Coronavirus

Originally Posted by heero_yuy

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.

It's a serious political failure amongst some of the most influential national leaders in the EU, worst of all Macron himself in France. They were so busy traducing the AstraZeneca vaccine in retaliation for being told they couldn't have as much of it as they wanted, they have caused public scepticism and arguably now enabled regulatory over-caution in the face of 'evidence' that might - just might - justify briefly pausing use of a medicine in normal times, in the absence of a massive, readily available data set to compare their domestic experience with.

Of course in the case of the AstraZeneca vaccine there is data from something like 12 million people and counting that says there's no evidence of a causal link with blood clots, plus a deliberate study of its safety in Finland that likewise determines it is as safe as the UK's MHRA, the EMA and WHO have said all along. The medicines regulators all over Europe are fiddling while Rome burns, and later this year they'll all be locked down again while we're increasingly getting back to normal. Their desire for self-flagellation is bizarre.

[Carth]

Originally Posted by Chris

snip . . and later this year they'll all be locked down again while we're increasingly getting back to normal.

Of course, that all depends on how well we keep on top of things. I'm not advocating a total lock down of our ports/airports, but we need to be very careful of who arrives from where and ensure they're clear, with double/triple checked details.

We've already seen an example recently of how one person slipped through the net and caused 'mild' panic

[jonbxx]

Originally Posted by Sephiroth

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?

The issue is that often, you don't know how hard or easy the tech transfer will be until you do it. When the contracts were signed off in mid August, the manufacturing process was still in development. Even going from lab scale to large scale at one manufacturing site is fraught with issues. This process has gone from Oxford Uni to AZ development to Cobra and Oxford Biomedica to pin down the production method. Cobra and Oxford Biomedica had the freedom to tinker about with the production to get it going well. Halix, Novasep, CSL, etc. don't have such a luxury.

There was a lot of risk signing off the contract in August and the contract acknowledges that risk. Hell, there was no idea if the vaccine would even work at that point!

It is known what step is causing the problems. How to fix it is the struggle and that is down to AZ, the manufacture and the supplier of the manufacturer to sort

[Sephiroth]

Originally Posted by jonbxx

The issue is that often, you don't know how hard or easy the tech transfer will be until you do it. When the contracts were signed off in mid August, the manufacturing process was still in development. Even going from lab scale to large scale at one manufacturing site is fraught with issues. This process has gone from Oxford Uni to AZ development to Cobra and Oxford Biomedica to pin down the production method. Cobra and Oxford Biomedica had the freedom to tinker about with the production to get it going well. Halix, Novasep, CSL, etc. don't have such a luxury.

There was a lot of risk signing off the contract in August and the contract acknowledges that risk. Hell, there was no idea if the vaccine would even work at that point!

It is known what step is causing the problems. How to fix it is the struggle and that is down to AZ, the manufacture and the supplier of the manufacturer to sort

I see your point, which boils down to AZ made commitments they couldn't keep. That is still a feared event that the EC should have examined. An unenforceable contract is of little use. Contingency would normally be built in for late delivery. A clause that says "the EC to be notified if a contracted delivery cannot be made" is a stable door analogy.

They fupped in spades.

But in a contract of this sort, it would have been "best endeavours", due to all the unknowns - the EU can’t manage the contract between AZ and Halix.

There could be no reasonable mitigation, as the only mitigation would be to build another production line, which could have exactly the same issues...

[1andrew1]

Originally Posted by Hugh

But in a contract of this sort, it would have been "best endeavours", due to all the unknowns - the EU can’t manage the contract between AZ and Halix.

There could be no reasonable mitigation, as the only mitigation would be to build another production line, which could have exactly the same issues...

To me, the mitigation was
- Multiple production sites.
- A portfolio approach to the vaccines procurement.

Relevant to remember that AstraZeneca was and is selling the vaccine to the world on a non-profit basis too.

Is Europe's AstraZeneca jab decision-making flawed?

(Spoiler alert: yes, it is).

Prof Sir David Spiegelhalter, an expert in understanding risk at Cambridge University, says it shows that sometimes you have to be bold in your decision-making.
'The precautionary principle can be a sensible way to make decisions in the face of scientific uncertainty.
"It favours inaction as a way of reducing risk. But the problem is that these are not normal times and inaction can be more risky than action."
What is needed in circumstances like these, according to Sir David, is to work out what is most likely on the balance of probability. That requires looking at both the direct and indirect evidence and the context those decisions are being made in.
"Making decisions when there is such uncertainty is incredibly difficult, but sometimes it can be harmful to wait for certainty. Not vaccinating people will costs lives."

[Sephiroth]

Originally Posted by Hugh

But in a contract of this sort, it would have been "best endeavours", due to all the unknowns - the EU can’t manage the contract between AZ and Halix.

There could be no reasonable mitigation, as the only mitigation would be to build another production line, which could have exactly the same issues...

That still doesn't justify that the EC did not perform adequate project management risk analysis.

You are right that there would be little by way of mitigation that they could engineer - but then they shouldn't have been so "how wonderful we are" if they couldn't know that the hoped for result might not materialise.

To my mind the term "best reasonable efforts" was the clue and I, as a project manager, would report major risks to my sponsors unless the assurances were satisfactory.

But you know all this, of course. Yes?



