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How NASTY can EU be?..........


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A balanced view from the FT

 

 

One thing is missing in the squabble between the European Commission and AstraZeneca over the shortfall in supply of coronavirus vaccine: the contract. The agreement, we are told, is confidential and the European Commission is calling on AstraZeneca for permission for it to be published.

 

The parties are bickering in public. AstraZeneca’s chief executive Pascal Soriot is reported as saying, “Our contract is not a contractual commitment. It’s a best effort.” In response, the European Commissioner Stella Kyriakides says, “The view that the company is not obliged to deliver because we signed a ‘best effort’ agreement is neither correct nor is it acceptable.” Who is right?

 

Without sight of the actual contract, there are limits on what anyone can say with absolute confidence about the terms agreed. But there is information in the public domain that indicates what may be the substance of them.

 

First, there is no doubt that the Commission intended to enter into “advance purchase agreements” to address the particular risks in the production and supply of vaccine from suppliers. This was the purpose of the EU vaccine strategy adopted in June 2020. A formal paper set out in detail the special procurement process to be followed and the content of the relevant contracts. 

 

In particular, the contracts would “de-risk the necessary investments related to both vaccine development and clinical trials, and the preparation of the at-scale production capacity along the entire vaccine production chain which is required for a rapid deployment of sufficient doses of an eventual vaccine in the EU and globally”.

 

So much for the intention. What was agreed? Here, we can look to an agreement that the EU entered into with another supplier that is in the public domain. A redacted version of that was published on 19 January on the commission website after it was shared with MEPs.

 

You can see that the term “reasonable best efforts” is used. It is defined at some length as, in effect, a reasonable degree of best effort to accomplish a given task in view of its complications. That indicates that it is likely also to be used for agreements with other suppliers — the commission is unlikely to have gone to the effort of drafting such a provision for just one supplier. It also shows that the commission is capable of agreeing a “reasonable best efforts” provision.

 

But a defined term in any legal instrument is only as important as how it is used in an operative clause. In the published contract, this term is used just once. At article 1.3, the contractor commits to use reasonable best efforts to do two specific things. First, to obtain EU marketing authorisation for the vaccine. And second, to establish sufficient manufacturing capacities to enable the supply of the agreed volumes of the vaccine to EU member states in accordance with an “estimated delivery schedule”.

 

The reference to an estimated schedule then takes us to another part of the contract where at article 1.12 both parties expressly agree that the scaling up of production may be delayed and, if so, the obligation of the supplier is to inform the commission as soon as reasonably possible, explain the reasons for such delay and submit a revised schedule.

 

There is nothing in these terms to indicate that they would be unique to the supplier in the published contract. Therefore, one can presume that the terms are also in the agreement with AstraZeneca.

 

If this presumption is correct then, going back to the public bickering, the CEO is right to say the “best efforts” provision is in the contract. There would be an obligation to provide reasonable best efforts to establish sufficient manufacturing capacities for delivery in accordance with an estimated schedule. A failure to comply with that schedule would only result in the supplier informing the commission of new estimates.

 

But it would not be a slam-dunk for AstraZeneca if there is actually such a provision. The “best efforts” term goes to establishing capacities, not to whether those capacities are diverted to supplying another customer. A best reasonable efforts provision is not a general excuse and its application can be tightly defined — the commissioner would have a good point as well.

 

So, on the basis of a published contract with another supplier, it looks as if AstraZeneca would have the benefit of a best-efforts clause, but it also looks as if that provision offers only limited protection. And that is why both sides believe they are in the right, because they are saying slightly different things. 

 

This episode shows why such public-supply contracts should not be confidential, because without sight of the contract, it is impossible to know who is right, about what. There is no good reason for secrecy; public supply contracts should always be in the public domain.

 

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CurtainRaiser - 2021-01-28 3:03 PM

 

A balanced view from the FT

 

One thing is missing in the squabble between the European Commission and AstraZeneca over the shortfall in supply of coronavirus vaccine: the contract. The agreement, we are told, is confidential and the European Commission is calling on AstraZeneca for permission for it to be published.

