What exactly is happening with AstraZeneca?

mick087

mick087 wrote: »

what you expect when dealing with an organization and not a elected government

Yeah, because Governments are renowned for their cohesive approaches and lack of disjointed approaches. Plus, everyone knows that nobody has ever stiffed a Government over a contract before....:rolleyes:

Aegir wrote: »

The chances of my family getting the vaccine this year were already small, now the EU commission putting their politics before all else has made that possibility even smaller.

I'm not sure how many times people can put this to you in any different ways that you might be able to understand......and I've no idea what you mean by 'putting politics before all else'. But here's one last attempt, to see if you can get your head around it. The situation so far, appears to look like this:

EU orders vaccine and supplies payment up front.
AZ says no problem, we'll have X amount available when you get it approved
EU begins approval process
AZ begins stockpiling
EU approves vaccine
AZ sells EU pre-paid vaccines to other buyers (possibly paying more per dose)
EU says "Ok, we're ready for X number of doses now"
AZ says "Sorry, lads, we only have 40% of X, you'll have to wait for the rest"
EU says "But you agreed to have X amount ready for us to use immediately, why aren't you honouring your side of the bargain?"
AZ replies
EU says "we are not happy with that reply, we will be taking this further"

titan18 wrote: »

They're meant to have been producing and stockpiling though for ages. How did they not know, and where's that stockpile gone?

1. They were
2. They did
3. Who knows? Gone to the highest bidder, more than likely

FileNotFound

Donald Trump wrote: »

Gas stuff is right.



https://www.bbc.com/news/health-55086927


https://www.irishtimes.com/business/health-pharma/admission-of-mistake-in-oxford-vaccine-dose-raises-doubts-over-reliability-1.4420289

Read that and it says was all 2 doses just some were under strength.. Direct quote below.

""While most of the volunteers in the trial got the correct dose for both of their two shots, some didn't.""

Banana Republic 1

is_that_so wrote: »

It's a HSE plan, not a government one. The only function of government here was to supply money. BTW do you have that Plan B to hand?

The government are using HSE and NPHET as a mud guard.

FileNotFound

Banana Republic 1 wrote: »

The government are using HSE and NPHET as a mud guard.

Oh yeah - it's all Michael's fault that an international Pharma company is playing games with the worlds largest trading body.

How could he let this happen!!!!!

Donald Trump

FileNotFound wrote: »

Read that and it says was all 2 doses just some were under strength.. Direct quote below.

""While most of the volunteers in the trial got the correct dose for both of their two shots, some didn't.""

They had submitted a plan for vaccination trials. They got approval based on that plan.
A contractor made a mistake. They immediately informed the authorities and received approval for a modified plan to incorporate different dosage rates into the plan.



Hardly my imagination now is it?

Banana Republic 1

FileNotFound wrote: »

Oh yeah - it's all Michael's fault that an international Pharma company is playing games with the worlds largest trading body.

How could he let this happen!!!!!

Read my earlier post before going off half cocked.

FileNotFound

Donald Trump wrote: »

They had submitted a plan for vaccination trials. They got approval based on that plan which was a single dose.
A contractor made a mistake. They immediately informed the authorities and received approval for a modified plan to incorporate different dosage rates into the plan.




Anyway, don't worry about it because you know everything and somehow apparently my "imagination" made it into the papers a few months ago.

Modification of clinical trials is hardly new now is it? Also did not see where it showed there original trials plan in the piece?

You may be right. Far from fallible me.

Cryptonovice

I am so deeply afraid that with the speed of the vaccine roll-out the virus is going to MUTATE and get ahead of all the efforts to date! Does anyone else foresee this happening? Like going back to square one over and over again! This is a living nightmare! I am sorry for the doom and gloom but its just how i feel

Deleted User

Deleted User wrote: »

I'm not sure how many times people can put this to you in any different ways that you might be able to understand......and I've no idea what you mean by 'putting politics before all else'. But here's one last attempt, to see if you can get your head around it. The situation so far, appears to look like this:

EU orders vaccine and supplies payment up front.
AZ says no problem, we'll have X amount available when you get it approved
EU begins approval process
AZ begins stockpiling
EU approves vaccine
AZ sells EU pre-paid vaccines to other buyers (possibly paying more per dose)
EU says "Ok, we're ready for X number of doses now"
AZ says "Sorry, lads, we only have 40% of X, you'll have to wait for the rest"
EU says "But you agreed to have X amount ready for us to use immediately, why aren't you honouring your side of the bargain?"
AZ replies
EU says "we are not happy with that reply, we will be taking this further"

And your assumptions are based on...?