---------- Post added at 18:36 ---------- Previous post was at 18:34 ----------

Originally Posted by 1andrew1

To me, the mitigation was
- Multiple production sites.
- A portfolio approach to the vaccines procurement.

Relevant to remember that AstraZeneca was and is selling the vaccine to the world on a non-profit basis too.

I refer you to my reply to Hugh. Multiple production sites that were not yet available at contract signing is a great red flag to the likes of me and no mitigation at all.

The portfolio approach yielded little as well.

Why are you defending those fools (again)?


---------- Post added at 18:38 ---------- Previous post was at 18:36 ----------

Originally Posted by Chris

Is Europe's AstraZeneca jab decision-making flawed?

(Spoiler alert: yes, it is).

See the EU for details.

[1andrew1]

Originally Posted by Sephiroth

[COLOR="Blue"]
I refer you to my reply to Hugh. Multiple production sites that were not yet available at contract signing is a great red flag to the likes of me and no mitigation at all.

The portfolio approach yielded little as well.

Why are you defending those fools (again)?

No sites were available to anyone in August when they contracted with AstraZeneca for an unproven vaccination. I'm sure Norway, Iceland, EU, UK, etc all understood the risks.

Jonbxx has neatly explained the processes. I hope that when you have had time to reflect upon his posts, you will be able to adjust your your perspectives to fully appreciate his insight.

(But we'd both better avoid going backwards and forwards too much as we'll bore the forum. )

[Sephiroth]

Originally Posted by 1andrew1

No sites were available to anyone in August when they contracted with AstraZeneca for an unproven vaccination. I'm sure Norway, Iceland, EU, UK, etc all understood the risks.

Jonbxx has neatly explained the processes. I hope that when you have had time to reflect upon his posts, you will be able to adjust your your perspectives to fully appreciate his insight.

(But we'd both better avoid going backwards and forwards too much as we'll bore the forum. )

Jon's insights were replied to thus:

I see your point, which boils down to AZ made commitments they couldn't keep. That is still a feared event that the EC should have examined. An unenforceable contract is of little use. Contingency would normally be built in for late delivery. A clause that says "the EC to be notified if a contracted delivery cannot be made" is a stable door analogy.

They fupped in spades.

I'll leave it at that because we are going round in circles.

Originally Posted by Chris

It's a serious political failure amongst some of the most influential national leaders in the EU, worst of all Macron himself in France. They were so busy traducing the AstraZeneca vaccine in retaliation for being told they couldn't have as much of it as they wanted, they have caused public scepticism and arguably now enabled regulatory over-caution in the face of 'evidence' that might - just might - justify briefly pausing use of a medicine in normal times, in the absence of a massive, readily available data set to compare their domestic experience with.

Of course in the case of the AstraZeneca vaccine there is data from something like 12 million people and counting that says there's no evidence of a causal link with blood clots, plus a deliberate study of its safety in Finland that likewise determines it is as safe as the UK's MHRA, the EMA and WHO have said all along. The medicines regulators all over Europe are fiddling while Rome burns, and later this year they'll all be locked down again while we're increasingly getting back to normal. Their desire for self-flagellation is bizarre.

The worst thing about it is that anti-vax sentiment is really hard to stop once you've set it running. If you've undermined faith not only in the vaccines but by extension the health experts who've developed, tested and recommended them then you can't easily fix it. A reassuring statement from your health regulator won't do anything because these are the same people whose advice and findings you've already told people to dismiss. As with all conspiratory thinking the very people best placed to debunk people's concerns and theories are part of the problem. Macron has undermined the very institutions he is going to later depend on to encourage an already vaccine sceptical public to take up the jab.

It's the same problem as MMR. One dodgy study undermined faith in vaccines for over a decade purely because its findings were promoted by papers like the Daily Mail and Private Eye who portrayed the efforts of regulators and the NHS to ally fears as part of an establishment stitch-up.

[tweetiepooh]

Originally Posted by Damien

The worst thing about it is that anti-vax sentiment is really hard to stop once you've set it running. If you've undermined faith not only in the vaccines but by extension the health experts who've developed, tested and recommended them then you can't easily fix it. A reassuring statement from your health regulator won't do anything because these are the same people whose advice and findings you've already told people to dismiss. As with all conspiratory thinking the very people best placed to debunk people's concerns and theories are part of the problem. Macron has undermined the very institutions he is going to later depend on to encourage an already vaccine sceptical public to take up the jab.

It's the same problem as MMR. One dodgy study undermined faith in vaccines for over a decade purely because its findings were promoted by papers like the Daily Mail and Private Eye who portrayed the efforts of regulators and the NHS to ally fears as part of an establishment stitch-up.

It's because it's the sort of new/report that people want to believe. They want to believe that someone, somewhere is doing something dodgy and it then takes the emphasis off themselves.

[GrimUpNorth]

As long as the UK doesn't jump on the stupid suspension bandwagon before the end of the week - I'm booked in at 9:10 am on Thursday and will be pretty fed up if the wheels drop off before then.

Originally Posted by GrimUpNorth

As long as the UK doesn't jump on the stupid suspension bandwagon before the end of the week - I'm booked in at 9:10 am on Thursday and will be pretty fed up if the wheels drop off before then.

There’s no chance of that happening. The evidence simply doesn’t support it. You’ll get your jab as scheduled.

[jonbxx]

It's looking good for over 50s soon - https://inews.co.uk/news/politics/ov...-jabbed-915170

Got my sleeve rolled up already!