What exactly is happening with AstraZeneca?

Melanchthon · 28-01-2021 01:37PM

melekalikimaka wrote: »

FT saying the germans are not going ahead with over 65s due to lack of data.

https://www.ft.com/content/e5b64f87-6f2b-3097-b04a-bb76c013a284

Yeah worrying , be interested to see what the EMA say.

Libb1964 · 28-01-2021 01:37PM

mick087 wrote: »

The vulnerable and elderly first yes.

Who decides who is a essential worker?

Yes you would think it would be good and right to order as a union.
But the questions remains why was they 3 moths behind other countries in ordering? 3 months to me seems along a terribly long time.

The Government has some sort of scale for essential workers which seems practical.

From what I understand it was because Europe had never ordered as a Union before, it was previously done by individual countries. It takes time to set up new systems.
I don't think the time frame is of any importance.A contract was signed. AZ overcommitted to both the EU and UK

CIARAN_BOYLE · 28-01-2021 01:40PM

Melanchthon wrote: »

https://www.ft.com/content/e5b64f87-6f2b-3097-b04a-bb76c013a284

Yeah worrying , be interested to see what the EMA say.

I wonder if the government will start rolling out Astra Zenaca to younger people if the EMA follows the Germans.

Renault 5 · 28-01-2021 01:42PM

Belgian regulators have launched an investigation into AstraZeneca’s coronavirus vaccine production site near Brussels on the request of the European commission, in an escalation of the row over shortages within the EU.

A first visit by officials from the Belgian federal medicines agency was completed on Wednesday at the site in Seneffe, Hainaut, the health ministry in Belgium said. Samples and records were taken from the plant and a further inspection of the facility is expected in the coming days.

The investigation was requested by the EU’s executive branch due to doubts over AstraZeneca’s explanation of an expected shortfall in vaccine deliveries to the EU.

https://www.theguardian.com/world/2021/jan/28/belgium-launches-investigation-of-astrazeneca-vaccine-plant

This will get interesting

28-01-2021 01:44PM

The tenor of the press release from the Dept. of Health on Monday evening, 25th where AstraZeneca was mentioned suggested that they intended to use it for those most at risk but not as quickly due to restricted supply. They'll probably have to revisit the topic tomorrow and press release to follow tomorrow evening.

ongarite · 28-01-2021 01:45PM

Melanchthon wrote: »

https://www.ft.com/content/e5b64f87-6f2b-3097-b04a-bb76c013a284

Yeah worrying , be interested to see what the EMA say.

The trials of this vaccine had low sample set from >65.
It's not that it's ineffective for this age group just there isn't enough evidence to say for sure.
Even the UK government have this warning on the vaccine on their website but are using it on >65s

It's absence of evidence not evidence of absence.

mohawk · 28-01-2021 01:46PM

CIARAN_BOYLE wrote: »

Mrna vaccines is a category of its own by my understanding.

If you have a mrna vaccine factory its not to hard to switch one to doing a different mrna vaccine.

Sanofi had a mrna vaccine of their own in trials and they were building factories for it. Those will be used for a different mrna vaccine now.

AFAIK there are no mrna vaccine factories in Ireland at present.

Yes agreed mRNA vaccines are not manufactured the same way as traditional vaccines. There wouldn’t be any factory in Ireland set up for it. It’s a chemical process rather than a biological process. However mRNA is not as stable as your traditional chemical drugs. You can’t use heat to kill any microbes which means you need clean rooms.

We have factory’s that make drugs from a chemical process and we have factory’s that use a biological process to make proteins. Neither type of factory is ideally equipped for mRNA production.

basill · 28-01-2021 01:48PM

Pete_Cavan wrote: »

This is what AZ themselves announced in June

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/astrazeneca-to-supply-europe-with-up-to-400-million-doses-of-oxford-universitys-vaccine-at-no-profit.html

They were gearing up to supply the doses from the end of 2020 since June. By the time the contract was signed, the client changed from IVA to EU, nothing changed from a production point of view. The contract firmed up on details but AZ were working towards its fulfillment since June.

Regardless of when the contract was signed, AZ are still bound by the terms of it. You can't sign a contract, take €300m payment upfront, and then in mid Jan revised EU the deliveries from 100m doses delivered by end March down to 31m. They have clearly fcked up.

