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

[chickenslegs]

14 hours ago, CorpusChristie said:

 

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

    

555, but ...

To be fair, they would be criticised either way.

First in the queue - selfish.

Let older folk and NHS go first - using others as guinea pigs.

[placeholder]

12 minutes ago, chickenslegs said:

555, but ...

To be fair, they would be criticised either way.

First in the queue - selfish.

Let older folk and NHS go first - using others as guinea pigs.

Have there ever been actual guinea pigs who volunteered to be vaccinated?

[chickenslegs]

5 minutes ago, placeholder said:

Have there ever been actual guinea pigs who volunteered to be vaccinated?

No.

But, if they knew how their sacrifice would contribute to medical research, I'm sure a few would have done so.

Quote

In 1907, vitamin C was discovered using guinea pigs (like humans they cannot produce the vitamin and need it supplied in their diet) and they have since contributed to 23 Nobel prizes for medicine or physiology. Guinea pig studies led to the discovery of the hormone adrenaline and helped develop replacement heart valves, blood transfusions, antibiotics and asthma medicines, as well as vaccines for diptheria and TB.

https://www.theguardian.com/science/2005/aug/25/thisweekssciencequestions1

 

[tifino]

2 minutes ago, chickenslegs said:

No.

But, if they knew how their sacrifice would contribute to medical research, I'm sure a few would have done so.

 

yeah, the 2 legged variety of guinea pig...  

 

 

wondering what happens to a victims body, when there had been some slip up (fridge glitch) instance at the -70c refrigerated storage, and the facility does not openly report its happening? 

[placeholder]

20 minutes ago, tifino said:

yeah, the 2 legged variety of guinea pig...  

 

 

wondering what happens to a victims body, when there had been some slip up (fridge glitch) instance at the -70c refrigerated storage, and the facility does not openly report its happening? 

Because slip-ups have been unprecedented in the medical community up until now? 

[puipuitom]

17 hours ago, teacherclaire said:

 Side effects? 

Will believe have to be inside the EU....

[puipuitom]

7 hours ago, Thingamabob said:

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

Has nothing to thank to be "free of EU bureaucracy". The EU Medicine Agency's view is still preferred by all EU member states, which.. each - as public health is NOT an EU subject - could also decide on their own. 

 

But, it is really a joke: a medicine, financed by Americans, but out of an idea, of Turkish fugitives living in Germany, produced in Ireland and Belgium, is NOT first tested and inspected by the EU, but the British - voluntarily - let themselves be the first massive guinea pigs to be tested on in an absolute scale...

Edited December 3, 2020 by puipuitom

[kingdong]

52 minutes ago, puipuitom said:

Has nothing to thank to be "free of EU bureaucracy". The EU Medicine Agency's view is still preferred by all EU member states, which.. each - as public health is NOT an EU subject - could also decide on their own. 

 

But, it is really a joke: a medicine, financed by Americans, but out of an idea, of Turkish fugitives living in Germany, produced in Ireland and Belgium, is NOT first tested and inspected by the EU, but the British - voluntarily - let themselves be the first massive guinea pigs to be tested on in an absolute scale...

The british,free to decide their own destiny now we,re free from outside interference.

[7by7]

23 hours ago, Thingamabob said:

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

 

23 hours ago, Lormak1 said:

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.

 

15 hours ago, kingdong said:

The british,free to decide their own destiny now we,re free from outside interference.

 

Why don't you guys ever check facts before posting such rubbish? Brexit has nothing whatsoever to do with this; despite what Rees-Mogg and others have claimed in their tweets.

 

Until the end of the transition period we are still subject to EU rules and regulations; including those of the EMA.

 

But those regulations allow each member state to temporarily authorise a new medicine or vaccine in an emergency. 

 

This is what the UK has done.COVID-19 vaccine authorised by medicines regulator

Quote

The MHRA started the rolling review of Pfizer/BioNTech’s data in October and the government asked the regulator to assess the vaccine for its suitability for authorisation under Regulation 174 of the Human Medicines Regulations, enabling the temporary supply of medicines to be authorised in response to a public health need, which the regulator has recommended.

 

Note that the current Human Medicines Regulations date back to 2012.

 

[TallGuyJohninBKK]

An update from Pfizer on their start-up logistics problems:

 

https://seekingalpha.com/news/3641506-supply-chain-issues-to-restrict-pfizer-covidminus-19-shipments-this-month

Supply chain issues to restrict Pfizer COVID-19 shipments this month

Pfizer (PFE -2.1%) expects to ship only half of the COVID-19 vaccine doses this year that it originally planned due to supply chain obstacles, a near-term problem considering its ultra-cold storage requirement of minus 70 degrees Celsius. A company spokesperson stated that the headwinds were due to a later-than-expected data readout from the pivotal trial and challenges scaling up the raw material supply chain.

