Is it all over for the AstraZeneca vaccine?

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shpalman
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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Sat Jun 26, 2021 12:13 pm

the trials and tribulations of a "world-saving" [sic.] jab
So much has gone wrong, and the well-intentioned folk at Oxford and AstraZeneca have taken so many blows, that it is hardly surprising that they wonder whether they have been the victims of a deliberate disinformation campaign.

It seems they have. There is clear evidence that the Oxford vaccine, and other jabs, have been targeted by Russians peddling disinformation in order to promote their own version, Sputnik V.
"and other jabs" - and yet weirdly Pfizer didn't suffer from confusing and contradictory statements on its efficacy because it wasn't the Russians who screwed up the dosing strategy in one section of the Phase III trial, leading to the fortuitous discovery of a more efficacious dosing regime which then wasn't the actual dosing regime recommended to the public anyway. And it wasn't the Russians who decided not to test the vaccine on older people at first i.e. those who need it most (idk maybe it would have made the efficacy look worse or something) so that in Europe, where we weren't nationalistically invested in it, we couldn't give it to older people, so then instead it caused reactions in younger people, so we had to stop while they said there wasn't a link to the vaccine oh wait yes there is, so now we can only give it to older people, except they don't want it because they (correctly) think it's less effective, and anyway it doesn't matter because they've not even supplied 40% of what they said they'd make their "best effort" to supply to the EU.

Oh and it may reduce transmission by two thirds is slightly effective maybe against asymptomatic covid.

Meanwhile the UK which has relied heavily on the AstraZeneca vaccine, getting it from India instead of letting the Indians vaccinate themselves with it, is now having 16,000 cases a day of the variant from India. Still, good that the UK got priority, thanks to getting AstraZeneca to make it instead of Merck.

So, yeah, all the Russians' fault.
A contractor accidentally supplied half-doses, according to AstraZeneca’s Sir Mene Pangalos, who headed the research once the company was on board.
No, the contractor supplied correctly. In Oxford they re-measured it badly.

Oh and it turns out that you can't just leave out data to make the results look slightly better?
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Re: Is it all over for the AstraZeneca vaccine?

Post by bob sterman » Sat Jun 26, 2021 1:14 pm

shpalman wrote:
Sat Jun 26, 2021 12:13 pm

"and other jabs" - and yet weirdly Pfizer didn't suffer from confusing and contradictory statements on its efficacy because it wasn't the Russians who screwed up the dosing strategy in one section of the Phase III trial, leading to the fortuitous discovery of a more efficacious dosing regime which then wasn't the actual dosing regime recommended to the public anyway. And it wasn't the Russians who decided not to test the vaccine on older people at first i.e. those who need it most (idk maybe it would have made the efficacy look worse or something) so that in Europe, where we weren't nationalistically invested in it, we couldn't give it to older people, so then instead it caused reactions in younger people, so we had to stop while they said there wasn't a link to the vaccine oh wait yes there is, so now we can only give it to older people, except they don't want it because they (correctly) think it's less effective, and anyway it doesn't matter because they've not even supplied 40% of what they said they'd make their "best effort" to supply to the EU.
Ah you see - it's only 40% of what they promised if you're thinking in terms of full doses. If the half-dose is more efficacious then they've supplied 80% of what they needed to supply! :D

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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Sat Jun 26, 2021 2:19 pm

Pfizer actually did something a bit like that, in that the price per vial and number of doses delivered was based on 5 doses per vial, but with the right kind of syringe the Italians worked out to get six doses per vial, but Pfizer wanted to keep the same price per dose rather than per vial, and also wanted the extra dose to count towards the number of doses delivered.
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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Sat Jun 26, 2021 2:24 pm

bob sterman wrote:
Sat Jun 26, 2021 1:14 pm
shpalman wrote:
Sat Jun 26, 2021 12:13 pm

