What exactly is happening with AstraZeneca?

astrofool · 23-04-2021 02:16PM

Bit cynical wrote: »

However wouldn't the UK also say how "f*cking hilarious" it is that the EU are two months behind the UK in vaccine administrations and increasingly falling further behind?

Yep, kudos to their rollout, it only came at the cost of 2.5 times more deaths than Ireland have had.

I think Germany will be happier with all the extra alive people in their country, don't you?

Also great news today that the EU is now completely self sufficient in vaccine production, another positive from the whole Brexit debacle.

And back on topic, AZ f*cking up again with deliveries next week, still not approved in the US and lost future EU contracts.

Tyrone212 · 23-04-2021 02:21PM

FT - Uk may increase age restrictions to 40+ , decision could come early next week.

New data yesterday.

"Britain's medicines regulator on Thursday said there had been 168 major blood clots with low platelets following a dose of AstraZeneca's (AZN.L) COVID-19 vaccine, a rate of 7.9 clots per million doses, a jump in incidence from the previous week's figure.

This was up from the 100 cases reported last week, when the overall case incidence was 4.9 per million doses.

The UK’s medicines regulator said the overall case fatality rate was 19 per cent, with 32 deaths reported up to April 14.

The cases, reported through the Yellow Card scheme, occurred in 93 women and 75 men aged from 18 to 93 years old. One was after a second dose.

Of the CVST cases, the average age is 47, while for the other major thromboembolic events the average age is 55."

drunkmonkey · 23-04-2021 02:37PM

Doesn't that completely swing the risk versus reward in the under 40's with no underlying conditions, it's probably a bit more depending age wise on who's data you listen to.

23-04-2021 02:40PM

astrofool wrote: »

Yes I do. The relevant part of the APA would only have been enforceable under emergency approval which AZ could have chosen. Under CMA that part of the APA isn't enforceable (and at least Russia Today seems to think that way as well :pac:).

However, I'm sure, no matter what, you will cling to your mistaken belief that the APA is enforceable over the European Medicine Authority decision even when AZ is making pay-outs (I don't think the Italy case will win as clots are already listed as a rare side effect), but at least in this case, the decision by the EU to wait for the Conditional Marketing Approval is paying dividends and keeps the manufacturers on the hook for their product, unlike the UK which will be handling any vaccine related pay-outs.

more waffle.

Can you actually provide anything to back up your bluster?

astrofool · 23-04-2021 02:57PM

correct horse battery staple wrote: »

Everything Tories touch turns to ****

I fully expect another wave in UK come autumn as not only are they not planning for booster shot production (see big Pfizer announcements there) this half arsed vaccination plus reopening too early plus the attitudes of public which already gave the world a breeding ground for that deadly Kent variant

As for AZ I hope they get dragged through courts in coming years, their brand is manure grade

The backbencher tories are cut from the same cloth as the GOP governors in the US, they just want things open regardless of how many get sick and die (as long as they themselves are kept safe of course).

josip · 23-04-2021 03:04PM

Woody79 wrote: »

https://twitter.com/laoneill111/status/1384966966474051588?s=20

A picture paints a thousand words...

NIAC should be ashamed of themselves.

So many missteps due to in their own words ABUNDANCE OF CAUTION.

Meanwhile UK has declared their pandemic over.

I agree with them.

Their pandemic is over.
...

Reminds me of Bush's mission accomplished in 2003

Just because someone says something doesn't make it true.
Especially when it's an Oxford professor being quoted by the Telegraph.
If it's over, why do they still have to wear masks and travel is restricted?

23-04-2021 03:43PM

astrofool wrote: »

Yes I do. The relevant part of the APA would only have been enforceable under emergency approval which AZ could have chosen. Under CMA that part of the APA isn't enforceable (and at least Russia Today seems to think that way as well :pac:).

However, I'm sure, no matter what, you will cling to your mistaken belief that the APA is enforceable over the European Medicine Authority decision even when AZ is making pay-outs (I don't think the Italy case will win as clots are already listed as a rare side effect), but at least in this case, the decision by the EU to wait for the Conditional Marketing Approval is paying dividends and keeps the manufacturers on the hook for their product, unlike the UK which will be handling any vaccine related pay-outs.

Aegir wrote: »

more waffle.

Can you actually provide anything to back up your bluster?

still waiting.

