What exactly is happening with AstraZeneca?

...Ghost...

HalfAndHalf wrote: »

Well that isn’t what I’m going for, to be honest I’m amazed I seem to be the only one saying this is suspect at best timing.

How would it explain the U.K. scientists completely missing this data.
How would it explain AZ getting away with surmising false data
How would it explain the EMA taking until today to discover the data submitted was incorrect.

Something doesn’t add up. Surely it’s not just me who thinks that?!?

It does seem like you're shilling tbh. To answer your questions...i'm gonna use more words

The UK has some of the best scientists (as do Europe). But the scientists are under UK government pressure. Fill in the blanks as to why.

Data can be falsified and rubber stamped by Governments. Think Olympics and Russia.

Perhaps the EMA were already aware of data inconsistencies which is partly the reason for the delay in approval.

hatrickpatrick

...Ghost... wrote: »

The UK has some of the best scientists (as do Europe). But the scientists are under UK government pressure. Fill in the blanks as to why.

My issue with this angle is, why are we to assume that the UK's scientists would be spineless yes-men who would allow their independence to be trampled upon by the government? Governments putting independents individuals or organisations under pressure to deliver a particular outcome doesn't have to lead to those organisations necessarily complying with such demands.

In Ireland, it more often than not seems to. I don't know if this is the case in other countries but I have no reason to assume that it is - I've always assumed that Ireland's issue with this is down to how socially tiny the upper echelons are and therefore how personal these things become. I doubt that's the case in a country with a significantly larger population. But I have no evidence either way.

This angle, on the other hand, is based entirely on the assumption that organisations in the UK do, indeed, kowtow to politicians running their mouths.

HalfAndHalf

...Ghost... wrote: »

It does seem like you're shilling tbh. To answer your questions...i'm gonna use more words

The UK has some of the best scientists (as do Europe). But the scientists are under UK government pressure. Fill in the blanks as to why.

Data can be falsified and rubber stamped by Governments. Think Olympics and Russia.

Perhaps the EMA were already aware of data inconsistencies which is partly the reason for the delay in approval.

So, my view being that it’s suspect timing to release currently unsubstantiated data is one side, the other view is that we’re saying the U.K. half of AZ have falsified figures, under instruction of the U.K. scientists on the orders of the U.K. government in the presumable hope that no one else would order the vaccine and therefore find out.

I’ll happily admit I’m wrong, it happens a lot just ask the wife, if it turns out that the over 65’s efficacy is only 8% but Jesus, that’s some alternative theory!

Donald Trump

Widdensushi wrote: »

I doubt if it suddenly becomes less efficient on your 65th birthday, I doubt many over 40 would be volunteering for that vaccine when they could wait for another.

I'd say that if you offered it to any 45 year old non-vaccine-skeptic in June and said "you can have this one now or wait til August for the other one" that they'd chance their arm with that one!

Danzy

...Ghost... wrote: »

It does seem like you're shilling tbh. To answer your questions...i'm gonna use more words

The UK has some of the best scientists (as do Europe). But the scientists are under UK government pressure. Fill in the blanks as to why.

Data can be falsified and rubber stamped by Governments. Think Olympics and Russia.

Perhaps the EMA were already aware of data inconsistencies which is partly the reason for the delay in approval.

Aren't you just Shilling in the opposite way and adding in lots of buts and perhaps.

It's not a replay of Brexit threads, as much as some think it is.

In the biggest economic, social and health crisis globally since the end of WW2, the EU is falling way behind in vaccinations compared to others and it is now to a degree that that risks 2021 being a milder replay of last year for the EU while others put it behind them.

The numbers are all that matters in this.

That's all there is.

HalfAndHalf

Donald Trump wrote: »

I'd say that if you offered it to any 45 year old non-vaccine-skeptic in June and said "you can have this one now or wait til August for the other one" that they'd chance their arm with that one!

I’m 42 and I’d bite an arm off to get it tbh.