"and other jabs" - and yet weirdly Pfizer didn't suffer from confusing and contradictory statements on its efficacy because it wasn't the Russians who screwed up the dosing strategy in one section of the Phase III trial, leading to the fortuitous discovery of a more efficacious dosing regime which then wasn't the actual dosing regime recommended to the public anyway. And it wasn't the Russians who decided not to test the vaccine on older people at first i.e. those who need it most (idk maybe it would have made the efficacy look worse or something) so that in Europe, where we weren't nationalistically invested in it, we couldn't give it to older people, so then instead it caused reactions in younger people, so we had to stop while they said there wasn't a link to the vaccine oh wait yes there is, so now we can only give it to older people, except they don't want it because they (correctly) think it's less effective, and anyway it doesn't matter because they've not even supplied 40% of what they said they'd make their "best effort" to supply to the EU.
Ah you see - it's only 40% of what they promised if you're thinking in terms of full doses. If the half-dose is more efficacious then they've supplied 80% of what they needed to supply! :D
Except as the Guardian explains, the researchers were wrong about it being more efficacious because it was a half dose, the increased efficacy was because of the longer gap between doses,* and then the UK decided to leave a longer gap between Pfizer doses too (against Pfizer protocol) which may or may not have helped the UK to breed a variant resistant to a single vaccine dose.

* - apparently; the regulator must have seen data which hasn't been published or at least I don't have in mind where they got this idea from.
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Re: Is it all over for the AstraZeneca vaccine?

Post by jdc » Sat Jun 26, 2021 3:40 pm

shpalman wrote:
Sat Jun 26, 2021 2:24 pm
bob sterman wrote:
Sat Jun 26, 2021 1:14 pm
shpalman wrote:
Sat Jun 26, 2021 12:13 pm

"and other jabs" - and yet weirdly Pfizer didn't suffer from confusing and contradictory statements on its efficacy because it wasn't the Russians who screwed up the dosing strategy in one section of the Phase III trial, leading to the fortuitous discovery of a more efficacious dosing regime which then wasn't the actual dosing regime recommended to the public anyway. And it wasn't the Russians who decided not to test the vaccine on older people at first i.e. those who need it most (idk maybe it would have made the efficacy look worse or something) so that in Europe, where we weren't nationalistically invested in it, we couldn't give it to older people, so then instead it caused reactions in younger people, so we had to stop while they said there wasn't a link to the vaccine oh wait yes there is, so now we can only give it to older people, except they don't want it because they (correctly) think it's less effective, and anyway it doesn't matter because they've not even supplied 40% of what they said they'd make their "best effort" to supply to the EU.
Ah you see - it's only 40% of what they promised if you're thinking in terms of full doses. If the half-dose is more efficacious then they've supplied 80% of what they needed to supply! :D
Except as the Guardian explains, the researchers were wrong about it being more efficacious because it was a half dose, the increased efficacy was because of the longer gap between doses,* and then the UK decided to leave a longer gap between Pfizer doses too (against Pfizer protocol) which may or may not have helped the UK to breed a variant resistant to a single vaccine dose.

* - apparently; the regulator must have seen data which hasn't been published or at least I don't have in mind where they got this idea from.
That's been bugging me too. Think I might have found it now: https://assets.publishing.service.gov.u ... 2.2021.pdf

See p.28 for quote below and Table 3.
In the SDSD group, after starting from similar immune responses to the first dose there is a
clear trend that longer dose intervals are associated with higher responses induced by the
second dose. The same pattern is reflected in the nAb responses. When comparing SDSD and
LDSD groups with the same dose interval, the immune response after the second dose is
similar. Given that the median dose interval in the LDSD group was 12 weeks compared with
7weeks in the SDSD group in Brazil and 10 weeks in the SDSD group in the UK, these data
suggest that the higher levels of immunogenicity engendered in the LDSD group are
influenced more by interval than by dose level.

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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Sun Jun 27, 2021 1:25 am

shpalman wrote:
Sat Jun 26, 2021 2:24 pm


Except as the Guardian explains, the researchers were wrong about it being more efficacious because it was a half dose, the increased efficacy was because of the longer gap between doses,* and then the UK decided to leave a longer gap between Pfizer doses too (against Pfizer protocol) which may or may not have helped the UK to breed a variant resistant to a single vaccine dose.

I believe it was in India that the delta variant evolved to evade one vaccine dose.
Delta changes everything.

