UK approves Pfizer-BioNTech COVID-19 vaccine, first in the world

[snoop1130]

UK approves Pfizer-BioNTech COVID-19 vaccine, first in the world

By Guy Faulconbridge and Paul Sandle

 

FILE PHOTO: Vials with a sticker reading, "COVID-19 / Coronavirus vaccine / Injection only" and a medical syringe are seen in front of a displayed Pfizer logo in this illustration taken October 31, 2020. REUTERS/Dado Ruvic/File Photo

 

LONDON (Reuters) - Britain approved Pfizer's COVID-19 vaccine on Wednesday, jumping ahead of the United States and Europe to become the West's first country to formally endorse a jab it said should reach the most vulnerable people early next week.

 

Prime Minister Boris Johnson touted the medicine authority's approval as a global win and a ray of hope amid the gloom of the novel coronavirus which has killed nearly 1.5 million people globally, hammered the world economy and upended normal life.

 

Britain's Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, in record time - just 23 days since Pfizer published the first data from its final stage clinical trial.

 

"It's fantastic," Johnson said. "The vaccine will begin to be made available across the UK from next week. It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."

 

The world's big powers have been racing for a vaccine for months in an attempt to be first to begin the long road to recovery.

 

The approval of a vaccine for use almost exactly a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

 

China has already given emergency approval for three experimental vaccines and has inoculated around 1 million people since July. Russia has been vaccinating frontline workers after approving its Sputnik V shot in August before it had completed late-stage testing on safety and efficacy.

 

But the European Union's drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, as it was based on more evidence and checks that the emergency procedure chosen by Britain.

 

British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need - the elderly, those in care homes and health workers.

 

'HISTORIC MOMENT'

 

The U.S. drugmaker said Britain's emergency use authorization marks a historic moment in the fight against COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

 

"This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK," said CEO Bourla.

 

"As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world."

 

Britain's medicines regulator approved the vaccine in record time - partly by doing a "rolling" concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.

 

"With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks," said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

 

"However, we need new independent clinical trials to monitor long-term safety and efficacy."

 

The U.S. Food and Drug Administration (FDA) is set to meet on Dec. 10 to discuss whether to recommend emergency use authorization of the Pfizer/BioNTech vaccine and the European Medicines Agency said it could give emergency approval for the shot by Dec. 29.

 

"The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development programme," said Ugur Sahin, chief executive and co-founder of BioNTech.

 

U.S. media reported on Tuesday that the White House had summoned FDA head Stephen Hahn to discuss why the U.S. agency hadn't moved faster to authorise Pfizer's vaccine.

 

FIRST IN LINE?

 

Britain said it would start vaccinating ordinary people early next week after it gets 800,000 doses from Pfizer's manufacturing centre in Belgium. The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine.

 

Johnson said last month that Britain had ordered 40 million doses of the Pfizer vaccine - enough for just under a third of the population as two shots of the jab are needed per person to gain immunity.

 

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centres would be set up across the country but he admitted distribution would be a challenge given that the vaccine must be shipped and stored at -70C (-94F), the sort of temperature typical of an Antarctic winter.

 

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days, from up to 15 days previously guided. Afterwards, the vaccine can be kept at fridge temperatures for up to 5 days.

 

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot is 94% successful in late-stage clinical trials. Moderna and Pfizer have developed their shots using new messenger RNA (mRNA) technology.

 

AstraZeneca said last month its COVID-19 shot, which is based on traditional vaccine technology, was 70% effective in pivotal trials and could be up to 90% effective.

 

-- © Copyright Reuters 2020-12-02

 

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[darksidedog]

11 minutes ago, snoop1130 said:

"With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks," said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

Without getting into how the UK got to this stage in the first place, I have to say that he is right and they are not left with much option other than to run with it. I hope these vaccines work, so the world can begin to have a semblance of normality about it again.

[edwinchester]

Yeah let a few million British senior citizens in the twilight of their lives be the real guinea pigs for testing the vaccine.

