What exactly is happening with AstraZeneca?

emmalynn19

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.

The EU literally paid AZ to produce and stockpile vaccine before authorisation was given.

Melanchthon

[Deleted User] wrote: »

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.


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?

There is no information that other countries have been paying more for the Astra Zeneca vaccine doses, in fact it's been denied (apart from a slight differences due to cost changes between countries).
They are delivering the vaccine at cost/very close to cost, which is why it's being considered so important outside the 1st world.

noodler

VinLieger wrote: »

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.

But a contract regarding supply would absolutely be valid.

If approval isnt given then there is no obligation to buy in the case of the APAs

emmalynn19

noodler wrote: »

If approval isnt given then there is no obligation to buy in the case of the APAs

Theyve already paid

titan18

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.

I think Trump had already done it, so Biden will just be following on. Happened with the PPE too.

VinLieger

noodler wrote: »

If approval isnt given then there is no obligation to buy in the case of the APAs

That has nothing to do with a contract being valid or not and the EU paid upfront as far as we know on the agreement that certain numbers would be available the second it was approved.

emmalynn19

emmalynn19 wrote: »

Ignore list for you.

I guess I am on your ignore list, so you won't read this, but can you point me to the part of the contract that details when, where and how many of the vaccines will be delivered?

VinLieger

VinLieger wrote: »

That has nothing to do with a contract being valid or not and the EU paid upfront as far as we know on the agreement that certain numbers would be available the second it was approved.

as far as we know based on what?

Donald Trump

mick087 wrote: »

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

If penicillin had been discovered due to negligence in what was supposed to have been a well managed and controlled experiment for something else, would it not make you a little bit worried about the control procedures in place?


A bit like going for an operation to have your tonsils removed and waking up after the operation to be told "we actually removed your balls instead .... but look on the bright side, we found out afterwards that one of them had early stages of cancer.".
You might steer clear of that surgeon for any future procedures!

cnocbui

emmalynn19 wrote: »

Theyve already paid

Yes, but when governments ask for their money back, they are unlikely to have a problem getting it.

noodler

emmalynn19 wrote: »

Theyve already paid

A small percentage was paid up front.

The vast majority of the bill has not

Aegir

Aegir wrote: »

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

Aegir wrote: »

..but can you point me to the part of the contract that details when, where and how many of the vaccines will be delivered?

Aegir wrote: »

as far as we know based on what?

Well you were pretty certain a few posts back not just about this contract but all the other contracts you made up in your head regarding other agreements made by other parties.

If you really thought that we couldn't discuss this unless we had seen the contracts then you wouldn't be discussing it. But we do know what the EU claims, without having seen the contracts, they say they were promised 100M doses in Q1. Unless you have evidence to the contrary that's the contract.

Donald Trump

cnocbui wrote: »

Yes, but when governments ask for their money back, they are unlikely to have a problem getting it.

But that's not good enough.


If I wanted to build a business and came to you and said "Lets do it between us. You put in 50k and I'll put in 50k and we'll try this. If it works it will be worth 1m. If it doesn't work though we won't be left with anything to show for it."



You give me the money, it works and I sell it for 1m. I then turn around and give you your 50k back and say "there you go - we're quits now" and keep 950k for myself.

Melanchthon

What happens if Astra Zeneca just pulls it's attempt at market authorisation in the EU.

For the record really don't think that will happen but it would resolve this headache for them and they have along with SinoVac and Sputnik the rest of the 2nd and 3rd world to vaccinate so wouldn't be short of orders.

Deleted User

Deleted User wrote: »

Well you were pretty certain a few posts back not just about this contract but all the other contracts you made up in your head regarding other agreements made by other parties.

If you really thought that we couldn't discuss this unless we had seen the contracts then you wouldn't be discussing it. But we do know what the EU claims, without having seen the contracts, they say they were promised 100M doses in Q1. Unless you have evidence to the contrary that's the contract.

what are you on about? what contracts did I make up in my head?

none of us have seen the contract, no one outside of the EU commission and Astra Zeneca has.

