What exactly is happening with AstraZeneca?

McGiver · 31-01-2021 05:48PM

Aegir wrote: »

thanks, I hadn't seen that.

So the UK is using the same criteria as Ireland then, deaths within 28 days, which I believe is the WHO recommended wat of doing it.

Link to the UK criteria please.

NeuralNetwork · 31-01-2021 05:50PM

There's going to be an element of vaccine nationalism in all of these arrangements during the rollout at early stages when supplies are tight. That's just somewhat inevitable.

I don't think any country or bloc is going to be entirely altruistic in this and it's somewhat ludicrous to think that any of them - the EU or the UK or the US or anyone else is not going to be motivated by trying to solve their own domestic crises as a priority.

The EU vaccine programme itself was created to prevent that becoming a hugely problematic issue within the EU itself as you would have had a situation where flow of products within the EU-27 might have been disrupted or wealthier countries (likely including Ireland) may have monopolised supply chain access.

Unfortunately, that's politics and human nature.

Once we're over this hump, which we will be by say March and April, the bigger global issue will be ensuring that we don't all then forget about COVAX and end up with a vaccinated rich part of the world and COVID haunting the developing world for decades, with a fortress of wealthy countries and long term travel issues.

Beyond this storm in a tea cup over AstraZeneca, that's where the problem will be.

Also, btw. To be fair to AstraZeneca, they're among the vaccine producers most likely to play a big part in reaching those populations. So will Janssen and a few others as they're cheaper and logistically far less challenging. Things haven't gone as smoothly as they could have, but I think we would also want to be a little careful not to vilify organisations that are moving at unprecedented speed and possibly becoming snarled up in vaccine nationalism from politicians and a shouting match that's more to do with nationalism than vaccines.

McGiver · 31-01-2021 05:51PM

Aegir wrote: »

so we don't need all those highly trained experts at the EMA trawling through tonnes of data and giving their educated opinion, we should just ask you?

Respond to the issue in question. I.e. Issues with the AZ clinical trial methodology which lead to the US lawsuit and longer EMA scrutiny.
AZ made a mess of the trial.

Parachutes · 31-01-2021 05:54PM

NeuralNetwork wrote: »

There's going to be an element of vaccine nationalism in all of these arrangements during the rollout at early stages when supplies are tight. That's just somewhat inevitable.

I don't think any country or bloc is going to be entirely altruistic in this and it's somewhat ludicrous to think that any of them - the EU or the UK or the US or anyone else is not going to be motivated by trying to solve their own domestic crises as a priority.

The EU vaccine programme itself was created to prevent that becoming a hugely problematic issue within the EU itself as you would have had a situation where flow of products within the EU-27 might have been disrupted or wealthier countries (likely including Ireland) may have monopolised supply chain access.

Unfortunately, that's politics and human nature.

Once we're over this hump, which we will be by say March and April, the bigger global issue will be ensuring that we don't all then forget about COVAX and end up with a vaccinated rich part of the world and COVID haunting the developing world for decades, with a fortress of wealthy countries and long term travel issues.

Third world will always have problems with diseases and pathogens that the developed world do not. That’s why you have to get jabbed for yellow fever and other nasties when travelling to those countries. The common sense thing to do would be the same thing for Covid, once you’ve been vaccinated in the last year for it travel away. At this stage we certainly should not be giving away vaccines when our own citizens need it. We can think about others later.

Pete_Cavan · 31-01-2021 05:56PM

From the AZ/EU contract

13.1. AstraZeneca. AstraZeneca represents, warrants and covenants to the Commission and the Participating Member States that:

(e) it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement;

AZ are now saying UK gets priority despite the contract they signed confirming such a situation doesn't exist. The UK may not have done anything wrong but AZ should have informed the EU of any priority with other customers.

NeuralNetwork · 31-01-2021 05:57PM

Parachutes wrote: »

Third world will always have problems with diseases and pathogens that the developed world do not. That’s why you have to get jabbed for yellow fever and other nasties when travelling to those countries. The common sense thing to do would be the same thing for Covid, once you’ve been vaccinated in the last year for it travel away. At this stage we certainly should not be giving away vaccines when our own citizens need it. We can think about others later.

My point is that there are arguments going on about vaccine nationalism that are simply not going to make sense. You've already got people online ranting and raving about it.

However, you can do both. There's money available and there's also products that can be licensed for local production at very low cost and that includes the AstraZeneca vaccine and others which can ultimately solve this without any diminishing of responses in Europe or the US or anywhere else.