Hurrache

Danzy wrote: »

Did you mean to quote some one else?

Not a sleight on you but pointing out the amusement of the wild variances in how people view what's happening, some say the EU are a bit blasé, others implying they're (as if we're not the EU) throwing a childish strop over not getting a contracted number of doses of a vacine for which they part funded.

I went down the rabbit hole earlier when wondering what the share prices were for those involved with the vaccines were and to see if the news today affected it. My jaw hit the floor when I saw what AZ shares are and were worth actually over the last few years. I'd never heard of them until this but had heard of some of the others and their share price is a pittance vs AZ.

noodler

Still no proof of this 8% claim actually being made?

Didn't the UK Lancet paper, now that we are talking about it, say something about there not being enough data on the over 55s to make a conclusion either way?

BuboBubo

Pigeon Chaser wrote: »

Ah, time to forget about AZ and invest in Sputnik...

It's probably just as good, maybe the EU should give them a call. It's worth researching anyway imo.

brickster69

EU Ombudsman starts inquiry into pharma contracts

https://corporateeurope.org/en/2021/01/eu-ombudsman-starts-inquiry-opaque-handling-commission-covid-19-vaccine-contracts

Danzy

Hurrache wrote: »

Not a sleight on you but pointing out the amusement of the wild variances in how people view what's happening, some say the EU are a bit blasé, others implying they're (as if we're not the EU) throwing a childish strop over not getting a contracted number of doses of a vacine for which they part funded.

My point is that the EU response has been weak regardless of what Astra Zeneca can deliver or promised to deliver.

I hope the EU gut them from nuts to neck if they pulled a fast one.

All we know for certain is that the EU vaccination program is now a problem for all of us in the EU.

People are either being vaccinated or not. It's that basic. As things stand for the last month in the EU, they are not.

Who or why doesn't beat results.

Hurrache

noodler wrote: »

Still no proof of this 8% claim actually being made?

It was explained why. Also it was apparently discussed today during a German local government conference, and doubts were also raised a while ago
https://twitter.com/MedEdHead/status/1353815353231618048?s=19
[https://twitter.com/washingtonski/status/1353841867029438465?s=19

Melanchthon

hatrickpatrick wrote: »

My issue with this angle is, why are we to assume that the UK's scientists would be spineless yes-men who would allow their independence to be trampled upon by the government? Governments putting independents individuals or organisations under pressure to deliver a particular outcome doesn't have to lead to those organisations necessarily complying with such demands.

In Ireland, it more often than not seems to. I don't know if this is the case in other countries but I have no reason to assume that it is - I've always assumed that Ireland's issue with this is down to how socially tiny the upper echelons are and therefore how personal these things become. I doubt that's the case in a country with a significantly larger population. But I have no evidence either way.

This angle, on the other hand, is based entirely on the assumption that organisations in the UK do, indeed, kowtow to politicians running their mouths.

I don't think the UK emergency approval of Oxford /Astra Zeneca is that hard to understand really.
They gave the approval on a balance of probability, as far as I understand it the Oxford trials weren't well designed for passing regulators but they put out a good bit of data, data indicated.
1) The vaccine doesn't cause harm and is safe
2) The vaccine has between 60%-90% effectiveness
3) This is the important bit, it reduced massively/eliminated severe symptoms/hospitalisation in the trial group.

In a non crisis situation the UK might not have given emergency authorisation, however it is an emergency. It's better on balance to have a vaccine out there that reduces very significantly hospilisation that's being rolled out fast, than leaving your population vulnerable because you want have something your even more sure about.

We should wait to see what the best thing is, we don't want to give out a sub-standard vaccine that doesn't halt infection completely is what the EMA are presumably thinking. I don't think they are factoring in other aspects. Same way NPHET doesn't care about financial costs etc.

UK emergency approval is a balanced one, where even if it's not as good as it could be, people are dying now, the vaccine at a minimum is safe, and the social tensions and economic costs are unprecedented.

