COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

Snow Garden

Some early footage from the Russian vaccine clinical trials.

The guy on the left is the control, the guy on the right took the vaccine.

The Unbearables

XsApollo wrote: »

Well the Russian vaccine will have been well tested and results known by the time the Russian population has been finished with the vaccinations.

They are basically the trial.
If it’s proven then the rest of the world will be begging for it.

And Russia will still be the bogey man according to many.

XsApollo

The Unbearables wrote: »

And Russia will still be the bogey man according to many.

The Russians are no fools.

YellowBucket

El Sueño wrote: »

I'd imagine the Russian vaccine must have some bit of substance? I mean surely the country that successfully sent the first man into space have some semblance of scientific pedigree.

That was the USSR, not modern Russia. It was a very different setup.

It also brought us Chernobyl, which it refused to admit even happened until it was impossible to deny due to radiation detectors going off in Europe and a load of other dodgy industrial accidents and coverups.

You build a reputation on trust and transparency in areas like vaccines and medicines.

stevek93

XsApollo wrote: »

The Russians are no fools.

Blyat.

darjeeling

JDD wrote: »

I'm no anti-vaxxer, and will definitely take the Oxford vaccine if it gets through the testing and approval process. But there's no way I'd take some two-bit rush job vaccine from Russia. Not for at least 12 months after a wide number of people had taken it with no side effects. I'd prefer to continue with lockdown thanks. I think most people living in western countries would feel the same.

For all the interest in the ~200 vaccine candidates, I expect we will be choosing from a small number of vaccine candidates that are being developed by or in conjunction with the big global pharmaceutical companies.

I think there is very little chance of this Russian vaccine candidate being approved and available here, and I very much doubt we will be using any of the Chinese vaccines either. Russia and China need vaccines too, and if their vaccine candidates work, then good for them. These vaccines might also be used in lower income countries with strong ties to Russia and China, but I cannot see them being used in Europe or the USA.

For those interested, the Russian vaccine candidate is one of several based on a replication-defective adenovirus with the spike protein gene from SARS-CoV-2 inserted. This time they're using not one but two human adenovirus strains - Ad5 and Ad26. The initial clinical trials used a boost approach, with one strain given initially and the second strain as a subsequent boost.

The Chinese CanSino vaccine candidate is a replication-defective Ad5 with the SARS-CoV-2 spike, while Johnson and Johnson's is the Ad26 equivalent.
Oxford's approach is to use a replication-defective chimp adenovirus with the spike gene rather than a human adenovirus strain, the idea being that using a vector to which no-one has prior exposure will mean a lower chance of it getting mopped up by any pre-existing neutralising antibodies before it can infect cells and deliver its spike gene payload to provoke a B and T cell response. I think, though, that the effect of prior exposure to circulating human adenovirus strains on immune responses generated by modified human adenovirus vaccine vectors remains to be seen.

YellowBucket

With Comrade Bone Spurs running the USA, you’d never know! He managed to import Russian ventilators, overriding US FDA approvals. They were never used but they were still imported and given special approval, despite the US and Europe and elsewhere being well capable of producing well known and approved systems with long track records.

The same model caught fire in hospitals in Russia.

There’s a lot of show boating going on from Russia and China. I would be a little circumspect.

Thierry12

JDD wrote: »

I'm no anti-vaxxer, and will definitely take the Oxford vaccine if it gets through the testing and approval process. But there's no way I'd take some two-bit rush job vaccine from Russia. Not for at least 12 months after a wide number of people had taken it with no side effects. I'd prefer to continue with lockdown thanks. I think most people living in western countries would feel the same.

Russia bad, UK good

Seriously :pac:

All these vaccines were ready months ago, Feb-April

Russian has some of the best

It's not rushed either, they are entering phase 3 trials like everyone else

YellowBucket

Known, very transparent, very robust European regulatory processes = good.
Unknown, non transparent, politically driven regulatory processes = not so good.

The rest is just flag waving nonsense.

With something like a vaccine or pharmaceuticals there’s an incredibly detailed and robust set of regulations for absolutely every aspect of it from clinical trials to production and that’s why they are generally extremely safe.

There’s no way I would trust an injectable from outside that system.

xvril

If you are young and have no underlying health conditions is there any point in taking the vaccine?

YellowBucket

xvril wrote: »

If you are young and have no underlying health conditions is there any point in taking the vaccine?

If we don’t get enough uptake to achieve herd immunity the whole thing will be a mess and the virus will continue to transmit and mutate and this will go on forever.