The last thing we need is COVID variants floating around and arriving back in for decades and decades to come. There is an opportunity to very comprehensively wipe out COVID-19 over the next few years. It will happen more slowly in some parts of teh worlds than others, but the objective should be to get rid of it.

ThePanjandrum · 31-01-2021 05:57PM

NeuralNetwork wrote: »

Liability isn't borne by the governments in the same way should something go wrong and the process is a lot more detailed and transparent.

I'm afraid that Articles 14 and 15 of the APA do indemnify AstraZeneca, liability is borne by the member states.

We don't know about comparative transparency because the UK contact is not in the public domain

PCeeeee · 31-01-2021 05:58PM

Can anyone descirbe to me what vaccine nationalism is? The procurement and supply of vaccines to your own nation? Is that not what everyone is at?

NeuralNetwork · 31-01-2021 06:01PM

PCeeeee wrote: »

Can anyone descirbe to me what vaccine nationalism is? The procurement and supply of vaccines to your own nation? Is that not what everyone is at?

I'd define it as an unreasonable blocking of supplies, particularly when those needs are being met. Or, using access to vaccines as a weapon of economic advantage to damage competitors or to pursue geopolitical objectives, which I think unfortunately was a route that Donald Trump was prepared to go down. I think we may have had a rather narrow escape from a very nasty trade dispute between some huge international players like the US and EU if that election had gone the other way.

However, I don't think that's something that applies in this case. It's just a bump in the road and a contractual dispute with a multinational and a load of jingoists (mostly, but not exclusively Brexiteers) whipping up a storm in a tea cup.

ThePanjandrum · 31-01-2021 06:10PM

Aegir wrote: »

I’d be interested in some clarification of this from someone in the pharma industry.

Is it as simple as “stockpiling”? These are pharma products that need to be kept at low temperature in a sterile environment. It’s not like you just stick them in boxes and pile them up in a warehouse.

We’re talking millions of doses here, how exactly do you stockpile them?

I would have thought the best solution would have been to ship them to the countries that are receiving them and let them build their own stocks, pretty much as Stephen Donnelly wanted to do, but was blocked by the Eu.

I'm not in pharma but I read about this. The AstraZeneca vaccine can be produced and stored in sub-zero temperatures but once it is taken out of storage and unfrozen to be put in vials its life is significantly shortened although I don't know how long it is before the doses are no longer usable. Therefore it is not "finished" until there are firm delivery dates. In the meantime you would imagine that the storage facilities are limited and this in turn could limit production. It might also be that you cannot practically switch off production and have to slow it down instead.

NeuralNetwork · 31-01-2021 06:12PM

ThePanjandrum wrote: »

I'm afraid that Articles 14 and 15 of the APA do indemnify AstraZeneca, liability is borne by the member states.

We don't know about comparative transparency because the UK contact is not in the public domain

In a legal context, if Ireland for example, rushed out authorisation without deferring to the EMA, the courts would probably take an extremely dim view of it if a case ended up before them at some stage down the road.

The liability risks are borne, but are reduced if the steps are gone through properly.

There are also serious issues with public confidence in some EU countries, notably France, that are being helped a lot by a robust EMA protocol.

NeuralNetwork · 31-01-2021 06:17PM

ThePanjandrum wrote: »

I'm not in pharma but I read about this. The AstraZeneca vaccine can be produced and stored in sub-zero temperatures but once it is taken out of storage and unfrozen to be put in vials its life is significantly shortened although I don't know how long it is before the doses are no longer usable. Therefore it is not "finished" until there are firm delivery dates. In the meantime you would imagine that the storage facilities are limited and this in turn could limit production. It might also be that you cannot practically switch off production and have to slow it down instead.

The AstraZeneca vaccine can be stored between 2ºC and 8ºC for at least 6 months.

It's actually far easier to distribute than most fresh dairy products.

The media coverage of it also made forecasts of producing up to 3bn doses in 2021 too.

I wonder if we are into over promising territory generally with this.

is_that_so · 31-01-2021 06:27PM

Posted on the vaccines thread in case people haven't seen it.

https://twitter.com/vonderleyen/status/1355942468001411072

astrofool · 31-01-2021 06:40PM

is_that_so wrote: »

Posted on the vaccines thread in case people haven't seen it.

https://twitter.com/vonderleyen/status/1355942468001411072

Great news, I'd imagine the threat hanging over the UK of the proven highly effective Pfizer vaccine supply being cut off will have helped here, and we get to see what the optimal efficacy dosage of AZ should be before the second dose comes around to us.

brickster69 · 31-01-2021 06:50PM

A little pointless talking about contracts as no one knows what is in the UK's contract. As far as i can make out the production and filling contracts have been signed by the Government / Oxford & 3 other different companies than Astra Zeneca itself.

