COVID-19 — Coronavirus

[Tim of the Oak]

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.

 

[Gaylord du Bois]

Unless Gavin apologises, I think we should halt the vaccine roll out.

 

[PannickAtTheDisco]

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,

 

[Ban-jani]

Unless Gavin apologises, I think we should halt the vaccine roll out.

Only if he makes his mother take it first, after apologising.

 

[Tim of the Oak]

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.

 

[03 March 2002]

Fauci apologises for saying UK 'rushed' vaccine

After apparent criticism from the US expert, the UK defended the safety and efficacy of the vaccine.

www.bbc.co.uk

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.

 

[twosips]

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 :)

 

[03 March 2002]

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.

 

[Churchlawtonblue]

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.

 

[twosips]

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!