You don't have the contract nor the specific terms contained within. Therefore you can't claim that Astra are not in compliance with the terms therein. I would suggest stop reading the Indo and Irish Times that only publish the EU press releases. I am reserving judgment.

mohawk · 28-01-2021 01:48PM

ongarite wrote: »

The trials of this vaccine had low sample set from >65.
It's not that it's ineffective for this age group just there isn't enough evidence to say for sure.
Even the UK government have this warning on the vaccine on their website but are using it on >65s

It's absence of evidence not evidence of absence.

The UK are also not following what happened in clinical trials and spacing out time between injections one and two. They are taking risks that other countries aren’t.

brickster69 · 28-01-2021 01:49PM

melekalikimaka wrote: »

FT saying the germans are not going ahead with over 65s due to lack of data.

I think you could tell that from the CEO's interview the other day. It sounded like that it was understandable and not a problem. There will be plenty of data available shortly to come from that age group you would imagine.

mick087 · 28-01-2021 01:49PM

CIARAN_BOYLE wrote: »

Probably nothing. A lot of people are inferring a lot.

According to an ec official speaking to the media the contract between the EU and AZ names 2 eu and 2 UK factories to supply the EU with vaccine.

According to Astra Zenaca the UK will be supplied from the UK and the EU will be supplied by the EU.

People are inferring that the UK government has pressured Astra Zenaca to keep all UK made vaccines in the UK.

This episode is really a court situation now.

froog · 28-01-2021 01:54PM

i'm starting to think the EU doesn't have a case here. the EU themselves stated there is no "first come first served" arrangement here, so surely that goes both ways. i.e. AZ has a number of contracts and can fulfil them to whatever capacity as they see fit.

as it stands they seem to be fulfilling both contracts equally:

2 million a week for britain.
a bulk delivery of 25 million sometime in march for EU.

unless the EU had specific contract clauses sayin you must fulfil EU contract before all others, their case is weak.

of course i'm only wildly speculating, no one has seen the contract!

Pete_Cavan · 28-01-2021 01:58PM

Melanchthon wrote: »

The damn German health minister himself has confirmed that they hadn't even started negotiating funding in June, Astra Zeneca clearly thought they were just about to reach the agreement but then the commission came in and it was drawn out. They were hardly going to gear up with no funding agreed at all.
That's partly why this row is so toxic.
Stop repeating the lie.

I have not come out with any lies, nevermind repeated them.

From AZs own press release in June;

AstraZeneca continues to build a number of supply chains in parallel across the world, including for Europe. The Company is seeking to expand manufacturing capacity further and is open to collaborating with other companies in order to meet its commitment to support access to the vaccine at no profit during the pandemic.

Pascal Soriot, Chief Executive Officer, said: “This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval. With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly.

You seem to be hung up on "have not started negotiations on the funding agreement of Astra Zeneca so far." That does not mean that AZ were not building up capacity and putting supply chains in place, they even said they were themselves! If the EU didn't take their vaccines, there were plenty of others who would. AZ weren't sitting around twiddling their thumbs until August.

That is beside the point as they still contractually to supply the EU and are obliged to supply them in accordance with that contract. They can't start adding in conditions now.

Joe_ Public · 28-01-2021 02:00PM

Yevon wrote: »

Am I right in saying that AZ are completing large scale testing in the USA on the vaccine? Hopefully the EMA are seeking preliminary data from every source possible in making their decision. If it's safe for 65+ and it prevents serious illness it should absolutely be rolled out to that group.

Yes but they can only take a decision right now based on data they have right now. Not sure when results from us trials are due, probably weeks away yet. The uk continue to roll it out but what if ultimately we get definitive data that shows lower efficacy rates for the elderly? Hopefully that wont happen but it would present them a bit of a dilemma if so.

Hurrache · 28-01-2021 02:09PM

froog wrote: »

i'm starting to think the EU doesn't have a case here. the EU themselves stated there is no "first come first served" arrangement here, so surely that goes both ways. i.e. AZ has a number of contracts and can fulfil them to whatever capacity as they see fit.

-Hey, builder man, where's me gaff?
-What, sure I'm in the middle of building it here for Paddy.
-But you said you'd be building mine.
-I did, but you didn't say it had to be built before anyone else who asked me to build theirs. Paddy told me he wanted it before you, and I said fair enough, because you never insisted on building it if anything else comes my way.

Libb1964 · 28-01-2021 02:10PM

Aegir wrote: »

20 miles from the nearest vaccine centre?

