COVID-19 — Coronavirus

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Why did someone as respectable and politically astute as Faucci make such a faux-pas.
Not being a part of the EU’s vaccine procurement programme seems to have worked well for us, at the moment.
However, without Brexit it is unlikely we would have done so.
I thought Fauci’s earlier outburst was poor and it’s good he’s reflected and changed his view.

I think the Government would be better off just saying we’ve backed some winners on the vaccine front, rather than going down the nationalist line. It’s pretty hypocritical given this German / Turkish designed vaccine that’s being produced by a US pharma company (in Belgium) and signed off with commendable speed by our regulator.
 
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I thought Fauci’s earlier outburst was poor and it’s good he’s reflected and changed his view.

I think the Government would be better off just saying we’ve backed some winners on the vaccine front, rather than going down the nationalist line. It’s pretty hypocritical given this German / Turkish designed vaccine that’s being produced by a US pharma company and signed off with commendable speed by our regulator.
oh no, not the Gundogan vaccine. It's going to duck out of tackling Covid at the first opportunity,
 
oh no, not the Gundogan vaccine. It's going to duck out of tackling Covid at the first opportunity,
Haha. I do think Gundo has been our best player over the last 6 weeks so every dog has its day / month and half.

By coincidence, I was thinking of the Fauci comments and he’s been under stress with the dreaded Chairman’s vote of confidence from the Doug Ellis like Donald Trump.
 

Fauci apologises. They'll approve it soon enough so it would look a bit silly to suggest scrutiny wasn't up to standard.

However, I found it interesting that our regulator takes the pharma company's analysis rather than doing its own. I say this as the Boeing 737 Max thread has re-appeared and we are all probably aware the main issue with that plane was that the regulator just took Boeing's word for gospel instead of doing its own due diligence (regulatory capture).
Regulatory approval involves the review of a dossier which details how the drug is made, the possible impurities, the formulation, the clinical trial results, the dosages used etc etc. The regulator won't do any analysis. They will demand certain questions are answered and if that requires generating more data then the applicant will have to do that and supply the data.

Analysis is almost always done by a trusted partner, co called Contract Manufacturing Organisation or Contract Research Organisation which has its own set of licences (issued by the MHRA/FDA/SwissMedic/whoever) and is yearly / more frequently audited by the Health Authorities as a requirement to keep that licence.

The analysis done is also not some slapdash approach. There are some very strict requirements outlined in what we call the ICH guidelines. ICH put together these guidelines and just about every single territory on Earth has bought into them. The guidelines outline minimum expected requirements to prove a test method is fit for purpose. It's scientifically sound and rigorous. There is no need for HA's to do testing. They are and should be able to trust the data presented to them.
 
Regulatory approval involves the review of a dossier which details how the drug is made, the possible impurities, the formulation, the clinical trial results, the dosages used etc etc. The regulator won't do any analysis. They will demand certain questions are answered and if that requires generating more data then the applicant will have to do that and supply the data.

Analysis is almost always done by a trusted partner, co called Contract Manufacturing Organisation or Contract Research Organisation which has its own set of licences (issued by the MHRA/FDA/SwissMedic/whoever) and is yearly / more frequently audited by the Health Authorities as a requirement to keep that licence.

The analysis done is also not some slapdash approach. There are some very strict requirements outlined in what we call the ICH guidelines. ICH put together these guidelines and just about every single territory on Earth has bought into them. The guidelines outline minimum expected requirements to prove a test method is fit for purpose. It's scientifically sound and rigorous. There is no need for HA's to do testing. They are and should be able to trust the data presented to them.

Do you mind me asking about your experience? Don't have to name companies or owt, but I'm genuinely fascinated to know how you know all this! Feel free to tell me to do one of course :)
 
Do you mind me asking about your experience? Don't have to name companies or owt, but I'm genuinely fascinated to know how you know all this! Feel free to tell me to do one of course :)
No problem.

>10 years across the drug development process from pre-clinical to post-marketing. Have prepared and defended over 10 regulatory submissions to EU/US/UK/Swiss/China/Japan/Africa and just about everywhere else.

Officially a Biomedical Scientist by degree with a PhD in Molecular Biology from Manchester.

Work for AZ.
 
Bloody hell mate have you been on the road to Damascus?
haha, not really Len, I have said on here several times when i have specifically diasagreed with the government. Namely over Cummings and his lies.
Then the way ppe was procured via MPs mates who had no experience in the industry. Rather than using approved and proven NHS suplliers that were ignored.

