What exactly is happening with AstraZeneca?

lucernarian · 25-02-2021 12:46AM

astrofool wrote: »

There has already been indications that the AZ vaccine will not get FDA approval due to concerns with how the trials were run, the proven efficacy and manufacture issues, it should come to light in the next few weeks. These details are of no surprise to most people working in the field, but I'm sure a few people will try and make it look political, and/or take a "Big pharma" angle (as if AZ themselves aren't part of this group..., and why the US would want to sour the UK/US relationship). It also may end up approved but with restrictions on who it can be used on.

Aside: not sure if Aegir is being serious or sarcastic with the Bill Gates posts

I suspect the latter, especially with the good evidence emerging regarding the Oxford vaccine in a 2 dose regimen in most important contexts. I expect an under-60 recommendation from the FDA. It won't matter much in the US if most of their first 10% coverage is already under way but inevitably any decision they make will influence world opinion.

brickster69 · 25-02-2021 12:47AM

joebloggs32 wrote: »

Its funny how those who constantly look for opportunities to knock this country completely disregarded any comparison to the UK six months ago if you were discussing case numbers or death rates per capita. They would instantly point to other nations like New Zealand, Taiwan etc.

Now all of a sudden its all about the success of the UK, and why cant we be more like them, completely ignoring our ties to the EU and the skullduggery AZ has pulled.

I am convinced their delay in applying for EMA approval was down to their inability to meet their deliveries.

Really hand on heart. Do you think if Ireland had the same data that France and Germany had and they both approved use for older people Ireland would of rejected it ?

Again, if Ireland in the morning had data that proved it was 100% safe in older people and Germany and France never had that data Ireland would change its rules to allow older people to take AZ by the afternoon ?

lucernarian · 25-02-2021 12:50AM

Strazdas wrote: »

But even then, it was the health authorities in each country that made the decision. Governments have no say in vaccine efficacy or whether it should be given or not.

The emergency authorisation route is still a state competency but I see your point

AngeloArgue · 25-02-2021 12:52AM

Strazdas wrote: »

But even then, it was the health authorities in each country that made the decision. Governments have no say in vaccine efficacy or whether it should be given or not.

But why not accept the advice of the EMU?

It gives an impression that they are not to be trusted.

Could you imagine the derision that say Texas would receive if they went against the recommendation of the Food & Drug Administration on vaccines in the USA?

No wonder people are losing confidence

lucernarian · 25-02-2021 01:02AM

brickster69 wrote: »

Really hand on heart. Do you think if Ireland had the same data that France and Germany had and they both approved use for older people Ireland would of rejected it ?

Again, if Ireland in the morning had data that proved it was 100% safe in older people and Germany and France never had that data Ireland would change its rules to allow older people to take AZ by the afternoon ?

It's certainly possible. Real evidence matters.

brickster69 · 25-02-2021 01:09AM

lucernarian wrote: »

It's certainly possible. Real evidence matters.

Bollox. Are you trying to say that if France and Germany approved AZ for use in older people. With the exact same data Ireland would reject it. Seriously, you believe that is possible ?

Psychedelic Hedgehog · 25-02-2021 01:10AM

The UK definitely struck lucky in two major areas, (1) the gamble of short term one dose efficacy being effective enough to forego the initial two dose/three weeks apart recommendation, and (2) their ability to divert domestic production of the AZ vaccine towards internal distribution, seemingly against the contract agreements with the EU (the details of which are up for debate).

I find it interesting that the EU (including Ireland) are no longer depending on previous AZ delivery forecasts for Q2 and onwards vaccine planning. Long term, this may bite AZ hard given that they appear to have prioritised UK interests.

Pete_Cavan · 25-02-2021 07:45AM

Psychedelic Hedgehog wrote: »

I find it interesting that the EU (including Ireland) are no longer depending on previous AZ delivery forecasts for Q2 and onwards vaccine planning. Long term, this may bite AZ hard given that they appear to have prioritised UK interests.

Noises coming from USA don't sound too promising either, even if they do approve it, they may not want to do business with them.

is_that_so · 25-02-2021 08:32AM

Pete_Cavan wrote: »

Noises coming from USA don't sound too promising either, even if they do approve it, they may not want to do business with them.

