Pfizer vaccine approved

[AVB]

6 hours ago, loriusgarrulus said:

The normal drug testing timeliness is that each phase is worked through and approved before the next phase is started. If the drug fails on one phase testing stops. Its an expensive business and many drugs get stopped in early stages due to ineffectiveness or side effects etc. By running studies in parallel at the same time and compressing the timeliness is extremely expensive as if a drug fails you have done more testing and incured more costs which is millions of pounds. Its not just the testing that is expensive. Initially small amounts of drug are produced in a laboratory. Further down the line  larger amounts are produced at pilot plants which are mini factory stage. Once a drug is approved it goes to factory scale production.

To speed the process once these vaccines looked promising they went straight to factory scale. Which means they are producing millions of doses ready to role them out. I think the Oxford vaccine is ready with 40 million doses at £3 a time. So thats £120 million invested just in the cost of the doses,  besides the accelerated testing programme costs. That £3 a dose is cost price without any profit to pay for the for the testing or future testing of new drugs. If they did not get approval at late stage development they have probably shelled out in excess of £200 million. That's why normally it takes 10 years in developement. On an accelerated developement the cost of failure is much higher.

All the normal stages of developement have been done, but in a much more expensive way.

Which again makes sense. However there is a danger that, because of the vast amount of money invested in it, it becomes critical that approval is given. And when stakes are high people sometimes push the boundaries. 

[martinj]

23 hours ago, Gordon R said:

Those who oppose the vaccine seem to think any adverse effects will show up almost immediately. There may or may not be adverse effects, but they may be years down the road. At what point will the anti-vaccine people declare it safe?

they never will, it's the nature of the beast, these are the same people who deny their kids MMR jabs

[Mungler]

8 minutes ago, snow white said:

The wife and myself are in or seventies and would be reluctant to have jab it’s not been tested long enough.

Fair enough, thank you for freeing up a place in the queue for others.

[loriusgarrulus]

Had our flu jab this year. Asked about the pneumonia jab and we had that last week. We will be in the que for the covid vaccine.

Both in our sixties. OH is diabetic and has psiaritic arthritis with the overactive immune system which makes him vulnerable to the cytokine storm that covid can cause. I have a heart problem. The risk from covid is much higher than the possible risk of any side effects from the vaccine.

 

27 minutes ago, AVB said:

Which again makes sense. However there is a danger that, because of the vast amount of money invested in it, it becomes critical that approval is given. And when stakes are high people sometimes push the boundaries. 

The cost of litigation if regulations and safety have not been adhered too is not worth the risk. Also the loss of confidence in the companies other products would not make it worth it.

[discobob]

2 hours ago, loriusgarrulus said:

The cost of litigation if regulations and safety have not been adhered too is not worth the risk. Also the loss of confidence in the companies other products would not make it worth it.

I believe they have (the manufacturers) been granted immunity from any claims by the Government - I may be wrong and just heard false news though

[serrac]

 

Still got warm and fuzzies about the vaccine?

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML

 

Short description:

 

The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed

Explanation:

For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.

Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health.

Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine.

Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far.

[JohnfromUK]

5 minutes ago, serrac said:

Still got warm and fuzzies about the vaccine?

If you are planning to be administering 100 million doses (2 doses for say 50 million people) - there will be a lot of side effects reported.  Some will no doubt be due to the vaccine (almost every medicine, drink, food etc. doesn't suit everyone) and some will be completely unrelated.  Some people in the trials made reports of a variety of minor symptoms, mostly 'fluey' or 'hangover' like.

Having the capability in place to handle that volume is important.  That they don't have it now is not unexpected since this is the largest fastest implemented vaccination programme ever I believe.

In a way, I am reassured that this is being pro-actively managed and IF there are any serious ones, will help them be indentified more quickly.

[oscarsdad]

13 minutes ago, serrac said:

 

Still got warm and fuzzies about the vaccine?

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

https://ted.europa.eu/udl?uri=TED:NOTICE:506291-2020:TEXT:EN:HTML

 

Short description:

 

The MHRA urgently seeks an Artificial Intelligence (AI) software tool to process the expected high volume of Covid-19 vaccine Adverse Drug Reaction (ADRs) and ensure that no details from the ADRs’ reaction text are missed

Explanation:

For reasons of extreme urgency under Regulation 32(2)(c) related to the release of a Covid-19 vaccine MHRA have accelerated the sourcing and implementation of a vaccine specific AI tool.

Strictly necessary — it is not possible to retrofit the MHRA’s legacy systems to handle the volume of ADRs that will be generated by a Covid-19 vaccine. Therefore, if the MHRA does not implement the AI tool, it will be unable to process these ADRs effectively. This will hinder its ability to rapidly identify any potential safety issues with the Covid-19 vaccine and represents a direct threat to patient life and public health.