I do know a thing or two about supply contracts though and i would be pretty sure that there are words like "Endeavour to deliver up to..." and things like that.

I would also expect to see something that puts some expectations on the EU as well, such as "You give us approval by this date and we will start deliveries on this date".

Astra Zeneca are not going to put millions of euros worth of vaccines in stock on the basis that the eu may or may not take them, it is not only unreasonable, it is morally ****ing unethical when other countries could be putting those vaccines to good use.

VinLieger

Aegir wrote: »

Astra Zeneca are not going to put millions of euros worth of vaccines in stock on the basis that the eu may or may not take them, it is not only unreasonable, it is morally ****ing unethical when other countries could be putting those vaccines to good use.

Well we know AZ are already morally unethical considering the original Oxford team pledged to donate the rights for their vaccine to any drug maker but then AZ stepped in and stopped that. In fact trying to use moral ethics as some kind of argument for being on pharmas side is ****ing hilarious.

FileNotFound

VinLieger wrote: »

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.

How is it Bollix?

I work in Pharma drug release for Bio/Small molecule drugs (no experience with Vaccines, and in fairness pandemic may mean new rules)

Once an MIA is granted the company is legally obliged to Blah blah blah. Market supply being the main thing. Efficacy is shown pre approval - has nothing to do with post approval. Where did you get that from?

How can a supply contract be enforced when the purchaser at this time refuses to legally acknowledge your drug as saleable?

There are probably very few examples of this in history - so not sure how people are so sure of there standing.

Donald Trump

Aegir wrote: »

what are you on about? what contracts did I make up in my head?

none of us have seen the contract, no one outside of the EU commission and Astra Zeneca has.

I do know a thing or two about supply contracts though and i would be pretty sure that there are words like "Endeavour to deliver up to..." and things like that.

I would also expect to see something that puts some expectations on the EU as well, such as "You give us approval by this date and we will start deliveries on this date".

Astra Zeneca are not going to put millions of euros worth of vaccines in stock on the basis that the eu may or may not take them, it is not only unreasonable, it is morally ****ing unethical when other countries could be putting those vaccines to good use.

That's some set of mental acrobatic contortions there.


So it's ok to ignore the contract as long as AZ is producing a product that it knows won't pass standard test requirements, and it is entitled to take the EU money by deception up front to fund themselves, and instead ship it to poorer countries that don't have those standards.


:pac:

Leroy42

None of us have seen th contract so we can only go on what has been said.

It seems nobody is disputing that an agreement was made for a certain number of vaccines to be delivered to the EU. We can be pretty certain of this since AZ has said that they cannot meet the number of vaccines.

Was there an agreement of a certain timeframe? Again, AZ has given reasons why they need to push back the delivery date. It would seem fairly safe to assume that at the very least a target date was agreed.

Did the EU pay up front? EU have said they have, AZ have not claimed otherwise, which would be a pretty strong hand to play if it was a lie. So again, I think it fairly safe to say we can take this as a given.

Was the contract contingent of circumstances? It certainly could be. The only thing to go show what is the EU have made such a fuss out of this, would be seem to go against their being a contingency clause in the contract. But we don't know for sure. It could be that the EU has misunderstood the contract they agreed and hitting out at what they perceive as bad faith by AZ, when in reality it could just be down to bad negotiion by the EU.

But that raises the question why AZ wouldn't include such a clause in the other contracts, which is why they cannot reduce those numbers but can for the EU.

AdamD

Aegir wrote: »

what are you on about? what contracts did I make up in my head?

none of us have seen the contract, no one outside of the EU commission and Astra Zeneca has.

I do know a thing or two about supply contracts though and i would be pretty sure that there are words like "Endeavour to deliver up to..." and things like that.

I would also expect to see something that puts some expectations on the EU as well, such as "You give us approval by this date and we will start deliveries on this date".