That may be a good thing for COVAX and the rest of the world as it is likely to be the vaccine of choice in many places and could speed up supplies.

mick087 · 25-02-2021 08:45AM

is_that_so wrote: »

That may be a good thing for COVAX and the rest of the world as it is likely to be the vaccine of choice in many places and could speed up supplies.

Yes it would be good news as the Oxford vaccine was all about non profit.

Its such a shame its become so political and now it seems with the richer countries its a business choice.

is_that_so · 25-02-2021 08:49AM

mick087 wrote: »

Yes it would be good news as the Oxford vaccine was all about non profit.

Its such a shame its become so political and now it seems with the richer countries its a business choice.

Well, their continuing underperforming on deliveries makes them somewhat unreliable partners and the politics is the flak that countries are getting for not vaccinating fast enough.

Pete_Cavan · 25-02-2021 08:51AM

is_that_so wrote: »

That may be a good thing for COVAX and the rest of the world as it is likely to be the vaccine of choice in many places and could speed up supplies.

Surely any unallocated doses will have to go to existing customers first, particularly those to whom they are behind on supplying?

mick087 · 25-02-2021 08:56AM

is_that_so wrote: »

Well, their continuing underperforming on deliveries makes them somewhat unreliable partners and the politics is the flak that countries are getting for not vaccinating fast enough.

Maybe if all the companies had followed the Oxford non for profit idea then the politicians would not be getting the flak. Sadley it don't work like this.

is_that_so · 25-02-2021 09:10AM

Pete_Cavan wrote: »

Surely any unallocated doses will have to go to existing customers first, particularly those to whom they are behind on supplying?

Some EU countries are already having problems giving AZ to people, so getting more of it will not help their programme. I can see it being donated to COVAX. With more vaccines likely to come on stream, AZ will probably become a smaller part of the overall response in some parts of the world. They'll certainly be in no rush to order more.

is_that_so · 25-02-2021 09:14AM

mick087 wrote: »

Maybe if all the companies had followed the Oxford non for profit idea then the politicians would not be getting the flak. Sadley it don't work like this.

Most are not making huge profits per unit, it's the sheer volume that will reap rewards. I really don't begrudge the likes of Moderna and BionTech making money out of this as it will fund research into more exciting areas like cancer and MS.

Pete_Cavan · 25-02-2021 09:42AM

is_that_so wrote: »

Some EU countries are already having problems giving AZ to people, so getting more of it will not help their programme. I can see it being donated to COVAX. With more vaccines likely to come on stream, AZ will probably become a smaller part of the overall response in some parts of the world. They'll certainly be in no rush to order more.

But it will be up to the purchaser, in this case the EU Commission, to decline the full amount it advance purchased. It will then be up to individual countries to decide what to do with their allocation, whether they get used or they send them elsewhere. It won't be for AZ to decide, they are still contracted to supply 300m doses.

is_that_so · 25-02-2021 09:47AM

Pete_Cavan wrote: »

But it will be up to the purchaser, in this case the EU Commission, to decline the full amount it advance purchased. It will then be up to individual countries to decide what to do with their allocation, whether they get used or they send them elsewhere. It won't be for AZ to decide, they are still contracted to supply 300m doses.

In the grand scheme of things 300m is a small quantity out of over 2bn and J&J changes the landscape completely. Sure, they'll have to deliver but I don't see the EU banking on them in any way and when they come will now be less of a concern. It's definitely a prime candidate for donations.

Pete_Cavan · 25-02-2021 09:53AM

is_that_so wrote: »

In the grand scheme of things 300m is a small quantity out of over 2bn and J&J changes the landscape completely. Sure, they'll have to deliver but I don't see the EU banking on them in any way and when they come will now be less of a concern. It's definitely a prime candidate for donations.

Possibly, I'm just saying it will be for the EU to decide what to do with any unused doses they have bought. Can't see them taking up the option for another 100m anyway.

25-02-2021 10:05AM

Share Price may be an indicator of how this is playing out.

