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

ACitizenErased

[Deleted User] wrote: »

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf

So it is pure red tape, thanks for the clarification.

seamus

ACitizenErased wrote: »

It’s going to be in fridges across the country in GP offices soon so I can’t really understand why you’re making that an issue

Ah come on now.

You think distribution centres just have a load of fridges they got from Power City and have them plugged into extension leads along the warehouse floor?

While refrigeration is easier to maintain than -80 freezers, that doesn't mean it's simple. The distribution centres still require a particular grade of fridge, considerably more accurate than the ones you get anywhere else, and hooked up to a system of redundant power supplies and gennys.
The fridges are continuously monitored to ensure the temperature is maintained. A variance of one degree over 24 hours and the entire batch might have to be dumped.

These facilities take weeks, if not months of planning and auditing before they actually go into use.

Hacking something together in an office building to save yourself a few hours of delivery, is not a risk worth taking.

ACitizenErased

ACitizenErased wrote: »

So it is pure red tape, thanks for the clarification.

Its really not. Its the code of regulations that cover the safety of all medicinal products

titan18

Deleted User wrote: »

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/v4_an16_201510_en.pdf

So to me, I see this part

Until a batch is certified, it
should remain at the site of manufacture or be shipped under quarantine to
another site which has been approved for that purpose by the relevant Competent
Authority.

and ask why can't a site in each country be designated and approved for that purpose pretty quickly. I would assume there already are ones in some countries anyway. It's not like we need to ship them to every GP, pharmacist yet, but having them in the country would allow a much quicker turn around.

josip

Deleted User wrote: »

Placing strategic stock in distribution centres at risk prior to approval is common in the industry -would need to remain in control of the manufacturer however

It would be highly likely that Orban, or some of the other fascist populists, would start administering AZ before EMA approval if they were in the country.
I can understand the EMA reluctance to allow all EU countries to secure stocks in advance.

Amirani

titan18 wrote: »

So to me, I see this part

Until a batch is certified, it
should remain at the site of manufacture or be shipped under quarantine to
another site which has been approved for that purpose by the relevant Competent
Authority.

and ask why can't a site in each country be designated and approved for that purpose pretty quickly. I would assume there already are ones in some countries anyway. It's not like we need to ship them to every GP, pharmacist yet, but having them in the country would allow a much quicker turn around.

What benefit is there to AstraZeneca to do that? Why would they give away their products before they're approved and paid for?

Or are you suggesting the EU pays for them all now and takes delivery regardless of whether the EMA goes on to approve it or not?

hynesie08

AdamD wrote: »

We're not talking 12 hours here. We're talking a delivery in mid-February versus having the vaccine ready to go on January 30th

"as contracted" middle of February, the EU themselves said there's no issue with the vaccine being distributed hours after approval.

If it's approved at 9am on the 29th, there's no reason except for logistics why it can't be getting put in arms by midday.......

Amirani

Amirani wrote: »

What benefit is there to AstraZeneca to do that? Why would they give away their products before they're approved and paid for?

Or are you suggesting the EU pays for them all now and takes delivery regardless of whether the EMA goes on to approve it or not?

I'm gonna go ahead and say it would absolutely pass the cost/benefit for Ireland to pay for their first couple of deliveries in advance of approval.

This vaccine costs peanuts and lockdowns do not. If that was an option it would be a complete no-brainer

ACitizenErased

seamus wrote: »

Ah come on now.

You think distribution centres just have a load of fridges they got from Power City and have them plugged into extension leads along the warehouse floor?

While refrigeration is easier to maintain than -80 freezers, that doesn't mean it's simple. The distribution centres still require a particular grade of fridge, considerably more accurate than the ones you get anywhere else, and hooked up to a system of redundant power supplies and gennys.
The fridges are continuously monitored to ensure the temperature is maintained. A variance of one degree over 24 hours and the entire batch might have to be dumped.

These facilities take weeks, if not months of planning and auditing before they actually go into use.

Hacking something together in an office building to save yourself a few hours of delivery, is not a risk worth taking.

1) It’s not going to be in an office building, so calm.
2) It’s not a few hours, it’s 2 weeks. They said mid February.

titan18

Amirani wrote: »

What benefit is there to AstraZeneca to do that? Why would they give away their products before they're approved and paid for?