Donald Trump

FileNotFound wrote: »

Modification of clinical trials is hardly new now is it? Also did not see where it showed there original trials plan in the piece?

You may be right. Far from fallible me.

The point was that the better dosage rate was found by accident. They did not plan on the dosage rate that turned out to be the best.




I did not mean to be smart in my reply. Apologies. I edited it out after.

mick087

Donald Trump wrote: »

The vaccines are produced by private companies who might decide not to take the risk to invest in ramping up production capability if they think they might not have a market at the end of it. That is why they would want a contract.


We could of course try to do it through the public sector. There are a few lads I know who work in the local council who haven't had much to do since the lockdowns because they aren't able to refurbish the vacated council properties.
Perhaps we should get them onto doing up an oul' vaccine for us?

Yes this is the society we have created private compaines investments dividends etc. I don't agree with it but until society votes to change then this is the world we live.


Maybe if we had a more fairer education system that allowed everyone to flourish then we might few more scientists from not only the local council but from all walks of life coming up with vaccines.

Aegir

Aegir wrote: »

And your assumptions are based on...?

Where am I making assumptions? Everything I've posted is based on information that is widely available and has been in the press for the past 3 days.

She reminded Mr Soriot that the EU has invested significant amounts in the company up front precisely to ensure that production is ramped up even before the conditional market authorisation is delivered by the European Medicines Agency.

The EU has been due to receive 100m doses in the first quarter of this year. But it is feared that the bloc will only receive half of that despite making large advance purchases ahead of authorisation of the vaccine by the European medicines agency.

Last Friday, the company AstraZeneca surprisingly informed the commission and the European Union member states that it intends to supply considerably fewer doses in the coming weeks than agreed and announced.

“This new schedule is not acceptable to the European Union. That is why I wrote a letter to the company at the weekend in which I asked important and serious questions.

https://www.theguardian.com/world/2021/jan/25/eu-threatens-to-block-covid-vaccine-exports-amid-astrazeneca-shortfall

Now, if you could kindly tell me how they're "playing politics", please and thank you?

BredonWimsey

Cryptonovice wrote: »

I am so deeply afraid that with the speed of the vaccine roll-out the virus is going to MUTATE and get ahead of all the efforts to date! Does anyone else foresee this happening? Like going back to square one over and over again! This is a living nightmare! I am sorry for the doom and gloom but its just how i feel

yeah i know what you mean. i also thought for a moment that maybe these delays are because they want to stagger it a bit and see how its working.

FileNotFound

mick087 wrote: »

Yes this is the society we have created private compaines investments dividends etc. I don't agree with it but until society votes to change then this is the world we live.


Maybe if we had a more fairer education system that allowed everyone to flourish then we might few more scientists from not only the local council but from all walks of life coming up with vaccines.

Without it you'd have no medicines - that's a pretty simple fact.

Could you imagine a Gov saying we are cutting social welfare to fund drug research that has a 1 in 100 chance of ever working. And then when it fails - Ooops there went the equivalent cost of the new Childrens hospital.

Until the EU approve the vaccine - not sure they really have a leg to stand on - any contract would have that as a prerequisite. Funding for R&D would not change that. Or so is my understanding.

In fairness our education system literally allows anyone to become a scientist haha. Hell we make thousands of them a year.

is_that_so

Banana Republic 1 wrote: »

The government are using HSE and NPHET as a mud guard.

Well, they might be if there was a need for a mudguard for something they are not doing The HSE run our vaccination programmes every year and how exactly do NPHET figure here?

greyday

Donald Trump wrote: »

I think that there are two things that maybe you don't fully understand. I will try to clear it up.


The first issue is not that there is not a contract. It is that an agreement was made, a contract was signed, money was handed over, but the product is now not going to be delivered.
You see, perhaps if AZ had been honest up front, the EU might have instead invested its money in a different company.


The other issue is that you may not understand the idea of a contract. If I sign a contract with you to do something, the conditions of that contract are not voided because I later find out that you already signed other contracts before mine. "first come first served" has no legal basis when a contract is in place.