 

This episode shows why such public-supply contracts should not be confidential, because without sight of the contract, it is impossible to know who is right, about what. There is no good reason for secrecy; public supply contracts should always be in the public domain.

Couldn't agree more with that.

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This video seems to be a reasonably good assumption of whats been going on. Its a week or two out of date. The source when I checked appears to be fairly impartial.

 

 

I tend to agree with Brian. We have played a bit of a blinder here but then we needed to as the gross incompetence that led us to this point meant we could not afford to hang about. Even a broken clock is right twice a day.

 

I just hope that all this does not need to a nationalistic fall out because its early days yet. Cooperation will still be key down the line.

 

Fantastic effort by the vaccine companies though and the NHS for getting it into peoples arms.

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Bulletguy - 2021-01-28 3:01 PM

 

Brian Kirby - 2021-01-28 1:28 PM

 

pelmetman - 2021-01-28 8:53 AM..................................

Rubbish *-) ..........

FACT 1........The EU signed their contract 3 months after the UK to save a few Shekels 8-) ........

FACT 2........They are now at the back of the queue ;-) ..........

FACT 3........They are now trying to blame anyone but themselves for THEIR INCOMPETENCE >:-) .........

FACT 4.........You LOSERS don't like it up EU (lol) (lol) (lol) ..........

In terms of the UK government's performance over ordering, and distributing, the vaccine, they have played a blinder. Sadly, it is the only blinder they have played. Their earlier delays, indecisions, and premature relaxations have led us in the unenviable position of having the vaccines administered in a sub-optimal, rather than optimal, way.

 

Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?

If government have over ordered vaccine supplies, why would Johnson find it necessary to increase the time gap to the second jab from one month to three months against manufacturers instructions?

 

As for the row between EU and AstraZeneca, EU has poured billions into funding medical research in UK which we've now lost but that apart, what is important is the contract the EU signed with Astra which they appear not to have fully committed to. I read where Astra claim they only agreed to supply the EU from Astras manufacturing plant//s within the EU and not from it's UK plant. The EU dispute this and say that was not in the contract. If we're not careful I can see this developing into a legal row and at this point I doubt it's in our favour but a stupid road to go down anyway. We are relying on continuing to trade with the EU, not just for vaccine, but we do need more supplies of BioNTech.

 

It was decided that it was more important that as many as possible got the first jab before starting the second jab for all.

 

As none of us actually know whats in the contract its difficult to deceide if the EU hissy fit is just a cover for them not managing it very well.

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Barryd999 - 2021-01-28 3:46 PM

 

This video seems to be a reasonably good assumption of whats been going on. Its a week or two out of date. The source when I checked appears to be fairly impartial.

 

 

I tend to agree with Brian. We have played a bit of a blinder here but then we needed to as the gross incompetence that led us to this point meant we could not afford to hang about. Even a broken clock is right twice a day.

 

I just hope that all this does not need to a nationalistic fall out because its early days yet. Cooperation will still be key down the line.

 

Fantastic effort by the vaccine companies though and the NHS for getting it into peoples arms.

 

Though the government has not been particularly speedy with decisions , our health and the decisions we make about what we eat and exercise have more to do with the deaths than just Boris.

Generally fit healthy people have not been the ones to die.

We are responsible for our own immune system.

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Bulletguy - 2021-01-28 3:01 PM

Brian Kirby - 2021-01-28 1:28 PM

pelmetman - 2021-01-28 8:53 AM..................................

Rubbish *-) ..........

FACT 1........The EU signed their contract 3 months after the UK to save a few Shekels 8-) ........

FACT 2........They are now at the back of the queue ;-) ..........

FACT 3........They are now trying to blame anyone but themselves for THEIR INCOMPETENCE >:-) .........

FACT 4.........You LOSERS don't like it up EU (lol) (lol) (lol) ..........

In terms of the UK government's performance over ordering, and distributing, the vaccine, they have played a blinder. Sadly, it is the only blinder they have played. Their earlier delays, indecisions, and premature relaxations have led us in the unenviable position of having the vaccines administered in a sub-optimal, rather than optimal, way.

Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?

