EU criticises 'hasty' UK approval of COVID-19 vaccine

[snoop1130]

EU criticises 'hasty' UK approval of COVID-19 vaccine

By Francesco Guarascio

 

FILE PHOTO: A dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer is pictured in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany. BioNTech SE 2020, all rights reserved/Handout via REUTERS

 

BRUSSELS (Reuters) - The European Union criticised Britain’s rapid approval of Pfizer and BioNTech’s COVID-19 vaccine on Wednesday, saying its own procedure was more thorough, after Britain became the first western country to endorse a COVID-19 shot.

 

The move to grant emergency authorisation to the Pfizer/BioNTech vaccine has been seen by many as a political coup for UK Prime Minister Boris Johnson, who has led his country out of the EU and faced criticism for his handling of the pandemic.

 

The decision was made under an ultra-fast, emergency approval process, which allowed the British drugs regulator to temporarily authorise the vaccine only 10 days after it began examining data from large-scale trials.

 

In an unusually blunt statement, the European Medicines Agency (EMA), which is in charge of approving COVID-19 vaccines for the EU, said its longer approval procedure was more appropriate as it was based on more evidence and required more checks than the emergency procedure chosen by Britain.

 

The agency said on Tuesday it would decide by Dec. 29 whether to provisionally authorise the vaccine from U.S. drugmaker Pfizer Inc and its German partner BioNTech SE.

 

A spokesman for the European Commission, the EU executive, said the EMA’s procedure was “the most effective regulatory mechanism to grant all EU citizens’ access to a safe and effective vaccine,” as it was based on more evidence.

 

Pfizer UK Country Manager Ben Osborn said, “We have provided complete data packages, the unblinded data, to both regulators. I think what you’re seeing is just the difference in the underlying process and timelines, as opposed to any difference in data submission.”

 

June Raine, the head of Britain’s Medicines and Healthcare products Regulatory Agency (MHRA), said, “The way in which the MHRA has worked is equivalent to all international standards.

 

“Our progress has been totally dependent on the availability of data in our rolling review and our rigorous assessment and independent advice we have received,” she added.

 

The EMA started a rolling review of preliminary data from Pfizer trials on Oct. 6, an emergency procedure aimed at speeding up possible approval, which usually takes at least seven months from reception of full data.

 

The UK regulator launched its own rolling review on Oct. 30, and analysed less data than made available to the EMA.

 

“The idea is not to be first but to have a safe and effective vaccine,” Germany’s Health Minister Jens Spahn told a news conference.

 

Asked about the emergency procedure used by Britain, he said EU countries had opted for a more thorough procedure to boost confidence in vaccines.

 

“If you evaluate only the partial data as they are doing they also take a minimum of risk,” the EMA’s former head Guido Rasi told an Italian radio.

 

“Personally I would have expected a robust review of all available data, which the British government has not done to be able to say that without Europe you come first,” he added.

 

‘PROBLEMATIC’

 

EU lawmakers were even more explicit in their criticism of Britain’s move.

 

“I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way,” said Peter Liese, an EU lawmaker who is a member of German Chancellor Angela Merkel’s party.

 

“A few weeks of thorough examination by the European Medicines Agency is better than a hasty emergency marketing authorisation of a vaccine,” said Liese, who represents the centre right grouping, the largest in the EU Parliament.

 

Under EU rules, the Pfizer vaccine must be authorised by the EMA, but EU countries can use an emergency procedure that allows them to distribute a vaccine at home for temporary use.

 

Britain is still subject to EU rules until it fully leaves the bloc at the end of the year.

 

“There is an obvious global race to get the vaccine on the market as fast as possible,” said Tiemo Wolken, an EU lawmaker from the socialist grouping, the second largest in the Parliament.

 

“However, I do believe that it is better to take the time and make sure that the quality, effectiveness and safety is guaranteed and matches our EU standards.”

 

-- © Copyright Reuters 2020-12-03

 

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[Bluespunk]

Hardly a surprise after Hancock’s snide remarks recently. 