Or are you suggesting the EU pays for them all now and takes delivery regardless of whether the EMA goes on to approve it or not?

Someone said earlier we had already paid a certain amount upfront, and I'd imagine the EMA between the rolling reviews and it being a week before the date they had down as approval know if things are looking likely to be approved by now.

If they do think it'll be approved, and surely they've got a good 80% of the work done by now on it, I fail to see why we wouldn't pay for the first deliveries considering how much we're paying to be in lockdown anyway. You could have 2-3 weeks of a head start by having them at approval date vs mid February which is 2-3 weeks less in lockdown at the end of this.

titan18

titan18 wrote: »

Someone said earlier we had already paid a certain amount upfront, and I'd imagine the EMA between the rolling reviews and it being a week before the date they had down as approval know if things are looking likely to be approved by now.

If they do think it'll be approved, and surely they've got a good 80% of the work done by now on it, I fail to see why we wouldn't pay for the first deliveries considering how much we're paying to be in lockdown anyway. You could have 2-3 weeks of a head start by having them at approval date vs mid February which is 2-3 weeks less in lockdown at the end of this.

I believed what ye are suggesting was possible, until I looked at this scenario within my own employer. Even if we pay up front, the manufacturer cannot deliver. Qualification of a new DC is not a trivial matter either.

We could however inventivise pharma companies to pool resources on DC's. eg. Give GSK for an example, an incentive to allow AZ to use their DC's in countries they have them in to position vaccines closer to the market.

Looking for imaginative solutions rather than simply throwing out regulations is the way to go

Melanchthon

Deleted User wrote: »

I believed what ye are suggesting was possible, until I looked at this scenario within my own employer. Even if we pay up front, the manufacturer cannot deliver. Qualification of a new DC is not a trivial matter either.

We could however inventivise pharma companies to pool resources on DC's. eg. Give GSK for an example, an incentive to allow AZ to use their DC's in countries they have them in to position vaccines closer to the market.

Looking for imaginative solutions rather than simply throwing out regulations is the way to go

Couldnt we go ahead with an Emergency Use Authorization to expedite delivery and then start dosing when EMA gives approval?

Irish Stones

seamus wrote: »

These facilities take weeks, if not months of planning and auditing before they actually go into use.

I agree that planning and setting up a facility for storing the vaccine doses takes weeks if not months, but they had all the time they needed, at least 6 months, since the industries announced they were going to produce the vaccines.
I don't think that Pfizer came out of the blue with its vaccine.

Wolf359f

Melanchthon wrote: »

Couldnt we go ahead with an Emergency Use Authorization to expedite delivery and then start dosing when EMA gives approval?

You could, but you wouldn't be getting any doses from what the EU have bulk purchased. You would need to wait until all the EU's doses get distributed to the EU before Ireland would get their additional doses.

ceegee

Melanchthon wrote: »

Couldnt we go ahead with an Emergency Use Authorization to expedite delivery and then start dosing when EMA gives approval?

Unless you want the HPRA to blindly authorise it without looking at any data then that would take longer than waiting 10 days for the EMA to approve it.

Melanchthon

Melanchthon wrote: »

Couldnt we go ahead with an Emergency Use Authorization to expedite delivery and then start dosing when EMA gives approval?

I heard someone from the commission giving a rationale as to why they chose not to. The EUA process is generally for release of experimental reasons .eg. its just come from the lab or development site and has not been scaled up for manufacture. The EUA process does not assess that controls in place in scaled up manufacturing site ensure that what is produced is the same as that done in the lab.

Van.Bosch

Sounds like AZ don’t have any to deliver until mid Feb anyway - maybe they have sold it all to the UK until then

JTMan

eoinbn wrote: »

JnJ will be before Curevac. JnJ phase 3 results will be released in the next few weeks. Curevac are probably administering the second dose of their 2 dose vaccine as I type this. I believe Curevac results will be released in March with delivery hopefully starting in April.

