COVID-19 — Coronavirus

[mosssideblue]

Doesn't is not correct but for all intents and purposes that's true yes. You description here is probably quite spot on for the average person to understand what's happening here.

Also, scientists will rarely ever say this happens at this time. What's more correct is that it has only been tested up to the 5th day and such we can only say it's stable for 5 days.

I got there eventually :)

 

[Healdplace]

595 all settings deaths

UK now topped 50,000 Covid deaths at 50, 365.

 

[Healdplace]

22, 950 cases

Up by 2538

 

[03 March 2002]

I'm quite interested in this.

Are you saying they've likely not had time to work out what temperature it has to be stored at yet and -70C is just the default position they take until they've worked out how long it takes to degrade at -20 or 2-8?

I would have thought that would be something they'd do straight away because of its ramifications for the logistics of widespread rollout.

You are correct.

The thing is manufactured to the scale of the planned clinical trials with the knowledge that by no means do all drugs entering clinical trials make it to market. Some even get shelved for other reasons, despite promising clinical trials. It sounds like not a lot of work to do those tests but it really is. They take time, if you want to demonstrate stability for 6 months, well guess what? it's on stability for 6 months, plus the time it takes to do the tests, often a week or 2, then a few more weeks to review data / produce reports and have QA work done. Stability studies usually comprise a large chunk of development.
There are rules and regulations to follow and usually you'd lay down several 100s/1000s of vials which eats into your development costs as these are no longer available for clinical trials.

There are some more novel therapeutics beginning to enter the market called Oligonucleotides which can cost in excess of $1M/gramme to manufacture and so you can imagine things like stability are the last thought once you know it's stable at -80c.

When you start to consider all these things you see why it costs ~15B to bring them to market.

 

[Healdplace]

Positivity rate on tests has fallen in week from 9.5% to 7.5% That looks promising.

And testing up 57,000 on yesterday.

 

[blueparrot]

Patients 873 v 1117 v 1257 v 1235 today - Patients DOWN - but then if you lose 103 to death in 48 hours numbers will go down.

ICU ventilators 72 v 85 v 94 v 93 today - decrease - but the same caveat of so many deaths will reduce these numbers.

Whilst you would think this was right, the graphs here have a new admissions button for hospital admissions and icu admissions,and are both decreasing

Scotland Coronavirus Tracker

Current and historical data of the Coronavirus outbreak in Scotland. Includes breakdowns by region, maps, charts, and more!

www.travellingtabby.com

 

[03 March 2002]

By this are you saying that they would need it to be at -70C for long term storage but that it's possible it is delivered out to inoculation centres from a regional hub and kept at -20C for a few hours while the vaccine doses are being administered?

Without committing to those number, the premise is what I'm saying. All focus will now switch to how to make it more stable/easier to transport/easier to administer etc. These are the areas the development costs are clawed back in. If we can make it for half as much and transport twice as much without affecting the cost, it's payday.

Look, we have hexagon but let's make a circle.

I do however still believe that the AZ/Oxford candidate is more of a decagon :)

 

[Len Rum]

595 all settings deaths

UK now topped 50,000 Covid deaths at 50, 365.

Approx 60k from death certificates and 65k excess.

 

[Healdplace]

England hospital patients down 11520 to 11306

That is a week to week rise of just 929.

 

[roubaixtuesday]

By this are you saying that they would need it to be at -70C for long term storage but that it's possible it is delivered out to inoculation centres from a regional hub and kept at -20C for a few hours while the vaccine doses are being administered?

The typical way this is done is to define a long term storage condition and period and test the product at start and end.

Also an "in use" period is defined - where the patient/pharmacist has the treatment. That might be, for instance with a bottle of pills designed to last a week, to demonstrate the contents are stable after the seal has been broken for a week. In this case it could be 5 days at fridge temperature.

Finally, transport studies are done, which demonstrate stability for limited periods of time outside of normal conditions eg high temperature excursions if sat on an airport in the sunshine in Texas for that bottle of pills, or perhaps a few hours at room temperature in this case. These can include freeze/thaw cycles as that can affect product performance more than temperature change per se.

Stability may need to be demonstrated with all of these concurrently ie period of shelf life at long term storage PLUS a transport excursion PLUS a period in use - as that's what will happen.

Exactly what studies are done depends on what is already known about the fundamental stability, the intended supply chain and end use. Typically, regulatory agencies will insist on new stability data for each site of manufacture, as subtle changes in manufacture can affect stability.

Now some speculation: This vaccine has not had very long in development at all, so stability data and understanding will be much more limited than usual. There may be almost none for some manufacturing sites. Also, it might be very difficult to characterise degradation for a long RNA strand - I doubt it is possible to precisely characterise, and I've no idea what criteria might be used. It might be that -80 is used because of the difficulty of defining how much degradation is acceptable, or to standardise between sites of manufacture.