[ourmanflint]

I am sure all those European citizens who die within the next month will be glad they didn't risk taking a vaccine with only 120* steps of risk assessment over one with 165* steps

 

 

 

* not actual numbers - for illustrative purposes only

[Bluespunk]

17 hours ago, ourmanflint said:

I am sure all those European citizens who die within the next month will be glad they didn't risk taking a vaccine with only 120* steps of risk assessment over one with 165* steps

 

 

 

* not actual numbers - for illustrative purposes only

Under eu rules any and all countries can fast track vaccines.
 

What the U.K. did is allowed under eu regulations, which the U.K. is currently still subject to. 

 

https://www.bbc.co.uk/news/55163730

[Scott]

Troll post removed.   This is a discussion forum.

 

[candide]

The vaccine will be out of stock anyway! Pfizer is able to produce max 50 million doses this year WW. With two doses per person, it's 25 million people who will get it WW, half of them in the U.S.

[daveAustin]

Sour grapes much. Who cares what the ****** EU thinks! This is chess not checkers. Big reason why UK citizens voted out because they are unbearably condescending and always sticking their oar in.

[Oldie]

The EU should leave the Brits alone. The EU is an awful organization not loved by many. But the EU and also the Euro are kept alive by some that have benefits. Whatever the Brits decide - it is their country. And honestly - I admire the Brits that they leave the EU and that they kept their own currency. In respect of the vaccine - somebody has to start to use it if it ever should be used. Otherwise it is useless. 

[sammieuk1]

At least we shot down one Junker with Boris's nimble footwork Rue Britannia a vaccine rules the waves  ????

[kingdong]

3 hours ago, Bluespunk said:

Under eu rules any and all countries can fast track vaccines.
 

What the U.K. did is allowed under eu regulations, which the U.K. is currently still subject to. 

 

https://www.bbc.co

.uk/news/55163730

Boris is his own man,whats the eu going to do?we,re out in 4 weeks.

[JonnyF]

Why is this EU stuffed suit commenting on this? It's the UK's business. We're not interested in opinions from Brussels, that's why we voted to leave their corrupt protectionist anti-democratic racket.

[Proboscis]

14 hours ago, ourmanflint said:

I am sure all those European citizens who die within the next month will be glad they didn't risk taking a vaccine with only 120* steps of risk assessment over one with 165* steps

 

 

 

* not actual numbers - for illustrative purposes only

Don't worry too much about that. The logistical problems with distributing a vaccine that requires storage at minus 80 degrees centigrade is not going to be rolled out very fast.

[Proboscis]

7 hours ago, daveAustin said:

Sour grapes much. Who cares what the ****** EU thinks! This is chess not checkers. Big reason why UK citizens voted out because they are unbearably condescending and always sticking their oar in.

What I love so much about the Brexiteers is that even in victory they are sour. The decision to bring out this vaccine early (which by the way was developed by a company led by a German couple of Turkish origin in combination with an American multinational) was heavily criticised by the Americans too. But you did not hear much about that in the British largely pro Brexit press.

 

A little news for Brexiteers and their supporters in the press - you have left the EU. Yes, you are gone. Yes, you are holding out on a number of strange issues that matter to less than 1% of your population (fishing and the so-called level playing field) but you have not fought for the export of services to the EU which is indeed strange, especially since the UK is a service based economy. Nor for a whole raft of other important issues that one would normally expect to be close to the heart of Conservatives but there you are.

 

But you have left the EU and really what the EU says no longer matters. Really. They do have the right to explain to their own much larger population, just as the Americans do, why they are not bringing out the vaccine at the same time. But that is nothing to do with you. The question for you is, has your government done the right thing by bringing out the vaccine early? IMHO, I think it is risky. Politically risky because any small wrinkle will be amplified by the antivaxers. Scientifically risky because there is always a possibility that a glitch could emerge. But that is my opinion. 

[loong]

8 minutes ago, Proboscis said:

Don't worry too much about that. The logistical problems with distributing a vaccine that requires storage at minus 80 degrees centigrade is not going to be rolled out very fast.

Yes, it requires long term storage at minus 80c. I can't remember where I read it, but it can be transported and then stored in a fridge at higher temperatures with a much shorter lifespan of 5 days. I really can't see any vaccine that will be used needing to last more than 5 days in the current situation.

[Bluespunk]

6 hours ago, kingdong said:

Boris is his own man,whats the eu going to do?we,re out in 4 weeks.