Since Nov 11th

AZ - 8785 to 7017
Pfizer - 36.47 - 33.75
BioNtech - 112.76 to 114.17
J& J - 147.8 to 162.59
Moderna - 82.44 to 144.79
Novavac - 85.01 to 239.94
Curevac - 61.94 to 98.17

Dyr · 25-02-2021 10:44AM

joebloggs32 wrote: »

Its funny how those who constantly look for opportunities to knock this country completely disregarded any comparison to the UK six months ago if you were discussing case numbers or death rates per capita. They would instantly point to other nations like New Zealand, Taiwan etc.

Now all of a sudden its all about the success of the UK, and why cant we be more like them, completely ignoring our ties to the EU and the skullduggery AZ has pulled.

I am convinced their delay in applying for EMA approval was down to their inability to meet their deliveries.

Completely ignoring the abyssmal failure of the EU throught the vaccine rollout and AZ having done nothing that was in breach of their contract with the EU

The Brits got their vaccine strategy right, we left ours to the EU and they made a pigs mickey of it.

Our ties to the EU have done us zero favours throughout the Lockdown, we have a government that sees itself as the branch manager for the head office in Brussels rather than capable of making its own decisions.

volchitsa · 25-02-2021 10:52AM

Bambi wrote: »

Completely ignoring the abyssmal failure of the EU throught the vaccine rollout and AZ having done nothing that was in breach of their contract with the EU

The Brits got their vaccine strategy right, we left ours to the EU and they made a pigs mickey of it.

Our ties to the EU have done us zero favours throughout the Lockdown, we have a government that sees itself as the branch manager for the head office in Brussels rather than capable of making its own decisions.

The idea that Ireland would have done better in a global free for all than the EU would be funny if it wasn't the same sort of crazed delusional thinking that fooled the Brits into imagining they'd do better ouside the EU than in - but at least they're a big enough economy to have some negotiating power on their own.

There's some sense in German citizens making the sort of comment you just made - but not for Ireland, that's deluded.

Dyr · 25-02-2021 11:02AM

volchitsa wrote: »

The idea that Ireland would have done better in a global free for all than the EU would be funny if it wasn't the same sort of crazed delusional thinking that fooled the Brits into imagining they'd do better ouside the EU than in - but at least they're a big enough economy to have some negotiating power on their own.

There's some sense in German citizens making the sort of comment you just made - but not for Ireland, that's deluded.

Building straw men there buddy.

Raisins · 25-02-2021 11:14AM

Bambi wrote: »

Completely ignoring the abyssmal failure of the EU throught the vaccine rollout and AZ having done nothing that was in breach of their contract with the EU

The Brits got their vaccine strategy right, we left ours to the EU and they made a pigs mickey of it.

Our ties to the EU have done us zero favours throughout the Lockdown, we have a government that sees itself as the branch manager for the head office in Brussels rather than capable of making its own decisions.

How do you know it wasn’t a breach of contract?

The Brits took a massive gamble and got lucky. That doesn’t mean the strategy was correct. Hindsight analysis. I wouldn’t swap Boris Johnson and the Tory government for what we have in a million years.

fly_agaric · 25-02-2021 11:15AM

AngeloArgue wrote: »

Every one of the approved vaccine producers have had delays to their projected supply figures but only AstraZeneca are singled out for particular wrath and fury.

Why is that?

There was also criticism of Pfizer over their production shortfall afair but explanations seem to have been accepted. I think it may have been notified sooner too + less of a bolt from the blue but not certain about that.

Also as far as I've read, EU locations are providing all the orders of Pfizer/Biontech vaccine apart from the USA, so it is easy for EU to know if they are prioritising their other orders over the EU one. Presumably they have reduced all the orders.

With AZ, the EU order is affected while the UK order will be unaffected.
UK production of the vaccine will be locked off for UK use until UK has sufficient vaccines that any export will not impair their own program. From what has come into public domain since re contracts etc. (EU one mentioning UK production etc.), that looks like it came as a surprise to the EU. That was naive in hindsight. Anything critical involving the UK or depending on them may be built on quicksand/thin ice post Brexit with the attitude & politics of the govt. there.