[bkk6060]

Good for the UK for buying the US technology as their vaccine company could not even give the correct doses during the trials and the results less effective.  

 

[overherebc]

59 minutes ago, bkk6060 said:

Good for the UK for buying the US technology as their vaccine company could not even give the correct doses during the trials and the results less effective.  

 

Well, it's really a German/American joint venture.

Biontec is not that huge and picked Pfizer to help get their idea on the vaccine going. I think the vaccine to be used in UK is actually coming from Belgium.

[ITMan]

I'm really heartened by the amount of people who are choosing not to take the vaccine. The queue will be short, unless they are just blagging. 

[sammieuk1]

Well done Boris had to get something right for once the Oxford vaccine will be out in weeks and a huge stockpile has already been made and ready to go .

Something I would like to see is anyone refusing a jab is not treated if infected. us Brits after the brexit debacle need to step up and lead the way as usual normality is coming ????????

[bkk6060]

9 hours ago, overherebc said:

Well, it's really a German/American joint venture.

Biontec is not that huge and picked Pfizer to help get their idea on the vaccine going. I think the vaccine to be used in UK is actually coming from Belgium.

Great, they worked together.

And,  like you said this vaccine is certainly not coming from the UK.

[overherebc]

32 minutes ago, bkk6060 said:

Great, they worked together.

And,  like you said this vaccine is certainly not coming from the UK.

Belgium is where it's being made.

[teacherclaire]

4 hours ago, ITMan said:

I'm really heartened by the amount of people who are choosing not to take the vaccine. The queue will be short, unless they are just blagging. 

 Side effects? 

[faraday]

5 minutes ago, teacherclaire said:

 Side effects? 

Incompatibly with life.

[teacherclaire]

4 minutes ago, faraday said:

Incompatibly with life.

 Let's wait and see. 

[CorpusChristie]

13 hours ago, snoop1130 said:

But the European Union's drug regulator said on Wednesday that its longer approval process for COVID-19 vaccines was safer, as it was based on more evidence and checks that the emergency procedure chosen by Britain.

 

British leaders said that, while they would love to get a jab themselves, priority had to be given to those most in need - the elderly, those in care homes and health workers.

 

   Very selfless of the Politicians  , NOT to place themselves first in the queue for the jab , letting others go before them .

    

[placeholder]

51 minutes ago, faraday said:

Incompatibly with life.

stop lying.

[faraday]

45 minutes ago, CorpusChristie said:

 

   Very selfless of the Politicians  , NOT to place themselves first in the queue for the jab , letting others go before them .

    

 

Let Boris be the first Jabee live on the Beeb!

[placeholder]

5 minutes ago, faraday said:

 

Let Boris be the first Jabee live on the Beeb!

What is far more significant is the rate of adoption by front line medical workers is going to be. Whaddya think the odds are that the vast majority of them will refuse to take a vaccine that according to your nonsense is "incompatibly [sic] with life".

[faraday]

7 minutes ago, placeholder said:

according to your nonsense is "incompatibly [sic] with life".

My post was a joke; clearly though you're unable to appreciate humour.

 

As for the incorrect spellin' of incompatibility, which you pointed out. This was due to the spell check.

 

Ok na?

 

Anything else?

[bkk6060]

2 hours ago, overherebc said:

Belgium is where it's being made.

Thanks for supporting my point.

Yes, at a Pfizer ( US company) facility in Belgium.

[overherebc]

15 minutes ago, bkk6060 said:

Thanks for supporting my point.

Yes, at a Pfizer ( US company) facility in Belgium.

Just accept the fact it's a joint effort, not a good ole boy single american effort.

[bkk6060]

35 minutes ago, overherebc said:

Just accept the fact it's a joint effort, not a good ole boy single american effort.

Oh yes, I agree.

Good they picked some smart competent partners and got it right.

[overherebc]

41 minutes ago, bkk6060 said:

Oh yes, I agree.

Good they picked some smart competent partners and got it right.

Absolutely.  Pfizer were really lucky that Biontech picked them.

[bkk6060]

3 minutes ago, overherebc said:

Absolutely.  Pfizer were really lucky that Biontech picked them.