...

It expects to ship 50M doses globally by the end of the month compared to its original plan of 100M. It still expects to ship more than 1B doses in 2021. Shipments will be made from final assembly and distribution centers in Kalamazoo, MI and Puurs, Belgium.

 

Original source:

https://www.wsj.com/articles/pfizer-slashed-its-covid-19-vaccine-rollout-target-after-facing-supply-chain-obstacles-11607027787

 

Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles

Pharma giant expects to ship half the doses it had originally planned after finding raw materials in early production didn’t meet its standards

When Pfizer Inc. said last month it expects to ship half the Covid-19 vaccines it had originally planned for this year, the decision highlighted the challenges drug makers face in rapidly building supply chains to meet the high demand.

 

“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

...

Pfizer and BioNtech are now on track to roll out 1.3 billion vaccines in 2021 and the 50 million dose shortfall this year will be covered as production ramps up.

 

Edited December 4, 2020 by TallGuyJohninBKK

[TallGuyJohninBKK]

Update on the Moderna vaccine:

 

https://seekingalpha.com/news/3641671-sell-siders-bullish-on-moderna-covidminus-19-vaccine

 

Sell-siders bullish on Moderna COVID-19 vaccine

"Staying on script, sell-side analysts are on board with Moderna's (NASDAQ:MRNA) mRNA-1273, expected to receive an FDA emergency use nod this month followed by a thumbs up in Europe next month.

 

Jefferies' Michael Yee says antibody levels remain high beyond three months and the trajectory continues to support likely protection against SARS-Cov-2 for about a year, in line with expectations.

...

Goldman analysts concur that the vaccine's effect is durable, noting that antibody levels have waned over time but remain higher than titers from people who have recovered from the respiratory infection."

 

[onthedarkside]

An off-topic post focused on Brexit-related, non-vaccine related issues has been removed. Also a trolling post that led to multiple replies.

 

 

[candide]

On 12/3/2020 at 1:07 PM, Thingamabob said:

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

 

On 12/3/2020 at 1:19 PM, Lormak1 said:

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.

Apart from the fact that this decision is still being allowed under EU law, the other fact that BioNTech has been financed by "EU bureaucracy" since 2019 also escaped your attention.

[candide]

8 hours ago, TallGuyJohninBKK said:

An update from Pfizer on their start-up logistics problems:

 

https://seekingalpha.com/news/3641506-supply-chain-issues-to-restrict-pfizer-covidminus-19-shipments-this-month

Supply chain issues to restrict Pfizer COVID-19 shipments this month

Pfizer (PFE -2.1%) expects to ship only half of the COVID-19 vaccine doses this year that it originally planned due to supply chain obstacles, a near-term problem considering its ultra-cold storage requirement of minus 70 degrees Celsius. A company spokesperson stated that the headwinds were due to a later-than-expected data readout from the pivotal trial and challenges scaling up the raw material supply chain.

...

It expects to ship 50M doses globally by the end of the month compared to its original plan of 100M. It still expects to ship more than 1B doses in 2021. Shipments will be made from final assembly and distribution centers in Kalamazoo, MI and Puurs, Belgium.

 

Original source:

https://www.wsj.com/articles/pfizer-slashed-its-covid-19-vaccine-rollout-target-after-facing-supply-chain-obstacles-11607027787

 

Pfizer Slashed Its Original Covid-19 Vaccine Rollout Target After Supply-Chain Obstacles

Pharma giant expects to ship half the doses it had originally planned after finding raw materials in early production didn’t meet its standards

When Pfizer Inc. said last month it expects to ship half the Covid-19 vaccines it had originally planned for this year, the decision highlighted the challenges drug makers face in rapidly building supply chains to meet the high demand.

 

“Scaling up the raw material supply chain took longer than expected,” a company spokeswoman said. “And it’s important to highlight that the outcome of the clinical trial was somewhat later than the initial projection.”

...

Pfizer and BioNtech are now on track to roll out 1.3 billion vaccines in 2021 and the 50 million dose shortfall this year will be covered as production ramps up.

 

This problem has been known for months

https://www.bloomberg.com/news/articles/2020-06-25/fear-of-vial-shortage-for-covid-vaccines-prompts-flurry-of-deals

[KhaoYai]

On 12/2/2020 at 12:16 PM, 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.  