If government have over ordered vaccine supplies, why would Johnson find it necessary to increase the time gap to the second jab from one month to three months against manufacturers instructions?

As for the row between EU and AstraZeneca, EU has poured billions into funding medical research in UK which we've now lost but that apart, what is important is the contract the EU signed with Astra which they appear not to have fully committed to. I read where Astra claim they only agreed to supply the EU from Astras manufacturing plant//s within the EU and not from it's UK plant. The EU dispute this and say that was not in the contract. If we're not careful I can see this developing into a legal row and at this point I doubt it's in our favour but a stupid road to go down anyway. We are relying on continuing to trade with the EU, not just for vaccine, but we do need more supplies of BioNTech.

Choice of words I think, Paul! :-) "Performance over ordering" was not intended to mean "performance in over-ordering", just that their performance, in placing the orders that they have placed, with the companies selected, was the blinder. I think that is entirely fair as, unfortunately to the considerable embarrassment of others, we have three viable vaccines approved and available.

 

The reason for the government delaying the second dose, IMO, has far more to do with the pace at which the numbers of doses can be produced, and the total number required - which in turn is a consequence of their failure, on three occasions, to react appropriately to the rate at which the virus was spreading. I think even a student virologist would advise that viruses mutate freely and unpredictably and, that being the case, the less the virus is circulating in a given population the better. Given the resource of scientific advice the government can call upon, it is a bit rich for them to claim surprise that mutations have arisen. The higher the amount of virus circulating, the higher the chance of a dodgy mutant emerging.

 

I have no idea what is in the various contracts, but I'd be surprised if AstraZenica have been foolish enough to accept a contract that ties them unconditionally to a specified rate of production when supplying a product that is biological in origin. Bugs don't always do as they are told, and AZ must know that! But then, you never know what lurks in the fine print! :-D More likely, I think, is that someone failed to spot the significance of a clause, or mis-read a clause, or that there is a translation error. The fuss is largely political window dressing, IMO, because the EU is embarrassed that its supply is running late and that only two of the vaccines under evaluation have, to date, passed. If I were living in an EU state which had decided to accept the EMA approved vaccines, and was tied to the EU's rate of delivery, I think I'd be pretty dissatisfied as well!

 

None of this is being helped by various idiots parading the UK's relative success in rolling out the vaccine to maximise the EU's discomfort. We actually have on order more vaccine than we are projected to need, so it might be rather more constructive to offer to divert any surplus to the EU if they wish to pick up the cost. Playing dog in the manger has never been a good ploy!

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jumpstart - 2021-01-28 3:48 PM

 

Bulletguy - 2021-01-28 3:01 PM

 

Brian Kirby - 2021-01-28 1:28 PM

 

pelmetman - 2021-01-28 8:53 AM..................................

Rubbish *-) ..........

FACT 1........The EU signed their contract 3 months after the UK to save a few Shekels 8-) ........

FACT 2........They are now at the back of the queue ;-) ..........

FACT 3........They are now trying to blame anyone but themselves for THEIR INCOMPETENCE >:-) .........

FACT 4.........You LOSERS don't like it up EU (lol) (lol) (lol) ..........

In terms of the UK government's performance over ordering, and distributing, the vaccine, they have played a blinder. Sadly, it is the only blinder they have played. Their earlier delays, indecisions, and premature relaxations have led us in the unenviable position of having the vaccines administered in a sub-optimal, rather than optimal, way.

 

Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?

If government have over ordered vaccine supplies, why would Johnson find it necessary to increase the time gap to the second jab from one month to three months against manufacturers instructions?

 

As for the row between EU and AstraZeneca, EU has poured billions into funding medical research in UK which we've now lost but that apart, what is important is the contract the EU signed with Astra which they appear not to have fully committed to. I read where Astra claim they only agreed to supply the EU from Astras manufacturing plant//s within the EU and not from it's UK plant. The EU dispute this and say that was not in the contract. If we're not careful I can see this developing into a legal row and at this point I doubt it's in our favour but a stupid road to go down anyway. We are relying on continuing to trade with the EU, not just for vaccine, but we do need more supplies of BioNTech.

