COVID-19: Vaccine and testing procedures Megathread Part 2 [Mod Warning - Post #1]

Danzy

Danzy wrote: »

It's a typo.

The FDA are not the toughest regulatory agency, with the very top experts. They just have the biggest clout. Their agents are not particularly well paid civil servants who when they reach a certain level move to the private sector

Cork2021

Right I’m going having a whiskey!

funnydoggy

Israel wouldn't have the results it has if it was 8% surely?!

Amirani

funnydoggy wrote: »

Israel wouldn't have the results it has if it was 8% surely?!

Israel is using Pfizer only.

Turtwig

That AZ statement is odd though. It doesn't reflect their published study.

funnydoggy

Ah, sorry. Got my vaccines mixed up

Happydays2020

Danzy wrote: »

There are different categories, clinical, emergency, etc. Some more strident than others, the yanks are looking at full approval. Not unusual for more information to be requested, unusual for it not to be.

The CDC is accepted to be the best in the world at this.

British next, that doesn't mean that they are infallible or always correct.

A key problem for the EMA is the best talent in it was British and left with Brexit. Not a skill set that can be quickly replicated or replaced.

In years to come they will probably be just as good.

The best talent left with Brexit? Are you sure?

Happydays2020

Happydays2020 wrote: »

Lots of info here

https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-astrazeneca/information-for-healthcare-professionals-on-covid-19-vaccine-astrazeneca

from what I am reading in that, 5.9% of trialists were over 65.

Baseline demographics were well balanced across COVID-19 Vaccine AstraZeneca and control treatment groups. Overall, among the participants who received COVID-19 Vaccine AstraZeneca, 94.1% of participants were 18 to 64 years old (with 5.9% aged 65 or older); 60.7% of subjects were female; 82.8% were White, 4.6% were Asian, and 4.4% were Black. A total of 2,070 (35.6%) participants had at least one pre-existing comorbidity (defined as a BMI ≥30 kg/m2, cardiovascular disorder, respiratory disease or diabetes). The median follow-up time post-dose 1 and post-dose 2 was 132 days and 63 days, respectively.

Of those 660 people, 2 contracted Covid. This means the results are too few to draw conclusions.

The number of COVID-19 cases (2) in 660 participants ≥65 years old were too few to draw conclusions on efficacy. However, in this subpopulation, immunogenicity data are available, see below.

I wonder where this 8% figure comes from?

funnydoggy

I think this sums up the last few days with this Oxford AZ business:

http://arethebritsatitagain.com/

Azatadine

Good news on the Pfizer/Israel data so far.

https://twitter.com/BNODesk/status/1353822952664551424?s=09

Happydays2020

After a lot of discipline we have now seen over the last four week a politicisation of Covid and the vaccine.

Amirani

Aegir wrote: »

from what I am reading in that, 5.9% of trialists were over 65.

Of those 660 people, 2 contracted Covid. This means the results are too few to draw conclusions.

I wonder where this 8% figure comes from?

Some useful info there.

Given so much is hinging on the immunogenicity benefits in the older age groups (given not enough data for efficacy), and AZ just re-emphasised these (specifically post-2nd dose) in their press statement, it's a wonder the UK are leaving a 12 week gap between doses.

Micky 32

Lads and lassies are any of ye getting motion sickness yet on this roller coaster ride?

Gael23

There’s something not right in AstraZeneca

funnydoggy

Micky 32 wrote: »

Lads and lassies are any of ye getting motion sickness yet on this roller coaster ride?

I've vomited a few times already lol!

PhoenixParker

Aegir wrote: »

from what I am reading in that, 5.9% of trialists were over 65.



Of those 660 people, 2 contracted Covid. This means the results are too few to draw conclusions.



I wonder where this 8% figure comes from?

At a guess, there are too few cases to draw conclusions = a wide confidence interval. Theyre probably 95% confident the efficacy is between 8% and 98% and that's where the 8% comes from.

Amirani

It's incredibly irresponsible for Bild and Handelsblatt to have published this if their sources are not very solid.

Probably irresponsible for them to have published at this stage regardless. Same goes for the Irish journalists that were quote-tweeting, but such is Twitter really.