A few things you dont understand, all contracts will have contingencies within them to deal with unforseen circumstances, the EU delayed signing a contract for an experimental vaccine which was not 100% guaranteed to work, a whole host of other Countries had signed contracts for this experimental vaccine on the chance that it would work but did so before the EU, any manufacturing issues that arises put the EU further back as they delayed their signing, hope you understand the basic common sense rather than have to go back to your house building contract analogy for 5 year olds, you really should know FIFO is built into most contracts/agreements by now, think of it this way, if the USA order a billion doses for delivery in First Quarter of 2021 in July 2020 and EU orders a billion doses for delivery in first quarter 2021 in october 2020, who do you think will get the first billion does if there are delays in production? Do you really think a contract would be signed by a manufacturer that guaranteed something they had not already made to a buyer without including caveats?

Aegir

Aegir wrote: »

And your assumptions are based on...?

What the EU said. They would have accepted if there was a real delay or problem with the vaccines, but they were unhappy with what Astrazeneca said, and are now trying to block exports.

Cryptonovice

Cryptonovice wrote: »

I am so deeply afraid that with the speed of the vaccine roll-out the virus is going to MUTATE and get ahead of all the efforts to date! Does anyone else foresee this happening? Like going back to square one over and over again! This is a living nightmare! I am sorry for the doom and gloom but its just how i feel

Unless the mutation stops the vaccine working there is no issue, and even if it did, the new vaccines would just be produced. We will probably have to update the vaccines every year or so anyway.

emmalynn19

So have AZ actually manufactured the stockpile of vaccines they were paid for by the EU or not? Or did they manufacture them and sell them elsewhere? That seems to be the crux of the matter.

Deleted User

Deleted User wrote: »

What the EU said. They would have accepted if there was a real delay or problem with the vaccines, but they were unhappy with what Astrazeneca said, and are now trying to block exports.

or maybe they just accepted a delivery schedule based on reasonable endeavors and when it became clear those reasonable endeavours were not going to suit them and the Pharma companies were going to do what they had said they would do all along and honour contracts in the order they were signed, they started throwing their weight around.

greyday

greyday wrote: »

A few things you dont understand, all contracts will have contingencies within them to deal with unforseen circumstances, the EU delayed signing a contract for an experimental vaccine which was not 100% guaranteed to work, a whole host of other Countries had signed contracts for this experimental vaccine on the chance that it would work but did so before the EU, any manufacturing issues that arises put the EU further back as they delayed their signing, hope you understand the basic common sense rather than have to go back to your house building contract analogy for 5 year olds, you really should know FIFO is built into most contracts/agreements by now, think of it this way, if the USA order a billion doses for delivery in First Quarter of 2021 in July 2020 and EU orders a billion doses for delivery in first quarter 2021 in october 2020, who do you think will get the first billion does if there are delays in production? Do you really think a contract would be signed by a manufacturer that guaranteed something they had not already made to a buyer without including caveats?

This is evidence free. The US didn't pay more for the vaccines and didn't pay in July 2020, the EU clearly paid ahead of time for them. This is why they are now demanding the vaccines. That they paid for.

It is also clear that AZ are lying - they claim to have production problems but are exporting to unnamed countries. The EU clearly doesn't believe them.

mick087

Banana Republic 1 wrote: »

When the dust I settled with AZ I think it will be very obvious that the government had no plan B. They had to dragged kicking and screaming into the green lighting mask wearing in public and now the border and quarantine thing like a disgraced TD from the Dail.

No elected government who is a member state of the EU organization would be at fault.

The fault is that of the EU organization itsellf.
My guess is they gambled during the negotiations, on the we are the EU do as we say attitude. But during these negotiations other countries was buying so are in line first.

emmalynn19

Aegir wrote: »

or maybe they just accepted a delivery schedule based on reasonable endeavors and when it became clear those reasonable endeavours were not going to suit them and the Pharma companies were going to do what they had said they would do all along and honour contracts in the order they were signed, they started throwing their weight around.

Thats not how contracts work.

Aegir

Aegir wrote: »

or maybe they just accepted a delivery schedule based on reasonable endeavors and when it became clear those reasonable endeavours were not going to suit them and the Pharma companies were going to do what they had said they would do all along and honour contracts in the order they were signed, they started throwing their weight around.

Or maybe the moon is made of cheese. The facts of the case are clear. The EU paid for vaccines it is not getting. How do you know what the order of contacts were signed in anyway? Is there some Brexit website with made up facts out there because you are all singing from he same sheet here.