Astra Zeneca are not going to put millions of euros worth of vaccines in stock on the basis that the eu may or may not take them, it is not only unreasonable, it is morally ****ing unethical when other countries could be putting those vaccines to good use.

That is literally what they agreed to. Why is that so difficult for you to get?

FileNotFound

Melanchthon wrote: »

What happens if Astra Zeneca just pulls it's attempt at market authorisation in the EU.

For the record really don't think that will happen but it would resolve this headache for them and they have along with SinoVac and Sputnik the rest of the 2nd and 3rd world to vaccinate so wouldn't be short of orders.

Not sure they will risk a mutli billion dollar company over a low profit short lifespan vaccine. I guess the answers is shareholders want cash and pissing off the EU is not a good way to make it.

AdamD

AdamD wrote: »

That is literally what they agreed to. Why is that so difficult for you to get?

can you show me the part of the contract that states this?

Donald Trump

Aegir wrote: »

I do know a thing or two about supply contracts though and i would be pretty sure that there are words like "Endeavour to deliver up to..." and things like that.

I heard that big Phil drafted the contract and that it actually said:


"ah sure lookit lads. Ye can deliver it whenever ye feel like it. It's grand. Don't worry about it".

Donald Trump

Donald Trump wrote: »

That's some set of mental acrobatic contortions there.

explain

Donald Trump wrote: »

So it's ok to ignore the contract as long as AZ is producing a product that it knows won't pass standard test requirements, and it is entitled to take the EU money by deception up front to fund themselves, and instead ship it to poorer countries that don't have those standards.

That's some set of mental acrobatic contortions there

Donald Trump

Donald Trump wrote: »

I heard that big Phil drafted the contract and that it actually said:


"ah sure lookit lads. Ye can deliver it whenever ye feel like it. It's grand. Don't worry about it".

in the middles of a pandemic, any seller of a product sought by governments the entire world over would actually be doing pretty much that, yes.

Mullaghteelin

Not in Kansas wrote: »

Absolutely Mick. A lot of talk about concerns over the education and future of our children being affected by the pandemic in recent days. Well actually, I'm far more worried about what kind of a world we will have if poorer countries are simply left behind in the vaccination programmes. The idea of a shared humanity will become meaningless, and what kind of a world is that for our children?

Thats the harsh reality of the world we live in. Utopian ideals like a shared humanity is an unrealistic fantasy. Could we trust military dictatorships to distribute the vaccine fairly amongst their populations? Will theocratic states be trusted to supply vaccines to religious minorites? Etc etc. The vaccine will become a weapon to be abused by corrupt or genocidal regimes.

I suspect the Chinese will be capable of suppling the developing world far sooner than "the West", but they will expect loyalty and access to natural resources in return.

Melanchthon

Mullaghteelin wrote: »

I suspect the Chinese will be capable of suppling the developing world far sooner than "the West", but they will expect loyalty and access to natural resources in return.

Not even just the developing world, look at Hungary and Serbia, two European countries.

Aegir

Aegir wrote: »

what are you on about? what contracts did I make up in my head?

These ones"

..they would do all along and honour contracts in the order they were signed, they started throwing their weight around.


You seemed pretty certain that there were other contracts out there. You also seem to think that contracts only matter in the order they are signed.

none of us have seen the contract, no one outside of the EU commission and Astra Zeneca has.

We don't have to see the contracts, we know what the EU has claimed and unless
you have extraordinary proof to the contrary - then what is claimed is due to the EU: ie 100M doses in Q1.

I do know a thing or two about supply contracts though and i would be pretty sure that there are words like "Endeavour to deliver up to..." and things like that.

So now while we can't speculate on the known details of the contract you can speculate on the details of it. Jesus wept. Sure there is probably an Endeavour clause but clearly the EU are claiming that AZ haven't met that opt out. AZ can produce enough but are prioritising other countries while claiming production issues. Hence the export ban.

I would also expect to see something that puts some expectations on the EU as well, such as "You give us approval by this date and we will start deliveries on this date".

