When will this shit end?

[steviewevie]

Just now, xxialac said:

Apologies!!!

accepted.

[stuartbert two hats]

6 minutes ago, Leyrulion said:

I think I'm right in saying that the Oxford vaccine didn't go for an interim analysis, or if it did the number of events is significantly higher then moderna or Pfizer.

 

With all these vaccines coming out quite quickly now we'll find ourselves in a bit of a problem for future vaccines. 

There's news today about another phase 3 trial starting that will report in 6-9months but if we know that we have at least 2 (potentially 3) workable vaccines that prevent infection is it ethical to continue with phase 3 trials for the other ones? 

How do you stop your trial participants from getting another vaccine that definitely works? 

And potentially huge problems in proving it works if infection in the community is significantly reduced. 

Thorny solutions for the future!

Good problems to have though.

[onthebeach]

Gosh - I’m hoping we are ‘allowed’ some cautious optimism if the Oxford/AstraZeneca vaccine gets over the line. I have noticed positivity being shut down here a bit recently - I’m certainly not expecting this to be the silver bullet and everything back to normal in a few months but I do think we will be in a much better place by Spring.

In my dark moments I watch this again ....

 

[steviewevie]

New Stateman's Stephen Bush arguing that all the good news on vaccines makes a brexit deal more likely....because means lockdowns and restrictions not going to be needed for much longer so leading to an economic recovery...which means they can't hide a no deal brexit downturn.

[steviewevie]

Just now, steviewevie said:

New Stateman's Stephen Bush arguing that all the good news on vaccines makes a brexit deal more likely....because means lockdowns and restrictions not going to be needed for much longer so leading to an economic recovery...which means they can't hide a no deal brexit downturn.

here...if you can see behind paywall...

https://www.newstatesman.com/politics/uk/2020/11/dominic-cummings-departure-won-t-make-difference-brexit-negotiations

[Toilet Duck]

4 minutes ago, Leyrulion said:

I think I'm right in saying that the Oxford vaccine didn't go for an interim analysis, or if it did the number of events is significantly higher then moderna or Pfizer.

 

With all these vaccines coming out quite quickly now we'll find ourselves in a bit of a problem for future vaccines. 

There's news today about another phase 3 trial starting that will report in 6-9months but if we know that we have at least 2 (potentially 3) workable vaccines that prevent infection is it ethical to continue with phase 3 trials for the other ones? 

How do you stop your trial participants from getting another vaccine that definitely works? 

And potentially huge problems in proving it works if infection in the community is significantly reduced. 

Thorny solutions for the future!

So...Yes, the Oxford trial does have an interim analysis planned (just the one, whereas Pfizer and Moderna had multiple ones)...as noted above, they also had more participants in the vaccinated arm of the trial, so if the vaccine works, then they will have fewer people at risk of infection/disease (both this and the higher number required to trigger unblinding mean a longer wait). As it happens, both Pfizer and Moderna overshot the number they needed for their first planned analysis (and had more than Oxford need too). 

As regards ethics of continuing trials, there remain many unanswered questions (how well do they perform in different populations?, how long does immunity last?, do they provide sterilising immunity?, can we reformulate to use other routes of administration?, can we combine with other vaccines? There will be trials going on for quite some time...at some point once we have fully approved vaccines they will become vaccine (standard of care) vs vaccine trials, but for the moment, they remain vaccine vs placebo (we are tying to show they work, later we will try to show they work better than what we have). 

You can't stop trial participants getting another vaccine should one be approved. It's a risk that is built into the design, you would just have to censor those participants from your analysis (and recruit more should you dip below the required participant number to adequately power your trial...unlikely that you would have that many drop out before you finished though). Trying to keep behaviour between the different arms of the trial consistent is exactly why Oxford used another vaccine as their control (rather than saline which doesn't produce much response so it lets participants guess whether they got the vaccine or the placebo...it also gives a more meaningful measure of the adverse effects as it compares to the reactions observed in an approved vaccine). 

Yes, now is the time to test as many vaccines as possible (while infection rates are high...they will take longer when infection rates fall). 

[zahidf]

wHAt AboUt SwEDeN

 

[steviewevie]

2 minutes ago, zahidf said:

wHAt AboUt SwEDeN

 

but are they closing places...or just continuing to ask people not to go...or if they do stay away from each other? Also...they still not asking people to wear masks?

[JoeyT]

4 minutes ago, Toilet Duck said:

So...Yes, the Oxford trial does have an interim analysis planned (just the one, whereas Pfizer and Moderna had multiple ones)...as noted above, they also had more participants in the vaccinated arm of the trial, so if the vaccine works, then they will have fewer people at risk of infection/disease (both this and the higher number required to trigger unblinding mean a longer wait). As it happens, both Pfizer and Moderna overshot the number they needed for their first planned analysis (and had more than Oxford need too). 