Does she live in Sealand?

Cambridge!!!!
I did just find out it was the Pfizer vaccine she had which might explain why she had to go to a specific centre.

Pete_Cavan · 28-01-2021 02:10PM

basill wrote: »

You don't have the contract nor the specific terms contained within. Therefore you can't claim that Astra are not in compliance with the terms therein. I would suggest stop reading the Indo and Irish Times that only publish the EU press releases. I am reserving judgment.

I said AZ are still bound by the terms of the contract, which they are. The EU, who have seen the contract and know the specific terms contained within, say AZ are breaching it by saying the EU will be supplied from EU plants only. Heres what the EU had to say;

https://ec.europa.eu/commission/presscorner/detail/en/SPEECH_21_267

I last communicated with you on Monday to express our serious concerns regarding the intention of AstraZeneca to supply considerably fewer doses in the coming weeks than agreed and announced.
...

The logic of these agreements was as valid then as it is now: we provide a de-risking investment up front, in order to get a binding commitment from the company to pre-produce, even before it gets authorisation.

Not being able to ensure manufacturing capacity is against the letter and the spirit of our agreement.
...

There's no priority clause in the Advance Purchase Agreement.

The only sources I have quoted are EU and AZ, the two parties directly involved.

Mitch Connor · 28-01-2021 02:10PM

froog wrote: »

i'm starting to think the EU doesn't have a case here. the EU themselves stated there is no "first come first served" arrangement here, so surely that goes both ways. i.e. AZ has a number of contracts and can fulfil them to whatever capacity as they see fit.

as it stands they seem to be fulfilling both contracts equally:

2 million a week for britain.
a bulk delivery of 25 million sometime in march for EU.

unless the EU had specific contract clauses sayin you must fulfil EU contract before all others, their case is weak.

of course i'm only wildly speculating, no one has seen the contract!

Or their contract said 100million by March. In which case 25million isn't what was agreed.

I don't think the argument is that EU should take precedence over GB.

My understanding is the EU are saying the contract says Xmillion to be manufactured at 4 named locations and delivered by March. AZ are now saying (again, my understanding of the argument as we see in the press) that you are only getting them from 2 of the 4 named plants, and you will only get a small percentage of the agreed number of doses.

So the EU are saying: fulfil your contract under the terms of your contract.

But the above is speculative too, until people see the contact we don't know who is lying

Melanchthon · 28-01-2021 02:11PM

ongarite wrote: »

The trials of this vaccine had low sample set from >65.
It's not that it's ineffective for this age group just there isn't enough evidence to say for sure.
Even the UK government have this warning on the vaccine on their website but are using it on >65s

It's absence of evidence not evidence of absence.

I understand this.
I have a few questions though.

What data can the German agency be drawing on? Isn't the EMA's process confidential? If it's not confidential we should be able to question the Irish regulators as they will have been given the same data (unless there is corruption/leaking happening). Basically are the Robert Koch Institute not most likely drawing on older data sets.

Second question, why release this statement today, the EMA is due to make a statement tomorrow with likely a bigger data set, we have been told again and again that the EMA is in charge of this process outside of emergency authorisation which if it was going to happen would have happened a month ago. Releasing this a day before the EMA is weird? What happens if the EMA approves its use for all ages, you've just screwed uptake, it's grossly irresponsible.
Nothing is lost by waiting a day or two before release.
Something funny is happening here in relation to internal German politics, same way with the senior government figure leaking last week.

mick087 · 28-01-2021 02:13PM

Libb1964 wrote: »

The Government has some sort of scale for essential workers which seems practical.

From what I understand it was because Europe had never ordered as a Union before, it was previously done by individual countries. It takes time to set up new systems.
I don't think the time frame is of any importance.A contract was signed. AZ over committed to both the EU and UK

Yes i would agree that they didn't have time to set this system up that has part due to it all going wrong. IMO the EU commission will not accept any blame or reasonability.
State members Elected governments should think very carefully about giving such powers away in the future.