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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Sun Jun 27, 2021 1:33 am

The Graun says 4 in a million cases of VITT.
But it did, the EMA and MHRA eventually ruled, albeit in only four in a million cases. It was enough for many European countries to restrict the vaccine’s use.
Published estimates of the incidence of VITT range from 1 case per 26,000 to 1 case per 127,000 doses of AstraZeneca/COVISHIELD administered. The estimates vary by country, with countries like Norway and Denmark reporting the highest rates. As of April 28, 2021, the rate of VITT in Canada has been estimated to be approximately 1 per 100,000 doses. Nearly all reported cases have occurred after the first dose. There have been few reported cases of VITT with the Janssen/Johnson & Johnson vaccine, so it is difficult to calculate a precise rate, but the incidence of VITT appears to be approximately 1 case per 500,000 vaccine doses administered.
https://covid19-sciencetable.ca/science ... ccination/
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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Sun Jun 27, 2021 2:14 am

I am extremely grateful to be double dosed with AZ, despite all its perceived problems. However I am not sure how it stacks up against Delta, so will continue to mask (double), distance, and stay home as much as possible, until it is safe.
Delta changes everything.

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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Tue Jun 29, 2021 8:42 am

molto tricky

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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Tue Jun 29, 2021 8:57 am

Well I'm also grateful to have been AZ double-dosed, especially as I managed to get my second one in before that recent confusion about not giving a second AZ dose to people even if they'd had AZ as a first dose, which rapidly became that they could have the second AZ dose with sufficiently informed consent. So all it did was mess things up for a week.

Actually I'm grateful about getting my first AZ dose on the morning of the first day which was available to me, because by the afternoon they'd already stopped while waiting for the EMA to say it was fine and there was no link between the vaccine and the deaths of a few middle-aged subjects, so all that did was mess things up for a week, and then it turned out that there was indeed a link. So if I'd waited a bit, I'd be double-dosed with Pfizer by now anyway as are some of my colleagues.

Still waiting to see what the Delta variant is going to do here. It's becoming a greater and greater proportion of the detected cases (maybe it's about 20% now), but cases (and deaths and hospital occupancy) continue to trend downwards.
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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Wed Jun 30, 2021 1:48 pm

molto tricky

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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Thu Jul 01, 2021 12:13 pm

jdc wrote:
Thu Jun 24, 2021 5:36 pm
There was a table of side effects from AZ and Pfizer broken down by first/second dose. It's somewhere on this forum I think, but I cba to find it. They did find that generally people got more side-effects from AZ first dose than AZ second and the opposite for Pfizer.
The international standard used for reporting side effect data (ICH E2B) doesn't have a field for which dose of a vaccine was the one that caused the reaction. So the truth is that, outside of the common, physically & temporally obvious side effects detected during the trials, nobody can say with any certainty which dose has the worst side effects.
You won't be surprised to learn that continent-wide & international efforts are underway to harmonise the use of the fields which could be used to contain this information in order to answer precisely this question with a reasonable degree of accuracy.

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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Thu Jul 01, 2021 1:00 pm

shpalman wrote:
Sat Jun 26, 2021 12:13 pm
the trials and tribulations of a "world-saving" [sic.] jab
So much has gone wrong, and the well-intentioned folk at Oxford and AstraZeneca have taken so many blows, that it is hardly surprising that they wonder whether they have been the victims of a deliberate disinformation campaign.

It seems they have. There is clear evidence that the Oxford vaccine, and other jabs, have been targeted by Russians peddling disinformation in order to promote their own version, Sputnik V.
The Russians have been targeting Pfizer more than AZ with their disinformation because their vaccine is so similar to AZ's that bad news about CHADOX would rub off on Sputnik the way it has on JnJ's vaccine

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Re: Is it all over for the AstraZeneca vaccine?

Post by shpalman » Thu Jul 01, 2021 1:05 pm

AZ vaccine doses manufactured by the Serum Institute in India (SII) are also known by a third name - Covishield.
And while they are identical to those made in Europe, the EU has not authorised them for use... five million Covishield-branded doses were shipped from India as part of the UK's 100-million-dose AZ order.
Seven EU countries approve India's Covid vaccines
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Re: Is it all over for the AstraZeneca vaccine?