Would you like me to help you out here?

Conditional Marketing Authorisation is the only route possible, so it isn't a case of which type of authorisation AZ applied for, it was a case of which route they were told to go down.

It's all explained here https://www.ema.europa.eu/en/events/public-stakeholder-meeting-development-authorisation-safe-effective-covid-19-vaccines-eu

The indemnity in the Curevac contract (what's that, the EU don't give indemnities, only the bould UK do that?) is much clearer, actually stating that it is exceptional times and this is why the indemnity is being given. Clause 1.23

brickster69 · 23-04-2021 03:55PM

Pfizer and Moderna contracts leaked

https://www.rai.it/dl/doc/2021/04/17/1618676600910_APA%20BioNTech%20Pfizer__.pdf

https://www.rai.it/dl/doc/2021/04/17/1618676613043_APA%20Moderna__.pdf

brickster69 · 23-04-2021 04:03PM

A bit of info on them both

https://tekdeeps.com/the-keys-to-the-eus-confidential-and-flawless-contracts-with-pfizer-and-moderna/

Bit cynical · 23-04-2021 04:05PM

correct horse battery staple wrote: »

Everything Tories touch turns to **** their actions led to at least 70000 needless deaths in UK

I fully expect another wave in UK come autumn as not only are they not planning for booster shot production (see big Pfizer announcements there) this half arsed vaccination plus reopening too early plus the attitudes of public which already gave the world a breeding ground for that deadly Kent variant

I would be wary of dismissing the UK prematurely however. Currently deaths are rising much higher in the EU whereas they have largely levelled off in the UK. Given the vaccinations gap between the EU and the UK is about two months and rising, the EU could end up much closer to the UK in deaths per capita than many would expect despite longer restrictions in the EU.

23-04-2021 04:06PM

brickster69 wrote: »

Pfizer and Moderna contracts leaked

https://www.rai.it/dl/doc/2021/04/17/1618676600910_APA%20BioNTech%20Pfizer__.pdf

https://www.rai.it/dl/doc/2021/04/17/1618676613043_APA%20Moderna__.pdf

interesting that the Curevac, Pfizer and Moderna contracts all have the same indemnity wording, but the AZ one is different.

They are all pretty comprehensive though.

brickster69 · 23-04-2021 04:22PM

The full AZ one

https://www.rai.it/dl/doc/2021/02/19/1613725900577_AZ_FIRMATO_REPORT.pdf

Must admit all of this " promised doses " was a load of bollox really. Page 40 clearly gives the estimated amounts to be supplied and all of this was based on approval being prior to Dec 2020. Seen as approval was given by the EMA on 29/1/2021 it's hard to see what AZ guaranteed to deliver really.

Tyrone212 · 23-04-2021 04:25PM

They cut their own target of 45k doses this week to 9k for Ireland. They're an absolute joke. EU is moving on without them and all the better. Soon to be old news.

astrofool · 23-04-2021 04:26PM

Aegir wrote: »

Would you like me to help you out here?

The only salient fact is that CMA requires the company that applies to accept liability, that's the beginning and end of any fact finding. For a company to have CMA for a medicine they also must accept the liability of that medicine.

If you can show the documentation that says that CMA means that the company doesn't accept liability then show it. The presentations you linked make no such claim. They also recommend the CMA as the most appropriate approach but don't mandate it.

LuckyLloyd · 23-04-2021 04:30PM

Tyrone212 wrote: »

They cut their own target of 45k doses this week to 9k for Ireland. They're an absolute joke. EU is moving on without them and all the better. Soon to be old news.

Yeah it's all a bit irrelevant really. Pfizer to get the job done.

Charles Babbage · 23-04-2021 04:33PM

Bit cynical wrote: »

I would be wary of dismissing the UK prematurely however. Currently deaths are rising much higher in the EU whereas they have largely levelled off in the UK. Given the vaccinations gap between the EU and the UK is about two months and rising, the EU could end up much closer to the UK in deaths per capita than many would expect despite longer restrictions in the EU.

Even in the EU in the next few weeks there will be substantial vaccination coverage of the groups most likely to die, so the death rate will shortly decline rapidly even if the number of cases does not.

23-04-2021 04:35PM

astrofool wrote: »

The only salient fact is that CMA requires the company that applies to accept liability, that's the beginning and end of any fact finding. For a company to have CMA for a medicine they also must accept the liability of that medicine.