Interesting blog on the contract

https://davidallengreen.com/2021/01/what-the-astrazeneca-agreement-actually-says/

31-01-2021 06:56PM

McGiver wrote: »

Link to the UK criteria please.

you literally quoted a poster who gave it.

Officially, it is anyone who dies in any setting within 28 days of a positive test.

McGiver wrote: »

Respond to the issue in question. I.e. Issues with the AZ clinical trial methodology which lead to the US lawsuit and longer EMA scrutiny.
AZ made a mess of the trial.

the trial data is all there and the relevant regulators appear to be happy with it and (apart from Germany) all seem to have come to the same conclusion.

But they obviously don't know as much about vaccine trials as you do. Fill us all in about the mess that AZ made of the trial.

31-01-2021 06:59PM

NeuralNetwork wrote: »

The AstraZeneca vaccine can be stored between 2ºC and 8ºC for at least 6 months.

It's actually far easier to distribute than most fresh dairy products.

The media coverage of it also made forecasts of producing up to 3bn doses in 2021 too.

I wonder if we are into over promising territory generally with this.

you still need cold storage though, I presume the way the pharma industry is set up with lean supply chains, there are limited amounts of cold storage available. I would have thought the normal supply lines would be make it and ship it straight away rather than stockpiling it.

I have a feeling that the Belgian plant has produced batches that AZ wanted to ship to each country, but the EU would allow this so AZ shipped it to the UK.

mista11 · 31-01-2021 07:09PM

brickster69 wrote: »

A little pointless talking about contracts as no one knows what is in the UK's contract. As far as i can make out the production and filling contracts have been signed by the Government / Oxford & 3 other different companies than Astra Zeneca itself.

Interesting blog on the contract

https://davidallengreen.com/2021/01/what-the-astrazeneca-agreement-actually-says/

A good read that, I encourage all those posters who still belive that Astrazenca has broken the contract to read it rather that try to interperet parts of the contract themselvels (with no legal foundation)

I havent found one article online, from anyone with legal credentials, who is supporting that the EU has any case against AZ

I had a quick read of the German and french papers and there is not one article talking about taking AZ to court (there is also no mention of the article 16 debacle either which i thought was strange) All the papers are talikng about is what a mess the EU have made of supply

NeuralNetwork · 31-01-2021 07:11PM

The pharma sector doesn't really use lean supply chains nor was there any issue with cold storage for this vaccine. It's quite a compact product and it only requires chill storage, nothing remarkable that would be in anyway challenging.

These aren't FMCG (Fast Moving Consumer Goods) type supply chains or the food / drinks sector. There are plenty of ways of holding supplies in stock.

The statement from AstraZeneca is that there were issues at the plant regarding yields, which means that they ran a biological process which resulted in less product than they had planned.

That is a part and parcel of biologics production. You can get start up issues which are quite tricky to resolve as you are dealing with biological agents, not relatively far more simple chemical reactions.

There are a lot of speculative reports about speculative reports into what people are speculating about feelings they had and relatively few facts.

I think I'll be waiting for those to emerge before I make any proclamations of what happened or didn't happen.

Beechwoodspark · 31-01-2021 07:12PM

smellyoldboot wrote: »

By happenstance, ITV News ended up on the TV tonight at 10. The smugness, jingoism and vitriol on display by the newsreader and "experts" in relation to this was a sight to behold. Could not believe what I was watching. Put me in mind of Fox News in the US with their very biased slant on stories. EU/UK and by extension Irish/UK relations are going to get very very ugly.

Hmmmm...yeh....they seized upon it. a certain type of Brit seems to be gloating over the sense that the UK has “pulled a fast one” over the EU.

mista11 · 31-01-2021 07:24PM

is_that_so wrote: »

Posted on the vaccines thread in case people haven't seen it.

https://twitter.com/vonderleyen/status/1355942468001411072

The extra 9 million was exactly what astrazenca said they would get on Friday which the commision rejected at that time

Expanding the manufacturing capcity is Astrazenca fufilling the "best endevours clause" in the contact

Lets hope they can turn something around in the short term and get us more vaccines

Natterjack from Kerry · 31-01-2021 07:53PM

Own goal by Irish government sinks EU, handing AstraZeneca UK clear victory in tense vaccine contest.