That is (sorry was) the reason for the "wrath and fury" imo, which appears to have died down now in any case.

astrofool · 25-02-2021 12:01PM

Bambi wrote: »

Completely ignoring the abyssmal failure of the EU throught the vaccine rollout and AZ having done nothing that was in breach of their contract with the EU

The Brits got their vaccine strategy right, we left ours to the EU and they made a pigs mickey of it.

Our ties to the EU have done us zero favours throughout the Lockdown, we have a government that sees itself as the branch manager for the head office in Brussels rather than capable of making its own decisions.

Let's break this down:

EU has secured enough vaccine for it's population multiple times over, and has been able to assist in ramping up the mRNA vaccine production to incredible volumes very quickly. The EU has also not thrown it's toys out of it's pram and stopped Pfizer going to the UK, as it looks the UK has done to the EU, the continued failure of AZ both in case studies, production capability and still missing data for efficacy and symptom reduction in older people has seen to that, such that it seems that the EU is not relying on them anymore.

The Brits did right in getting their manufacture supply in place (if you ignore where Pfizer and their first batches of AZ came from of course), and approved the medicines as a lower standard to the EU so they could get them into arms quicker, as a vaccine friendly nation, this is fine, Europe has some countries that are sceptical of vaccines, so approved at a higher standard to the UK to ensure high uptake of vaccines (which worked well for mRNA, but didn't for AZ due to the missing datasets as outlined before).

If we were to have gone alone, we would be at the back of the queue for vaccines, we would have been outbid by the EU, Israel and any other number of countries, and we would have had to do our own medicine certification independent of the EU process.

The UK has got a little bit lucky that AZ works quite well, but took a big risk that it would, and they could have been left with nothing. In addition, their awful handling of COVID on the ground has also left them not following manufacturer guidelines for use of the vaccines, which is incredibly stupid for a brand new medicine, and an unnecessary risk to take. I would not see a strategy that has many single point of failure as the right strategy, the EU strategy is robust, and will mean the bloc is vaccinated ahead of most of the rest of the world, which is important as it is a larger bloc of people than both the US and the UK. The UK gambled on AZ efficacy, approving early, changing their dosage regime and hoarding supplies, each one could have failed, and may still fail, all for the benefit of a few weeks.

As it is, we'll lag the UK in rollout by a few weeks, but importantly, our most vulnerable and healthcare workers are already covered (many with the full regimen), and has allowed us to move onto the next most vulnerable groups. Also, just as importantly, those groups have been vaccinated using a medicine with proven efficacy for their age groups, so we don't have to worry about missing datasets there (I'm 90% sure that AZ will prove effective for older people, but that is my opinion, not based on data, if my opinion is wrong, the UK could be in a very bad place again).

Dyr · 25-02-2021 01:23PM

Raisins wrote: »

How do you know it wasn’t a breach of contract?

The Brits took a massive gamble and got lucky. That doesn’t mean the strategy was correct. Hindsight analysis. I wouldn’t swap Boris Johnson and the Tory government for what we have in a million years.

I'm not the one making the claim buddy, the contract is public, feel free to point out where it was breached or alternately, stop whinging about it.

Brits got lucky
Israelis got lucky
Yanks got lucky
Denmark got lucky

EU must have been very unlucky eh? Signing a contract under Belgian law that lacked the attention to detail the Brits had and lacked the common law system that the UK and Ireland have to back it up. Thats some amount of bad luck right there

robinph · 25-02-2021 01:40PM

The UK wasn't taking massive risks with the vaccine program.

Throwing money at it early wasn't a gamble, they were throwing money at everything at that stage and if the vaccine was a total dud then it would just be added to the list of failures. But that was a big list so one more makes no difference.
It wasn't a big risk to approve it early. The trial data was in and is the same data that other bodies used to approve it.
It wasn't even a big risk to approve it for over 60s despite the lack of significant trial data. There was also a lack of anything to suggest that it would be dangerous to give to over 60s. Worst case was that it did nothing, but compared to lots of people dying from covid against most people not dying of covid may as well stick a potentially useless vaccine in people's arms and see.
Likewise with the longer gap between the doses, far better to have lots of people partially protected than a small number of people highly protected (and still way above the effectiveness that was being anticipated from any vaccinations this time last year).