If you can show the documentation that says that CMA means that the company doesn't accept liability then show it. The presentations you linked make no such claim. They also recommend the CMA as the most appropriate approach but don't mandate it.

Yes, the advanced purchase agreement between the European Union and Astra Zeneca.

The Eu and by extension the member states, give Astra Zeneca, Curevac, Moderna and Pfizer as well as their affiliates, a fairly comprehensive indemnity.

If the EMA give a conditional approval which includes the manufacturer assuming all liability and a third party then decides to buy those products but also give an indemnity, then that is entirely up to them. If the indemnity was conditional on the type of marketing approval, then the contract would state that.

It is understandable that it is done this way. If the manufacturers took in the liability of a vaccine programme for millions of people, their risk would be enormous and they would need to charge hundreds of times the cost per dose to cover their risk. They would also be pulling the drug every time there was an issue and effectively take it out of the control of the member state.

Wolf359f · 23-04-2021 04:38PM

brickster69 wrote: »

The full AZ one

https://www.rai.it/dl/doc/2021/02/19/1613725900577_AZ_FIRMATO_REPORT.pdf

Must admit all of this " promised doses " was a load of bollox really. Page 40 clearly gives the estimated amounts to be supplied and all of this was based on approval being prior to Dec 2020. Seen as approval was given by the EMA on 29/1/2021 it's hard to see what AZ guaranteed to deliver really.

So if AZ decided to delay the application to the EMA, that's ok in your eyes. If they decided to take the money, never actually submit for EMA approval and instead used all production for other countries where they bothered to apply for approval, that's all fine and dandy in your eyes.
In essence, EU bad, AZ good.

brickster69 · 23-04-2021 04:42PM

Wolf359f wrote: »

So if AZ decided to delay the application to the EMA, that's ok in your eyes. If they decided to take the money, never actually submit for EMA approval and instead used all production for other countries where they bothered to apply for approval, that's all fine and dandy in your eyes.
In essence, EU bad, AZ good.

Not at all. From what i remember the EU required extra data from the trials which AZ never had which held this up. Quite sure it was not deliberate just a bit of a rush job given the circumstances. Still estimated quantities, using best reasonable efforts, based on a delayed approval do not equal " promised " deliveries or guaranteed deliveries.

fly_agaric · 23-04-2021 04:46PM

Wolf359f wrote: »

So if AZ decided to delay the application to the EMA, that's ok in your eyes. If they decided to take the money, never actually submit for EMA approval and instead used all production for other countries where they bothered to apply for approval, that's all fine and dandy in your eyes.
In essence, EU bad, AZ good.

Seems so.

The company has delivered for the Golden Boy customer UK, pulled out all the stops to try & make sure they won't go short of vaccines and that is all that matters for some people.

If anyone else is disgruntled with them they must be the ones with a problem!

astrofool · 23-04-2021 04:46PM

brickster69 wrote: »

A bit of info on them both

https://tekdeeps.com/the-keys-to-the-eus-confidential-and-flawless-contracts-with-pfizer-and-moderna/

This is actually a good read and highlights that the manufacturers will be taking on liability for their medicines. If they make a bad batch and poison someone, they pay that out, if it's found out they hid some adverse effects during the trial, they take it on, so it encourages the manufacturers to have a high bar.

An example would be AZ with CVST, if it's found that this was occurring during the trial and they missed it due to negligence, then they would be liable. In the UK, the UK government took on that liability. Now the vaccine already lists clots as a side effect, so that may be the get out, but if the Italian woman sues and they found that AZ/Oxford knew of the clots and didn't disclose them then AZ would be the ones making the payout. Were it an English woman, then Boris would be making the payout.

Aegir wrote: »

They would also be pulling the drug every time there was an issue and effectively take it out of the control of the member state.

This is exactly what J&J did in response to reports of CVST events with rollout only resuming once the instructions and disclaimers were updated, you have just described something that happened and a perfect example of why Europe went the CMA route and not the emergency route because it puts the onus back on the manufacturers. If we only had one vaccine available, it's easy to see it going down the emergency route, but Pfizer have done such a good job that this has been unnecessary and have set a very high bar for both deliveries and production quality and quantity that AZ have struggled with (likely as they're new to the vaccine business).

brickster69 wrote: »

Not at all. From what i remember the EU required extra data from the trials which AZ never had which held this up. Quite sure it was not deliberate just a bit of a rush job given the circumstances. Still estimated quantities, using best reasonable efforts, based on a delayed approval do not equal " promised " deliveries or guaranteed deliveries.

