts the liability onto them, if you get a bad batch of AZ vaccine, you can sue them, if the vaccine doesn't do what the instructions say, you can sue them. It would be interesting to see whether the blood clots are something they are liable for, or an increased risk of a known side effect (as most vaccines list this as a potential side effect already).

People keep choosing to ignore that the EMA has approved the vaccines at a higher standard than the MHRA as some sort of attack on "big pharma" that they're pushing unproven medicines into the market. This is not true no matter how much it is repeated. Spreading this lie is also spreading Fear, Uncertainty and Doubt, and I have no doubt that those spreading it here will be trying to spread it in other threads in the weeks and months ahead.

08-04-2021 07:30PM

LLMMLL wrote: »

Earlier you were talking about not being sent to the back of the queue but just being able to “wait” for your preferred vaccine.

You still haven’t explained how this would work in practice, even if an age restriction is put in place.

Say AZ is limited to over 60s. Once we vaccinate them with AZ we then have to do everyone else in order of age. When your age group is being vaccinated there will not be an unlimited supply of Pfizer. There is likely to be 1/4 AZ.

If you are assigned AZ it seems likely you will refuse. Can you specify exactly what should happen in this case?

And I never said I wanted to choose my exact vaccine, but you know that because we've already discussed it.

Why do you think that if AZ is banned in my age group I would try to insist on Pfizer? I will take whatever is offered to me, I just don't want AZ due to the safety issue.

astrofool · 08-04-2021 07:32PM

Flying Fox wrote: »

It's 2021, we have pretty sophisticated IT systems that can handle bookings.

On the portal, a simple "are you willing to accept an Astrazeneca vaccine?" with a Yes/No option and a link to information about the blood clot risks would suffice. Some will accept it if it means getting vaccinated quicker. Those who don't will be allocated the next available slot for one of the other vaccines.

It really doesn't need to be as difficult as you're making out.

People are really bad at evaluating risk, all this will do is decrease the vaccine supply by 1/4 and take 25% longer to get people immunised. The only option is to put people to the back of the queue until everyone is vaccinated.

08-04-2021 07:33PM

LLMMLL wrote: »

And for those that choose no what happens? Where does their vaccine come from?

The other 80% of our supply!

Christ on a bike...

08-04-2021 07:36PM

astrofool wrote: »

People are really bad at evaluating risk, all this will do is decrease the vaccine supply by 1/4 and take 25% longer to get people immunised. The only option is to put people to the back of the queue until everyone is vaccinated.

Plenty of other countries have restricted it so they clearly feel it's warranted. Are you suggesting all of those regulators are terrible at assessing risk?

LLMMLL · 08-04-2021 08:04PM

Flying Fox wrote: »

And I never said I wanted to choose my exact vaccine, but you know that because we've already discussed it.

Why do you think that if AZ is banned in my age group I would try to insist on Pfizer? I will take whatever is offered to me, I just don't want AZ due to the safety issue.

I’m using Pfizer as a shorthand for all the others. All the others combined are about 3/4. Let’s just call them Pfizer as it’s easier than listing all the brand nAmes.

So the question stands. If you are offered AZ and refuse where is your other vaccine going to come from if you are not put to the back of the queue?

LLMMLL · 08-04-2021 08:06PM

Flying Fox wrote: »

The other 80% of our supply!

Christ on a bike...

But we have restricted supply. If you refuse AZ but think you should be offered another vaccine without being moved to the back of the queue then it must come from someone else’s allotted vaccine. What if this person doesn’t want to give it to you?

Miike · 08-04-2021 08:17PM

astrofool wrote: »

Already explained above, AZ could have gone for emergency approval and put liability onto the governments, they chose conditional marketing approval which puts the liability onto them, if you get a bad batch of AZ vaccine, you can sue them, if the vaccine doesn't do what the instructions say, you can sue them. It would be interesting to see whether the blood clots are something they are liable for, or an increased risk of a known side effect (as most vaccines list this as a potential side effect already).

