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Old Jan 27, 2020, 9:09 am
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Old Jan 25, 2021, 7:57 pm
  #7291  
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Originally Posted by SoFlyOn

Astrazeneca is still recruiting for their trial in the US, and it's estimated it will be around that end of the first quarter that they may have a package ready for FDA submission.
I saw a Business Insider article from early January that referenced “April” for AZ results. But Fauci and others have been saying this more recently. Maybe there will be some data coming out sooner?
Fauci: Approval of AstraZeneca and Johnson & Johnson vaccines likely 'weeks away'
https://thehill.com/homenews/sunday-...ely-weeks-away

Last edited by TTT; Jan 25, 2021 at 8:33 pm
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Old Jan 25, 2021, 9:09 pm
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Originally Posted by TTT
I saw a Business Insider article from early January that referenced “April” for AZ results. But Fauci and others have been saying this more recently. Maybe there will be some data coming out sooner?

https://thehill.com/homenews/sunday-...ely-weeks-away
There seems to some mixed messaging in the above article:
“They're going to have to get their data and safety monitoring board to look at it to see if it is appropriate to start, you know, essentially putting the package together to get an emergency use authorization. But we're weeks away, not months away, for sure,” he added.

It's not clear how long it's going to take for AZ to put its package together for FDA submission. I guess its going to hinge on how good the data is and whether the FDA have any reservations ... I think one thing that is clearly of concern is what the efficacy is in older trial participants.

There will be considerable consternation from the public if the efficacy is considerably lower than the Pfizer and Moderna vaccines.
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Old Jan 26, 2021, 3:14 am
  #7293  
 
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Originally Posted by exp
There's still doubt about the AZ efficacy data, now with some German paper claiming efficacy for people over 65 is less than 10%.
It seems this has been widely debunked

https://www.sciencemediacentre.org/e...y-in-over-65s/

Apparently they may have been confused by the sample size in the trials (around 8% of which were over 65). I hope Oxford/AZ come down on Handelsblatt like a ton of bricks.

Although that is not to say efficacy in the RCTs hasn't been overestimated. I suspect it has, but not substantially, and even with small sample sizes the group differences are extremely unlikely to be due to chance.

Incidentally, I highly recommend Science Media Centre. Their curation of expertise in response to press releases/news articles is excellent and they provide consistently balanced intepretation to new research publications.
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Old Jan 26, 2021, 6:40 am
  #7294  
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Originally Posted by SoFlyOn
There will be considerable consternation from the public if the efficacy is considerably lower than the Pfizer and Moderna vaccines.
The messaging is going to have to be very well crafted if that's the case (not something that has excelled so far in this pandemic). And the perception of distribution will be a challenge too. E.g. does AZ get sent to Utqiagvik because it's easier to ship there or because it's less efficacious? I'm curious how the UK is messaging the AZ vs Pfizer dosing to prevent comparison across options.
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Old Jan 26, 2021, 6:48 am
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Originally Posted by TTT
The messaging is going to have to be very well crafted if that's the case (not something that has excelled so far in this pandemic). And the perception of distribution will be a challenge too. E.g. does AZ get sent to Utqiagvik because it's easier to ship there or because it's less efficacious? I'm curious how the UK is messaging the AZ vs Pfizer dosing to prevent comparison across options.
Indeed. I don't want to sound cynical but it would almost help if the Israeli data demonstrate slightly poorer efficacy for the Pfizer/BioNTech vaccine in real-world data analyses compared to the RCT to bring it more in line with AZ.
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Old Jan 26, 2021, 12:35 pm
  #7296  
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Originally Posted by doctoravios
Indeed. I don't want to sound cynical but it would almost help if the Israeli data demonstrate slightly poorer efficacy for the Pfizer/BioNTech vaccine in real-world data analyses compared to the RCT to bring it more in line with AZ.

Some more early data from Israel:

Israel’s Maccabi Healthcare Services revealed Monday that only 0.015 percent of people are getting infected in the week after receiving their second shot.

Maccabi said it has 128,600 members who have seen seven days pass since full vaccine protection kicked in — and only 20 have caught the coronavirus after they were considered immunized.

Leading immunologist Cyrille Cohen told The Times of Israel that among the general population, around 0.65% are infected in a given week.
https://www.timesofisrael.com/week-a...lis-get-covid/


None of the 20 infected patients required hospitalization:

Ekka Zohar also noted that she found that none of the 20 vaccinees was hospitalized or suffered from a fever higher than 38.5 degrees. That may be an indicator that the vaccine prevents serious illness even when people are infected, she said, but added that it is impossible to know what trajectory their symptoms would have taken without the vaccine.
Of course they need to track this cohort of 128k patients for a few more weeks or couple of months to see if the trend holds up.
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Old Jan 26, 2021, 1:01 pm
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J&J have just announced that they are expecting to report vaccine trial data early next week.
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Old Jan 26, 2021, 3:02 pm
  #7298  
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Today Chris Whitty said we can do double the people with a single dose as we can do with giving out two doses in the same time.