There was a lot of issue with data from the trials that delayed things, this is still ongoing in the US. Again, another huge risk taken here by the UK (that seems to have paid off) in approving under emergency approval. I'm sure we will see lawsuits in the UK around this as the MHRA also missed this data due to losing access to the EU database.

nomdeboardie · 23-04-2021 04:55PM

monkeybutter wrote: »

surely your immune system response would be at its strongest when getting the second dose of say AZ so, but it is still effective

I may be misunderstanding your question, but I think the idea is that the immune response against the proteins of adenovirus-type vector, which enclose the coronaviral spike mRNA, and would efficiently inject it into our cells on the first injection, would themselves provoke antibodies that would coat the viral vector on subsequent injections, reducing the ability of the mRNA to get in and make the spike again

23-04-2021 05:20PM

astrofool wrote: »

This is actually a good read and highlights that the manufacturers will be taking on liability for their medicines. If they make a bad batch and poison someone, they pay that out, if it's found out they hid some adverse effects during the trial, they take it on, so it encourages the manufacturers to have a high bar.

did you miss this bit then?

The contracts also confirm that, in the event of side-effect damage, compensation will fall almost exclusively to the States. The concessions made to pharmaceutical companies in the area of civil liability have been debated across Europe for months. But the text reiterates that the use “occurs in a period of epidemic conditions and the administration of the products will be carried out under the exclusive responsibility of the Member States.”

astrofool wrote: »

An example would be AZ with CVST, if it's found that this was occurring during the trial and they missed it due to negligence, then they would be liable. In the UK, the UK government took on that liability. Now the vaccine already lists clots as a side effect, so that may be the get out, but if the Italian woman sues and they found that AZ/Oxford knew of the clots and didn't disclose them then AZ would be the ones making the payout. Were it an English woman, then Boris would be making the payout.

and you know this how?

astrofool wrote: »

This is exactly what J&J did in response to reports of CVST events with rollout only resuming once the instructions and disclaimers were updated, you have just described something that happened and a perfect example of why Europe went the CMA route and not the emergency route because it puts the onus back on the manufacturers. If we only had one vaccine available, it's easy to see it going down the emergency route, but Pfizer have done such a good job that this has been unnecessary and have set a very high bar for both deliveries and production quality and quantity that AZ have struggled with (likely as they're new to the vaccine business).

what?

You are staring something straight in the face and refusing to accept it is there.

brickster69 · 23-04-2021 05:39PM

Fact of the matter is what did AZ guarantee to deliver to the EU ? The answer is nothing, because no company did or could.

IRISHSPORTSGUY · 23-04-2021 05:59PM

I think when we take a step back after all this is over we'll realise AZ played a decent part in the roll out. They were able to get a vaccine to market a lot sooner than J&J and CureVac and in larger quantities here than Moderna.

It's just a shame they failed to scale up to the levels we thought they would and their deliveries were erratic, but it's an unprecedented time in global history I guess.

23-04-2021 06:11PM

IRISHSPORTSGUY wrote: »

I think when we take a step back after all this is over we'll realise AZ played a decent part in the roll out. They were able to get a vaccine to market a lot sooner than J&J and CureVac and in larger quantities here than Moderna.

It's just a shame they failed to scale up to the levels we thought they would and their deliveries were erratic, but it's an unprecedented time in global history I guess.

I saw it described as going from making your own sour dough bread, to mass producing sour dough pizzas.

You need to put some of the batch aside to produce the next batch and the more you put aside, the less you have to use. After a while it snowballs and yiu are producing loads and putting loads aside to produce future batches, but it takes time.

I don’t know how accurate that is, but to a layman it kind of explained this idea of yields etc.

astrofool · 23-04-2021 06:50PM

Aegir wrote: »

did you miss this bit then?

and you know this how?

Because that is what the approval by CMA covers, you keep clinging to the contracts made before approval and before any deliveries despite the changes happening on the ground since then, of which one was for companies to go with CMA meaning they take liabilities on events such as these.