Sonic the Shaghog

Every tweet lads have linked here about it only being 8% have all become unavailable so have they been deleted? Bit suss to be taking them down if they can back up their claim surely

Hurrache

Sonic the Shaghog wrote: »

Every tweet lads have linked here about it only being 8% have all become unavailable so have they been deleted? Bit suss to be taking them down if they can back up their claim surely

Author of the story only posted an English thread 2 posts above yours.

Beasty

HalfAndHalf wrote: »

I’m 42 and I’d bite an arm off to get it tbh.

Make sure you don't bite the wrong one off just after the jab.....

Melanchthon

HalfAndHalf wrote: »

So, my view being that it’s suspect timing to release currently unsubstantiated data is one side, the other view is that we’re saying the U.K. half of AZ have falsified figures, under instruction of the U.K. scientists on the orders of the U.K. government in the presumable hope that no one else would order the vaccine and therefore find out.

I’ll happily admit I’m wrong, it happens a lot just ask the wife, if it turns out that the over 65’s efficacy is only 8% but Jesus, that’s some alternative theory!

“For example, it could be that a lower confidence interval was calculated on very preliminary data based on very few cases with a very wide interval, then a very low value of efficacy would be found, which would be misleading. The authors of The Lancet paper say additional data will become available and it will be best to rely on those data.”

https://www.sciencemediacentre.org/expert-reaction-to-reports-from-germany-that-the-oxford-astrazeneca-covid-19-vaccine-has-8-efficacy-in-over-65s/

...Ghost...

hatrickpatrick wrote: »

My issue with this angle is.......

The poster above answered better than I. Good points made, but simply put, when jobs are threatened, spines turn to jelly.

HalfAndHalf wrote: »

So, my view being that it’s suspect timing to release currently unsubstantiated data is one side, the other view is that we’re saying the U.K. half of AZ have falsified figures, under instruction of the U.K. scientists on the orders of the U.K. government in the presumable hope that no one else would order the vaccine and therefore find out.

I’ll happily admit I’m wrong, it happens a lot just ask the wife, if it turns out that the over 65’s efficacy is only 8% but Jesus, that’s some alternative theory!

The truth wouldn't necessarily read like a James Bond movie. As I have pointed out already, there are not so distant examples of such state interference with matters of great importance.

Danzy wrote: »

Aren't you just Shilling in the opposite way and adding in lots of buts and perhaps.

It's not a replay of Brexit threads, as much as some think it is.

In the biggest economic, social and health crisis globally since the end of WW2, the EU is falling way behind in vaccinations compared to others and it is now to a degree that that risks 2021 being a milder replay of last year for the EU while others put it behind them.

The numbers are all that matters in this.

That's all there is.

Well no. I clearly said in my first post that most of what we have is speculation. My opinions are derived from experience on how these political games usually play out and I strongly suspect AZ will be shown to be at fault with a likelihood of UK involvement. You don't find it odd that their supply is not hampered even though the next biggest player has reported supply issues?

Bit cynical

...Ghost... wrote: »

Well no. I clearly said in my first post that most of what we have is speculation. My opinions are derived from experience on how these political games usually play out and I strongly suspect AZ will be shown to be at fault with a likelihood of UK involvement. You don't find it odd that their supply is not hampered even though the next biggest player has reported supply issues?

If AZ can show they had manufacturing issues resulting in the current delay are they not in the clear? Yes it might be a bit unfair that the UK's supply was unaffected, but are AZ in fact under any obligation to be fair with allocations? AZ can argue that the allocation was made before the the manufacturing problems and it was simply unfortunate that the EU's supply got hit.

...Ghost...

Bit cynical wrote: »

If AZ can show they had manufacturing issues resulting in the current delay are they not in the clear? Yes it might be a bit unfair that the UK's supply was unaffected, but are AZ in fact under any obligation to be fair with allocations? AZ can argue that the allocation was made before the the manufacturing problems and it was simply unfortunate that the EU's supply got hit.

