Coronavirus (2021) thread

Status
Not open for further replies.
MillionMilesAway said:
I assumed (possibly wrongly based on your post) that an Emergency Use authorisation goes hand in hand with less/shorter trialling, and also hand in hand with a higher chance of revised advice being given when issues arise. My meaning was more that it's only there being an emergency that got it authorised so quickly.
Click to expand...

There are different procedures (radically different in some instances) that tend to get lumped as "Emergency Use Authorisation". I think the following is correct, but I get confused too.

1. The UK MHRA granted a genuine public health emergency use authorisation originally, last year when were in the EU (or still under EU juristiction through the transitional arrangements). Whilst no data whatever is *required* for this, the MHRA actually undertook a full review of the data. That was to enable approval in the UK faster than the EMA were prepared to undertake their review.

2. The MHRA and EMA both reviewed using a "rolling review". This means the individual parts of the submission (clinical, non-clinical, quality) are sent in as soon as the data is available rather than as one package at the end. That speeds up the review process, but doesn't require any less data per se.

3. "Conditional Approval" has been granted. That means that more data is required for a permanent approval, but it doesn't mean the data is incomplete for it's current use. For instance, paediatric studies are required. Here's the EU summary of what conditions are attached to the approval:

Since Vaxzevria has been given conditional authorisation, the company that markets the vaccine will continue to provide results from the clinical trials, which are ongoing. These trials and additional studies will provide information on how long protection lasts, including against new variants of the virus, how well the vaccine prevents severe COVID-19, how well it protects older people, immunocompromised people, children and pregnant women, and whether it prevents asymptomatic cases.

In addition, independent studies of COVID-19 vaccines coordinated by EU authorities will also give more information on the vaccine’s long-term safety and benefit in the general population.

The company will also carry out studies to provide additional assurance on the pharmaceutical quality and testing of the vaccine as the manufacturing continues to be scaled up.

Note that no additional safety studies are mandated. The vaccine is approved for the prevention of symptomatic disease in a general population and all the data normally required for that has been provided.
 
roubaixtuesday said:
The only condition of emergency use was individual batch testing.

As I understand it, could be wrong.
Click to expand...
Just to put a bit more meat on the bones, the data from each batch are submitted and each batch is individually released for use by the MHRA under the article described, according to predefined specifications.

Traditionally a validation of the procedure and analytical tests is done and the licence is granted after demonstration of successfully validation. The releasing site then tests each batch and issues a certificate of analysis which is used to release the batch, aka the regulatory authorities don't need to review themselves.
 
BlueAnorak said:
Very true.
The side effect is worse than that for Heparin (which has a similar side effect) and you get a dose of that if you're admitted to hospital with Covid as the risk for clots when ill with Covid are immense.
Click to expand...
Absolutely awful stuff that low molecular weight heparin. It's an analytical bomb site. Wouldn't work on the stuff ever again!
 
Just posting the risk.

The numbers for CVST in women under 30s probably exceed deaths from the the pill. However if the MHRA were in charge of driving it would be banned tomorrow.

Chance of CVST =
79/20,000,000 = 0.0000395 = 0.00395%

Chance of CVST death =
19/20,000,000 = 0.00000095 = 0.000095%

Chance of a clot while on the pill
= 7.5/100,000 = 0.000075 = 0.0075
Of which around 1% will die
= 0.00000075 = 0.000075%

Chance of clot for woman under 40 not on the pill.
= 1/10k = 0.00001
Of which dying from a clot under 40 not on the pill is again 1% = 0.0000001 = 0.00001%

Raw chance of dying in a car crash this year =
1/20,000 = 0.00005 = 0.005%
 
Last edited:
BlueAnorak said:
The numbers for CVST in women under 30s probably exceed deaths from the the pill. However if the MHRA were in charge of driving it would be banned tomorrow.

Chance of CVST =
79/20,000,000 = 0.0000395 = 0.00395%

Chance of CVST death =
19/20,000,000 = 0.00000095 = 0.000095%

Chance of a clot while on the pill
= 7.5/100,000 = 0.000075 = 0.0075
Of which around 1% will die
= 0.00000075 = 0.000075%

Chance of clot for woman under 40 not on the pill.
= 1/10k = 0.00001
Of which dying from a clot under 40 not on the pill is again 1% = 0.0000001 = 0.00001%

Raw chance of dying in a car crash this year =
1/20,000 = 0.00005 = 0.005%
Click to expand...
I get your point and I largely agree but they are just doing their job.

They haven't revoked authorisation, they've made a recommendation but have stressed the point, in alignment with the EMA that the benefits outweigh the risks at this time.

I see nothing wrong with the events of today and I have company stock taking hits left and right since approval was granted.
 
03 March 2002 said:
I get your point and I largely agree but they are just doing their job.

They haven't revoked authorisation, they've made a recommendation but have stressed the point, in alignment with the EMA that the benefits outweigh the risks at this time.

I see nothing wrong with the events of today and I have company stock taking hits left and right since approval was granted.
Click to expand...
I know they're doing their job.
I was just posting the risk stats.
 
roubaixtuesday said:
The specific issue turned up now would *never* be discovered in any clinical trial - it's just too rare. It would only ever turn up on rollout.

This is not to do with the speed of development.
Click to expand...

