What exactly is happening with AstraZeneca?

hatrickpatrick

The news has been full of stories about AstraZeneca having slashed their initial vaccine deliveries to the EU by 60% and the knock on fallout from that. But what’s either being buried in all the reporting, or simply hasn’t been reported at all, is what exactly happened? What’s the reason for the delay? Technical, logistical, commercial, etc?

I assumed it was similar to what was happening with Pfizer, which is essentially an issue of manufacturing capacity being reduced by an upgrade to their production facility. But what seems odd about the AstraZeneca situation is the anger directed towards them from officials and leaders, plus public statements that “They must honour their delivery commitments”, indicating that this isn’t an act-of-God type mishap in manufacturing, but an act of incompetence and/or willful reneging on the agreement - perhaps their capacity has remained the same but they’ve “bumped” the EU’s order in priority because others are paying more, or something along these lines?

Does anyone know what exactly the situation is? I can’t seem to find anything beyond extremely vague statements at the moment.

GPoint

AstraZeneca vaccine production unscathed after fire breaks out at Serum Institute of India complex

https://www.fiercepharma.com/manufacturing/astrazeneca-vaccine-production-unscathed-after-fire-breaks-out-at-serum-institute


This was few days ago, however their announcements about delays came out around the same time.

Donald Trump

I got the impression that the EU signed up which would have allowed the company to proceed with pushing through development and testing and building up capacity as they already had a buyer guaranteed. EU might even have put a chunk of money down as prepayment to allow them to speed it up.

It seems now that there is an implication that they are deciding that now they have the final product in the bag and ready to go that they might be tempted to supply others before fulfilling their contractual obligations.

hatrickpatrick

Donald Trump wrote: »

I got the impression that the EU signed up which would have allowed the company to proceed with pushing through development and testing and building up capacity as they already had a buyer guaranteed. EU might even have put a chunk of money down as prepayment to allow them to speed it up.

It seems now that there is an implication that they are deciding that now they have the final product in the bag and ready to go that they might be tempted to supply others before fulfilling their contractual obligations.

This would make more sense than a genuine production capacity issue, certainly. Surely the consequence of doing this would be profound in terms of international contractual law not to mention EU licensing etc? Or is it a case of that being enough of a gamble to take given the potential money to be made in other markets?

NeuralNetwork

The European Commission is concerned about where its money went basically.

AstraZeneca were paid €336 million as a downpayment to assist with the R&D and production expansion effort and there's a commitment to order €750m worth of product from them. That isn't small change.

Stella Kyriakides, European Commissioner for Health and Food Safety's statement:

https://www.youtube.com/watch?v=HLIs2tZ7Cp4

As to what's happening. The answer is we don't know, but by the looks of it we'll be finding out shortly. She seems to be absolutely furious and I don't think they would kick off that level of undiplomatic language without there being more to this than a little misunderstanding.

Hopefully that's all it is though, but we'll see. There's a meeting tonight.

I'm kind of wondering if AZ had done some of the at risk manufacturing, but were peeved by the EMA's comments over Christmas that better data was needed, so they decided EMA approval was going to take longer than they had originally anticipated and shipped what they had made elsewhere where approval was closer or granted. Thinking they could catch up by the time EMA approval came through.

el Fenomeno

For her to come out and specifically mention concerns that they've sold/delivered then elsewhere is pretty sensational. Usually these accusations are hinted at or suggested, but to outright say it - yikes.

froog

the level of anger would seem to point to the EU knowing AZ is thinking about or has already supplied other customers, cutting into the EU agreement. rather than simple supply calculation/capacity f#ckups.

NeuralNetwork

Yeah it would seem quite unlikely she'd come out that strong on the topic if it were something small.

froog

on the radio now - AZ are playing hardball. talk of the UK not having any supply problems.

this won't end well.

Hurrache

Don't think it's them playing hardball, they've been caught in a lie of their own making by initially claiming the issue was supply problems, yet these supply problems aren't having an affect on any other customer.

Cerveza

China has some involvement too.

...Ghost...

My initial thoughts when I heard about the shortage was that AZ were supplying the UK with the batches destined for the EU.

edited to add: https://news.sky.com/story/covid-19-astrazeneca-to-cut-covid-19-vaccine-delivery-to-eu-by-60-reports-12195923

Fr_Dougal

NeuralNetwork wrote: »

The European Commission is concerned about where its money went basically.

