Oxford vaccine - when?

[Florelei]

I need this to be approved. It feels like it has been a long time coming.

I can’t put up with much more of all this awfulness.

This claim is really...one that from a science perspective they should not have made. The 9/10 one. They could have just not said it and waited for more robust data given that it was based on an error, on a small sample and included no over 55s.

Just to clarify, although no one is offering me one I would take any one of the 3 vaccines on the market currently!

ChaBishkoot what is your academic background?

The Wired article implies cherry picking but according the Lancet the pooling was pre specified.

The reason why the study had to be expanded was logical - due to the low U.K. prevalence over the summer.

As discussed the dosing error was quickly identified and cleared with the regulator.

And there’s more than one strand of evidence to indicate that the results of the 1.5 dose regime were not chance such as the apparent impacts on transmission as well as symptomatic cases.

I just think the wired article is reaching a bit.

The reason why the study had to be expanded was logical - due to the low U.K. prevalence over the summer.

In particular in Oxford, almost no one was getting covid over that period.

@ChaBishkoot

This claim is really...one that from a science perspective they should not have made. The 9/10 one. They could have just not said it and waited for more robust data given that it was based on an error, on a small sample and included no over 55s.

Ok, but given that it is interim data, they specify the exact numbers and also refer to how the different dosing came about I’m honestly still failing to see how the press release can be described as a ‘massive fuck up’. All this data is being thoroughly reviewed is it not? What’s wrong with saying this is what we have found so far?

Seems like there's some problem with it they've not told us about

Seems like there's some problem with it they've not told us about

I would be extremely surprised if that was the case. What's your reasoning behind this?

I don’t think there is a problem that anyone has not told us about. Absolutely not.
That’s not how these things work. They are all subject to very very heavy scrutiny- right from the trial protocol to the actual conduct of the trial. And a high profile trial like this will bring even more scrutiny.

@CoronaIsWatching

Seems like there's some problem with it they've not told us about

Why would you choose to believe that when any delays are easily accounted for by the thing we do know about, ie the issue with dosing?

Bless them and the work they’re doing

Are you Sarah Gilbert's mother, ForBlueSkies?!

Nothing really new but the latest I could find
www.google.co.uk/amp/s/www.bbc.com/news/amp/health-55302595

I thought this podcast was good at answering some of the questions about the Oxford vaccine, though more information has since become available.

podcasts.apple.com/gb/podcast/how-to-vaccinate-the-world/id1540300666?i=1000500808856

In particular I think it helped outline some of the differences due to carrying out a combined Phase 2/3 study as opposed to a Phase 3 study.

This was a good short interview on some issues on comparing the vaccines and also why the design of the Oxford trials ended up a bit more complicated:

podcasts.apple.com/gb/podcast/coronavirus-what-you-need-to-know/id1503075715?i=1000500210544

The OP mentioned an agreement whereby you can only vaccinate so many of your population until other countries catch up. That sounds like Covax www.google.co.uk/amp/s/amp.theguardian.com/global-development/2020/sep/21/landmark-moment-156-countries-agree-to-covid-vaccine-allocation-deal

It’s not clear at all from this, but my guess would be the agreement applies only to the distribution of vaccines that are secured under the scheme.

There is still going to be a problem with equitable distribution www.nytimes.com/2020/12/15/us/coronavirus-vaccine-doses-reserved.html

At the end of the Panorama programme the VP of AZ said that they expected results from the US arm of the trial in weeks. He said they had recruited lots of people and they were getting lots of events, which is really promising ( assuming they're in the control group ).

It's all with the standard dosing regimen, but may be enough to get through the regulators if they need more than the existing interim results.

Info on the US trial:

www.nih.gov/news-events/news-releases/phase-3-clinical-testing-us-astrazeneca-covid-19-vaccine-candidate-begins

I think it will be a great relief if/when this happens. I have to ask though - there are posters on MN who are such doom mongers you wonder how they get through life or who try and use this as an opportunity to trash the government.

Going out against Tier policies, saying you are going to do what you like because of Cummings. We know the more mixing we do the more risks we run. If you have a party with 30 people you do realise that you will be the losers in this. Not Boris and co. YOU!!

[quote ATieLikeRichardGere]The OP mentioned an agreement whereby you can only vaccinate so many of your population until other countries catch up. That sounds like Covax www.google.co.uk/amp/s/amp.theguardian.com/global-development/2020/sep/21/landmark-moment-156-countries-agree-to-covid-vaccine-allocation-deal

It’s not clear at all from this, but my guess would be the agreement applies only to the distribution of vaccines that are secured under the scheme.

There is still going to be a problem with equitable distribution www.nytimes.com/2020/12/15/us/coronavirus-vaccine-doses-reserved.html[/quote]
Yes that was my understanding too - the COVAX scheme only binds members to the allocation of vaccines apportioned/supplied under the scheme.

There appears to be nothing binding individual members (i.e. wealthy countries) from entering into separate bilateral purchase contracts with vaccine manufacturers. That's exactly what we - the UK - have done. And arguably with some success. 🥴

Were that not the case (ie signatories were straightjacketed /limited to COVAX supply only) then I don't think wealthy nations would have been prepared to subscribe to the scheme in the first place....

Interestingly Oxford have released more detailed data from earlier stage trials looking at the immune response with different dose regimens

www.reuters.com/article/health-coronavirus-astrazeneca-oxford-idUSKBN28R2IU

The booster doses of the vaccine are both shown to induce stronger antibody responses than a single dose, the standard dose/standard dose inducing the best response

Is this a prelude to the SD/SD getting an emergency licence, pending further research on the half dose/SD regime?

That’s interesting. I can’t quite understand why they would release that info now. I suppose these results are what you would expect though.

Shortly after Christmas they are saying

www.independent.co.uk/news/uk/oxford-vaccine-approve-christmas-covid-b1776481.html

The reporting on the dosing regimens seems a bit confused though. They don’t really explain that the phase 1/2 trial compared the SD/LD and SD/SD rather than the LD/SD.

Yes, the team must be so frustrated that they didn't look at the LD/SD in the earlier trials. I'd guess that they'll give emergency use to the SD/SD and quickly arrange a trial to look at the LD/SD in larger and more diverse populations. Obviously it depends on what the latest data set shows, but presumably that doesn't include the LD/SD group.

Although there could have been more cases in the groups considered in the interim analysis which would increase confidence in the results.

Fingers crossed that's the case and a load of people in the placebo group have contacted the infection ( but not been too ill obviously)