The only way a vaccine will work is if we get widespread uptake.

darjeeling

YellowBucket wrote: »

Known, very transparent, very robust European regulatory processes = good.
Unknown, non transparent, politically driven regulatory processes = not so good.

The rest is just flag waving nonsense.

With some being like a vaccine or pharmaceuticals there’s an incredibly detailed and robust set of regulations for absolutely every aspect of it from clinical trials to production and that’s why they are generally extremely safe.

There’s no way I would trust an injectable from outside that system.

Here's an opportunity for another TWiV plug - this week they interviewed a former chief of staff of the FDA under Obama. She described the approval process for drugs and vaccines, saying that they would be dealing with an entire roomful (is that a word?) of documentary evidence. That's going to mean that organisations without the expertise and the experience of interacting with US and EU regulators aren't going to get very far.

Diabhalta

mike_ie wrote: »

Mod: Quit spamming threads with memes and no substance - this is not the only thread you're doing so in. Next one will earn a mod action.

who is spamming? ten posts in one thread is spamming, two or three here and there isn't.

And who are you anyway, telling me what to do? Please stay away two meters from me. And wear a mask.

Diabhalta

boards.ie was always a strange place...

LuckyLloyd

xvril wrote: »

If you are young and have no underlying health conditions is there any point in taking the vaccine?

Yes:

i) there is a death rate for 18 - 35 year olds, however infestimal it may be
ii) there is growing evidence that a percentage of all age ranges who contract and recover from the virus suffer debilitating side effects such as chronic fatigue for months after - and this is irrespective of how acute the actual infection is for the person involved
iii) there is some evidence of extremely healthy people such as professional athletes suffering heart problems as a result of contracting the virus: https://www.si.com/college/2020/08/09/ncaa-cardiac-inflamation-coronavirus-myocarditis-concerns
iv) by vaccinating yourself you prevent the possibility of you contracting it and passing it on to people older and less healthy than you perceive yourself to be
v) by vaccinating yourself you contribute to a drive for herd immunity in the population as a whole

YellowBucket

The problem is that with anything like this it’s potentially high risk. If you roll out some rushed vaccine which hasn’t been through adequate tests and you have a big issue where it causes a reaction or it just doesn’t do very much at all, then you have a situation where you’ve at best undermined public trust and could end up undermining a whole vaccination programme.

At worst a poorly tested vaccine could cause a lot of medical problems and injuries.

That’s why this can’t just skip through regulatory systems and red tape isn’t always a negative.

Atlantic Dawn

Fair play to the Russians, first man in space and first Covid 19 vaccine.

Thierry12

xvril wrote: »

If you are young and have no underlying health conditions is there any point in taking the vaccine?

If the young and healthy don't take it, herd immunity won't work

This vaccine will probably be like the reverse of how a vaccine like flu vaccine works

Young and healthy will take it

Immune compromised with the likes of Hiv/Aids, cancer patients etc and the very old probably won't take it

Haven't seen the breakdown demographic of the people in the trials, but big pharma didn't want to include Hiv patients in them, can't see them including too many sick people in them

seanb85

Thierry12 wrote: »

If the young and healthy don't take it, herd immunity won't work

This vaccine will probably be like the reverse of how a vaccine like flu vaccine works

Young and healthy will take it

Immune compromised with the likes of Hiv/Aids, cancer patients etc and the very old probably won't take it

Haven't seen the breakdown demographic of the people in the trials, but big pharma didn't want to include Hiv patients in them, can't see them including too many sick people in them

The Oxford/Astra Zeneca candidate have enrolled HIV patients in the South Africa portion of their trials.

The_Brood

The Russians have saved us. Yet important that the vaccine is safe of course, but this is not the first time the Russians have developed important vaccines.

The sickening thing will be if the EU, the US play political ****games and refuse jump head on into this vaccine. They will of course mask this under "we need to be sure" but it won't be that, it will be political reluctance to allow Russia to take massive credit after years of ****ting on them. Watch this space.

Sconsey

The_Brood wrote: »

The Russians have saved us. Yet important that the vaccine is safe of course, but this is not the first time the Russians have developed important vaccines.

The sickening thing will be if the EU, the US play political ****games and refuse jump head on into this vaccine. They will of course mask this under "we need to be sure" but it won't be that, it will be political reluctance to allow Russia to take massive credit after years of ****ting on them. Watch this space.

I dunno, if the Russian vaccine does turn out to be effective and safe, barring any better alternatives, I think the EU will jump on it. The economic benefits would have to outweigh any political face-saving. Maybe I am naive, I hope not.