AstraZeneca were paid €336 million as a downpayment to assist with the R&D and production expansion effort and there's a commitment to order €750m worth of product from them. That isn't small change.

Stella Kyriakides, European Commissioner for Health and Food Safety's statement:

https://www.youtube.com/watch?v=HLIs2tZ7Cp4

As to what's happening. The answer is we don't know, but by the looks of it we'll be finding out shortly. She seems to be absolutely furious and I don't think they would kick off that level of undiplomatic language without there being more to this than a little misunderstanding.

Hopefully that's all it is though, but we'll see. There's a meeting tonight.

Blatantly obvious, non-EU countries have paid above the odds for supply, and AZ have supplied them instead of fulfilling their EU orders.

NIMAN

Probably right.

At the end of the day, most things like this boil down to money.

L1011

They gave the UK stock that was being held for other countries on the assumption that it would be replaced before it was approved in those other countries. This was mentioned at the time they did it.

That is now catching up with them.

Does this undersupply fall somewhere in the Brexit context....

Seriously bad grace by the sounds of it.

Sweet.Science

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

bennyl10

Sweet.Science wrote: »

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

could easily sue if the conntract is broken

CIARAN_BOYLE

Sweet.Science wrote: »

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

Depends on the contract.

They may be able to demand financial damages or leave Astra Zenaca the choice of paying damages or importing to the eu from other countries.

Sweet.Science

bennyl10 wrote: »

could easily sue if the conntract is broken

Doesn't really help on the supply though . May affect future supply if they did sue

Russman

Sweet.Science wrote: »

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

True enough, but good luck to AZ getting any other future product onto shelves in the EU. It’s a big market to p1ss off at the expense of one the size of the UK. Europeans have long memories.

Donald Trump

Sweet.Science wrote: »

Doesn't really help on the supply though . May affect future supply if they did sue

They would still be liable to fulfill existing contracts.


If they did indeed pull a fast one then they shouldn't be let away with it.


Sounds a bit like a dodgy builder tactic where he gets paid up-front for an extension and then picks up other jobs in the meantime as he can because he knows the person who paid up front just has to sit and wait.

HalfAndHalf

Grabs popcorn, sits back to watch the thread turn into a ‘those bloody Brits it’s all a Brexit stitch up forgetting the company is half owned by a Swedish company’!!

Sweet.Science

Donald Trump wrote: »

They would still be liable to fulfill existing contracts.


If they did indeed pull a fast one then they shouldn't be let away with it.


Sounds a bit like a dodgy builder tactic where he gets paid up-front for an extension and then picks up other jobs in the meantime as he can because he knows the person who paid up front just has to sit and wait.

Yeah I agree they have opened themselves up for a massive lawsuit

Money in 5 yrs time is pointless now though

drunkmonkey

Fr_Dougal wrote: »

Blatantly obvious, non-EU countries have paid above the odds for supply, and AZ have supplied them instead of fulfilling their EU orders.

They might have paid over the odds but it's still cheaper than what Pfizer & Co were offering them, I was listening to one of the girls on the team making it, think she was Irish a few weeks ago, the intention was to get it to the poorer counties first as the others were too expensive.

HalfAndHalf

Sweet.Science wrote: »

Yeah I agree they have opened themselves up for a massive lawsuit

Money in 5 yrs time is pointless now though

How so? There are precisely zero facts as yet and just because there’s been some very unstatesmanlike rants coming out of Brussels it’s not what you think, it’s what you can prove.

All anyone has been told as yet is that there’s been a fire in an Indian plant and production issues at a Belgian plant, the latter being the cause of the Pfizer and BioNtech delays.

MrMusician18

Sweet.Science wrote: »

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

Export ban would probably be the most serious consequence.

emo72

They sold to the Brits, and their delivery van had broke down. I'm not forgetting about you guvnor, I'll give you a call next week, gotta fly mate, me missus is on the other line.

Danzy

Sweet.Science wrote: »

What option does the EU have here ? Other than accepting they have been shafted and wait for the supplies to come ?

They could pull the finger out and get it approved.

The response has been pretty limp wristed for the last few months.

