COVID-19: Vaccine/antidote and testing procedures Megathread [Mod Warning - Post #1]

GeorgeBailey

Micky 32 wrote: »

“Data submitted to the European Medicines Agency (EMA) by Pfizer/BioNTech and Moderna for their Covid-19 vaccine candidates is "very robust", according to its executive director.”


"We have a data set of over 30,000 subjects who have been followed through the clinical trials. This gives us a very robust data set on which to make a decision, both on safety and efficacy," Emer Cooke said at a European Parliament committee meeting.“

“The agency is expected to complete reviews by 29 December for the Pfizer/BioNTech vaccine and 12 January for the Moderna vaccine at the latest.”

"We cannot guarantee there will be a positive outcome," Ms Cooke said.“

Equals a headline of "EMA Approval Now In Doubt"

hmmm

Pfizer peer reviewed data now out.
https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

100% effectiveness in the over 75s Albeit with a small sample of about 1500 in total - 5 Covid cases in the Placebo group.

Micky 32

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

I’d say very unlikely that it won’t be approved.

stephenjmcd

Micky 32 wrote: »

I’d say very unlikely that it won’t be approved.

Oh absolutely, however it just can't be seen to be open and closed with them going into the review with a pre judged outcome

is_that_so

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

That's just an EMA version of a CMO statement!

daydorunrun

GeorgeBailey wrote: »

Equals a headline of "EMA Approval Now In Doubt"

Micky 32 wrote: »

I’d say very unlikely that it won’t be approved.

I think George is referring to what headlines our National media will conjure up for a few clicks.

GeorgeBailey

daydorunrun wrote: »

I think George is referring to what headlines our National media will conjure up for a few clicks.

Exactly that

seamus

EMA has the right idea tbh. They know the pressure to approve is enormous. No end of public and private interests who want them to just push it through without proper review.

So they give a date that's way out there to avoid having to deliver an approval before they're good and ready.

If they go all the way to 29th December, I'll eat my hat.

stephenjmcd

seamus wrote: »

EMA has the right idea tbh. They know the pressure to approve is enormous. No end of public and private interests who want them to just push it through without proper review.

So they give a date that's way out there to avoid having to deliver an approval before they're good and ready.

If they go all the way to 29th December, I'll eat my hat.

Likewise. I'd be surprised if we didn't hear next week or early Christmas week, 21st /22nd, they'll go shortly after FDA is my guess.

Moderna to follow first week or new year I'd say

Micky 32

GeorgeBailey wrote: »

Exactly that

Sorry, my brain wasn’t in tune when i read your comment. i should have known!

Hmmzis

Just read the Pfizer/BNT paper. Exceptional results, nothing to add, nothing to take away from it. Quite the contrast to Oxford's paper, the deeper I look at it the messier it gets. Let's hope Moderna's is more like Pfizer/BNT's.

For me personally the most important bit out of Oxford's data is the weekly swabs in the UK. No matter how you slice and dice it, it quite definitely shows that even the full/full dose reduces viral spread.
In table 2 if you look at the SD/SD row from the UK for asymptomatic cases there is no statistically significant difference, but that's not the whole story. The symptomatic row for the same UK arm shows a reduction of cases/infections. So the two rows there show a nearly complete picture of all infections in that trial arm regardless of symptoms. My naïve point estimate puts that value at ~40% for the SD/SD regiment.

This is good news for other vaccines as well when it comes to preventing viral spread.

Stheno

Hmmzis wrote: »

Just read the Pfizer/BNT paper. Exceptional results, nothing to add, nothing to take away from it. Quite the contrast to Oxford's paper, the deeper I look at it the messier it gets. Let's hope Moderna's is more like Pfizer/BNT's.

For me personally the most important bit out of Oxford's data is the weekly swabs in the UK. No matter how you slice and dice it, it quite definitely shows that even the full/full dose reduces viral spread.
In table 2 if you look at the SD/SD row from the UK for asymptomatic cases there is no statistically significant difference, but that's not the whole story. The symptomatic row for the same UK arm shows a reduction of cases/infections. So the two rows there show a nearly complete picture of all infections in that trial arm regardless of symptoms. My naïve point estimate puts that value at ~40% for the SD/SD regiment.

This is good news for other vaccines as well when it comes to preventing viral spread.

Do you I u think the Oxford data is badly presented?

hmmm

Hmmzis wrote: »

Just read the Pfizer/BNT paper. Exceptional results, nothing to add, nothing to take away from it.

The longer I think about the Pfizer results, the more I don't understand why they didn't do a one dose test. I know regulators can only work from the data they have, but the one shot data looks exceptional.

If I was Pfizer, I'd run an immediate new phase 3 using just one dose. We can follow up with a booster dose later, but an immediate doubling of supply would be spectacular. Worst case is it doesn't work, and it wouldn't take much to prove.

schmoo2k

hmmm wrote: »

The longer I think about the Pfizer results, the more I don't understand why they didn't do a one dose test. I know regulators can only work from the data they have, but the one shot data looks exceptional.

If I was Pfizer, I'd run an immediate new phase 3 using just one dose. We can follow up with a booster dose later, but an immediate doubling of supply would be spectacular. Worst case is it doesn't work, and it wouldn't take much to prove.

I suspect that doesn't make financial sense for them to volunteer to do it...

Hmmzis

Stheno wrote: »

Do you I u think the Oxford data is badly presented?