 

It was decided that it was more important that as many as possible got the first jab before starting the second jab for all.

I know that and i'm not at all comfortable with it. This is a life saving vaccine and you don't ignore manufacturers instructions just to score a few thousand more 'hits'. This is not a competition despite certain elements seeing it as such.

 

As none of us actually know whats in the contract its difficult to deceide if the EU hissy fit is just a cover for them not managing it very well.

See my post up thread in reply to Curtain Raiser.

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Brian Kirby - 2021-01-28 4:53 PM

 

Bulletguy - 2021-01-28 3:01 PM

Brian Kirby - 2021-01-28 1:28 PM

pelmetman - 2021-01-28 8:53 AM..................................

Rubbish *-) ..........

FACT 1........The EU signed their contract 3 months after the UK to save a few Shekels 8-) ........

FACT 2........They are now at the back of the queue ;-) ..........

FACT 3........They are now trying to blame anyone but themselves for THEIR INCOMPETENCE >:-) .........

FACT 4.........You LOSERS don't like it up EU (lol) (lol) (lol) ..........

In terms of the UK government's performance over ordering, and distributing, the vaccine, they have played a blinder. Sadly, it is the only blinder they have played. Their earlier delays, indecisions, and premature relaxations have led us in the unenviable position of having the vaccines administered in a sub-optimal, rather than optimal, way.

Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?

If government have over ordered vaccine supplies, why would Johnson find it necessary to increase the time gap to the second jab from one month to three months against manufacturers instructions?

As for the row between EU and AstraZeneca, EU has poured billions into funding medical research in UK which we've now lost but that apart, what is important is the contract the EU signed with Astra which they appear not to have fully committed to. I read where Astra claim they only agreed to supply the EU from Astras manufacturing plant//s within the EU and not from it's UK plant. The EU dispute this and say that was not in the contract. If we're not careful I can see this developing into a legal row and at this point I doubt it's in our favour but a stupid road to go down anyway. We are relying on continuing to trade with the EU, not just for vaccine, but we do need more supplies of BioNTech.

None of this is being helped by various idiots parading the UK's relative success in rolling out the vaccine to maximise the EU's discomfort. We actually have on order more vaccine than we are projected to need, so it might be rather more constructive to offer to divert any surplus to the EU if they wish to pick up the cost. Playing dog in the manger has never been a good ploy!

Good point. Well i'm about to find out for myself now as my GP surgery just called to let me know I can have the vaccine next Friday. I forgot to ask which type they have and I will see what they tell me regards when my second jab is due.

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Bullet:

I know that and i'm not at all comfortable with it. This is a life saving vaccine and you don't ignore manufacturers instructions just to score a few thousand more 'hits'. This is not a competition despite certain elements seeing it as such.

 

The whole point is to lessen the burden on the NHS , not cure everyone. If more people have the first jab they will have some more immunity thus helping the NHS

The best immunity is making sure we are healthy,diet exercise especially gut biome.

 

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jumpstart - 2021-01-28 4:02 PM

 

Barryd999 - 2021-01-28 3:46 PM

 

This video seems to be a reasonably good assumption of whats been going on. Its a week or two out of date. The source when I checked appears to be fairly impartial.

 

 

I tend to agree with Brian. We have played a bit of a blinder here but then we needed to as the gross incompetence that led us to this point meant we could not afford to hang about. Even a broken clock is right twice a day.

 

I just hope that all this does not need to a nationalistic fall out because its early days yet. Cooperation will still be key down the line.

 

Fantastic effort by the vaccine companies though and the NHS for getting it into peoples arms.

 

Though the government has not been particularly speedy with decisions , our health and the decisions we make about what we eat and exercise have more to do with the deaths than just Boris.

Generally fit healthy people have not been the ones to die.

We are responsible for our own immune system.

 

Its not just a case of the decisions not being speedy enough, they have also made some terrible decisions. You would assume the government should know how unhealthy its citizens are so on that basis this makes those failures even worse! They know there are issues with health in the UK as well as poverty and an aging population so their decisions should have been made earlier without haste and the restrictions been tighter.