Given potential supply issues and more mass vaccine centres opening, is that really true?

The Oxford vaccine had a better efficacy rate with 1.5 jabs rather than two full doses. Is there a reason we aren't using our limited supply more widely by adopting this, rather than two full doses?
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Old Jan 26, 2021, 3:15 pm
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The US has just reached an agreement with Pfizer and Moderna to purchase an additional 200 million doses to be delivered by the end of the third quarter. In total that adds up to 2 doses of either mRNA vaccine for 300 million people in the US (total population ~330 million).
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Old Jan 26, 2021, 3:45 pm
  #7300  
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Originally Posted by PxC
Today Chris Whitty said we can do double the people with a single dose as we can do with giving out two doses in the same time.

Given potential supply issues and more mass vaccine centres opening, is that really true?

The Oxford vaccine had a better efficacy rate with 1.5 jabs rather than two full doses. Is there a reason we aren't using our limited supply more widely by adopting this, rather than two full doses?
the 1.5 shot dosage was an accident, not planned at all. And they only jabbed a small percentage of the total trial population with that dosage. That is why there are questions about whether those results are reliable.
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Old Jan 26, 2021, 6:54 pm
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Originally Posted by exp
the 1.5 shot dosage was an accident, not planned at all. And they only jabbed a small percentage of the total trial population with that dosage. That is why there are questions about whether those results are reliable.
Not only that, no one over the age of 55 were given 1.5 shot dosage.
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Old Jan 26, 2021, 7:05 pm
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Originally Posted by exp
the 1.5 shot dosage was an accident, not planned at all. And they only jabbed a small percentage of the total trial population with that dosage. That is why there are questions about whether those results are reliable.
Anyway, the AZ vaccine has 62% efficacy, no matter how you package it. That's the efficacy from their standard dose group, and that's the doses in use. It's still much better than nothing, but not in the same league with the other 2 mRNA ones.
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Old Jan 27, 2021, 12:56 pm
  #7303  
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Originally Posted by freedom2020
Anyway, the AZ vaccine has 62% efficacy, no matter how you package it. That's the efficacy from their standard dose group, and that's the doses in use. It's still much better than nothing, but not in the same league with the other 2 mRNA ones.
I'm curious to see the data from a "cleaner" study once the US data comes out. I think the mixing of data from the BR, ZA, & UK studies resulted in some less than perfect data. Having one study, under the same protocol will help.

But as you said, it's much better than nothing!
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Old Jan 27, 2021, 4:30 pm
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Originally Posted by TTT
I'm curious to see the data from a "cleaner" study once the US data comes out. I think the mixing of data from the BR, ZA, & UK studies resulted in some less than perfect data. Having one study, under the same protocol will help.

But as you said, it's much better than nothing!
Unlike the UK's MHRA, the FDA requires raw data from the clinical trial. Of particular interest will be the vaccine efficacy vs age. At the time of the UK submission the older participants in the trial were the most recently vaccinated - leading to uncertainty as to what the relative efficacy is in older individuals. There has been speculation that the EMA (EU authority) might only allow the AstraZeneca vaccine in younger individuals. The approval decision on the AstraZeneca application is expected from the EMA this Friday.

https://www.bmj.com/content/371/bmj.m4725/rr-0
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Old Jan 28, 2021, 12:32 am
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Originally Posted by FlitBen
Trials for the Sinovac candidate have not been too promising.
Sinovac: Brazil results show Chinese vaccine 50.4% effective
- Last week researchers at the Butantan Institute, which has been conducting the trials in Brazil, announced that the vaccine had a 78% efficacy against "mild-to-severe" Covid-19 cases.

But on Tuesday they revealed that calculations for this figure did not include data from a group of "very mild infections" among those who received the vaccine that did not require clinical assistance. With the inclusion of this data, the efficacy rate is now 50.4%, said researchers. But Butantan stressed that the vaccine is 78% effective in preventing mild cases that needed treatment and 100% effective in staving off moderate to serious cases.

The Sinovac trials have yielded different results across different countries. Last month Turkish researchers said the Sinovac vaccine was 91.25% effective, while Indonesia, which rolled out its mass vaccination programme on Wednesday, said it was 65.3% effective. Both were interim results from late-stage trials. -
I just learned from Chinese media that in defining symptomatic infections, The threshold of fever for SinoVax trials is 37.3C, while the threshold of fever for both Pfizer and Moderna is 38C. If this is true, then the 50.4% efficacy rate is likely an underestimate if the criteria of the two mRNA trials are considered more standard .
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