An Ri rua

HalfAndHalf wrote: »

How so? There are precisely zero facts as yet and just because there’s been some very unstatesmanlike rants coming out of Brussels it’s not what you think, it’s what you can prove.

All anyone has been told as yet is that there’s been a fire in an Indian plant and Belgian plant, the latter being the cause of the Pfizer and BioNtech delays.

2 fires? One fire is unfortunate...

CIARAN_BOYLE

Danzy wrote: »

They could pull the finger out and get it approved.

The response has been pretty limp wristed for the last few months.

Tell me what vaccination regime should be applied on approval?

When should the second dose happen?

Danzy

Astra Zeneca is one of the few that aren't cashing in on this and are providing it for cost.

Their plant in India is not meeting production targets, due to shortage of a specific ingredient from China.

China presumably using it up for its own vaccine.

HalfAndHalf

An Ri rua wrote: »

2 fires? One fire is unfortunate...

Original post edited. Fire at Indian plant and production issues at plant in Belgium.

basill

HalfAndHalf wrote: »

Grabs popcorn, sits back to watch the thread turn into a ‘those bloody Brits it’s all a Brexit stitch up forgetting the company is half owned by a Swedish company’!!

Its a plc. The original Zeneca shareholders who received 53.5% of the shares following the merger with Astra AB weren't necessarily Swedish.

Indian plant would appear to be a separate entity and exclusively for the production of local product called Covishield. Would appear to be a red herring.

Sweet.Science

HalfAndHalf wrote: »

How so? There are precisely zero facts as yet and just because there’s been some very unstatesmanlike rants coming out of Brussels it’s not what you think, it’s what you can prove.

All anyone has been told as yet is that there’s been a fire in an Indian plant and Belgian plant, the latter being the cause of the Pfizer and BioNtech delays.

Surely in the unlikelihood of 2 fires occuring at 2 separate plants at least it would be easy to explain

However they can't provide a reason for the delay

It stinks

HalfAndHalf

CIARAN_BOYLE wrote: »

Tell me what vaccination regime should be applied on approval?

When should the second dose happen?

What’s that got to do with the time it’s taking to sign off on the AZ vaccine. That’s just deflecting!

They’ve all jumped into throwing their weight around yet we’re still 4 days off from them approving the vaccine they’re moaning they won’t get enough of anyway!

Dressoutlet

Tbh I'm pissed off at the EU telling Ireland we can't have a supply ready for when it's approved. They're taking their time and punishing the UK for brexit (not a fan of brexit myself, I support the EU) but risking the rest of our health's for spite. AZ should tell the EU to go fxxk themselves.

HalfAndHalf

basill wrote: »

Its a plc. The original Zeneca shareholders who received 53.5% of the shares following the merger with Astra AB weren't necessarily Swedish.

Indian plant would appear to be a separate entity and exclusively for the production of local product called Covishield. Would appear to be a red herring.

Ah a quick Google fact. Thanks. Irrelevant to it being a U.K./Swedish company entirely.

Danzy

CIARAN_BOYLE wrote: »

Tell me what vaccination regime should be applied on approval?

When should the second dose happen?

The regime that follows best medical practice driven by the evidence.

The 2nd dose is ditto.

The EU has been lax on the response, that's hardly contentious.

Donald Trump

HalfAndHalf wrote: »

Grabs popcorn, sits back to watch the thread turn into a ‘those bloody Brits it’s all a Brexit stitch up forgetting the company is half owned by a Swedish company’!!

The main connection with Brexit was that Brexit allowed the UK ruling classes to use the workers as guinea pigs for the vaccine roll out



It also allows the UK to jump the queue and outbid the EU countries and potentially start a bidding war for short-term optics.

Mike3549

Dressoutlet wrote: »

Tbh I'm pissed off at the EU telling Ireland we can't have a supply ready for when it's approved. They're taking their time and punishing the UK for brexit (not a fan of brexit myself, I support the EU) but risking the rest of our health's for spite. AZ should tell the EU to go fxxk themselves.

Its not EU who tells that, its AZ

CIARAN_BOYLE

HalfAndHalf wrote: »

What’s that got to do with the time it’s taking to sign off on the AZ vaccine. That’s just deflecting!