That's a very important point. I'm hearing people say "Told you it was rushed", missing the point you'd never pick up such a rare occurrence in the trials, trials which showed the vaccine would hugely reduce hospitalisation and death.

It's not clear that taking the vaccine increases the risk of this rare side effect more than not taking it either.
 
unicorn said:
It's not clear that taking the vaccine increases the risk of this rare side effect more than not taking it either.
Click to expand...

I think that is true of blood clots in general, but not of this specific rare condition, which it does now seem is clearly correlated to the AZ vaccine.
 
HOSPITAL DATA

Back to normal daily reports - outside of weekends - in future.

The news is okay . Another fall over 100 patients in day and UK has only 18 above 3000 patients in hospital with Covid down from nearly 40,000 in January. Ventilators sub 400 in England and 500 in UK. With dates when numbers were lower for both slipping back regularly in early October. South West not now just sub 100 patients but single figures on ventilators.





UK total:


Patients down to 3018 - it was 39, 248 at the peak on 18 Jan - (fall of 36, 230 in 79 days) :- lowest since 3 October

Ventilators down to 440 it was 4077 at the peak on 24 Jan - (fall of 3637 in 73 days) : lowest since 8 October


England only:-


ADMISSIONS:-

188 Covid admissions (5 April) following 156, 179, 178, 180, 225, 283, 277 in the week before.



PATIENTS:-

Patients down today by 102 to 2486 v 3084 last week :- lowest since 4 October.

Peak was 34, 336 on 18 Jan (fall 31, 850 in 79 days)

Ventilators: down 13 to 393 v 501 last week :- lowest since 9 October

Peak was 3736 on 24 Jan (fall 3343 in 73 days)



Regions:



Patient // Ventilators // change in past 5 days to today and v last week



East UP 2 to 200 v 237 // down 5 to 28 v 46

London down 24 to 577 v 689 // down 5 to 121 v 153

Midlands down 27 to 502 v 631 // down 2 to 79 v 111

NE & Yorks down 22 to 454 v 514 // down 2 to 70 v 79

North West down 24 to 457 v 591 // UP 2 to 61 v 69

South East UP 2 to 210 v 309 // UP 2 to 27 v 31

South West down 9 to 86 v 113 // down 3 to 7 v 12`
 
Last edited:
Full details on the risk in the Telegraph now....

The age graphs are the most important (attached). Basically those below 30 with a low exposure risk are better off taking a different jab. Foe everyone else the maths are still in favour...
 

Attachments

  • Screenshot_20210407-212514_Chrome.jpg
    Screenshot_20210407-212514_Chrome.jpg
    515.4 KB · Views: 30
BlueAnorak said:
Just posting the risk.

The numbers for CVST in women under 30s probably exceed deaths from the the pill. However if the MHRA were in charge of driving it would be banned tomorrow.

Chance of CVST =
79/20,000,000 = 0.0000395 = 0.00395%

Chance of CVST death =
19/20,000,000 = 0.00000095 = 0.000095%

Chance of a clot while on the pill
= 7.5/100,000 = 0.000075 = 0.0075
Of which around 1% will die
= 0.00000075 = 0.000075%

Chance of clot for woman under 40 not on the pill.
= 1/10k = 0.00001
Of which dying from a clot under 40 not on the pill is again 1% = 0.0000001 = 0.00001%

Raw chance of dying in a car crash this year =
1/20,000 = 0.00005 = 0.005%
Click to expand...
On the other hand, for a 25 year old, the chance of Covid killing you is about 1 in 10,000 and the chance of catching it with current rates of 3000 a day is about 1 in 1,000 over a month so the overall chance of dying of Covid over a month is 1 in 10,000,000. On that basis it makes perfect sense to hang on a bit for the other vaccine for that age group. For the older age groups where Covid is much more likely to kill you, it makes perfect sense not to wait and to take the AZ vaccine if offered.

Edit: Just seen your post above. I think we’re saying pretty much the same thing.
 
BlueHammer85 said:
and still you get morons saying we shouldn’t have locked down. Could you imagine the toll. Brazil is the reality.
Click to expand...

They are looking at a death toll near 600,000 by July. People there are being reinfected with new variants, Someone needs to get a grip on the situation as it could end up effecting the rest of the planet.
 
feedmpenzaandhewillscore said:
They are looking at a death toll near 600,000 by July. People there are being reinfected with new variants, Someone needs to get a grip on the situation as it could end up effecting the rest of the planet.
Click to expand...

He is a complete loon -

The far-right populist made the inflammatory declaration on Thursday, as Brazil’s already dire Covid situation deteriorated and its average daily death toll rose above that of the United States.

“Stop all this fussing and whining. How long are you going to keep on crying?” Bolsonaro asked supporters in the midwestern state of Goiás, where nearly 9,000 people have died.
 
roubaixtuesday said:
I think that is true of blood clots in general, but not of this specific rare condition, which it does now seem is clearly correlated to the AZ vaccine.
Click to expand...
Thanks. I confess that a clear correlation to AZ isn't what I understood from the press conference, but BBC says "The regulator said this was not proof the jab had caused the clots. But it said the link was getting firmer."
 
Last edited:
Status
Not open for further replies.
Unread Posts

Don't have an account? Register now and see fewer ads!

SIGN UP
Back
Top