And what has that got to do with what I posted?

 

The fact remains, that fast tracking of vaccines is possible within the eu and brexit had nothing to do with britain being able to do so. 

[herfiehandbag]

As they we old say here, in response to the EU: "up to you!"

 

We're gone...

[puipuitom]

17 hours ago, Bluespunk said:

Under eu rules any and all countries can fast track vaccines.
 

What the U.K. did is allowed under eu regulations, which the U.K. is currently still subject to. 

 

https://www.bbc.co.uk/news/55163730

On the Day the European Medicine Agency got the files of Pfizer, the UK started to use their stuff for vaccination. I wish the British much luck. We in the EU will see a month later, want the results were. Probably o.k., but that is different as.. 'close to sure". 

Public health is NOT an issue of the EU, as every member state, and even every region ( compare: England, Scotland, Wales, N. Ireland) take these decisions on their own.

[puipuitom]

On 12/4/2020 at 3:59 AM, Oldie said:

The EU should leave the Brits alone. The EU is an awful organization not loved by many. But the EU and also the Euro are kept alive by some that have benefits. Whatever the Brits decide - it is their country. And honestly - I admire the Brits that they leave the EU and that they kept their own currency. In respect of the vaccine - somebody has to start to use it if it ever should be used. Otherwise it is useless. 

That's why even a British investigation gave, by far all EU citizens are happy to be in the EU.

 

[kingdong]

9 hours ago, Bluespunk said:

And what has that got to do with what I posted?

 

The fact remains, that fast tracking of vaccines is possible within the eu and brexit had nothing to do with britain being able to do so. 

A lot of things were possible regarding britains people re the eu however our greedy lazy politicians chose to do nothing instead concentrating on keeping their snouts in the trough,merely pointing this out,also perhaps its lucky scotland didn,t desert the union and defect to the eu or you,d still be waiting.

[7by7]

1 minute ago, kingdong said:

A lot of things were possible regarding britains people re the eu however our greedy lazy politicians chose to do nothing instead concentrating on keeping their snouts in the trough,merely pointing this out,also perhaps its lucky scotland didn,t desert the union and defect to the eu or you,d still be waiting.

 So you are now saying that all the problems the UK had with he EU were, and presumably still are, the fault of "our greedy lazy politicians (who) chose to do nothing instead concentrating on keeping their snouts in the trough?"

 

I wonder who you have in mind.

[kingdong]

9 hours ago, Proboscis said:

What I love so much about the Brexiteers is that even in victory they are sour. The decision to bring out this vaccine early (which by the way was developed by a company led by a German couple of Turkish origin in combination with an American multinational) was heavily criticised by the Americans too. But you did not hear much about that in the British largely pro Brexit press.

 

A little news for Brexiteers and their supporters in the press - you have left the EU. Yes, you are gone. Yes, you are holding out on a number of strange issues that matter to less than 1% of your population (fishing and the so-called level playing field) but you have not fought for the export of services to the EU which is indeed strange, especially since the UK is a service based economy. Nor for a whole raft of other important issues that one would normally expect to be close to the heart of Conservatives but there you are.

 

But you have left the EU and really what the EU says no longer matters. Really. They do have the right to explain to their own much larger population, just as the Americans do, why they are not bringing out the vaccine at the same time. But that is nothing to do with you. The question for you is, has your government done the right thing by bringing out the vaccine early? IMHO, I think it is risky. Politically risky because any small wrinkle will be amplified by the antivaxers. Scientifically risky because there is always a possibility that a glitch could emerge. But that is my opinion. 

If the " anti vaxers " are anything like the remainers this should lead to some extremely entertainingposts in the future.

[kingdong]

2 minutes ago, 7by7 said:

 So you are now saying that all the problems the UK had with he EU were, and presumably still are, the fault of "our greedy lazy politicians (who) chose to do nothing instead concentrating on keeping their snouts in the trough?"

 

I wonder who you have in mind.

How long you got?

[CG1 Blue]

19 hours ago, Bluespunk said:

Under eu rules any and all countries can fast track vaccines.
 

What the U.K. did is allowed under eu regulations, which the U.K. is currently still subject to. 

 

https://www.bbc.co.uk/news/55163730

How gracious of the EU to allow the UK to do this ????  