AZ will have very detailed reports on their entire manufacturing regime, past present and future. This is why the EU want to investigate not withstanding less than satisfactory answers thus far. So, if AZ have indeed had manufacturing issues tied to and equating to the sum of the losses to the EU inventory, then they will have quelled some suspicion, but it does not put them in the clear.

Fact is, they signed an APA and took hundreds of millions of euros upfront for the supply. So, yes AZ are obligated to meet the agreed allocations subject to whatever is in the contract.

<<Snipping CT level allegations>>

Bit cynical

...Ghost... wrote: »

AZ will have very detailed reports on their entire manufacturing regime, past present and future. This is why the EU want to investigate not withstanding less than satisfactory answers thus far. So, if AZ have indeed had manufacturing issues tied to and equating to the sum of the losses to the EU inventory, then they will have quelled some suspicion, but it does not put them in the clear.

I suspect that they did have some manufacturing issues and that question will come down to why it was the EU that was mainly affected. Were AZ obliged by contract to prioritize the EU in the event of supply issues; were they obliged to spread the burden equally or was there simply no clause in the contract dealing with this eventuality?

Ficheall

Wasn't the AZ data always a bit iffy? Not testing enough people over 65, deciding half a dose was best based on a tiny sample, and iirc some vagueness over what they counted as an post-vaccine infection? I'd assumed there'd have been more rigorous investigation since - is this just 8% thing just poking at the how the original data was used?

McGiver

Danzy wrote:

As things stand for the last month in the EU, they are not.

What???
9M EU citizens were vaccinated as of yesterday. Some countries' data are few days old so in reality it could be up to 9.5M.

The EMA is approving products for one of the largest and very well regulated markets in the world. There is nothing to speed up. The approval process may be a bit slower than in the US due to more rigorous and careful approach. But that's it.

The reality is - AZ applied to EMA late after the UK emergency approval, the data was dodgy, they were asked to provide more data, however the EMA starting a rolling review and still expecting more data from AZ because what they provided so far is insufficient.
https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu
And on top they are potentially breaching contract with the EU by selling EU pre ordered stuff elsewhere.

But sure it's the EU's fault that they diversified the vaccine portfolio as much as possible, that Sanofi got issues in the clinical trial and that AZ presented crap data to EMA late and that the UK approved their own vaccine without proper scrutiny.

Too many euro bashing trolls and eurosceptic drivel on this thread. Daily Express quoted, really??? Should be tagged by mods as fake news.

McGiver

Ficheall wrote: »

Wasn't the AZ data always a bit iffy? Not testing enough people over 65, deciding half a dose was best based on a tiny sample, and iirc some vagueness over what they counted as an post-vaccine infection? I'd assumed there'd have been more rigorous investigation since - is this just 8% thing just poking at the how the original data was used?

The EMA says on its website insufficient data provided.
Eurobashers say - EMA slow, AZ good, UK good, EU bad.
Whom do you believe/trust?

CIARAN_BOYLE

Ficheall wrote: »

Wasn't the AZ data always a bit iffy? Not testing enough people over 65, deciding half a dose was best based on a tiny sample, and iirc some vagueness over what they counted as an post-vaccine infection? I'd assumed there'd have been more rigorous investigation since - is this just 8% thing just poking at the how the original data was used?

8% comes from Bild.

That's enough to put in it the trash heap.

I haven't seen a more creditable source backing it.

I do have doubts about the Astra Zenaca vaccine but it's definitely got better efficacy at all ages than 8%. It wouldn't have made it this far if it was that bad.

I haven't read the original German language article as its behind a pay wall and I'm not going to pay for Bild.

Banana Republic 1

hatrickpatrick wrote: »

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.

My first though was the a British backlash against the customs delays.

Hurrache

CIARAN_BOYLE wrote: »

8% comes from Bild.

That's enough to put in it the trash heap.

I haven't seen a more creditable source backing it.