But its not US technology - do your homework.

[KhaoYai]

Typical and expected comments about the vaccine on here - so many experts that apparently have more knowledge than the scientists. I think a great many will change their minds when they are refused entry to a country or to even fly on a particular airline if they haven't had the vaccine.

 

I'll bet my last £ that Thailand announces just such a policy - No Vaccine, No Entry in the first 6 months of next year. Hope you lot are happy to never leave the country again because if you do, you won't be coming back ????.

[teacherclaire]

On 12/2/2020 at 8:19 PM, 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.

The small German biotech firm BioNTech, started by a husband and wife team with Turkish roots, had never brought a vaccine to market before.

But its experimental technology has now become the first authorised for use
in the Western world to help end the coronavirus pandemic.

Along with its US partner Pfizer, BioNTech on Wednesday said its Covid-19 vaccine has been granted approval by Britain, with a rollout planned for as early as next week

 

https://www.thelocal.de/20201202/biontech-how-the-german-firm-is-leading-the-covid-19-vaccine-race

[overherebc]

6 minutes ago, teacherclaire said:

The small German biotech firm BioNTech, started by a husband and wife team with Turkish roots, had never brought a vaccine to market before.

But its experimental technology has now become the first authorised for use
in the Western world to help end the coronavirus pandemic.

Along with its US partner Pfizer, BioNTech on Wednesday said its Covid-19 vaccine has been granted approval by Britain, with a rollout planned for as early as next week

 

https://www.thelocal.de/20201202/biontech-how-the-german-firm-is-leading-the-covid-19-vaccine-race

It just seems a shame that some other people are treating it a race based on 'we wanted our country/vaccine' to be first.

I'm happy they're going forward with vaccines and also happy that it's not me that will be getting the logistics together for who and when is first considering it's a two shot system with a time limit on storage.

[onthedarkside]

A COVID conspiracy theory video from a dubious source has been removed.

 

[sharksy]

On 12/4/2020 at 11:54 AM, 7by7 said:

 

 

 

Why don't you guys ever check facts before posting such rubbish? Brexit has nothing whatsoever to do with this; despite what Rees-Mogg and others have claimed in their tweets.

 

Until the end of the transition period we are still subject to EU rules and regulations; including those of the EMA.

 

But those regulations allow each member state to temporarily authorise a new medicine or vaccine in an emergency. 

 

This is what the UK has done.COVID-19 vaccine authorised by medicines regulator

 

Note that the current Human Medicines Regulations date back to 2012.

 

Source: Guido Faukes

 

Smug Remainers have today been crowing that the Pfizer vaccine was approved today in the UK under the EU medicines regime (all EU law still applies to the UK until the end of this month). Whilst vaccine approval is reserved matter for the European Medical Agency, the EU Medicines Directive generously allows national medicines regulators (like the UK’s MHRA) to temporarily approve products for use in response to the spread of pathogens. Like Covid-19.

Yet the fact is that had the UK remained a member of the EU it would not have been able to approve the vaccine this quickly. As Jens Spahn, the German health minister, explained earlier today, despite the exemption in EU law, EU member states took a collective decision to take a common approach to vaccine approval. As a result of Brexit the UK is not an EU member state and therefore not locked into that common approach…

“All 27 member states will have access to vaccines at the same time otherwise some member states may have have been able to procure vaccines at an earlier stage that others”

“We have member states including, Germany, who could have issued such an emergency authorisation if we’d wanted to. But we decided against this and what we opted for was a common European approach to move forward together.”

And moving at the speed of 27 is evidently slower than moving at the speed of one…

UK Ministers are today correctly saying that the law was changed in October to allow this all to happen. What they are referring to is amending the Human Medicines Regulations to clarify ambiguity surrounding the “temporary” vaccine approval EU law grants to member states – those ambiguities factoring into the the reasons the EU decided to move collectively. The UK’s law changes ensure that vaccines ‘temporarily’ authorised under the EU’s regulations are treated in the same way as fully licensed products. The changes ensure rollout can happen, whereas under the EU directive, advertising and distribution could have been hindered…

[placeholder]

1 hour ago, sharksy said:

Source: Guido Faukes

 

Smug Remainers have today been crowing that the Pfizer vaccine was approved today in the UK under the EU medicines regime (all EU law still applies to the UK until the end of this month). Whilst vaccine approval is reserved matter for the European Medical Agency, the EU Medicines Directive generously allows national medicines regulators (like the UK’s MHRA) to temporarily approve products for use in response to the spread of pathogens. Like Covid-19.