It's very noisy and the various splits and sub-analyses make it difficult to draw reasonable conclusions from it.
The LD/SD looks ok on the surface until you look deeper into the description of how that part of the trial was executed. The kicker is that in addition to a lower dose they SD booster was given after 3 months and not the nominal 4 weeks. The SD/SD data is also made harder to interpret for similar reasons as a large portion of trial participants got the boosters well outside the nominal 4 weeks. There is a split analysis of <6 weeks to booster and >6 weeks. From that it looks like there is a noticeable benefit waiting longer that 6 weeks for the SD/SD regiment.

So, does the vaccine work? Yes, absolutelly.
What doses and at what intervals do we need to get the 62%? Not sure, can't quite tell yet with any reasonable confidence.
What doses and at what intervals do we need to get the 90%? Even less clear than for the 62%.
What about the 70%? Statistics.

MerlinSouthDub

Hmmzis wrote: »

So, does the vaccine work? Yes, absolutelly.
What doses and at what intervals do we need to get the 62%? Not sure, can't quite tell yet with any reasonable confidence.
What doses and at what intervals do we need to get the 90%? Even less clear than for the 62%.
What about the 70%? Statistics.

I wonder if there is enough data to conclude that the half dose/full dose regimen is at least as good as the full dose/full dose regimen? That would be a very valuable conclusion.

Cork2021

Hmmzis wrote: »

It's very noisy and the various splits and sub-analyses make it difficult to draw reasonable conclusions from it.
The LD/SD looks ok on the surface until you look deeper into the description of how that part of the trial was executed. The kicker is that in addition to a lower dose they SD booster was given after 3 months and not the nominal 4 weeks. The SD/SD data is also made harder to interpret for similar reasons as a large portion of trial participants got the boosters well outside the nominal 4 weeks. There is a split analysis of <6 weeks to booster and >6 weeks. From that it looks like there is a noticeable benefit waiting longer that 6 weeks for the SD/SD regiment.

So, does the vaccine work? Yes, absolutelly.
What doses and at what intervals do we need to get the 62%? Not sure, can't quite tell yet with any reasonable confidence.
What doses and at what intervals do we need to get the 90%? Even less clear than for the 62%.
What about the 70%? Statistics.

Still no issue with approval across all the agencies? Even 70% will do and give the higher efficacy vaccines to the most vulnerable

Cork2021

Leaks happening

https://twitter.com/micheallehane/status/1337149983787790342?s=21

brisan

Cork2021 wrote: »

Leaks happening

https://twitter.com/micheallehane/status/1337149983787790342?s=21

Christ on a bike
If it is GPs Nurses AND pharmacists giving these vaccines out it will take years and not months
What about the large scale vaccination centres with army personnel on board y

stephenjmcd

brisan wrote: »

Christ on a bike
If it is GPs Nurses AND pharmacists giving these vaccines out it will take years and not months
What about the large scale vaccination centres with army personnel on board y

Army medics are already trained and more are being training. The army are represented on the vaccine task force. Independent ran the story last weekend

Henryq.

stephenjmcd wrote: »

Army medics are already trained and more are being training. The army are represented on the vaccine task force. Independent ran the story last weekend

The more the better

I think we need to pull together on this one across the board

Hmmzis

MerlinSouthDub wrote: »

I wonder if there is enough data to conclude that the half dose/full dose regimen is at least as good as the full dose/full dose regimen? That would be a very valuable conclusion.

Taken at face value, there is. The catch being that you'd have to take the booster after 3 months, not 4 weeks (as per trial execution and not trial protocol). That leaves the question open of what the LD prime does in regards of protection in those 3 months. It needs more data to show a better picture. I think most of the regulators wish they could approve it yesterday, but they all need a more robust data set. I'd be very curious what MHRA in the UK will do here.

Deeper Blue

brisan wrote: »

Christ on a bike
If it is GPs Nurses AND pharmacists giving these vaccines out it will take years and not months
What about the large scale vaccination centres with army personnel on board y

Curious as to why you think this, would it not be a case of the more people administering vaccines the better?

ACitizenErased

The more the merrier. Pharmacists are incredibly experienced from the flu vaccine.

Hmmzis

Cork2021 wrote: »

Still no issue with approval across all the agencies? Even 70% will do and give the higher efficacy vaccines to the most vulnerable

The 70% is a statistical value, it's actually not a point estimate of any of the dosing regiments. The SD/SD is 62% overall and the LD/SD is 90% overall, with the caveats mentioned in the previous post from me.

hmmm

https://www.youtube.com/watch?v=zDzE-tTisSo

Live FDA panel reviewing the Pfizer vaccine - and they've just voted (17 to 4) to approve it.

ACitizenErased

hmmm wrote: »

https://www.youtube.com/watch?v=zDzE-tTisSo

Live FDA panel reviewing the Pfizer vaccine - and they've just voted (17 to 4) to approve it.

I really do hope the EMA is not far behind

Micky 32

You’d have to wonder why the 4 voted against it. Do they not want this crisis over or something?

stephenjmcd

hmmm wrote: »

https://www.youtube.com/watch?v=zDzE-tTisSo

Live FDA panel reviewing the Pfizer vaccine - and they've just voted (17 to 4) to approve it.

Just to note thats an independent committee.

Their feedback from today now goes back to the FDA who have the final say in the coming days to approve or not. They'll approve it but just because the committee voted to endorse doesn't mean its approved for use just yet, it'll be a few more days before the FDA come to a judgement

Russman

Micky 32 wrote: »

You’d have to wonder why the 4 voted against it. Do they not want this crisis over or something?

The dissenting voices at the discussion (not sure if that translated into the votes) were mostly to do with the age being from 16 upwards, they wanted it to be 18 upwards. One guy only wanted to approve it for HCWs and care home residents for the moment, based on the rationale that that’s all that would be getting it for the first few months anyway and then they’d have more safety data before general approval.