In a tight technical match, it was a game of two halves - one for the anoraks rather than the casual fans. Despite having all the possession, the EU was eventually handed its ass, when an old EU border weakness of one of its minor players, Ireland, proved the Achilles heal. The EU seemed well in control despite that weakness having been worked on for the previous 4 years, and, it was thought, made secure in a detailed article. Despite the tough play from AZ UK for much of the game, when the EU upped the anti to press for the win, Ireland was not up to the higher stakes game, and handed the opposition the match with an own goal late on Friday. There was no recovery for the EU, having to satisfy itself with a late consolation score that really just put them back where they were on Friday. The EU, conforming to its stereotype of eternal internal wrangling and lost in translations, were no match in the end for the astute play of the UK. Rule Britannia!

brickster69 · 31-01-2021 08:04PM

mista11 wrote: »

A good read that, I encourage all those posters who still belive that Astrazenca has broken the contract to read it rather that try to interperet parts of the contract themselvels (with no legal foundation)

I havent found one article online, from anyone with legal credentials, who is supporting that the EU has any case against AZ

I had a quick read of the German and french papers and there is not one article talking about taking AZ to court (there is also no mention of the article 16 debacle either which i thought was strange) All the papers are talikng about is what a mess the EU have made of supply

It was good. The funny thing is that the EU could not take UK vaccines either, because the contracts for UK production were signed after the EU one. So no contracts were in effect at the time, to impede EU production. A simple google search would find that out in 5 minutes.

No doubt roll out will step up and we can all get sorted ASAP.

Bit cynical · 31-01-2021 08:11PM

mista11 wrote: »

there is also no mention of the article 16 debacle either which i thought was strange

I don't think the border issue was ever big in the EU outside of Ireland. It was only significant temporarily during Brexit negotiations when it was a convenient stumbling block from the EU's perspective, something to make the UK's life a little harder. If it were not for Ireland's position on the border, some other issue would have to have been employed.

Hence, when it appeared that the EU was falling behind Brexit UK in the vaccines, the border could be closed by Brussels without much thought; they themselves not placing any value on it. Dublin had to phone them up to remind them that they once pretended to care about the border.

brickster69 · 31-01-2021 08:11PM

Good thing for Ireland if the EU are rolling out to vulnerable groups first Ireland's allocation could be more with France and Germany not wanting to use them

downcow · 31-01-2021 09:30PM

brickster69 wrote: »

Good thing for Ireland if the EU are rolling out to vulnerable groups first Ireland's allocation could be more with France and Germany not wanting to use them

I see just now on the news that UK hopes to not just help developing countries with spare vaccines but is keen to help neighbours as well, as soon as all vulnerable groups are vaccinated. So hopefully that will be additional vaccines for Roi to fill the gap

Stark · 31-01-2021 09:33PM

They're always so good to us.

lawred2 · 31-01-2021 09:41PM

...Ghost... wrote: »

I was thinking exactly this. Their plan puts the rest of the world at risk. If they are only giving a portion of the required dose, they are creating a serious risk of the virus mutating into a strain which defeats the vaccine.

Do you actually know what you're taking about? Are you a scientist?

ThePanjandrum · 31-01-2021 09:43PM

NeuralNetwork wrote: »

The pharma sector doesn't really use lean supply chains nor was there any issue with cold storage for this vaccine. It's quite a compact product and it only requires chill storage, nothing remarkable that would be in anyway challenging.

The AstraZeneca vaccine is frozen between manufacture and finishing. See, for example, the Daily Telegraph:

A further 15 million doses [of the AstraZeneca vaccine] are frozen and stored in bulk, waiting to be shipped and then defrosted and put in glass vials in a process known as "fill and finish".

https://www.telegraph.co.uk/news/2021/01/05/public-health-england-wont-work-sundays-deliver-covid-19-vaccines/?li_source=LI&li_medium=liftigniter-onward-journey

I've read this elsewhere too, such as this:

Currently AstraZeneca is keeping the vaccine frozen in large containers, and will only add a final ingredient, put it into vials and keep it at fridge temperature when the vaccine gets closer to approval.

https://www.sharenet.co.za/views/views-article.php?views-article=487112

monkeybutter · 31-01-2021 09:46PM

lawred2 wrote: »

Do you actually know what you're taking about? Are you a scientist?

They are a ghost

The more people get it the more chance it will mutate into a zombie apocalypse

That is all

What exactly is happening with AstraZeneca?

Comments