Coronavirus

[Sephiroth]

Originally Posted by 1andrew1

<SNIP>

I agree that they should have been all over that, although we don't know to what extent they were or they weren't over that. But that tangential point does not make your case that they knew the contract could not be fufilled. Only Captain Hindsight would know.

And you've yet to acknowledge that your point about no risk mitigation was similarly invalid.

Andrew, I don't know what you do for a living. But I live in the world of projects. Risk analysis and risk mitigation are matters of expertise ahead of any feared event. My projects also involve safety of life - and if the vaccine isn't in that class, my whatsit's a kipper.

In the EU vaccine case, one of the feared events is (should be in any competent organisation) late/non-delivery. The EC fupped badly here and then started a campaign to shake the blame off their shoulders,

It's no good you trading nonsense here by looking at the square root of a few words. Nobody agrees with you (that might provoke a few Remainers!).

[1andrew1]

Originally Posted by Sephiroth

Andrew, I don't know what you do for a living. But I live in the world of projects. Risk analysis and risk mitigation are matters of expertise ahead of any feared event. My projects also involve safety of life - and if the vaccine isn't in that class, my whatsit's a kipper.

In the EU vaccine case, one of the feared events is (should be in any competent organisation) late/non-delivery. The EC fupped badly here and then started a campaign to shake the blame off their shoulders,

It's no good you trading nonsense here by looking at the square root of a few words. Nobody agrees with you (that might provoke a few Remainers!).

I'm discussing this around facts, not on politics. If you wish to steer it in the latter direction that's your choice but if you're confident about your assertions then I question the need to do so.

I'm familiar with risk mitigation and I've explained how the EU and UK have similarly achieved this to the extent that it was possible - multiple suppliers and multiple plants. I'm not sure what I can do further here.

Only Captain Hindsight could have forseen that a reputable multinational company could not fufill its contracts so badly. That's a risk that anyone signing a contract with AstraZeneca and indeed the other manufacturers took.

I'll repeat again that I accept the EU procurement plan was not as agile as the UK's and I've never argued otherwise. But that does not take away from the fact that your assertions which I understand to be:
- The EU knew that when it signed the AstraZeneca contract that it could not be fufilled
- The EU did not mitigate the risks
I view as being factually incorrect.

[Sephiroth]

You are writing total rubbish. I will leave it at that.

Yes please.Let's not go round and round conversation wise.

[jonbxx]

Originally Posted by Sephiroth

Andrew, I don't know what you do for a living. But I live in the world of projects. Risk analysis and risk mitigation are matters of expertise ahead of any feared event. My projects also involve safety of life - and if the vaccine isn't in that class, my whatsit's a kipper.

In the EU vaccine case, one of the feared events is (should be in any competent organisation) late/non-delivery. The EC fupped badly here and then started a campaign to shake the blame off their shoulders,

It's no good you trading nonsense here by looking at the square root of a few words. Nobody agrees with you (that might provoke a few Remainers!).

There was always going to be a risk in this vaccine project as it uses contract manufacturers such as Halix (as well as others such as Oxford Biomedica and Cobra) Normally, a drug products manufacturing process uses a set suite of equipment. If demand increases, the drug companies are more likely to replicate their factory rather than replacing with a bigger one as it is much, much easier to copy a production process exactly than start messing with things.

This situation is different - each factory will have different equipment. The 'Tech Transfer' process has to take notice of this. If the production process is robust, it will tend to forgive small changes in equipment and processes but I get the impression that the AZ vaccine production process is not really there, it seems finicky. In all honesty, it wouldn't have made it to market in normal times due to this lack of production robustness.

From a regulatory point of view, AZ need to prove that the vaccine produced at a site (in this case Halix) is the same as the one submitted for approval. If the analysis results during production and the final product is different from what was submitted for approval, it is not the same drug and will not be approved. The stage Halix (and Novasep) are at is trying to get to the stage of churning out vaccine that matches the approved product. They can't submit for approval by the EMA until this happens.

Lack of understanding of the production and being in a hurry has led us to where we are now - 'Tech Transfer hell'

[Sephiroth]

I never doubt a word you say on this topic.

However, you have described a ‘feared event’ perfectly. It is clear to me that the EC did not do due diligence on the manufacture and are hence in the current unlocked for situation.

In all honesty, it wouldn't have made it to market in normal times due to this lack of production robustness.

[tweetiepooh]

I do have to agree that the EU dropped the ball. If they knew that the suppliers needed to make applications and hadn't they should have reminded the companies to get all their ducks in order. Just sitting back and then saying that it's up to the company (if that's what happened) really isn't an acceptable situation.

Originally Posted by tweetiepooh

I do have to agree that the EU dropped the ball. If they knew that the suppliers needed to make applications and hadn't they should have reminded the companies to get all their ducks in order. Just sitting back and then saying that it's up to the company (if that's what happened) really isn't an acceptable situation.