The US on the other hand, yeah I could see them rubbishing it no matter what.

TomSweeney

xvril wrote: »

If you are young and have no underlying health conditions is there any point in taking the vaccine?

I would, you may have a better chance overall if you are young, but I would not want to get this virus, it's a right little **** of a thing, some nightmare stories from healthy young fit people with this.

darjeeling

The_Brood wrote: »

The Russians have saved us. Yet important that the vaccine is safe of course, but this is not the first time the Russians have developed important vaccines.

The sickening thing will be if the EU, the US play political ****games and refuse jump head on into this vaccine. They will of course mask this under "we need to be sure" but it won't be that, it will be political reluctance to allow Russia to take massive credit after years of ****ting on them. Watch this space.

Russia is effectively conducting a mass phase III trial of a vaccine candidate. They're pretending it's an approved vaccine, but that's just PR spin.

The reality is that there are multiple phase III trials of other vaccine candidates ongoing, including some candidates that are much more likely to get approval here and for which we have already negotiated options to buy millions of doses. No-one is going to be getting an unapproved Russian vaccine, even if Russia had the manufacturing capacity to supply us.

Thierry12

seanb85 wrote: »

The Oxford/Astra Zeneca candidate have enrolled HIV patients in the South Africa portion of their trials.

After alot of opposition

Moderna the same

jv2000

darjeeling wrote: »

Russia is effectively conducting a mass phase III trial of a vaccine candidate. They're pretending it's an approved vaccine, but that's just PR spin.

The reality is that there are multiple phase III trials of other vaccine candidates ongoing, including some candidates that are much more likely to get approval here and for which we have already negotiated options to buy millions of doses. No-one is going to be getting an unapproved Russian vaccine, even if Russia had the manufacturing capacity to supply us.

What we have here is the Russian equivalent of an EU "Conditional Authorisation". In order for this to be true the early clinical trial data should have shown a positive risk/benefit profile and the data required for a full authorisation will have been laid out (ie the Phase III trial). Without seeing any of the data it is hard to know what they have and of course if it would actually get a conditional authorisation in any other region or country. There are many Regulatory mechanisms like this now available globally and where the is a serious medical need there will always be a case for authorisation. Look at remdisivar in EU, US, Japan, Australia.....

darjeeling

jv2000 wrote: »

What we have here is the Russian equivalent of an EU "Conditional Authorisation". In order for this to be true the early clinical trial data should have shown a positive risk/benefit profile and the data required for a full authorisation will have been laid out (ie the Phase III trial). Without seeing any of the data it is hard to know what they have and of course if it would actually get a conditional authorisation in any other region or country. There are many Regulatory mechanisms like this now available globally and where the is a serious medical need there will always be a case for authorisation. Look at remdisivar in EU, US, Japan, Australia.....

To my knowledge there is no published data for phase I or II trials looking at safety and immunogenicity of the Gamaleya vaccine candidate, and they have not even conducted a phase III trial to look at efficacy. i.e. no test has been carried out in humans to verify that the vaccine candidate actually protects people from infection or disease.

There is more basis for approving use of the Moderna and Oxford/Astrazeneca vaccine candidates right now than the Gamaleya vaccine candidate.

Sweet.Science

Whats the latest with the Oxford one? I assume that won't be too far behind.

Cordell

Atlantic Dawn wrote: »

Fair play to the Russians, first man in space and first Covid 19 vaccine.

They also had the first death in space. Let's hope this time things are different
Yes, they did cut corners, according to the established rules and regulations in the western word, but maybe just this time, it this emergency, it's the right thing to do.

TomSweeney

Sweet.Science wrote: »

Whats the latest with the Oxford one? I assume that won't be too far behind.

In the third phase of testing, think they'll have results soon, they are aiming for late 2020 / early 2021

jv2000

darjeeling wrote: »

To my knowledge there is no published data for phase I or II trials looking at safety and immunogenicity of the Gamaleya vaccine candidate, and they have not even conducted a phase III trial to look at efficacy. i.e. no test has been carried out in humans to verify that the vaccine candidate actually protects people from infection or disease.

There is more basis for approving use of the Moderna and Oxford/Astrazeneca vaccine candidates right now than the Gamaleya vaccine candidate.

Completely agree. We have no idea what the Russians actually approved and I would have doubts it would meet the requirements for conditional or accelerated mechanisms over the Moderna or Oxford/AZ vaccines (outside of Russia).