Libb1964 · 28-01-2021 02:14PM

Melanchthon wrote: »

Maybe your right I am not super familiar with how the process is in England but this seems odd.
As far as I know the oldest are getting vaccinated by GP's with Astra Zeneca, while the old but slightly less old are getting called into the vaccination centers which are using Pfizer more?
Source:elderly relatives

Yes, she had the Pfizer vaccine.
She had told me it wasn't the one they kept very cold, so there was miscommunication.
She is a "healthy" independent 84 year old, but obviously some of the other people there should've gone to their gps

Melanchthon · 28-01-2021 02:19PM

Libb1964 wrote: »

Yes, she had the Pfizer vaccine.
She had told me it wasn't the one they kept very cold, so there was miscommunication.
She is a "healthy" independent 84 year old, but obviously some of the other people there should've gone to their gps

Ah it's a relief anyway! Have very mixed feelings these days, real relief to have elderly relatives under the UK system getting their doses but then looking at the way the Irish/EU thing seems to be slipping and it's just depressing

monkeybutter · 28-01-2021 02:22PM

Libb1964 wrote: »

Cambridge!!!!
I did just find out it was the Pfizer vaccine she had which might explain why she had to go to a specific centre.

yours is the best post so far in this thread, it was a thing of beauty

Libb1964 · 28-01-2021 02:24PM

mick087 wrote: »

Yes i would agree that they didn't have time to set this system up that has part due to it all going wrong. IMO the EU commission will not accept any blame or reasonability.
State members Elected governments should think very carefully about giving such powers away in the future.

Blame for what?
The same thing would've happened if all the independent EU Countries had bought the vaccine individually. Everyone would be trying to outbid each other and the poorer countries wouldn't have a chance.
AZ promised more than it could deliver

28-01-2021 02:27PM

froog wrote: »

i'm starting to think the EU doesn't have a case here. the EU themselves stated there is no "first come first served" arrangement here, so surely that goes both ways. i.e. AZ has a number of contracts and can fulfil them to whatever capacity as they see fit.

as it stands they seem to be fulfilling both contracts equally:

2 million a week for britain.
a bulk delivery of 25 million sometime in march for EU.

unless the EU had specific contract clauses sayin you must fulfil EU contract before all others, their case is weak.

of course i'm only wildly speculating, no one has seen the contract!

If a preexisting arrangement with the UK was to take precedence, this should have been disclosed by AZ at the contract stage.

mick087 · 28-01-2021 02:30PM

Melanchthon wrote: »

Ah it's a relief anyway! Have very mixed feelings these days, real relief to have elderly relatives under the UK system getting their doses but then looking at the way the Irish/EU thing seems to be slipping and it's just depressing

Maybe lessons will be learned from this and future roll outs of the vaccines will run to plan.
But i agree its very depressing.

mick087 · 28-01-2021 02:38PM

Libb1964 wrote: »

Blame for what?
The same thing would've happened if all the independent EU Countries had bought the vaccine individually. Everyone would be trying to outbid each other and the poorer countries wouldn't have a chance.
AZ promised more than it could deliver

But they have not brought the vaccine independently, member states gave these powers to the EU Commission.
Was Germany not already in the pipeline to order this vaccine for themselves until the EU stepped took over with with slow negotiating tactics.

Donald Trump · 28-01-2021 02:42PM

mick087 wrote: »

Yes i would agree that they didn't have time to set this system up that has part due to it all going wrong. IMO the EU commission will not accept any blame or reasonability.
State members Elected governments should think very carefully about giving such powers away in the future.

Yet you were also calling for a hypothetical as-yet-unformed and unelected body to coordinate the vaccine on a global scale.

Wolf359f · 28-01-2021 02:45PM

mick087 wrote: »

But they have not brought the vaccine independently, member states gave these powers to the EU Commission.
Was Germany not already in the pipeline to order this vaccine for themselves until the EU stepped took over with with slow negotiating tactics.

They could have started negotiating last March for all it's worth, AZ would still have only sought approval this Jan and they still would have had a shortfall in production/delivery.

If there was only 30mil doses ready Q1 and all EU member states done their own deals, I'd say we would be far down the pecking order and it most certainly wouldn't have been rolled out equally.

basill · 28-01-2021 02:47PM

I heard the EU talk about "best effort" yesterday. AZ CEO mentions same. Its the sort of wording that politicians love as it is suitably vague and doesn't hold them accountable. To include it in a commercial legally binding contract and be relying on it now would appear to be foolhardy if that is the case.

AZ CEO states a number of times in the following interview that they never committed to the EU, only offered "best effort".

https://www.welt.de/politik/ausland/article225095715/Astra-Zeneca-CEO-I-do-believe-we-treated-Europe-fairly.html

What exactly is happening with AstraZeneca?

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