People keep choosing to ignore that the EMA has approved the vaccines at a higher standard than the MHRA as some sort of attack on "big pharma" that they're pushing unproven medicines into the market. This is not true no matter how much it is repeated. Spreading this lie is also spreading Fear, Uncertainty and Doubt, and I have no doubt that those spreading it here will be trying to spread it in other threads in the weeks and months ahead.

Actually turns out you're 100% correct, my apologies! The EU has agreed to make payouts above a certain publicly undisclosed threshold however.

Russman · 08-04-2021 08:22PM

robinph wrote: »

The numbers are pretty even once you allow for the ratio's that have been vaccinated.

Are they’re really ? Not doubting you at all, just slightly surprised as a lot of the commentary has been that it’s much more prevalent in women. Interesting.

Russman · 08-04-2021 08:27PM

astrofool wrote: »

People are really bad at evaluating risk, all this will do is decrease the vaccine supply by 1/4 and take 25% longer to get people immunised.

That could well be what happens if NIAC were to go the route of adding an age restriction. I guess it depends on where they end up drawing the line with regard to risk. Honestly can’t really see them not following the likes of Germany, France etc and even the UK.

08-04-2021 08:30PM

Miike wrote: »

Actually turns out you're 100% correct, my apologies! The EU has agreed to make payouts above a certain publicly undisclosed threshold however.

Are you sure? Clause 14 looks to be a pretty clear indemnity, providing the product is manufactured in accordance with cGMP and there is no willful wrongdoing.

Turtwig · 08-04-2021 08:32PM

Russman wrote: »

Are they’re really ? Not doubting you at all, just slightly surprised as a lot of the commentary has been that it’s much more prevalent in women. Interesting.

Most of the cases identified so far have occurred in women. The EMA pretty much said there was no specific at risk group identified yet.

It's quite possible the higher reported number of incidences among females simply reflects the profile of vaccinations so far.

astrofool · 08-04-2021 08:46PM

Aegir wrote: »

Are you sure? Clause 14 looks to be a pretty clear indemnity, providing the product is manufactured in accordance with cGMP and there is no willful wrongdoing.

If they had chosen to go the emergency approval route, then yes, but they went the conditional marketing route. I doubt it will happen, but would be interesting if the UK ended up footing any liability bills, while AZ would have to pay out on any EU cases (same applies for Pfizer, Moderna, J&J). May also explain why MHRA dismissed the blood clot issues so readily, while it took longer for the EMA to respond (hopefully the MHRA keeps away from politics).

08-04-2021 08:50PM

astrofool wrote: »

If they had chosen to go the emergency approval route, then yes, but they went the conditional marketing route. I doubt it will happen, but would be interesting if the UK ended up footing any liability bills, while AZ would have to pay out on any EU cases (same applies for Pfizer, Moderna, J&J). May also explain why MHRA dismissed the blood clot issues so readily, while it took longer for the EMA to respond (hopefully the MHRA keeps away from politics).

The indemnity doesn’t make any mention of the approval type, only that the member states indemnify AZ against any claims.

astrofool · 08-04-2021 08:53PM

Flying Fox wrote: »

Plenty of other countries have restricted it so they clearly feel it's warranted. Are you suggesting all of those regulators are terrible at assessing risk?

And plenty of countries haven't restricted it, we're not seeing the issues that other countries have seen, so it's not being restricted, and it means that if we gave people a choice of vaccine, the net effect would be to reduce our supply by 25% (or whatever amount AZ make up) and increasing the rollout time, the only sane response to someone refusing a particular vaccine is to put them to the end of the queue and they can get vaccinated once everyone who isn't being choosy is done.

astrofool · 08-04-2021 08:58PM

Aegir wrote: »

The indemnity doesn’t make any mention of the approval type, only that the member states indemnify AZ against any claims.