Post by jdc » Thu Jul 01, 2021 4:30 pm

tom p wrote:
Thu Jul 01, 2021 12:13 pm
jdc wrote:
Thu Jun 24, 2021 5:36 pm
There was a table of side effects from AZ and Pfizer broken down by first/second dose. It's somewhere on this forum I think, but I cba to find it. They did find that generally people got more side-effects from AZ first dose than AZ second and the opposite for Pfizer.
The international standard used for reporting side effect data (ICH E2B) doesn't have a field for which dose of a vaccine was the one that caused the reaction. So the truth is that, outside of the common, physically & temporally obvious side effects detected during the trials, nobody can say with any certainty which dose has the worst side effects.
You won't be surprised to learn that continent-wide & international efforts are underway to harmonise the use of the fields which could be used to contain this information in order to answer precisely this question with a reasonable degree of accuracy.
They're the side effects that people were offering anecdotes on, so actually the side effect info from trials was fine for my purposes.

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Re: Is it all over for the AstraZeneca vaccine?

Post by WFJ » Thu Jul 01, 2021 8:59 pm

WFJ wrote:
Thu Jun 24, 2021 6:41 am
shpalman wrote:
Thu Jun 24, 2021 6:16 am
Australia plans to stop using AstraZeneca Covid vaccine by October

To be fair in Europe we'll probably have stopped using it by then too, but that's because we'll have vaccinated everybody.
They will start giving booster jabs once everyone is fully vaccinated. My guess is that these will all be Moderna, BioNTech or to-be-release newer vaccines.
Earlier than I thought.
Der Spiegel wrote: Vaccination Committee changes recommendations for those initially vaccinated with Astrazeneca
Regardless of age, all people who initially received Astrazeneca should now receive an mRNA vaccine as their second dose. STIKO [the German vaccination committee] stress the importance of the second vaccination dose.

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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Thu Jul 01, 2021 11:09 pm

Do we have enough Pfizer to vaccinate the rest of Europe? Should we accelerate the approval of Russian, Chinese and Cuban vaccines to give us more options?
Delta changes everything.

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Re: Is it all over for the AstraZeneca vaccine?

Post by jdc » Fri Jul 02, 2021 12:45 am

Herainestold wrote:
Thu Jul 01, 2021 11:09 pm
Do we have enough Pfizer to vaccinate the rest of Europe? Should we accelerate the approval of Russian, Chinese and Cuban vaccines to give us more options?
Depends. Have they decided to Pfizer because it's superior to AZ or because there's more available? If the former, doesn't that also apply to the vaccines you're referring to?

If it's the latter, you might have to rule out the Russian vaccine anyway: https://www.reuters.com/business/health ... 021-05-14/
President Vladimir Putin has trumpeted the vaccine around the world, and said in March that Russia had signed agreements for the production of 700 million doses abroad.

But Russia had produced just 33 million vaccines as of May 12 and exported fewer than 15 million, according to a Reuters tally that counted each vaccine as consisting of two doses.

Russia's output is much lower than the hundreds of millions being made each month by Pfizer (PFE.N) and AstraZeneca (AZN.L).
If they've only exported a fraction of the doses they've already promised are they really in a position to help their EU friends?

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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Fri Jul 02, 2021 1:47 am

jdc wrote:
Fri Jul 02, 2021 12:45 am
Herainestold wrote:
Thu Jul 01, 2021 11:09 pm
Do we have enough Pfizer to vaccinate the rest of Europe? Should we accelerate the approval of Russian, Chinese and Cuban vaccines to give us more options?
Depends. Have they decided to Pfizer because it's superior to AZ or because there's more available? If the former, doesn't that also apply to the vaccines you're referring to?

If it's the latter, you might have to rule out the Russian vaccine anyway: https://www.reuters.com/business/health ... 021-05-14/
President Vladimir Putin has trumpeted the vaccine around the world, and said in March that Russia had signed agreements for the production of 700 million doses abroad.

But Russia had produced just 33 million vaccines as of May 12 and exported fewer than 15 million, according to a Reuters tally that counted each vaccine as consisting of two doses.

Russia's output is much lower than the hundreds of millions being made each month by Pfizer (PFE.N) and AstraZeneca (AZN.L).
If they've only exported a fraction of the doses they've already promised are they really in a position to help their EU friends?
My impression was that the AZ extremely rare but potentially fatal adverse effects was driving this phenomenon. Its seems better to have more options
both because of potential adverse effects and supply issues. The Russian, Chinese and Cuban vaccines appear to have fewer adverse effects as well.
Delta changes everything.