Other sources have been linked to a few times, most recently on the previous page.

CIARAN_BOYLE

Hurrache wrote: »

Other sources have been linked to a few times, most recently on the previous page.

I still haven't seen another source repeating the 8% claim even looking at the last few pages. A Twitter poster who sums up articles on his new feed is the only source of the 8% on the previous page.

I repeat there is some dodgy data with AZ but the 8% seems to come out of left field.

Articles I've read credits the 8% to Bild.

Joe_ Public

CIARAN_BOYLE wrote: »

I still haven't seen another source repeating the 8% claim even looking at the last few pages. A Twitter poster who sums up articles on his new feed is the only source of the 8% on the previous page.

I repeat there is some dodgy data with AZ but the 8% seems to come out of left field.

Articles I've read credits the 8% to Bild.

I think the twitter posts were based on a journalist from the Handelsblaat newspaper which ran the story concurrently with bild. Whatever about bild, Handelsblaat would seem a very reputable publication, a kind of German equivalent of the Financial Times.

mick087

Once again it's everyone else to blame except the EU.

Why some countries was out buying vaccines the EU was trying to negotiate a better deal

This is an appalling mess.

This organization know as the EU has only itself to blame.
Who from the EU will be accountable ?

Hurrache

mick087 wrote: »

Once again it's everyone else to blame except the EU.

Why some countries was out buying vaccines the EU was trying to negotiate a better deal

This is an appalling mess.

This organization know as the EU has only itself to blame.
Who from the EU will be accountable ?

Erm, they had ordered and funded the vaccines, hence the problem. They weren't trying to negotiate a better deal. You don't seem to understand the story at all.

Ficheall

Hurrache wrote: »

You don't seem to understand the story at all.

This is not a barrier to commenting on any of these threads.

mick087

Hurrache wrote: »

Erm, they had ordered and funded the vaccines, hence the problem. They weren't trying to negotiate a better deal. You don't seem to understand the story at all.

So eveyone else is to blame again except anyone from the EU.
Who is accountable from the EU?

Ficheall

mick087 wrote: »

So eveyone else is to blame again except anyone from the EU.
Who is accountable from the EU?

You know when you order a pizza and it arrives two hours late? That's actually your own fault.

ixoy

mick087 wrote: »

Who is accountable from the EU?

Why would they be accountable for AZ's production issues?

average_runner

...Ghost... wrote: »

AZ will have very detailed reports on their entire manufacturing regime, past present and future. This is why the EU want to investigate not withstanding less than satisfactory answers thus far. So, if AZ have indeed had manufacturing issues tied to and equating to the sum of the losses to the EU inventory, then they will have quelled some suspicion, but it does not put them in the clear.

Fact is, they signed an APA and took hundreds of millions of euros upfront for the supply. So, yes AZ are obligated to meet the agreed allocations subject to whatever is in the contract.

Basically AZ has looked after their own people first. I am sure Boris was well aware of this also.


EU needs to look at it self and figure out why we are so slow in certifying these vaccines compare to the rest of the world.

mick087

Ficheall wrote: »

You know when you order a pizza and it arrives two hours late? That's actually your own fault.

I have never had a pizza arrive 2 hours late.

Hurrache

mick087 wrote: »

So eveyone else is to blame again except anyone from the EU.
Who is accountable from the EU?

Well you're accountable for failing to understand what's happening. Once you take time to, everything else should fall into place.

mick087

ixoy wrote: »

Why would they be accountable for AZ's production issues?

Exactly why would they indeed.

Hurrache

average_runner wrote: »

Basically AZ has looked after their own people first. I am sure Boris was well aware of this also.


EU needs to look at it self and figure out why we are so slow in certifying these vaccines compare to the rest of the world.

Sure, why doesn't every run rush to certify everything anyway, even if they've questions for which they're waiting for more data and explanations for.

average_runner

Hurrache wrote: »

Sure, why doesn't every run rush to certify everything anyway, even if they've questions for which they're waiting for more data and explanations for.

