Coronavirus (2021) thread

[03 March 2002]

I worry that these vaccines have been too rushed.
This development is concerning.

Dear lord if you saw the things I've seen in just 10 years, you'd about shit your pants.

 

[roubaixtuesday]

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.

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.

 

[03 March 2002]

The only condition of emergency use was individual batch testing.

As I understand it, could be wrong.

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.

 

[03 March 2002]

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.

Absolutely awful stuff that low molecular weight heparin. It's an analytical bomb site. Wouldn't work on the stuff ever again!

 

[BlueAnorak]

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%

 

[03 March 2002]

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%

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.

 

[BlueAnorak]

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.

I know they're doing their job.
I was just posting the risk stats.

 

[unicorn]

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.

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.

 

[03 March 2002]

I know they're doing their job.
I was just posting the risk stats.

You said the part about the MHRA banning driving if they were in charge.

 

[BlueAnorak]

You said the part about the MHRA banning driving if they were in charge.

If they were in charge of driving, then from those stats they would ban it