Yet the fact is that had the UK remained a member of the EU it would not have been able to approve the vaccine this quickly. As Jens Spahn, the German health minister, explained earlier today, despite the exemption in EU law, EU member states took a collective decision to take a common approach to vaccine approval. As a result of Brexit the UK is not an EU member state and therefore not locked into that common approach…

“All 27 member states will have access to vaccines at the same time otherwise some member states may have have been able to procure vaccines at an earlier stage that others”

“We have member states including, Germany, who could have issued such an emergency authorisation if we’d wanted to. But we decided against this and what we opted for was a common European approach to move forward together.”

And moving at the speed of 27 is evidently slower than moving at the speed of one…

UK Ministers are today correctly saying that the law was changed in October to allow this all to happen. What they are referring to is amending the Human Medicines Regulations to clarify ambiguity surrounding the “temporary” vaccine approval EU law grants to member states – those ambiguities factoring into the the reasons the EU decided to move collectively. The UK’s law changes ensure that vaccines ‘temporarily’ authorised under the EU’s regulations are treated in the same way as fully licensed products. The changes ensure rollout can happen, whereas under the EU directive, advertising and distribution could have been hindered…

Had the UK remained in the EU, would it have been required to follow this plan?

[7by7]

17 hours ago, sharksy said:

Source: Guido Faukes

 

Smug Remainers have today been crowing that the Pfizer vaccine was approved today in the UK under the EU medicines regime (all EU law still applies to the UK until the end of this month). Whilst vaccine approval is reserved matter for the European Medical Agency, the EU Medicines Directive generously allows national medicines regulators (like the UK’s MHRA) to temporarily approve products for use in response to the spread of pathogens. Like Covid-19.

Yet the fact is that had the UK remained a member of the EU it would not have been able to approve the vaccine this quickly. As Jens Spahn, the German health minister, explained earlier today, despite the exemption in EU law, EU member states took a collective decision to take a common approach to vaccine approval. As a result of Brexit the UK is not an EU member state and therefore not locked into that common approach…

“All 27 member states will have access to vaccines at the same time otherwise some member states may have have been able to procure vaccines at an earlier stage that others”

“We have member states including, Germany, who could have issued such an emergency authorisation if we’d wanted to. But we decided against this and what we opted for was a common European approach to move forward together.”

And moving at the speed of 27 is evidently slower than moving at the speed of one…

UK Ministers are today correctly saying that the law was changed in October to allow this all to happen. What they are referring to is amending the Human Medicines Regulations to clarify ambiguity surrounding the “temporary” vaccine approval EU law grants to member states – those ambiguities factoring into the the reasons the EU decided to move collectively. The UK’s law changes ensure that vaccines ‘temporarily’ authorised under the EU’s regulations are treated in the same way as fully licensed products. The changes ensure rollout can happen, whereas under the EU directive, advertising and distribution could have been hindered…

 

A copy and paste job so good you posted it three times!

 

At least you named the source this time; even though you failed to link to it.

 

I responded to Paul Staines misinformation in the other topic where you posted it.

 

 

 

 

[7by7]

16 hours ago, placeholder said:

Had the UK remained in the EU, would it have been required to follow this plan?

 

No, it's a voluntary agreement which any and all of the 27 members could have chosen to opt out of. They still can at anytime of their choosing.

 

[placeholder]

2 minutes ago, 7by7 said:

 

No, it's a voluntary agreement which any and all of the 27 members could have chosen to opt out of. They still can at anytime of their choosing.

 

So this claim from Sharksy (above) is BS?

"The UK’s law changes ensure that vaccines ‘temporarily’ authorised under the EU’s regulations are treated in the same way as fully licensed products. The changes ensure rollout can happen, whereas under the EU directive, advertising and distribution could have been hindered…"

[7by7]

8 minutes ago, placeholder said:

So this claim from Sharksy (above) is BS?

"The UK’s law changes ensure that vaccines ‘temporarily’ authorised under the EU’s regulations are treated in the same way as fully licensed products. The changes ensure rollout can happen, whereas under the EU directive, advertising and distribution could have been hindered…"

 

Not total. In his blog Staines posted some BS coupled with twisting some facts and ignoring others.

 

As I said in the other topic: each and every EU member has the right under the regulations to unilaterally approve a new drug or vaccine in an emergency. Parliament did pass an emergency law in October to enable this unilateral approval; which is S.O.P. in such situations; nothing to do with Brexit.