Aegir wrote: »

what?

You are staring something straight in the face and refusing to accept it is there.

Oh come on, fill this in more, what what?

The facts say that EU citizens are covered for liability by the companies that manufacture the vaccines, if something goes wrong in the manufacture of those vaccines that isn't covered under the instructions list, the companies that manufacture the vaccines will be liable for damages. If something occurs that hasn't been uncovered already and isn't shown to be negligence by the manufacturer (to take an extreme example, 12 months after usage an arm falls off), then that liability would be handled by the EU as part of CMA, this is quite an unlikely situation, but is possible, it's also one of the reasons that CMA requires a lot more data for sign off such that the EU is satisfied that those events won't occur. For the UK citizen all these cases would be liable by the UK government.

This (in my opinion) may also explain why the UK was slow to admit to CVST issues with AstraZeneca despite having the data while the EU reported on it immediately, the EU didn't need to worry about taking indemnity while the UK did, so it was in their best interest to play it down.

Again, the salient fact is that an EU citizen is better covered by issues with a vaccine being under CMA issued by the EMA than a UK citizen with a vaccine under emergency approval by the MHRA. This also puts a block on one of the anti-vax arguments that the manufacturers aren't liable, they are, they have a lot to lose if they don't ensure their medicine aren't tested to a very high safety level with all events reported transparently.

astrofool · 23-04-2021 06:53PM

Aegir wrote: »

I saw it described as going from making your own sour dough bread, to mass producing sour dough pizzas.

You need to put some of the batch aside to produce the next batch and the more you put aside, the less you have to use. After a while it snowballs and yiu are producing loads and putting loads aside to produce future batches, but it takes time.

I don’t know how accurate that is, but to a layman it kind of explained this idea of yields etc.

I think the unfortunate thing is that they put it all at risk by overextending themselves early on, had they spent a bit longer building up the active ingredient a lot of the supply issues may not have occurred, even if it meant pushing back the rollout dates. I don't think the UK government would have allowed this however and the EU suffered on delivery as a result.

23-04-2021 08:21PM

astrofool wrote: »

Because that is what the approval by CMA covers, you keep clinging to the contracts made before approval and before any deliveries despite the changes happening on the ground since then, of which one was for companies to go with CMA meaning they take liabilities on events such as these.

Oh come on, fill this in more, what what?

The facts say that EU citizens are covered for liability by the companies that manufacture the vaccines, if something goes wrong in the manufacture of those vaccines that isn't covered under the instructions list, the companies that manufacture the vaccines will be liable for damages. If something occurs that hasn't been uncovered already and isn't shown to be negligence by the manufacturer (to take an extreme example, 12 months after usage an arm falls off), then that liability would be handled by the EU as part of CMA, this is quite an unlikely situation, but is possible, it's also one of the reasons that CMA requires a lot more data for sign off such that the EU is satisfied that those events won't occur. For the UK citizen all these cases would be liable by the UK government.

This (in my opinion) may also explain why the UK was slow to admit to CVST issues with AstraZeneca despite having the data while the EU reported on it immediately, the EU didn't need to worry about taking indemnity while the UK did, so it was in their best interest to play it down.

Again, the salient fact is that an EU citizen is better covered by issues with a vaccine being under CMA issued by the EMA than a UK citizen with a vaccine under emergency approval by the MHRA. This also puts a block on one of the anti-vax arguments that the manufacturers aren't liable, they are, they have a lot to lose if they don't ensure their medicine aren't tested to a very high safety level with all events reported transparently.

I give up.

Your ability to deny the blatantly obvious is commendable.

23-04-2021 08:31PM

astrofool wrote: »

I think the unfortunate thing is that they put it all at risk by overextending themselves early on, had they spent a bit longer building up the active ingredient a lot of the supply issues may not have occurred, even if it meant pushing back the rollout dates. I don't think the UK government would have allowed this however and the EU suffered on delivery as a result.

Remember all that talk about the U.K. signing a contract and the Eu claiming it wasn’t like a queue in a butchers shop?

Turns out it was more like a queue in a sour dough pizza shop but the U.K. decided to not only get their order in three months earlier, but also gave the baker a stand alone factory to make their pizzas in.

I look forward to your next bitter little dig.

What exactly is happening with AstraZeneca?

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