Not sure why I'm repeating this, but conditional marketing approval means the manufacturer takes on the liability, if AZ wanted the EU to take on the liability, as is their right in the contract, they would have gone for emergency approval, the EMA guidelines are quite clear here.

It also means we can trust the EMA guidance as there is no financial aspect to the approval for them, unlike the MHRA who are potentially causing financial payouts for the UK government. It is interesting that none of the manufacturers have gone for non-emergency approval with the UK, but all went with CMA with the EU, might be the EU has the better contracts after all :pac: (sorry, know this is like a red rag to a bull for all those who were shouting "contracts!" previously).

JP Liz V1 · 08-04-2021 09:01PM

https://www.independent.ie/irish-news/health/no-change-toastrazeneca-vaccine-in-ireland-despite-uk-limitingjab-to-over-30s-amid-blood-clot-reports-40285070.html

Russman · 08-04-2021 09:04PM

astrofool wrote: »

And plenty of countries haven't restricted it, we're not seeing the issues that other countries have seen, so it's not being restricted, and it means that if we gave people a choice of vaccine, the net effect would be to reduce our supply by 25% (or whatever amount AZ make up) and increasing the rollout time, the only sane response to someone refusing a particular vaccine is to put them to the end of the queue and they can get vaccinated once everyone who isn't being choosy is done.

Not necessarily. With respect, there are genuine concerns out there (however irrational you or I may think they are), and flippantly disregarding them as simply just being choosy and sending them to the back of the line won’t work or help them. We all want as many people vaccinated as possible.
Who knows which way NIAC will go, maybe they’ll decide our AZ ratio is so low that we’re likely to hardly see any cases, maybe they’ll go with an age limit. Maybe Pfizer new plant can make up any shortfall.

Turtwig · 08-04-2021 09:04PM

JP Liz V1 wrote: »

https://www.independent.ie/irish-news/health/no-change-toastrazeneca-vaccine-in-ireland-despite-uk-limitingjab-to-over-30s-amid-blood-clot-reports-40285070.html

Given that this is an evolving situation why are you reporting on a day old article relating to decisions made yesterday?

astrofool · 08-04-2021 09:09PM

Russman wrote: »

Not necessarily. With respect, there are genuine concerns out there (however irrational you or I may think they are), and flippantly disregarding them as simply just being choosy and sending them to the back of the line won’t work or help them. We all want as many people vaccinated as possible.
Who knows which way NIAC will go, maybe they’ll decide our AZ ratio is so low that we’re likely to hardly see any cases, maybe they’ll go with an age limit. Maybe Pfizer new plant can make up any shortfall.

If people are given a choice this does 2 things:

Increases the logistics involved and slows the rollout
No one will choose the AZ vaccine, even if they would have normally taken it, because given a choice, everyone would choose mRNA or J&J, again, slowing the rollout

So the net effect is a slower rollout. The only way to handle it is to not give a choice, and put those who refuse to the back of the queue.

LLMMLL · 08-04-2021 09:13PM

astrofool wrote: »

If people are given a choice this does 2 things:
Increases the logistics involved and slows the rollout

No one will choose the AZ vaccine, even if they would have normally taken it, because given a choice, everyone would choose mRNA or J&J, again, slowing the rollout

So the net effect is a slower rollout. The only way to handle it is to not give a choice, and put those who refuse to the back of the queue.

Exactly. This isn’t about ignoring people’s concerns or punishing the hesitant. It’s about public health and what is the best overall strategy.

Back of the queue system and no vaccine choice are currently the best options for public health.

Kermit.de.frog · 08-04-2021 09:13PM

I have to be honest as things currently stand I would not feel comfortable getting the AZ jab at this stage.

I'd hope for options by the time it gets to my age group down the line.

I know it's probably fine but the seed of doubt has become a little too grown for me.