As regards ethics of continuing trials, there remain many unanswered questions (how well do they perform in different populations?, how long does immunity last?, do they provide sterilising immunity?, can we reformulate to use other routes of administration?, can we combine with other vaccines? There will be trials going on for quite some time...at some point once we have fully approved vaccines they will become vaccine (standard of care) vs vaccine trials, but for the moment, they remain vaccine vs placebo (we are tying to show they work, later we will try to show they work better than what we have). 

You can't stop trial participants getting another vaccine should one be approved. It's a risk that is built into the design, you would just have to censor those participants from your analysis (and recruit more should you dip below the required participant number to adequately power your trial...unlikely that you would have that many drop out before you finished though). Trying to keep behaviour between the different arms of the trial consistent is exactly why Oxford used another vaccine as their control (rather than saline which doesn't produce much response so it lets participants guess whether they got the vaccine or the placebo...it also gives a more meaningful measure of the adverse effects as it compares to the reactions observed in an approved vaccine). 

Yes, now is the time to test as many vaccines as possible (while infection rates are high...they will take longer when infection rates fall). 

Are you thinking more next week than this for the Oxford trial results?

Perhaps next Monday is looking likely given the last two have yielded trial results?

Or is this another case of #thereisnopattern a la Glastonbury announcements 

[zahidf]

I made the mistake of looking at the Great Reset hashtag. Yikes

[steviewevie]

 

[Toilet Duck]

1 minute ago, JoeyT said:

Are you thinking more next week than this for the Oxford trial results?

Perhaps next Monday is looking likely given the last two have yielded trial results?

Or is this another case of #thereisnopattern a la Glastonbury announcements 

Definitely no pattern! (though, being random, it could of course be next Monday!). Results are imminent, based on the fact it uses spike protein as target and the fact that other adenovirally delivered vaccines seem to be working, I'd be optimistic about it. 

[zahidf]

1 minute ago, steviewevie said:

 

Well stupid 70 year old  ILL HAVE IT

[Toilet Duck]

3 minutes ago, steviewevie said:

 

It's gonna be interesting to see what happens when Pfizer go to the FDA next week...Technically, the FDA will have to ignore one of their criteria for issuing emergency use authorisation if they approve it (you are supposed to have at least 5 cases of severe disease in the placebo group to prove that it works, but none of the participants in the Pfizer trial had severe disease...Moderna are grand, they had 11 cases of severe disease, all in the control group). 

[Paul ™]

12 minutes ago, zahidf said:

I made the mistake of looking at the Great Reset hashtag. Yikes

Loads of idiots about. Seems to be a high percentage of tin foil hatters here in central Portugal 😏

[kalifire]

After seven months of zero infections, the state of South Australia suddenly has a cluster. Just 17 cases, all linked to people who worked at a hotel quarantine, but just goes to show has fragile this situation is.

[zahidf]

 

 

 

[Fuzzy Afro]

11 days post lockdown now and we really should be hoping to see the effects of those changes get baked into the daily numbers now. 21350 last Monday. BristOliver suggests we need < 20000 today to indicate that the lockdown is starting to work. 

[zahidf]

19 minutes ago, Fuzzy Afro said:

11 days post lockdown now and we really should be hoping to see the effects of those changes get baked into the daily numbers now. 21350 last Monday. BristOliver suggests we need < 20000 today to indicate that the lockdown is starting to work. 

I personally think will need a few more days ( 14 days post lockdown) for these things to start coming down

[Crazyfool01]

28 minutes ago, Fuzzy Afro said:

11 days post lockdown now and we really should be hoping to see the effects of those changes get baked into the daily numbers now. 21350 last Monday. BristOliver suggests we need < 20000 today to indicate that the lockdown is starting to work. 

Won’t we now into the phase of the last minute rush to get things done last visits to friends etc knowing that lockdown is incoming after it slipped out but wasn’t yet imposed ... I’d think from Thursday too 

[zahidf]

Depressing

 

[alanr]

BBC this morning

[shoptildrop]

This is really good map showing changes in infection rates (personally glad to see the North West doing better) - I can only add the link unfortunately

https://drive.google.com/file/d/1Rm9BgAIc452nkRrUAt01cji61OlneJtk/view

 

 

[SwedgeAntilles]

1 hour ago, steviewevie said:

but are they closing places...or just continuing to ask people not to go...or if they do stay away from each other? Also...they still not asking people to wear masks?

At the moment, just asking people not to go. That's been the case for a while now, they recently announced they were going to introduce the 10pm curfew here too, but have stopped short on closing places. No change yet on mask wearing.

[steviewevie]

23 minutes ago, crazyfool1 said:

Won’t we now into the phase of the last minute rush to get things done last visits to friends etc knowing that lockdown is incoming after it slipped out but wasn’t yet imposed ... I’d think from Thursday too 

is there two weeks between getting infected to showing symptoms?