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Re: Is it all over for the AstraZeneca vaccine?

Post by headshot » Fri Jul 02, 2021 7:24 am

Herainestold wrote:
Fri Jul 02, 2021 1:47 am
. The Russian, Chinese and Cuban vaccines appear to have fewer adverse effects as well.
How well do they protect against the Delta variant?

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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Fri Jul 02, 2021 7:37 am

jdc wrote:
Thu Jul 01, 2021 4:30 pm
tom p wrote:
Thu Jul 01, 2021 12:13 pm
jdc wrote:
Thu Jun 24, 2021 5:36 pm
There was a table of side effects from AZ and Pfizer broken down by first/second dose. It's somewhere on this forum I think, but I cba to find it. They did find that generally people got more side-effects from AZ first dose than AZ second and the opposite for Pfizer.
The international standard used for reporting side effect data (ICH E2B) doesn't have a field for which dose of a vaccine was the one that caused the reaction. So the truth is that, outside of the common, physically & temporally obvious side effects detected during the trials, nobody can say with any certainty which dose has the worst side effects.
You won't be surprised to learn that continent-wide & international efforts are underway to harmonise the use of the fields which could be used to contain this information in order to answer precisely this question with a reasonable degree of accuracy.
They're the side effects that people were offering anecdotes on, so actually the side effect info from trials was fine for my purposes.
Oh yeah, I wasn't intending to criticise the relevance of your data to the discussion, just offering an insight into the problems when it comes to the more important and concerning side effects

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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Fri Jul 02, 2021 7:45 am

Herainestold wrote:
Fri Jul 02, 2021 1:47 am
The Russian, Chinese and Cuban vaccines appear to have fewer adverse effects as well.
In your expert opinion, how would you compare the adverse effect reporting systems of Russia, China & Cuba* with the ICH regions? How likely are they to detect a very rare, but important, side effect?
How would you compare the level of transparency in these countries with the ICH regions too? If they have detected such a rare side effect, how likely are they to publicise it and act on it? When answering, please remember that there is a massive conflict of interest in that the vaccines are effectively owned and manufactured by the governments.
Hungary has dosed a substantial proportion of its population with Sputnik using emergency authorisation of distribution. What rules are there for reporting side effects to products authorised using that route? How do you report side effects in Hungary & what is the level of side effect reporting there? How likely is it that Orban's fascist government would admit that their emergency authorisation has harmed their people?
You see, statements like that can only be made if you actually know these sorts of things.
If you can't offer a sensible opinion on these matters, and can't provide actual figures on the rates of adverse effects in terms of harm per million doses, then you shouldn't make such bold and silly statements.

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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Fri Jul 02, 2021 7:49 am

Herainestold wrote:
Thu Jul 01, 2021 11:09 pm
Do we have enough Pfizer to vaccinate the rest of Europe? Should we accelerate the approval of Russian, Chinese and Cuban vaccines to give us more options?
How is Sputnik manufactured? How reliable is the process? How well do they adhere to GMP? How will we know what's actually going into our arms (or how will regulators really know what's going into the arms of the citizens they are sworn to protect)?
Your expert opinion on this would be most welcome, as it might help persuade regulators that they shouldn't worry about Gamaleya's approach to such matters

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Re: Is it all over for the AstraZeneca vaccine?

Post by Herainestold » Fri Jul 02, 2021 1:43 pm

I think you have to look at how well they work in practise. Real experts -people like you- can look at the details.
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Re: Is it all over for the AstraZeneca vaccine?

Post by tom p » Fri Jul 02, 2021 3:19 pm

We do look at the details. Details are important. That's where the devil lies, and where you find out whether things actually work as well as claimed. And that's why nobody will be rushing to approve sputnik with undue haste.
There are already plenty of alternatives and so there is no urgent rush to stick any old stuff in our citizens.
Oh, and it is impossible to approve something that hasn't been submitted for approval. Since no Chinese or Cuban vaccines have been submitted for approval, they cannot be approved.
You will hear all about it when (if) they are ever submitted for approval. Until then, banging on about how Europe should approve them is utterly pointless.

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