08-04-2021 09:14PM

astrofool wrote: »

Not sure why I'm repeating this, but conditional marketing approval means the manufacturer takes on the liability, if AZ wanted the EU to take on the liability, as is their right in the contract, they would have gone for emergency approval, the EMA guidelines are quite clear here.

It also means we can trust the EMA guidance as there is no financial aspect to the approval for them, unlike the MHRA who are potentially causing financial payouts for the UK government. It is interesting that none of the manufacturers have gone for non-emergency approval with the UK, but all went with CMA with the EU, might be the EU has the better contracts after all :pac: (sorry, know this is like a red rag to a bull for all those who were shouting "contracts!" previously).

Can you point to the part of the contract that states this, because all I can see is the EU giving an indemnity with no mention of it being subject to anything other than willful misconduct or a breach of cGMP guidelines.

LLMMLL · 08-04-2021 09:16PM

Kermit.de.frog wrote: »

I have to be honest as things currently stand I would not feel comfortable getting the AZ jab.

I'd hope for options by the time it gets to my age group down the line.

It’s highly unlikely there will be “options” if by options you mean that you get a choice.

But the odds of getting a vaccine other than AZ are pretty good. If you are not due to get vaccinated for a few months I wouldn’t be worrying about it.

But I also would not be relying on the unlikely scenarios of vaccine choice or paying for a vaccine.

micks_address · 08-04-2021 09:19PM

Anyone done the maths on how much slower it will be if they pull Astra? I think I seen only 600k of it due before end of June? Even if there’s a risk of one person dying from Astra side effects wouldn’t it make sense to wait a few weeks? If someone said to me hey you can have Astra now or a different one four weeks later I’d probably wait

Russman · 08-04-2021 09:22PM

astrofool wrote: »

If people are given a choice this does 2 things:
Increases the logistics involved and slows the rollout

No one will choose the AZ vaccine, even if they would have normally taken it, because given a choice, everyone would choose mRNA or J&J, again, slowing the rollout

So the net effect is a slower rollout. The only way to handle it is to not give a choice, and put those who refuse to the back of the queue.

And maybe NIAC will decide a delay in the rollout is inevitable as clearly some countries have. Maybe they won’t, as other countries have done. like as I say, who knows.
Your second point about no one choosing AZ is interesting though - we’re not a million miles off coercing people to take a vaccine that they’d prefer an alternative to, purely in the interest of expediency. If enough people refused, the back of the queue would come round pretty quickly.

I’m not saying there definitely should be a choice, I just don’t believe it’s as simple as take it or its the back of the line for you. I don’t know what the middle ground or nuanced solution is.

FileNotFound · 08-04-2021 09:29PM

Was just watching BBC news and they had a piece on the risks of AZ vaccine.

Essentially for every 100k in current UK climate

In 60-69 age group 14.1 people would enter ICU without vaccine but only 0.2 will develop serious blood clots if vaccinated.

Then for the 20-29 age group, 0.8 people would enter ICU without vaccine but 1.1 will develop serious blood clots if vaccinated.

Doesn't seem great when looking at younger age groups.

Realistically it would just mean use AZ in the slightly older groups. Hard to get someone young and healthy to be happy with a shot that carries similar or potentially more risk than covid!!

Wolf359f · 08-04-2021 09:30PM

Turtwig wrote: »

Given that this is an evolving situation why are you reporting on a day old article relating to decisions made yesterday?

At the moment the vast majority of AZ is going to a very high risk group 18-69. Then anyone aged 65-69, then high risk 65-69 and followed by high risk 18-64.
All of those mentioned are at risk from covid complications and death, so I believe the benefits outweigh the risk.

Once we start getting down to younger groups, then yes I would expect an age restriction on AZ or we may have a better idea of what's the main underlying factor for the rare brain clots etc...

There is a different risk analysis between a healthy 20 year old and a 20 year old with severe underlying illnesses. Restricting it via age may not be the best idea until all people with underlying conditions are done.

What exactly is happening with AstraZeneca?

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