Once again while we can not speculate on the main headline of the contract you seem to be able to pluck the very details from your ass. If that were in the contract the EU would be in no position to demand and AZ would issue a statement saying the EU didn't live up it its side of the bargain. AZ haven't done so.

Astra Zeneca are not going to put millions of euros worth of vaccines in stock on the basis that the eu may or may not take them, it is not only unreasonable, it is morally ****ing unethical when other countries could be putting those vaccines to good use.

It was up to the company to fulfil its 100M obligations once the EU approved, they were aware that process was in place. Therefore they should have ramped up, or be in a position to ramp up to meet the contract.

It is totally and utterly moral for the EU to demand what it paid for and totally immoral for rogue regimes to jump in and steal the agreed upon doses. And this isn't just about money, it is about lives. The company executives need to be held responsible criminally for any difference in deaths that will happen across the EU because of the failure to vaccinate due to the shortfall.

FileNotFound

Ah sure once J&J get going this might be redundant.

1 Billion units of theirs stocked and ability to make 2 billion a year.

That with the fact its a single dose one makes it the real game changer, or one can hope.

emmalynn19

noodler wrote: »

A small percentage was paid up front.

The vast majority of the bill has not

The EU is paying €1.78 per dose and have paid €298 million euro up front. How is that a small percentage?

Leroy42

Aegir wrote: »

can you show me the part of the contract that states this?

But why are the EU claiming it and AZ not denying it?

I have laid out the basis for the claims, you seem to simply be ignoring the reality on the basis that until you see the contract nothing is known or agreed.

emmalynn19

FileNotFound wrote: »

Ah sure once J&J get going this might be redundant.

1 Billion units of theirs stocked and ability to make 2 billion a year.

That with the fact its a single dose one makes it the real game changer, or one can hope.

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

Renault 5

Leroy42 wrote: »

But why are the EU claiming it and AZ not denying it?

I have laid out the basis for the claims, you seem to simply be ignoring the reality on the basis that until you see the contract nothing is known or agreed.

AstraZeneca's silence is deafening.

is_that_so

emmalynn19 wrote: »

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

Probably by now, it was mentioned a while back.

KrustyUCC

emmalynn19 wrote: »

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

Yes Pfizer have

Buddy working in Ringaskiddy got his first shot on the 16th of January

is_that_so

Renault 5 wrote: »

AstraZeneca's silence is deafening.

No harm to having a little less noise at present but two things needed, how it happened and how can it be fixed.

trellheim

Folks.

Facts :

1: The "contract" for AZ vaccine is known as an Advance Purchase Agreement or APA
2: In there is amounts of vaccine, how much paid, and by when delivered, plus lots of legalese "as production allows etc".
3: Although as folks pointed out, no CMA ( Conditional Marketing Approval) has yet been approved for AstraZeneca, we (the EU) paid up front in advance of CMA to secure our place in line for the vaccine WHETHER or NOT approved.

4: Now - and this is important - there are NO public details of the APA out there; it's confidential and both AZ and the Commission have refused to release them citing confidentiality. Anyone stating "outside the terms of the contract" except the Commission or AZ is talking through their hat basically. "Delayed delivery?" - might be covered - do we know ? No idea.

If you dont like this, petitition the Commission to release the APA details, theyve refused the Europarl and everyone else so far.

trellheim

I'd add a rider to that saying although AZ APA is confidential, Curevac released their APA publicly , we think because the US regulators forced them to.

See https://ec.europa.eu/info/sites/info/files/curevac_-_redacted_advance_purchase_agreement_0.pdf

(heavily redacted but you get the idea)

NOTE FOR REPETITION THATS THE CUREVAC ONE NOT THE AZ ONE , AND CUREVAC IS NOT APPROVED EITHER.

coastwatch

emmalynn19 wrote: »

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

That doesn't seem right, different standards here I suppose.
Not even Ugur Sahin, the CEO and Co-Founder of Biotech or the employees were allowed to have the vaccine in Germany, because the vaccine priority there is on a legal basis.
At 07:35 in this video.

https://www.youtube.com/watch?v=TOT8ElNBbo4

FileNotFound

emmalynn19 wrote: »

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

The missus works for them and its only onsite staff - office wfh staff are being promised no such thing.