PhoenixParker

PhoenixParker wrote: »

At a guess, there are too few cases to draw conclusions = a wide confidence interval. Theyre probably 95% confident the efficacy is between 8% and 98% and that's where the 8% comes from.

so they could have said it was 98% effective, but that would have attracted less clicks.

It is a wide range, but 8% just seems like scare mongering.

Turtwig

Amirani wrote: »

Some useful info there.

Given so much is hinging on the immunogenicity benefits in the older age groups (given not enough data for efficacy), and AZ just re-emphasised these (specifically post-2nd dose) in their press statement, it's a wonder the UK are leaving a 12 week gap between doses.

Pardon my ignorance, 12 week gap between doses?

Hurrache

Amirani wrote: »

Probably irresponsible for them to have published at this stage regardless. Same goes for the Irish journalists that were quote-tweeting, but such is Twitter really.

Nothing irresponsible about tweeting other sources. People would be complaining if journalists weren't doing so too, whinging about a cover up or something.

lbj666

PhoenixParker wrote: »

At a guess, there are too few cases to draw conclusions = a wide confidence interval. Theyre probably 95% confident the efficacy is between 8% and 98% and that's where the 8% comes from.

And the UK based on the other group including those with chronic illness projected that it would be at the upper end of that confidence interval.

Did the US trials include over 65? Or do we've to now wait til studies from the UK come through.

Amirani

Turtwig wrote: »

Pardon my ignorance, 12 week gap between doses?

https://www.bbc.com/news/uk-55777084

They're giving Dose 1 and Dose 2 in the UK 12 weeks apart.

This is been particularly criticised on the Pfizer vaccine, as it's not been tested under such conditions.

It's been defended on AstraZeneca as some of the trial data supported it (they left such a gap in certain trial cohorts). I'm not sure if the trial data supports a 12 week gap for 65+ though, it would seem an even narrower subset of what's already a smallish cohort of 65+.

plodder

Aegir wrote: »

so they could have said it was 98% effective, but that would have attracted less clicks.

It is a wide range, but 8% just seems like scare mongering.

Could it be some "rule" that the lower value at 95% confidence is what is assumed/used, and that would be the outcome if the rule is applied? Though it really points to the data just not being good enough.

Amirani

Amirani wrote: »

https://www.bbc.com/news/uk-55777084

They're giving Dose 1 and Dose 2 in the UK 12 weeks apart.

This is been particularly criticised on the Pfizer vaccine, as it's not been tested under such conditions.

It's been defended on AstraZeneca as some of the trial data supported it (they left such a gap in certain trial cohorts). I'm not sure if the trial data supports a 12 week gap for 65+ though, it would seem an even narrower subset of what's already a smallish cohort of 65+.

it is worth pointing out that the 12 weeks is a maximum and will depend on supply.

nearly 500,000 people have already had their second dose.

plodder wrote: »

Could it be some "rule" that the lower value at 95% confidence is what is assumed/used, and that would be the outcome if the rule is applied? Though it really points to the data just not being good enough.

I have no idea how the EMA use the figures, but as a poster pointed out earlier, it seems very unlikely that the numbers will just fall off a cliff when some reaches 65.

In brighter vaccine news India are giving the stuff away

https://www.washingtonpost.com/world/asia_pacific/india-vaccine-diplomacy/2021/01/21/0d5f0494-5b49-11eb-a849-6f9423a75ffd_story.html

Danzy

Happydays2020 wrote: »

The best talent left with Brexit? Are you sure?

The EMA Left London in Spring 19 for Amsterdam.

Much of its top talent stayed to work in Britain.

froog

what a mess. jesus

quartz1

froog wrote: »

what a mess. jesus

Complete Mess

lbj666

Hurrache wrote: »

Nothing irresponsible about tweeting other sources. People would be complaining if journalists weren't doing so too, whinging about a cover up or something.

It shows a total cluelessness by journalists on the subject matter they are covering all bloody day that they would retweet something like that without using some form of validation. Nope as long as a someone else tweets it its fine to present as news.

Christ, if its potential catostrophic news and rte arent running with it you know it cant be right.

plodder

The 8% figure if it has any basis at all is probably very misleading, but am I right in thinking that the EMA process underway is for a "normal" approval rather than the emergency basis used by the UK? If that is the case, it would hardly be that surprising if the EMA didn't approve it for over 65's given the paucity of efficacy data for that cohort, at least until more data becomes available?