Yes, certainly.

As is the UK for choosing them as they produced a proper vaccine.

Hope it all goes well for the UK.

[TallGuyJohninBKK]

Curious we go thru the entire OP article re the Pfizer vaccine approval, and not even one passing mention of the fact that it has to be kept and stored at super below freezing temperatures in order to remain viable -- a capability that most regular facilities simply don't have.

 

That issue with Pfizer's vaccine has been a major issue for its prospects in the U.S.  Not that it likely won't be approved there. It probably will be. But there's already been huge planning and logistics work occurring of just how authorities will be able to get the vaccine to folks in the U.S. once approved.

 

It would have been more reassuring to hear something about how far along the UK is in working out those kinds of important logisitics details.

 

https://www.cbsnews.com/news/covid-vaccine-pfizer-distribution-logistical-nightmare/
 

Quote

 

Pfizer's vaccine must be kept at nearly minus 100 degrees Fahrenheit to remain effective. That's about 20 degrees colder than extreme winter temperatures at the South Pole. Early on, experts warned that the U.S. lacked the necessary ultra-cold storage trucks and cargo planes needed to ship hundreds of millions of doses at sub-sub-zero temperatures.
 

In order to get around that, Pfizer has developed specially built deep-freeze "suitcases" that can be tightly sealed and shipped even in non-refrigerated trucks. But while Pfizer may have solved the problem of how to ship the frozen vaccine, these highly engineered shipping containers create other problems, particularly for the hospitals, pharmacies and outpatient clinics that will have to administer the vaccinations to hundreds of millions of Americans.

 

 

[Trip Hop]

7 hours ago, bkk6060 said:

Thanks for supporting my point.

Yes, at a Pfizer ( US company) facility in Belgium.

It's also being manufactured in Newbridge, Ireland.  A whole section of the plant has been rearranged to cope with it.  A friend who works there told me this several weeks ago before it was even approved.

[bkk6060]

9 minutes ago, Trip Hop said:

It's also being manufactured in Newbridge, Ireland.  A whole section of the plant has been rearranged to cope with it.  A friend who works there told me this several weeks ago before it was even approved.

Yes, they have expanded to several countries creating jobs and helping economies.

The more the better when it comes to this vaccine development.

 

Pfizer has over approximately 4,000 colleague across 5 locations based in Cork, Dublin, and Kildare. Total capital investment by the company in Ireland exceeds $7billion. Pfizer's business interests in Ireland are diverse which include manufacturing, shared services, R&D, treasury and commercial operations.

Edited December 3, 2020 by bkk6060

[Sujo]

Im in, happy to take it. But afraind i will be way down the waiting list.

[BangkokReady]

23 hours ago, snoop1130 said:

"It's fantastic," Johnson said. "The vaccine will begin to be made available across the UK from next week. It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again."

I want to feel good about it, but anything this guy says is generally garbage.

[overherebc]

1 hour ago, TallGuyJohninBKK said:

Curious we go thru the entire OP article re the Pfizer vaccine approval, and not even one passing mention of the fact that it has to be kept and stored at super below freezing temperatures in order to remain viable -- a capability that most regular facilities simply don't have.

 

That issue with Pfizer's vaccine has been a major issue for its prospects in the U.S.  Not that it likely won't be approved there. It probably will be. But there's already been huge planning and logistics work occurring of just how authorities will be able to get the vaccine to folks in the U.S. once approved.

 

It would have been more reassuring to hear something about how far along the UK is in working out those kinds of important logisitics details.

 

https://www.cbsnews.com/news/covid-vaccine-pfizer-distribution-logistical-nightmare/
 

 

On BBC news they are reporting on arrival at the vaccine centres it has a normal fridge life of 5 days.

[Thingamabob]

Free of EU bureaucracy the UK is now able to move faster with approvals. Could be risky though. Hopefully not.

[Lormak1]

The UK has been able to get this approved in record time because it is now free of the lumbering socialist dinosaur that is EU beaurocracy. We are more nimble and fleet of foot.