Pfizer WFH staff told they are not back on site until July. No indication they will get vaccine.

FileNotFound

coastwatch wrote: »

That doesn't seem right, different standards here I suppose.
Not even Ugur Sahin, the CEO and Co-Founder of Biotech or the employees were allowed to have the vaccine in Germany, because the vaccine priority there is on a legal basis.
At 07:35 in this video.

https://www.youtube.com/watch?v=TOT8ElNBbo4

Tiny number of critical staff only - lets not forget these companies still function 100% making all the other life saving medication we need. Pandemic or no.

When you really think about it critical front line workers - Pharma on site staff (which is now critical staff only in most cases) far more important than teachers.

slievenamon fella

emmalynn19 wrote: »

Hopefully. Interestingly, J&J have commited to vaccinating all of their staff here as soon as the vaccine is available.


Wonder have Pfizer started vaccinating staff?

Pfizer's started vaccinating staff two weeks ago. was lucky enough to get it myself.

noodler

trellheim wrote: »

Folks.

Facts :

1: The "contract" for AZ vaccine is known as an Advance Purchase Agreement or APA
2: In there is amounts of vaccine, how much paid, and by when delivered, plus lots of legalese "as production allows etc".
3: Although as folks pointed out, no CMA ( Conditional Marketing Approval) has yet been approved for AstraZeneca, we (the EU) paid up front in advance of CMA to secure our place in line for the vaccine WHETHER or NOT approved.

4: Now - and this is important - there are NO public details of the APA out there; it's confidential and both AZ and the Commission have refused to release them citing confidentiality. Anyone stating "outside the terms of the contract" except the Commission or AZ is talking through their hat basically. "Delayed delivery?" - might be covered - do we know ? No idea.

If you dont like this, petitition the Commission to release the APA details, theyve refused the Europarl and everyone else so far.

Point 3 is wrong as far as I know.

We do not pay if there is no regulatory approval.

CIARAN_BOYLE

noodler wrote: »

Point 3 is wrong as far as I know.

We do not pay if there is no regulatory approval.

We've already paid.

trellheim

Point 3 is wrong as far as I know.

We do not pay if there is no regulatory approval.

like I said in point 4 - you might be right - no-one knows. Anyone saying they do know truthfully works for AZ or the Commission. But I do think, as several have said, that money has changed hands already, to help fund vaccine development.

emmalynn19

FileNotFound wrote: »

The missus works for them and its only onsite staff - office wfh staff are being promised no such thing.

Pfizer WFH staff told they are not back on site until July. No indication they will get vaccine.

Interesting my missus works for them too and says she's been told it will be made available to all perm staff and their families.

noodler

CIARAN_BOYLE wrote: »

We've already paid.

A small percentage upfront for the r&d. Unknown if this is refundable.

The majority of the bill in all APAs has not been paid.

noodler

trellheim wrote: »

like I said in point 4 - you might be right - no-one knows. Anyone saying they do know truthfully works for AZ or the Commission.

Or the HSe, DoH or any parliamentary tbf.

SD is on record saying we don't pay but my sleuthing is letting me down for the link just this second. It was a PQ or Dail speech.

emmalynn19

noodler wrote: »

A small percentage upfront for the r&d. Unknown if this is refundable.

The majority of the bill in all APAs has not been paid.

We've paid for about half the ordered doses up front, not a 'small percentage'

noodler

emmalynn19 wrote: »

We've paid for about half the ordered doses up front, not a 'small percentage'

Untrue.

Any evidence to support that?

We will have paid Pfizer more as there one is approved but we have not paid half the bill for any APA where the company has not got regulatory approval.