If AZ were fulfilling contracts in the order that the signed the EU would have no cause foe concern. But clearly they are concerned, and are demanding that AZ fulfilled its obligations.

There is no evidence that other countries have previous contractural agreements. if you can find that evidence, produce it.

Leroy42

Aegir wrote: »

or maybe they just accepted a delivery schedule based on reasonable endeavors and when it became clear those reasonable endeavours were not going to suit them and the Pharma companies were going to do what they had said they would do all along and honour contracts in the order they were signed, they started throwing their weight around.

Where are you getting this idea that the order of signing contracts has any implications on the legality of the contract?

AZ signed the EU contract in full knowledge of the other contracts, they signed it anyway. They agreed that they would meet the EU requirements, knowing they had other commitments.

It is not for the EU to decide if AZ can meet their commitments.

But the EU paid for the contract up front to agree the deal.

mick087

mick087 wrote: »

No elected government who is a member state of the EU organization would be at fault.

The fault is that of the EU organization itsellf.
My guess is they gambled during the negotiations, on the we are the EU do as we say attitude. But during these negotiations other countries was buying so are in line first.

Your "guess" is worthless. If that were the case then AZ would say it, and wouldn't hide behind fake claims of production issues. Nor would the EU have a case. To prove it though you have to produce evidence.

mick087

Donald Trump wrote: »

I think that one thing that should also be remembered, for those people who would be pushing for regular steps to be ignored so that something could be approved earlier.

The AZ vaccine was found to be more effective when given in two doses.

How was that discovered? Who came up with that idea?

Answer - nobody did. They made a mess up in one of the trials. Even though it actually led to an accidentally beneficial discovery, it wouldn't exactly inspire overall confidence in their procedures.

Penicillin was discovered by accident
I belive the chap who discovered it was often described as a careless lab technician.

Leroy42

Deleted User wrote: »

Your "guess" is worthless. If that were the case then AZ would say it, and wouldn't hide behind fake claims of production issues. Nor would the EU have a case. To prove it though you have to produce evidence.

Exactly. AZ initially said it was due to production issues. The EU asked why the EU seemed to be the only ones getting hit by this production issues.

It is only now that people are making the spurious claims about timing of contracts etc.

CIARAN_BOYLE

emmalynn19 wrote: »

So have AZ actually manufactured the stockpile of vaccines they were paid for by the EU or not? Or did they manufacture them and sell them elsewhere? That seems to be the crux of the matter.

Personally I would consider either answer to be unacceptable.

cnocbui

HalfAndHalf wrote: »

The issue with your hypothetical is that AS have already informed Australia that their initial delivery will be short, due to the exact same reasons the EU deliveries will.

I don't think Australia is too worried about that, as it looks like it might be a bit of a dud vaccine:

Scientists call for pause on AstraZeneca vaccine rollout

By Liam Mannix and Aisha Dow
January 12, 2021 — 11.45pm

The Australian and New Zealand Society for Immunology says the federal government should immediately pause the planned rollout of the AstraZeneca vaccine because it may not be effective enough to generate herd immunity.

https://www.smh.com.au/national/scientists-call-for-pause-on-astrazeneca-vaccine-rollout-20210112-p56tjt.html

intellectual dosser

While the EU should demand full transparency, and take its next €900m elsewhere, the threat of meddling with free markets puts everyone in an uncomfortable position. It sets a dangerous precedent for everyone.

Leroy42

Leroy42 wrote: »

Exactly. AZ initially said it was due to production issues. The EU asked why the EU seemed to be the only ones getting hit by this production issues.

It is only now that people are making the spurious claims about timing of contracts etc.

Not that contracts work that way anyway. They aren't first come first served. If you promise 100M units of something in Q1 your other promises have no bearing on that. Not that that looks like it is the case here.

emmalynn19

CIARAN_BOYLE wrote: »

Personally I would consider either answer to be unacceptable.

If I was to guess Id say they produced the vaccines, then flogged them to the Brits thinking they'd have enough time to replenish stocks before the EMA approved them, then ran into manufacturing issues in Belgium.

AdamD

intellectual dosser wrote: »

While the EU should demand full transparency, and take its next €900m elsewhere, the threat of meddling with free markets puts everyone in an uncomfortable position. It sets a dangerous precedent for everyone.

I doubt the EU care too much about an uncomfortable postition, given the seriousness of the situation (lives are literally at stake) and the level of power the EU as a bloc has.