It's certainly not how the process would work normally, but it's not normal times. Try anything as long as it's not worse than what's happening so far.

astrofool · 25-02-2021 02:55PM

Bambi wrote: »

I'm not the one making the claim buddy, the contract is public, feel free to point out where it was breached or alternately, stop whinging about it.

Brits got lucky
Israelis got lucky
Yanks got lucky
Denmark got lucky

EU must have been very unlucky eh? Signing a contract under Belgian law that lacked the attention to detail the Brits had and lacked the common law system that the UK and Ireland have to back it up. Thats some amount of bad luck right there

a) Denmark are in the EU
b) The AZ contract clearly states for AZ to use best effort to fulfil the supplies, best effort implies that all countries would be treated equally (unless of course the UK contract says "super best effort++"), AZ is clearly not doing that, but given the efficacy issues and J&J coming on stream before AZ can sort it's supplies, it looks like the EU is just moving on from it (can't get vaccines if they don't got vaccines)
c (for robinph)) They were not approved with the same data, the emergency use authorisation of the UK requires less data than conditional marketing approval with the EU

MrMusician18 · 25-02-2021 02:57PM

astrofool wrote: »

Let's break this down:

EU has secured enough vaccine for it's population multiple times over, and has been able to assist in ramping up the mRNA vaccine production to incredible volumes very quickly. The EU has also not thrown it's toys out of it's pram and stopped Pfizer going to the UK, as it looks the UK has done to the EU, the continued failure of AZ both in case studies, production capability and still missing data for efficacy and symptom reduction in older people has seen to that, such that it seems that the EU is not relying on them anymore.

The Brits did right in getting their manufacture supply in place (if you ignore where Pfizer and their first batches of AZ came from of course), and approved the medicines as a lower standard to the EU so they could get them into arms quicker, as a vaccine friendly nation, this is fine, Europe has some countries that are sceptical of vaccines, so approved at a higher standard to the UK to ensure high uptake of vaccines (which worked well for mRNA, but didn't for AZ due to the missing datasets as outlined before).

If we were to have gone alone, we would be at the back of the queue for vaccines, we would have been outbid by the EU, Israel and any other number of countries, and we would have had to do our own medicine certification independent of the EU process.

The UK has got a little bit lucky that AZ works quite well, but took a big risk that it would, and they could have been left with nothing. In addition, their awful handling of COVID on the ground has also left them not following manufacturer guidelines for use of the vaccines, which is incredibly stupid for a brand new medicine, and an unnecessary risk to take. I would not see a strategy that has many single point of failure as the right strategy, the EU strategy is robust, and will mean the bloc is vaccinated ahead of most of the rest of the world, which is important as it is a larger bloc of people than both the US and the UK. The UK gambled on AZ efficacy, approving early, changing their dosage regime and hoarding supplies, each one could have failed, and may still fail, all for the benefit of a few weeks.

As it is, we'll lag the UK in rollout by a few weeks, but importantly, our most vulnerable and healthcare workers are already covered (many with the full regimen), and has allowed us to move onto the next most vulnerable groups. Also, just as importantly, those groups have been vaccinated using a medicine with proven efficacy for their age groups, so we don't have to worry about missing datasets there (I'm 90% sure that AZ will prove effective for older people, but that is my opinion, not based on data, if my opinion is wrong, the UK could be in a very bad place again).

That's not accurate. Approval and purchasing are completely separate processes.

Strazdas · 25-02-2021 03:00PM

Bambi wrote: »

I'm not the one making the claim buddy, the contract is public, feel free to point out where it was breached or alternately, stop whinging about it.

Brits got lucky
Israelis got lucky
Yanks got lucky
Denmark got lucky

EU must have been very unlucky eh? Signing a contract under Belgian law that lacked the attention to detail the Brits had and lacked the common law system that the UK and Ireland have to back it up. Thats some amount of bad luck right there

What's getting a bit overlooked here is that the AZ row has been greatly overstated in the context of the EU's vaccine rollout. Latest stats from the HSE shows that Pfizer has been administered TEN times more than AZ in Ireland and the numbers for Europe are similar.

All that actually happened in Jan-Feb is that the EC had a big row with a single pharma company over deliveries.

What exactly is happening with AstraZeneca?

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