Reasons of extreme urgency — the MHRA recognises that its planned procurement process for the SafetyConnect programme, including the AI tool, would not have concluded by vaccine launch. Leading to a inability to effectively monitor adverse reactions to a Covid-19 vaccine.

Events unforeseeable — the Covid-19 crisis is novel and developments in the search of a Covid-19 vaccine have not followed any predictable pattern so far.

Did you look at the dates? It was months ago, contract awarded and all before they got the data on the three vaccines so assumed risk mitigation. 

[AVB]

I loved Gavin Williamsson’s response on LBC when challenged about other countries concerns over our speed of approval  

“Well I just reckon we've got the very best people in this country and we've obviously got the best medical regulator, much better than the French have, much better than the Belgians have, much better than the Americans have. 

'That doesn't surprise me at all because we're a much better country than every single one of them.”

[serrac]

4 hours ago, JohnfromUK said:

If you are planning to be administering 100 million doses (2 doses for say 50 million people) - there will be a lot of side effects reported.  Some will no doubt be due to the vaccine (almost every medicine, drink, food etc. doesn't suit everyone) and some will be completely unrelated.  Some people in the trials made reports of a variety of minor symptoms, mostly 'fluey' or 'hangover' like.

Having the capability in place to handle that volume is important.  That they don't have it now is not unexpected since this is the largest fastest implemented vaccination programme ever I believe.

In a way, I am reassured that this is being pro-actively managed and IF there are any serious ones, will help them be indentified more quickly.

Then hopefully we'll get daily updates on the number and severity of adverse reactions to the vaccine along with the Covid infections and deaths so we can all make informed decisions about the relative risks.

[JohnfromUK]

1 minute ago, serrac said:

Then hopefully we'll get daily updates on the number and severity of adverse reactions to the vaccine along with the Covid infections and deaths so we can all make informed decisions about the relative risks.

Sounds like a plan. 

From what I have read, there have been about 45,000 trials with no 'safety concerns' raised and side effects when they occur seem to be either flu like of hangover like.  I saw someone who had been in the trials interviewed and he said he had a days mild flu like symptoms after the first dose and nothing after the second dose.

People report side effects from the normal 'flu jab, but I have it every year without any noticeable side effect.

[Smokersmith]

The US (Fauci) has criticised the UK approval process.

He added that they will very shortly announcing their own approval for the vaccine !!

Go figure!!

[ordnance]

1 hour ago, Smokersmith said:

The US (Fauci) has criticised the UK approval process.

He added that they will very shortly announcing their own approval for the vaccine !!

Go figure!!

Questions will be asked in America why is the UK getting a vaccine, why are we not. Fauci is just deflecting by saying they are stricter approving a vaccine. Its a joke that Trump is trying to take the credit some wanting it called the Trump vaccine, that would guarantee some would not get it, who would want some Trump injected into them. 

Edited December 3, 2020 by ordnance

[grrclark]

19 minutes ago, ordnance said:

Questions will be asked in America why is the UK getting a vaccine, why are we not. Fauci is just deflecting by saying they are stricter approving a vaccine. Its a joke that Trump is trying to take the credit some wanting it called the Trump vaccine, that would guarantee some would not get it, who would want some Trump injected into them. 

Stormy Daniels did....

Being serious, I agree the comments from Fauci are political.

[peck]

3 hours ago, JohnfromUK said:

Sounds like a plan. 

From what I have read, there have been about 45,000 trials with no 'safety concerns' raised and side effects when they occur seem to be either flu like of hangover like.  I saw someone who had been in the trials interviewed and he said he had a days mild flu like symptoms after the first dose and nothing after the second dose.

People report side effects from the normal 'flu jab, but I have it every year without any noticeable side effect.

Those who are on the trials do not know whether they have had the proper vaccine or a placebo. All trials are run with a placebo in place, you do not know whether you have had the proper vaccine or not, so it may be that with your mate its just coincidence. 

[ordnance]

10 minutes ago, peck said:

Those who are on the trials do not know whether they have had the proper vaccine or a placebo. All trials are run with a placebo in place, you do not know whether you have had the proper vaccine or not, so it may be that with your mate its just coincidence. 

If people didn't take medication because of possible side-effects, they would take nothing. 

[JohnfromUK]

26 minutes ago, peck said:

Those who are on the trials do not know whether they have had the proper vaccine or a placebo.

This was an interview and was after the trial had been completed and the 'debrief' had occurred.  I presume the person was then told if he had been trial group or control group.