Larbre34

With the amount of public money in their product, they should be stripped of the formula and it should be presented in open source to any other manufacturer in the field for production assessment. Animal products, industrial products, other bio/pharma makers, anyone.

intellectual dosser

AdamD wrote: »

I doubt the EU care too much about an uncomfortable postition, given the seriousness of the situation (lives are literally at stake) and the level of power the EU as a bloc has.

I know that I care, it sets a precedent that in future the EU can play around with markets as it feels.

intellectual dosser

intellectual dosser wrote: »

I know that I care, it sets a precedent that in future the EU can play around with markets as it feels.

id sooner be safe and healthy,than worry about free markets tbh

intellectual dosser

intellectual dosser wrote: »

While the EU should demand full transparency, and take its next €900m elsewhere, the threat of meddling with free markets puts everyone in an uncomfortable position. It sets a dangerous precedent for everyone.

Imposing export controls is common. The US does it all the time, for national security, on strategic tech exports, and other reasons.

political analyst

Cerveza wrote: »

China has some involvement too.

But China has its own vaccines, doesn't it?

fly_agaric

intellectual dosser wrote: »

While the EU should demand full transparency, and take its next €900m elsewhere, the threat of meddling with free markets puts everyone in an uncomfortable position. It sets a dangerous precedent for everyone.

I don't know, you can't allow companies to get away with such behaviour (if they [ie AstraZeneca] have somehow gypped the EU + its member states).

It demonstrates to the others in the market that there will be consequences for some business decisions.

Wouldn't agree with the EU "meddling" with any other companies or their operations though.

Leroy42

Leroy42 wrote: »

Where are you getting this idea that the order of signing contracts has any implications on the legality of the contract?

AZ signed the EU contract in full knowledge of the other contracts, they signed it anyway. They agreed that they would meet the EU requirements, knowing they had other commitments.

It is not for the EU to decide if AZ can meet their commitments.

But the EU paid for the contract up front to agree the deal.

can you point me to the part of the contract that details the delivery schedule?

Deleted User

Deleted User wrote: »

Not that contracts work that way anyway. They aren't first come first served. If you promise 100M units of something in Q1 your other promises have no bearing on that. Not that that looks like it is the case here.

as none of us have seen the contract, we don't know how it works

emmalynn19

Aegir wrote: »

as none of us have seen the contract, we don't know how it works

Just stop.

Inquitus

It seems the AZ Vaccine has a few questions over it, none have been properly substantiated, but there are questions on its efficacy for over 65's. Also there are other questions about the UK strategy of holding off on the 2nd vaccine and what impact that also has on efficacy. We'll have to wait to see how this plays out, but it is possible the UK is vaccinating its way not out of a hole, but into one, time will tell!

emmalynn19

emmalynn19 wrote: »

Just stop.

stop what? talking sense?

FileNotFound

Deleted User wrote: »

Imposing export controls is common. The US does it all the time, for national security, on strategic tech exports, and other reasons.

Biden is literally planning to do that - its also the reason EU demands all EU sold Drugs are made/QC tested in the EU.


Besides it is my simple understanding that there was no binding contract until the EU issued AZ with an MIA for their vaccine.

So until that is done I guess AZ do what they do. I imagine that once approval is given AZ will magic up enough to appease the EU.

FileNotFound

Aegir wrote: »

as none of us have seen the contract, we don't know how it works

In Pharma no contract is valid until Market Authorisation is given

Not sure why that would have changed for this vaccine.

So not sure all this contract chat really means anything to be fair.

is_that_so

FileNotFound wrote: »

Biden is literally planning to do that - its also the reason EU demands all EU sold Drugs are made/QC tested in the EU.


Besides it is my simple understanding that there was no binding contract until the EU issued AZ with an MIA for their vaccine.

So until that is done I guess AZ do what they do. I imagine that once approval is given AZ will magic up enough to appease the EU.

That gives them 3 days!

emmalynn19

Aegir wrote: »

stop what? talking sense?

Ignore list for you.

VinLieger

FileNotFound wrote: »

In Pharma no contract is valid until Market Authorisation is given

Not sure why that would have changed for this vaccine.

So not sure all this contract chat really means anything to be fair.

Well thats absolute bo11ox if a contract has been signed then its valid.

You might talking about the contract as regards efficacy of the drug which would be part of the contract itself.

But a contract regarding supply would absolutely be valid.