 

Of course as per my Stanley Johnson thread, its perhaps convenient to them that tens of thousands of fat and old people have died so maybe it was deliberate.

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jumpstart - 2021-01-28 5:18 PM

 

The whole point is to lessen the burden on the NHS , not cure everyone. If more people have the first jab they will have some more immunity thus helping the NHS The best immunity is making sure we are healthy,diet exercise especially gut biome.

According to this report from the BMJ it varies according to which vaccine.

 

How effective is just one dose?

A paper published in the New England Journal of Medicine stated that the efficacy of the Pfizer-BioNTech vaccine was 52.4% between the first and second dose (spaced 21 days apart).5 However, in its “green book” Public Health England said that during the phase III trial most of the vaccine failures were in the days immediately after the first dose, indicating that the short term protection starts around day 10.6 Looking at the data from day 15 to 21, it calculated that the efficacy against symptomatic covid-19 was around 89% (95% confidence interval 52% to 97%). Meanwhile, Pfizer has said that it has no evidence that the protection lasts beyond the 21 days.

 

In the case of the Oxford-AstraZeneca vaccine, PHE said, “High protection against hospitalisation was seen from 21 days after dose one until two weeks after the second dose, suggesting that a single dose will provide high short term protection against severe disease . . . An exploratory analysis of participants who had received one standard dose of the vaccine suggested that efficacy against symptomatic covid-19 was 73% (95% CI 48.79-85.76%).”

 

What do the manufacturers say?

In a joint statement Pfizer and BioNTech said, “The safety and efficacy of the vaccine has not been evaluated on different dosing schedules as the majority of trial participants received the second dose within the window specified in the study design . . . There is no data to demonstrate that protection after the first dose is sustained after 21 days.”

 

The European Medicines Agency has said that the gap between the first and second doses of the Pfizer-BioNTech vaccine should not exceed 42 days. “Any change to this would require a variation to the marketing authorisation as well as more clinical data to support such a change, otherwise it would be considered as ‘off-label use,’” the agency said.7

 

AstraZeneca did not reply to a request for comment from The BMJ.

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If like Pelmethead, you're laughing at the AstraZeneca EU vaccine mess, worth remembering that for as long as Europe's unvaccinated, travel restrictions will continue and the less likely an EU holiday becomes. It's a common problem, no point jumping up and down trapped here with your blue passport in your greenhouse.
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Bulletguy - 2021-01-28 4:59 PM..............................

I know that and i'm not at all comfortable with it. This is a life saving vaccine and you don't ignore manufacturers instructions just to score a few thousand more 'hits'. This is not a competition despite certain elements seeing it as such...........................

I don't think that was the reasoning. We are in a position where a highly virulent version of the virus arose and circulated in the UK, leading to a far higher rate than had previously been experienced or anticipated. Leaving aside the reasons or responsibilities for that, and just taking it on a "we are where are" basis, there are only two realistic options.

 

One is to stick to the prescribed dosage of two injections 21 days apart, and accept that as a consequence only around 50% of the vulnerable gain protection over any period of time, leading to more infections, more hospital admissions, and more deaths among the other 50%.

 

The other is to delay the second injection and divert all the available doses into 100% of the vulnerable over the same period of time, to provide them with a better than 50% level of protection (actually quoted as 70% plus), bringing them greater protection overall than the first option. The public health benefit of this option is that the pool of injected people grows faster, meaning the pool of unprotected people falls faster, so reducing the size of the unprotected reservoir for the virus to infect, and thereby reducing the rate of infection, of Covid hospital admissions (creating increasing capacity for treatment of non-Covid cases), and of deaths.

 

There is an acknowledged residual risk that some may not gain such good protection, and so may become infected, but indications are that such infection will be relatively mild. Providing the second dose is given before the protection of the first dose significantly declines (which is expected to be achieved by the nine week delay to the second dose), the actual level of protection for each individual is not expected to differ significantly whichever option is taken.

 

The public health benefit of the second option is the much faster suppression of the virus generally and the freeing of hospital beds for non-Covid cases. So imperfect, yes, but on balance I think the best that can be achieved given where we are.