And why didn't other countries need this extra data?


Are we saying the scientist in other countries are not as good?

HalfAndHalf

Hurrache wrote: »

Erm, they had ordered and funded the vaccines, hence the problem. They weren't trying to negotiate a better deal. You don't seem to understand the story at all.

Erm, keep hearing this ‘EU funded the AZ vaccine’....

This isn’t exactly how it sounds and the EU weeent the only ones, the U.K. and US also ‘funded’ them, the US to the tune of a billion dollars...

This ‘funding’ was just an up front payment for product, it wasn’t a charitable donation!

MrMusician18

McGiver wrote: »

What???
9M EU citizens were vaccinated as of yesterday. Some countries' data are few days old so in reality it could be up to 9.5M.

The EMA is approving products for one of the largest and very well regulated markets in the world. There is nothing to speed up. The approval process may be a bit slower than in the US due to more rigorous and careful approach. But that's it.

The reality is - AZ applied to EMA late after the UK emergency approval, the data was dodgy, they were asked to provide more data, however the EMA starting a rolling review and still expecting more data from AZ because what they provided so far is insufficient.
https://www.ema.europa.eu/en/news/ema-starts-first-rolling-review-covid-19-vaccine-eu
And on top they are potentially breaching contract with the EU by selling EU pre ordered stuff elsewhere.

But sure it's the EU's fault that they diversified the vaccine portfolio as much as possible, that Sanofi got issues in the clinical trial and that AZ presented crap data to EMA late and that the UK approved their own vaccine without proper scrutiny.

Too many euro bashing trolls and eurosceptic drivel on this thread. Daily Express quoted, really??? Should be tagged by mods as fake news.

The EMA is not any more careful than the FDA tbf

Hurrache

average_runner wrote: »

And why didn't other countries need this extra data?


Are we saying the scientist in other countries are not as good?

They've made a series of blunders when dealing with the US, who have yet to authorises its use, and in a story in the Ney York Times from the end of December, have said

Yet independent scientists and industry analysts have criticized AstraZeneca and Oxford for not being sufficiently transparent about their early results, the design of their studies and safety issues. Most critically, it is not clear how well the vaccine works.

CIARAN_BOYLE

average_runner wrote: »

And why didn't other countries need this extra data?


Are we saying the scientist in other countries are not as good?

Some countries are treating this as an emergency and granting emergency use authorisation. It's basically ask for less data and approve early.

It's an interesting question if we should have done this?

Hurrache

HalfAndHalf wrote: »

Erm, keep hearing this ‘EU funded the AZ vaccine’....

This isn’t exactly how it sounds and the EU weeent the only ones, the U.K. and US also ‘funded’ them, the US to the tune of a billion dollars...

This ‘funding’ was just an up front payment for product, it wasn’t a charitable donation!

It was clarified on a number of times in this thread that they part funded it, so nothing is being hidden or muddied. And the funding wasn't just an upfront payment, it was paid upfront to fund the R&D.

Mitch Connor

CIARAN_BOYLE wrote: »

Some countries are treating this as an emergency and granting emergency use authorisation. It's basically ask for less data and approve early.

It's an interesting question if we should have done this?

Ireland on its own? Probably not, imo. I don't think Ireland should have started a european rush on the vaccine by going out on our own.

average_runner

Hurrache wrote: »

They've made a series of blunders when dealing with the US, who have yet to authorises its use, and in a story in the Ney York Times from the end of December, have said

Yet the USA supply will not be affected!!!
Something is way off here. EU are the bosses, bucks stop here and they need to amend the situation asap. By whatever means.
AZ might be at fault, but that is of no use to us, EU is paid big bucks for this and should have a backup plan

If this was the HSE, people would be calling for their heads here

BredonWimsey

...Ghost... wrote: »

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

wow just goes to show the morality of these pharmaceutical companies. but they are contractually bound to comply with the agreement with the EU