Russia Approves Vaccine

[Lightning]

Maybe good news.

Russia approves Sputnik V Covid vaccine despite testing safety concerns

Drug, given to one of Putin’s daughters, to skip large-scale safety trials before rollout

www.theguardian.com

 

[kurienp]

Unlikely.

I am in favour of fast-tracking ... but not when Phase 3 trials seems to have been completely ignored. However, as with everything, in dire circumstances, you need to take quick decisions, which can back-fire. If this saves a few lives - good ... but if it causes issues in the long term, then god help them.

 

[GrannyJen]

Bit old ....

The WHO was banging on about this two weeks ago.

I find myself in two minds as a clinical trial guinea pig for many....

They are in effect promoting a large-scale phase three by offering a vaccine to anyone who volunteers to take it, although without any of the follow - up checks or wide scale understanding of it's efficacy ....

Some of the phase-3 limitations though for volunteers in strictly controlled trials are utterly bloody laughable (or that might just be my jaundice with some of the stupidity that comes out of PHE) and seem designed to drag trials out for years and years.

This is a different situation. The virulence of this virus means that most, at sometime, are going to get it. The restrictions to allow that inevitability to happen without crippling health services instead cripples societies and economies. It is worth short-circuiting the system for this once?

 

[WelshGas]

Bit old ....

The WHO was banging on about this two weeks ago.

I find myself in two minds as a clinical trial guinea pig for many....

They are in effect promoting a large-scale phase three by offering a vaccine to anyone who volunteers to take it, although without any of the follow - up checks or wide scale understanding of it's efficacy ....

Some of the phase-3 limitations though for volunteers in strictly controlled trials are utterly bloody laughable (or that might just be my jaundice with some of the stupidity that comes out of PHE) and seem designed to drag trials out for years and years.

This is a different situation. The virulence of this virus means that most, at sometime, are going to get it. The restrictions to allow that inevitability to happen without crippling health services instead cripples societies and economies. It is worth short-circuiting the system for this once?

News to me that PHE is involved in any way at all with the testing and licensing of a new vaccine.

How vaccines are tested, licensed and monitored

vk.ovg.ox.ac.uk

You live and learn.

 

[GSX1300R]

Yes and our Dog has just had kittens......

 

[GregW]

Russian Roulette

 

[WelshGas]

Russian Roulette

Too True.

 

[GrannyJen]

News to me that PHE is involved in any way at all with the testing and licensing of a new vaccine.

How vaccines are tested, licensed and monitored

vk.ovg.ox.ac.uk

You live and learn.

I tend to associate the MHRA with PHE, wrongly or rightly.

Every time I sign up for a new trial I get about 18 pages of literature .... a lot of it regulatory, that basically tells me that informed consent is not enough.

 

[GrannyJen]

Russian Roulette

Probably right.

I'm on a phase 3 at the moment and every three months have to have a complete check over.

 

[WelshGas]

I tend to associate the MHRA with PHE, wrongly or rightly.

Every time I sign up for a new trial I get about 18 pages of literature .... a lot of it regulatory, that basically tells me that informed consent is not enough.

Two different entities. PHE is for England only/
MHRA is a UK Authority.

It was not unknown in the past, and in other countries, for people to sign up for Medical Trials of one sort or another for the express purpose of extorting money from the organisation, usually in cahoots with someone with legal knowledge. Nowadays they have to cover all basis.

 

[GrannyJen]

Two different entities. PHE is for England only/
MHRA is a UK Authority.

I never actually said PHE were the regulatory authority Paul, although I do accept my words were somewhat ambiguous.

The intent was to point out my views on what happens with many of these regulatory bodies is probably totally jaundiced with my experiences with PHE. I was, just two years ago, involved with an influenza research trial where despite ticking every box possible was deemed non-acceptable because of a formula that the regulatory body itself ultimately accepted was too discriminatory. Whilst considering myself pretty unique I do still wonder how many, apart from me, ideal candidates were ruled out for a formula not properly thought through.

In terms of the Russian roulette I am equally sceptical of what public media prints. Given that a phase 3 can involve up to 5,000 volunteers have they totally junked the regulatory process or in fact dressing up a next phase release as a "licensed to all". It does talk of volunteers in various limited capacities so far. How much is PR, how much is risk junking? I take more notice of the WHO from whose reaction I deduce it is totally junking of the phase 3 monitoring.

 

[Anthony1]

I saw a video today that reported more people died from the flu who had had the flu vaccine, than those who did not have the flu vaccine.

Alleged Covid deaths worldwide 733,000
Other respiratory deaths worldwide, over the same period 7.9 million.

Professor Thomas Barody a gastroenterologist and Director of the Centre of Digestive Diseases, Australia, pointed to a treatment for coronavirus which has already been tested on patients with close to 90-100 per cent success rate involving a concoction of three drugs: Ivermectin, Doxy-Cycline, and Zinc.

I am afraid I am a non believer.