They’ve all jumped into throwing their weight around yet we’re still 4 days off from them approving the vaccine they’re moaning they won’t get enough of anyway!

Astra Zenaca did a trial based on the second dose being 3 weeks after the first dose. The efficacy was 62%.

They had a second regimen of a half dose and then 4-5 months later a full dose with efficacy of around 90%. Astra Zenaca said that this was wrong and it was flawed.

Astra Zenaca have then come up with a 3rd regimen with very little data of taking one dose and 12 weeks later taking a second dose. There was next to no trial data on it bus Astra zenaca said they thing it's the best based on some lab based data.

If we are to approve the vaccine and a dosage regimen we should have some better data. Hopefully the ema have better data now but the above is a summary of what they had last time.

Russman

Dressoutlet wrote: »

Tbh I'm pissed off at the EU telling Ireland we can't have a supply ready for when it's approved. They're taking their time and punishing the UK for brexit (not a fan of brexit myself, I support the EU) but risking the rest of our health's for spite. AZ should tell the EU to go fxxk themselves.

Ireland is the EU and a company can’t release unapproved medicinal products before they’re approved. It’s not the EU just saying we can’t.

You really want us to go short of vaccines because you have the hump with the EU ?

HalfAndHalf

Donald Trump wrote: »

The main connection with Brexit was that Brexit allowed the UK ruling classes to use the workers as guinea pigs for the vaccine roll out



It also allows the UK to jump the queue and outbid the EU countries and potentially start a bidding war for short-term optics.

U.K. ruling classes use workers as guinea pigs......jump the queue.......Jesus Christ I’ve heard it all now!!! LOL!!!

Danzy

Dressoutlet wrote: »

Tbh I'm pissed off at the EU telling Ireland we can't have a supply ready for when it's approved. They're taking their time and punishing the UK for brexit (not a fan of brexit myself, I support the EU) but risking the rest of our health's for spite. AZ should tell the EU to go fxxk themselves.

To a degree countries are pushing their own, drives jobs etc but it's just not getting on with it mostly.

Donald Trump

Danzy wrote: »

They could pull the finger out and get it approved.

The response has been pretty limp wristed for the last few months.

Because they are not taking shortcuts? Or allowing exceptions that wouldn't normally be allowed? Hardly limp-wristed is it?



UK seem happy enough to bung over a large wad and start injecting it into their citizens without asking too many questions. Seems like the UK basically kinda said "ok, we trust you guys and won't question you."

HalfAndHalf

CIARAN_BOYLE wrote: »

Astra Zenaca did a trial based on the second dose being 3 weeks after the first dose. The efficacy was 62%.

They had a second regimen of a half dose and then 4-5 months later a full dose with efficacy of around 90%. Astra Zenaca said that this was wrong and it was flawed.

Astra Zenaca have then come up with a 3rd regimen with very little data of taking one dose and 12 weeks later taking a second dose. There was next to no trial data on it bus Astra zenaca said they thing it's the best based on some lab based data.

If we are to approve the vaccine and a dosage regimen we should have some better data. Hopefully the ema have better data now but the above is a summary of what they had last time.

Yep, we know all this, it was widely reported, it still doesn’t answer your initial response of what’s this got to do with the fact we’re still 4 days away from it being approved!

Dressoutlet

Mike3549 wrote: »

Its not EU who tells that, its AZ

No, Brussels told Ireland they are not to order doses.

HalfAndHalf

Donald Trump wrote: »

Because they are not taking shortcuts? Or allowing exceptions that wouldn't normally be allowed? Hardly limp-wristed is it?



UK seem happy enough to bung over a large wad and start injecting it into their citizens without asking too many questions. Seems like the UK basically kinda said "ok, we trust you guys and won't question you."

Or, back in reality, they amended the approval process and signed off as results were given instead of waiting until the end then start reading through a ton of documentation from the 1st page!

CIARAN_BOYLE

HalfAndHalf wrote: »

Yep, we know all this, it was widely reported, it still doesn’t answer your initial response of what’s this got to do with the fact we’re still 4 days away from it being approved!

Lets see if I can make it simple.

Data is bad.

Ema need to take time and do due diligence to study the data in depth.

Ema wont take shortcuts.

If anyone wants to complain about the approval not coming through I want them to explain the data and their favoured dosage regimen.