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Covid-19 #27: A Handful of Stars, A Fistful of Dollars


Fragile Bird

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18 minutes ago, rotting sea cow said:

This is getting surreal.

 

This is just our daily AZ news. You should already have been accustomed to it ...  no idea what they did, perhaps angered a god of chance or so...

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7 minutes ago, ljkeane said:

It's weird.

My understanding is that all these trials are ongoing, they just release interim results once they hit the requisite number of cases. So the numbers probably are changing a bit as the proportion of variant cases increases. How outdated could the numbers be though? They've only recently reached enough cases to submit. It's hard to imagine there could have been any drastic changes that it'd be worth trying to fudge, especially when they're going to be publicly submitting the data very soon anyway. I think we'll just have to wait and see what it's about.

I'm concerned that an public statement by regulatory bodies was deemed necessary instead of going through internal channels. WTF?

 

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I'm at a loss. UK cases seem to show there is definitely a degree of efficacy to the AZ vaccine - and I doubt the improvement is only due to other vaccines. It would be helpful if they stopped fucking up unnecessarily and complied with procedures. They're just putting themselves in trouble when there's no major need.

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This AZ business is entirely ridiculous. I mean what to believe at this point?

Meanwhile I got my serology results back which I can’t make any sense of. 
The tested thingy is IgM+IgG “N” Eclia immunoassay and its value is 36 and that’s a seropositive result because it’s above 1. What what does this even mean? Do I have both IgM and IgG in my system which means it’s still a recovery phase rather than only IgG which is the long term protection? As for the value, what does that imply? Is it low is it high is it average, should I expect two weeks of protection or two months? This test was a waste of money. At least the lady told me I should wait another 10 days before the next PCR. 

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1 hour ago, rotting sea cow said:

I'm concerned that an public statement by regulatory bodies was deemed necessary instead of going through internal channels

That is the oddest thing.  I'm sure the vaccine is fine.  Somebody misfiled something.  But because of the AZ curse (outside UK), something had to go wrong!

Speaking of corrections...

17 hours ago, Padraig said:

I also saw mention today that the 2nd UK factory (mentioned in the EU contract) has never come on stream.  Cobra?

I read something else that completely contradicted the basis for the above, so it is safe to ignore.  Reporters are confused by all this.  Some are still saying that the EU is getting AZ from the US, which is almost certainly untrue.  Maybe some ingredients.

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Just heard a report on CNBC about the controversy. They commented that there were always questions for drug companies about results but that this was made public means someone was very concerned at the data safety monitoring board.

They then read out a just-issued press release from AZ saying that their data was interim data based on a cut-off date of Feb. 17. Perhaps the questions are about the data after the cut-off point?

My recollection of the initial data that came out from Pfizer and Moderna was that their efficacy was “better than 90%” in their first reports, which was upgraded to 94.5% with the final data. So does that mean they think the final data will drop the efficacy number? That doesn’t sound right because US numbers dropped hugely by mid-February.

At this point in time the other thing that starts to pick up vibes is my cynical political antennae. There are three big US-related vaccines already with a fourth in the approval process. Why not cast doubt on the UK one? Just me speaking here, but I see so many “independent” bodies that history has shown weren’t that independent after all. Cynical, totally cynical.

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57 minutes ago, Fragile Bird said:

Just heard a report on CNBC about the controversy. They commented that there were always questions for drug companies about results but that this was made public means someone was very concerned at the data safety monitoring board.

They then read out a just-issued press release from AZ saying that their data was interim data based on a cut-off date of Feb. 17. Perhaps the questions are about the data after the cut-off point?

Ok. I've seen the new press release

but why the NIAID decided to comment on a press release, when we and they know that it's just for publicity? The only possible reason is these numbers grossly misleading or the PR is seen as an attempt to pressure the regulatory bodies. It doesn't make sense.

 

57 minutes ago, Fragile Bird said:

At this point in time the other thing that starts to pick up vibes is my cynical political antennae. There are three big US-related vaccines already with a fourth in the approval process. Why not cast doubt on the UK one? Just me speaking here, but I see so many “independent” bodies that history has shown weren’t that independent after all. Cynical, totally cynical.

It has crossed my mind a number of times. The Oxford vaccine is the only one that it's being offered "at cost" and at the same time has large contracts due to the COVAX initiative. This might not be what a number of people like.

On the other hand, AZ has been hit by a large number of seemingly unrelated problems (trials, production, transparency, safety, contracts, etc) that it's hard to imagine that it can all be due to some corrupt actors or just bad press.

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Putin will be vaccinated 'in private', so they might as well be giving him a sugar shot for all we know (the Sputnik vaccine has had some criticism I believe). I mean, for someone who likes being photographed shirtless all the time it seems an odd choice.

Anyway, I am interested to hear what human-lizard hybrids Tucker Carlson and Sean Hannity have to say about this choice by the very virile and non-senile Russian leader.