 

Who needs to hang around for the EMA when (from the article you posted): 

 

"The MHRA is well-regarded as a world leader in the regulation of medicine, and it has certainly chosen to move faster with vaccine approval than the EMA.

 

[Natai Beach]

From a personal point of view I am happy they will be the guinea pigs for this vaccine. Thailand is scheduled to get it in May.

 

So if there are any adverse affects hopefully it will show up before then. 
 

Also must consider Boris has promised a lot but failed badly with the English having the most deaths in all of Europe and an even higher death rate than the USA. 

Trump is copping a heap of flak for his handling of it, but BJ has done worse. Now he is taking a gamble to reverse it. 
I wish him all the best. 
Good luck BJ.

[billd766]

20 hours ago, Natai Beach said:

From a personal point of view I am happy they will be the guinea pigs for this vaccine. Thailand is scheduled to get it in May.

 

So if there are any adverse affects hopefully it will show up before then. 
 

Also must consider Boris has promised a lot but failed badly with the English having the most deaths in all of Europe and an even higher death rate than the USA. 

Trump is copping a heap of flak for his handling of it, but BJ has done worse. Now he is taking a gamble to reverse it. 
I wish him all the best. 
Good luck BJ.

 

I think you need to revise your figures for covid deaths.

 

Covid deaths in the UK.

Cases
1.67M   +14,878   Recovered     Deaths   60,113

 

LINK

 

Covid deaths in the USA

Cases   14.2M   +217K

Deaths   276K   +2,857

 

LINK

 

 

[Bluespunk]

40 minutes ago, kingdong said:

A lot of things were possible regarding britains people re the eu however our greedy lazy politicians chose to do nothing instead concentrating on keeping their snouts in the trough,merely pointing this out,also perhaps its lucky scotland didn,t desert the union and defect to the eu or you,d still be waiting.

No idea why are you think I’m Scottish, though I will certainly investigate citizenship when the country is free from the “union”

 

And again nothing you say above has any relevance to my posts. 
 

[Bluespunk]

22 minutes ago, CG1 Blue said:

How gracious of the EU to allow the UK to do this ????  

 

Who needs to hang around for the EMA when (from the article you posted): 

 

"The MHRA is well-regarded as a world leader in the regulation of medicine, and it has certainly chosen to move faster with vaccine approval than the EMA.

 

The eu rules allow fast tracking, britain’s decision to do so has nothing to do with brexit as hancock misleadingly claimed ???? or anyone being gracious.  

[kingdong]

40 minutes ago, Natai Beach said:

From a personal point of view I am happy they will be the guinea pigs for this vaccine. Thailand is scheduled to get it in May.

 

So if there are any adverse affects hopefully it will show up before then. 
 

Also must consider Boris has promised a lot but failed badly with the English having the most deaths in all of Europe and an even higher death rate than the USA. 

Trump is copping a heap of flak for his handling of it, but BJ has done worse. Now he is taking a gamble to reverse it. 
I wish him all the best. 
Good luck BJ.

Hope you make it to may.

[kingdong]

24 minutes ago, Bluespunk said:

No idea why are you think I’m Scottish, though I will certainly investigate citizenship when the country is free from the “union”

 

And again nothing you say above has any relevance to my posts. 
 

Merely pointing out there was a way things Should have been done in this country but weren,t,and how this has changed with a bit of strong leadership.

[loong]

45 minutes ago, Natai Beach said:

From a personal point of view I am happy they will be the guinea pigs for this vaccine. Thailand is scheduled to get it in May.

 

So if there are any adverse affects hopefully it will show up before then. 
 

Also must consider Boris has promised a lot but failed badly with the English having the most deaths in all of Europe and an even higher death rate than the USA. 

Trump is copping a heap of flak for his handling of it, but BJ has done worse. Now he is taking a gamble to reverse it. 
I wish him all the best. 
Good luck BJ.

Quote

Also must consider Boris has promised a lot but failed badly with the English having the most deaths in all of Europe and an even higher death rate than the USA. 

Funny that you use the amount for UK deaths compared to Europe but death rate to compare to the USA.

UK is 7th in Europe for deaths per capita.

Lower than Belgium, Spain and Italy.