Are you in the right thread

[1andrew1]

Originally Posted by tweetiepooh

I do have to agree that the EU dropped the ball. If they knew that the suppliers needed to make applications and hadn't they should have reminded the companies to get all their ducks in order. Just sitting back and then saying that it's up to the company (if that's what happened) really isn't an acceptable situation.

As jonbxx has outined, all Covid 19 manufacturers need to apply to the relevant authority to be licensed but this can only be done once the vaccine is being produced. It's not something the manufacturers need reminding about nor is it something that can be done until the factory is producing the vaccine in question. Which no factory was doing when the contracts were signed.

jonbxx From a regulatory point of view, AZ need to prove that the vaccine produced at a site (in this case Halix) is the same as the one submitted for approval. If the analysis results during production and the final product is different from what was submitted for approval, it is not the same drug and will not be approved. The stage Halix (and Novasep) are at is trying to get to the stage of churning out vaccine that matches the approved product. They can't submit for approval by the EMA until this happens.

[Pierre]

The whole politicisation of the tragic murder of Sarah Everard and subsequent demonising of all men and boys is less about female safety and a worrying furthering of identity politics.

Probably needs its own thread.

Originally Posted by Pierre

The whole politicisation of the tragic murder of Sarah Everard and subsequent demonising of all men and boys is less about female safety and a worrying furthering of identity politics.

Probably needs its own thread.

Great minds think alike ... thread split is now complete, and all discussion of Sarah Everard and the police handling of her vigil now goes here: https://www.cableforum.uk/board/show...php?t=33709895

[heero_yuy]

Quote from The Sun:

Italy has been plunged back into lockdown as a third Covid wave sweeps across Europe.

The French government is to evacuate patients from Paris using special planes as hospitals reach breaking point amid the chaos of the Europe's vaccine roll out.

Germany and Poland are also seeing a surge in cases and the infection rate EU is now at its highest level since the beginning of February, with the spread of new Covid variants behind the rise.

The new wave of cases comes amid the shambles of the EU's vaccine rollout, which has been hampered by production delays, political infighting and public skepticism over the Astrazeneca jab.

As the UK appears on course to easing restrictions and vaccinating all adults by early June, the Europe appears to be heading in the opposite direction.

Chaos and ineptitude. The hall mark of the EU.

While they agonise over a few blood clot cases no larger than the normal un-jabbed population their unprotected citizens are dying while AZ vaccine lies unused in freezers.

[jonbxx]

Originally Posted by Sephiroth

I never doubt a word you say on this topic.

However, you have described a ‘feared event’ perfectly. It is clear to me that the EC did not do due diligence on the manufacture and are hence in the current unlocked for situation.

The and EC and EMA wouldn't have knowledge of how easy or hard the tech transfer would be, they would work on information from the manufacturer. Some tech transfers are easy, some are not. I have seen issues where exactly the same equipment and chemicals are used at two sites and the results are different. Unexpected quirks pop up all the time but these are usually ironed out behind closed doors.

If AZ promised the tech transfer done by a certain time and manufacturing to start, to an extent, their word is taken on it as they would be the experts in their manufacturing process. Even the EMA would only be looking at how the production at site x, y or z is done in terms of quality and safety, not if it works at all.

[Carth]

Originally Posted by heero_yuy

Chaos and ineptitude. The hall mark of the EU.

Italy has been plunged back into lockdown as a third Covid wave sweeps across Europe.

The French government is to evacuate patients from Paris using special planes as hospitals reach breaking point amid the chaos of the Europe's vaccine roll out.

Germany and Poland are also seeing a surge in cases and the infection rate EU is now at its highest level since the beginning of February, with the spread of new Covid variants behind the rise.

Seems rather strange then, that this story appeared on Friday:

France reopens borders for UK tourists to take holidays without need for Covid vaccination
https://www.itv.com/news/2021-03-12/...id-vaccination

France has eased its border restrictions, allowing British tourists to take holidays there from Friday - without any need to prove they've had a coronavirus vaccine.

But anyone wanting to enter France must have evidence of a negative coronavirus test taken within the previous 72 hours, said tourism minister Jean-Baptiste Lemoyne.

reminds me of that chant 'you don't know what you're doing'

[Sephiroth]

Originally Posted by jonbxx

The and EC and EMA wouldn't have knowledge of how easy or hard the tech transfer would be, they would work on information from the manufacturer. Some tech transfers are easy, some are not. I have seen issues where exactly the same equipment and chemicals are used at two sites and the results are different. Unexpected quirks pop up all the time but these are usually ironed out behind closed doors.

If AZ promised the tech transfer done by a certain time and manufacturing to start, to an extent, their word is taken on it as they would be the experts in their manufacturing process. Even the EMA would only be looking at how the production at site x, y or z is done in terms of quality and safety, not if it works at all.

The EC project delivery manager would have the knowledge of how to do a risk analysis. They did have a project manager, didn't they?