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33 minutes ago, IheartIheartTesla said:

Putin will be vaccinated 'in private', so they might as well be giving him a sugar shot for all we know (the Sputnik vaccine has had some criticism I believe). I mean, for someone who likes being photographed shirtless all the time it seems an odd choice.

 

I kinda don’t believe that he hasn’t been vaccinated yet (with something, whatever that may be) - so my guess is this is the reason for privacy. 

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14 minutes ago, RhaenysBee said:

I kinda don’t believe that he hasn’t been vaccinated yet (with something, whatever that may be) - so my guess is this is the reason for privacy. 

Meh, I'd agree he's almost certainly been vaccinated already, but absolutely would have a saline solution jab for show.

...

Unless he's phobic.

That hard-man image may not like the idea ofnhim feinting or crying at the sight of a needle.

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22 minutes ago, IheartIheartTesla said:

Vaccine hesitancy is a bigger deal in Russia than many other places (more than even the US), so it makes his decision doubly odd.

Could also be some Stalin-esque paranoia at play here, where he doesnt trust a doctor to jab him with poison.

That does not seem impossible. 

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Putin might be a bit paranoid when it comes to these things (seems to be a lot of security around him), but even then, Russia is so full of anti-vaxxers and people suspicious about Sputnik that it would be massively helpful to be publicly vaccinated. Heck, he might actually fill himself a syringe with water from a bottle he had previously tasted, if he fears to be novichoked. But then, if he fears so much, how could he actually take any vaccine or any medicine; I can't see the odds of being poisoned during public vaccination being higher than being poisoned during closed-doors event.

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1 minute ago, Karlbear said:

Read the other posts.

I’m more suspicious of why they made this statement publicly. Novavax has been before them for two months now, how come the board hadn’t been making public statements about their information?

AZ had a cut-off date of Feb. 17 (which is triggered, I think, when they hit a certain number of cases) and have said in a press release that of course they’ll supply more data. Just like Novavax has had to.

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12 minutes ago, Fragile Bird said:

Read the other posts.

I’m more suspicious of why they made this statement publicly. Novavax has been before them for two months now, how come the board hadn’t been making public statements about their information?

AZ had a cut-off date of Feb. 17 (which is triggered, I think, when they hit a certain number of cases) and have said in a press release that of course they’ll supply more data. Just like Novavax has had to.

To my knowledge Fauci hadn't been quoted before this, which in my mind makes this a bit bigger of a deal than a press release issue. 

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It's genuinely really weird. Here's quite a decent twitter thread on the process of reporting trial results by someone who appears to know what he's talking about.

By the sound of it Astrazeneca haven't just plucked a number out of the air the 'interim results' is a set thing that has been reported without controversy in other trials. Basically when you hit 75 cases you get the interim results. But because you spend time putting together the results and give the DSMB time to look at the data by the time you submit 'finalised interim' results you probably have more than 75 cases. In this case 141 because things seem to have been moving quite fast. 150 cases is when you hit your 'final results' and it seems that we've now passed that number so in a short space of time there's been final interim results and preliminary final results. That's were the confusion seems to lie.

It's a bit strange from both sides here. The obvious thing for Astrazeneca to do would be to say to the DSMB before their press release 'we're going to release the interim results' (which to be fair they did clearly identify as the interim results) and if there's an issue that maybe resolve it in private. On the other hand kicking up a big fuss about it is also a little odd by the US authorities. Just say something like 'ok those are the interim results, we're reviewing the final data now'.

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32 minutes ago, Fragile Bird said:

Novavax has been before them for two months now, how come the board hadn’t been making public statements about their information?

I presume Novavax hasn't publicly quoted figures that didn't agree with what Fauci had?

3 hours ago, rotting sea cow said:

On the other hand, AZ has been hit by a large number of seemingly unrelated problems (trials, production, transparency, safety, contracts, etc) that it's hard to imagine that it can all be due to some corrupt actors or just bad press.

Right.  While US Pharma may benefit from AZ having some trouble, US Inc certainly wouldn't.   The sooner this pandemic is gone, the better for everyone.  Miscommunication or a mistake is much more likely than anything nefarious.

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https://www.washingtonpost.com/world/astrazeneca-oxford-vaccine-concerns/2021/03/23/2f931d34-8bc3-11eb-a33e-da28941cb9ac_story.html

Quote

he letter goes on to explain that while the company announced its vaccine was 79 percent effective on Monday, the panel had been meeting with the company through February and March and had seen data showing the vaccine may be 69 to 74 percent effective, and had “strongly recommended” that information should be included in the news release

also this:

Quote

But U.S. officials said the data and safety monitoring board and the company had been going back and forth for weeks over how AstraZeneca was handling the data. They said the board advised the company to use a later data analysis with more cases but that the company did not follow the recommendation. The board was dismayed to see the company’s news release on Monday highlighting the 79 percent overall efficacy, the officials said.

 

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