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On January 26, AstraZeneca CEO Pascal Soriot gave an interview to the Italian newspaper La Repubblica, explaining the situation in more detail. There are two stages to vaccine production, he said: the production of the drug substance (the vaccine itself) and production of the final product (putting the vaccine in vials for use). These steps are carried out in different locations in different countries.

 

Mr Soriot said that there have been teething problems with the first step, as the yield of the vaccine-production process is often not high enough. This has been resolved in UK plants, as they started production earlier due to the UK signing its supply agreement with AstraZeneca three months before the EU. But these issues are yet to be resolved at the Belgian plant supplying Europe.

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Pfizer has also reduced supply of its vaccine in Europe as it looks to upscale its production capacity. Meanwhile, vaccine development by the Louis Pasteur Institute and Merck in France has been abandoned, while the French medical giant Sanofi is also struggling with its programme. The EU is seeing multiple hedged bets failing.
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jumpstart - 2021-01-28 7:08 PM

 

Pfizer has also reduced supply of its vaccine in Europe as it looks to upscale its production capacity. Meanwhile, vaccine development by the Louis Pasteur Institute and Merck in France has been abandoned, while the French medical giant Sanofi is also struggling with its programme. The EU is seeing multiple hedged bets failing.

 

On page 2 of this thread I already linked to a story about EU cooperation

 

https://www.bloomberg.com/news/articles/2021-01-27/sanofi-to-make-millions-of-biontech-pfizer-s-covid-vaccine-doses

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Guest pelmetman
Brian Kirby - 2021-01-28 1:28 PM

 

pelmetman - 2021-01-28 8:53 AM..................................

Rubbish *-) ..........

FACT 1........The EU signed their contract 3 months after the UK to save a few Shekels 8-) ........

FACT 2........They are now at the back of the queue ;-) ..........

FACT 3........They are now trying to blame anyone but themselves for THEIR INCOMPETENCE >:-) .........

FACT 4.........You LOSERS don't like it up EU (lol) (lol) (lol) ..........

1 Is not a fact. Yes, they signed three months later than the UK. However, the reason for that delay being that they prioritised money over speed, unless you have corroborating evidence, is mere assertion. You forgot to add that the EU has only approved two vaccines to date, with a total of 670 million doses ordered.

2 Is a fact, as I said in my original post that you didn't read.

3 Is also a fact, as I said in my original post that you didn't read.

4 Is merely your confirmation bias, and is irrelevant.

 

In terms of the UK government's performance over ordering, and distributing, the vaccine, they have played a blinder. Sadly, it is the only blinder they have played. Their earlier delays, indecisions, and premature relaxations have led us in the unenviable position of having the vaccines administered in a sub-optimal, rather than optimal, way.

 

Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?

 

"Taking comfort from someone else having been bigger fools than our own government isn't much of an endorsement though, is it?"

 

What you mean is ;-) ...........

 

You hate us Brexiteers being proved right (lol) (lol) (lol) ..........

 

 

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Guest pelmetman
jumpstart - 2021-01-28 6:52 PM

 

Shows where all the plants are....

 

Metro.co.uk: Manufacture of a new Covid vaccine is starting in Scotland today.

https://metro.co.uk/2021/01/28/manufacture-of-new-valneva-covid-vaccine-is-starting-in-scotland-13981038/

 

That's interesting ;-) .........

 

So the UK has 3 factories.........and the 27 other EU countries has just 4 between them 8-) ........

 

Looks like a Slam Dunk in the Drug Wars for Brexit Blighty >:-) .........

 

 

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pelmetman - 2021-01-29 8:46 AM

 

That's interesting ;-) .........

 

So the UK has 3 factories.........and the 27 other EU countries has just 4 between them 8-) ........

 

Looks like a Slam Dunk in the Drug Wars for Brexit Blighty >:-) .........

 

 

There are 270 different vaccines in development, in the EU there are more than thirty production facilities producing a variety of vaccines, which is probably why the Metro took their link down. But as ever it got the gammons waving their flags.

 

https://vac-lshtm.shinyapps.io/ncov_vaccine_landscape/

 

 

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