The lack of support for the arts and entertainment industry at grass roots level is also appalling. I have written to my Tory MP complaining about that.

Williamson is a complete idiot who isnt up to the job imo. His pathetic decisions are deeply affecting my youngest daughter and her future career, she is in her final gcse year and has missed 6 weeks of classroom teaching because of isolating this term alone and nearly three and half months last year. I have also written to my MP every time she has had to isolate and miss lessons which is three times, i have told her he is inept and clearly isnt up to the job. His words today do nothing to dispel my belief in his inability to cock things up.
 
No problem.

>10 years across the drug development process from pre-clinical to post-marketing. Have prepared and defended over 10 regulatory submissions to EU/US/UK/Swiss/China/Japan/Africa and just about everywhere else.

Officially a Biomedical Scientist by degree with a PhD in Molecular Biology from Manchester.

Work for AZ.

Thanks mate, really great insight!
 
Of course it’s cringeworthy but slagging off another country for getting emergency approval for a vaccine is ten times worse and potentially damaging in terms of take up. For once, our government aren’t the biggest cunts in this pathetic spat which was started by others.
There is truth in what you say.
 
No problem.

>10 years across the drug development process from pre-clinical to post-marketing. Have prepared and defended over 10 regulatory submissions to EU/US/UK/Swiss/China/Japan/Africa and just about everywhere else.

Officially a Biomedical Scientist by degree with a PhD in Molecular Biology from Manchester.

Work for AZ.
wow, very impressed fella, Great to have someone with this expertise on the forum. Thanks for sharing your knowledge.
 
The governments bragging approach and that utter fucking imbecile Williamson’s actions have now added fuel to the fire of conspiracy cunts.

They could have kept quiet and likely not had these accusations by the EU and that yank.

Fucking morons.
The man is useless at his job aswell as an utter emabarssment. Needs to go.
 
haha, not really Len, I have said on here several times when i have specifically diasagreed with the government. Namely over Cummings and his lies.
Then the way ppe was procured via MPs mates who had no experience in the industry. Rather than using approved and proven NHS suplliers that were ignored.

The lack of support for the arts and entertainment industry at grass roots level is also appalling. I have written to my Tory MP complaining about that.

Williamson is a complete idiot who isnt up to the job imo. His pathetic decisions are deeply affecting my youngest daughter and her future career, she is in her final gcse year and has missed 6 weeks of classroom teaching because of isolating this term alone and nearly three and half months last year. I have also written to my MP every time she has had to isolate and miss lessons which is three times, i have told her he is inept and clearly isnt up to the job. His words today do nothing to dispel my belief in his inability to cock things up.
He is one of those politicians who lacks self awareness and whose brain and mouth fail on a regular basis to co-ordinate their strategy before notifying others of their view.
 
there will still be posters that tell him he is wrong, because on twitter x said this, and produce some kind of link to belittle his knowledge. This is BM
Maybe, but i very much suspect that they will come off pretty battered in any debate. Lol. Going to be pretty one sided imho.
 
Strange irony that the U.S. took so long to allow AZ/Oxford to re-start the American arm of its trial, presumably in an attempt to propel Pfizer/Moderna ahead in the race, yet the U.K. will end up vaccinating people well before the U.S. vaccinates anyone.
 
Not sure if any others saw it, thought it might have had a mention on here, but some horrific shit on the news last night about the virus goings on in Russia.

All about their lies with regards to numbers of dead, video showing body bags just piled up in corridors, people being refused treatment, more and more mass graves being dug and used.

Apparently their official death toll is circa 40k yet guesstimates saying it’s at least 10x that figure!

It‘s serious shit this virus, as also seen by some of the other figures now across Europe too - the Germans especially showing how bad it can get as it’s far far worse over there at the moment and they did well in first wave.
 
Williamson's comments were this morning and I swear these comments have come out in the afternoon onwards. Feel free to correct me. Facui's were certainly today.
The first I heard about Fauci’s comments were yesterday morning around 8AM and given the time difference between us and the States, they must’ve already been a few hours old, so anything Williamson said was after Fauci. The EU were at it the day before IIRC.
Anyway, Fauci’s apologised now so he knows he fucked up. We just need the EU to follow his lead and Williamson to put a sock in it and this will all be forgotten about soon enough.
 
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