[Nuke]

On 02/12/2020 at 15:51, AVB said:

Interesting that the EU are raising concerns over the speed of approval and insisting their process is better. No surprise there. Assuming that the vaccine is safe then the fact that we have got it quicker than EU counties is one of the benefits of Brexit. 

Suits me fine, the more people that have taken it before it's allowed here in Sweden the better.

/Markus

Edited December 3, 2020 by Nuke

[serrac]

On 03/12/2020 at 17:07, JohnfromUK said:

Sounds like a plan. 

From what I have read, there have been about 45,000 trials with no 'safety concerns' raised and side effects when they occur seem to be either flu like of hangover like.  I saw someone who had been in the trials interviewed and he said he had a days mild flu like symptoms after the first dose and nothing after the second dose.

People report side effects from the normal 'flu jab, but I have it every year without any noticeable side effect.

I very much doubt there will be proactive public reporting of ADRs as that would not play well with the "all vaccines are safe and effective" manta.

Mild flu like symptoms would be classed as side-effects rather than Adverse Drug Reactions since it is expected most recipients of the vaccine (~80%) would experience them to some degree.  Given the huge workload involved in rolling out the vaccine the chances of someone who experiences these expected symptoms successfully navigating receptionist triage to get an appointment with a GP or other medical professional in order to submit an ADR must be close to zero.  ADRs are much more likely to be submitted when a reaction to the vaccine requires an actual medical intervention.  Mild flu symptoms would not represent "a direct threat to patient life and public health" so that is not what is in view here.

AstraZenica's trial was twice halted due to 2 vaccine recipients demonstrating neurological symptoms.  It was determined the first had a previously undiagnosed case of Transverse Myelitis and the vaccine was not implicated.  The details on the second are less clear but a "source" told the New York Times it was also transverse myelitis.  Bearing in mind the normal incidence of TM is ~4 per million it stretches credulity that two previously un-diagnosed cases should spontaneously begin to exhibit symptoms shortly after vaccination in a cohort of only ~18,000 trial subjects.

Transverse Myelitis has been recorded in some patients as a complication of Covid-19 infection.  Given that the mode of operation of the mRNA vaccines is to (irreversibly) alter the recipient's genetic code to make the cells generate coronavirus-like fragments of DNA to prompt an enhanced immune response, is it too implausible that the vaccine has the capacity to trigger the same effect on the spinal cord as the infection itself?

 

[oscarsdad]

46 minutes ago, serrac said:

Given that the mode of operation of the mRNA vaccines is to (irreversibly) alter the recipient's genetic code to make the cells generate coronavirus-like fragments of DNA to prompt an enhanced immune response

Utter utter absolute tripe - again spreading misinformation with the danger that it may lead to people believing it and avoiding a vaccine for the wrong reasons. 
 

the mRNA in the vaccine instructs cells how to make a Covid spike protein. The mRNA is then broken down by enzymes. At no point does the mRNA go anywhere near the nucleus of the cell or the recipients genetic material. An mRNA vaccine absolutely does not alter the recipient’s genetic code. 

[Mungler]

1 hour ago, serrac said:

Given that the mode of operation of the mRNA vaccines is to (irreversibly) alter the recipient's genetic code to make the cells generate....

 

Do you think I could get the genetic code of a Linford Christie and the usual accoutrements that come with that?  

[grrclark]

1 hour ago, oscarsdad said:

Utter utter absolute tripe - again spreading misinformation with the danger that it may lead to people believing it and avoiding a vaccine for the wrong reasons. 
 

the mRNA in the vaccine instructs cells how to make a Covid spike protein. The mRNA is then broken down by enzymes. At no point does the mRNA go anywhere near the nucleus of the cell or the recipients genetic material. An mRNA vaccine absolutely does not alter the recipient’s genetic code. 

Well said.  

[Docleo]

9 hours ago, oscarsdad said:

Utter utter absolute tripe - again spreading misinformation with the danger that it may lead to people believing it and avoiding a vaccine for the wrong reasons. 
 

the mRNA in the vaccine instructs cells how to make a Covid spike protein. The mRNA is then broken down by enzymes. At no point does the mRNA go anywhere near the nucleus of the cell or the recipients genetic material. An mRNA vaccine absolutely does not alter the recipient’s genetic code. 

Thank you!

[oowee]

On 03/12/2020 at 20:58, JohnfromUK said:

This was an interview and was after the trial had been completed and the 'debrief' had occurred.  I presume the person was then told if he had been trial group or control group.

Apparently they will now be told in order that they know if they need to que for vaccination or not. 

[JohnfromUK]

3 minutes ago, oowee said:

Apparently they will now be told in order that they know if they need to que for vaccination or not. 

Yes, I assumed something like that would be the case.  I can see no point in withholding it once the trial is complete and results are 'in'.