What exactly is happening with AstraZeneca?

FileNotFound

greyday wrote: »

5 months difference of signing for the vaccine and then refused to order more even when suggested strongly by owners of Germany company BioNtech.

Like everything else it is first come first served when issues arise, you might show us the contract stipulation which says that the EU gets preference to receive vaccines before all those Countries who ordered and paid before the EU for the vaccines.
I am betting you wont show that part of the contract because it does not exist.

This is like watching lost kids argue about stuff they know nothing of.

BY law at this time AZ cannot sell the EU anything - approval pending.

Approval is pending in most of the world for the AZ vaccine as they literally did not complete all the necessary checks - Thus the EMA correctly told them go back and finish stuff.

AZ are now in a position that they are unsure of the approval date in the EU and the UK has approved them. (This part is conjecture) AZ have decided to sell their stock where it can be sold

The EU contract won't be binding until post approval. When they get their MIA.

FileNotFound

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?

What plan B would they have - there is only 1 plan - get vaccines and vaccinate - supply and demand have been handed over the the EU and I think rightly in the long run.

Are the gov going to invent their own vaccine???? You would swear the HSE and Irish Gov had any say the way people moan about them.

Renault 5

The European Commission (EC) reached an agreement with AZ in August 2020 for up to 400 million doses of the COVID-19 vaccine.

- Around 80 million doses of the AZ/Oxford University vaccine were expected to be delivered by the end of March.

- The British drugmaker also agreed to deliver over 80 million doses of the vaccine in the second quarter.

It would be interesting to know what AZ have told the EU what the in the delivery update and how many doses are currently going to other Non EU countries.

CelticRambler

is_that_so wrote: »

Is there some blame on the EU? Quite probably but in such a novel scenario mistakes are likely to happen.

To all those claiming that the EU has "made a balls" of this, it might be worth remembering that at this time last year the EU had no, absolutely no power to do anything about anything with regard to healthcare in the 27 member states. Apart from the approval of medicines (for reasons of Single Market regulation) is one area that has never come under the EU's umbrella.

So for the last fourteen months, the people in the EU have not only being trying to come up with a coherent plan for the immediate and medium-term future (including drafting rules for cooperation that never existed before), but also have had to deal with more than two dozen national governments being utterly incompetent in their own handling of the problem, then over-reacting with yet more stupidity that makes the situation worse for everyone.

fly_agaric

Aegir wrote: »

you clearly did read my full post as you went to the trouble of deleting the relevant bit. Here, I will add it for your benefit.
I believe that is relevant.

oh I read it.

How you believe Ireland's nakedly corrupt government and health services are preventing you and your family being vaccinated (because you don't have an "in") does not really connect to the moan about the EU.

Can you explain the connection to me there?

Do you believe the (Irish) government should have refused to take part in the EU vaccination framework?

Is that it?

Donald Trump

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.

FileNotFound

Renault 5 wrote: »

It would be interesting to know what AZ have told the EU what the in the delivery update and how many doses are currently going to other Non EU countries.

How many have granted approval to the AZ drug - you'll find very few.

I imagine most AZ vaccine is headed to the UK.

They can only ship and sell where they are approved.

ACitizenErased

AZ News:
https://twitter.com/DarrenEuronews/status/1354043685177085953?s=20

FileNotFound

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.

Thats quite an imagination you have - all the vaccines bar J&J are gone 2 dose - we have used boosters for years - yet this is all an accident haha.

Gas stuff.

Donald Trump

FileNotFound wrote: »

Thats quite an imagination you have - all the vaccines bar J&J are gone 2 dose - we have used boosters for years - yet this is all an accident haha.

Gas stuff.

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

In an interview Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures.

He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses.

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.