If Bayer get on board with production then it could be a significant boost to the EU supply pipeline as I don't think the US or UK have an order from Curevac

Thanks. Given that official projections don't include J&J, CureVac and Novavax vaccines and given that production is likely to exceed estimates with other vaccines, how soon do people think that all vaccinations can be complete ahead of official conservative estimates? Is late June possible?

y2k2020

Van.Bosch wrote: »

Sounds like AZ don’t have any to deliver until mid Feb anyway - maybe they have sold it all to the UK until then

They seemed to have promised alot but delivered very little

UK supposedly were to get 2m does a week from last week, has that happended?

AZ are saying they can produce 500m doses a month in India

Less talk more action needed from both EMA and AZ, both at fault for this disaster

Amirani

y2k2020 wrote: »

They seemed to have promised alot but delivered very little

UK supposedly were to get 2m does a week from last week, has that happended?

AZ are saying they can produce 500m doses a month in India

Less talk more action needed from both EMA and AZ, both at fault for this disaster

What disaster?

ACitizenErased

Amirani wrote: »

What disaster?

Not getting any deliveries for 2-3 weeks after approval is probably what the poster is referring to

ixoy

y2k2020 wrote: »

Less talk more action needed from both EMA and AZ, both at fault for this disaster

Disaster now is it? Hyperbole is strong today.
You also can't just magic increased doses out, unless we chuck in some homeopathy.

y2k2020

ACitizenErased wrote: »

Not getting any deliveries for 2-3 weeks after approval is probably what the poster is referring to

Exactly

Being jumped on already I see, only pats on the back here regarding vaccines, no criticism allowed

ACitizenErased

y2k2020 wrote: »

Exactly

Being jumped on already I see, only pats on the back here regarding vaccines, no criticism allowed

While I agree it is not ideal I don’t think there is anything we can do about it unfortunately

titan18

Deleted User wrote: »

I believed what ye are suggesting was possible, until I looked at this scenario within my own employer. Even if we pay up front, the manufacturer cannot deliver. Qualification of a new DC is not a trivial matter either.

We could however inventivise pharma companies to pool resources on DC's. eg. Give GSK for an example, an incentive to allow AZ to use their DC's in countries they have them in to position vaccines closer to the market.

Looking for imaginative solutions rather than simply throwing out regulations is the way to go

I would have thought we'd have a DC for AstraZeneca surely, or at least if none are in Ireland, there's likely some within Europe that they could be distributed out to and then rolled out from there. I'm not sure where the main manufacturing bases are that they're being rolled out from, but if there was a DC in France or Netherlands, it would allow us to get them faster if delivered there.

Le Bruise

It's annoying/frustrating that they won't bend the rules rather than a disaster I would say.

I assume the rollout plan was based on the mid-February delivery and that this is not new information to Stephen Donnelly? If it is I'd be far more worried!

titan18

Le Bruise wrote: »

It's annoying/frustrating that they won't bend the rules rather than a disaster I would say.

I assume the rollout plan was based on the mid-February delivery and that this is not new information to Stephen Donnelly? If it is I'd be far more worried!

I'd hope so, but just wasted days really, and every day wasted is another day extra of lockdown, cases, deaths so imo, governments and EU should be doing whatever they can to remove barriers here whilst ensuring safety of the vaccine is still considered. I don't want us to to all UK on this like, but there's a happier middle ground than that imo.

Le Bruise

titan18 wrote: »

I'd hope so, but just wasted days really, and every day wasted is another day extra of lockdown, cases, deaths so imo, governments and EU should be doing whatever they can to remove barriers here whilst ensuring safety of the vaccine is still considered. I don't want us to to all UK on this like, but there's a happier middle ground than that imo.

Completely agree, every day we can shave off the roll out is vital at this stage!

GreeBo

MerlinSouthDub wrote: »

The Astra Zeneca vaccine is very cheap, a couple of euros a dose. Pay the supplier, and get moving. Very little lost even if it doesn't get approved (it's possible approval might be delayed, but very unlikely it won't be approved). It's time to put health and lives ahead of costs and bureaucracy.

Well the EU is on the hook for 400M doses, so at $4 thats 1.6Bn, not something you would want to be seen to be throwing away should it not get approval.

I would agree with your last point, just not sure you can label it all "bureaucracy"

GreeBo

titan18 wrote: »

I'd hope so, but just wasted days really, and every day wasted is another day extra of lockdown, cases, deaths so imo, governments and EU should be doing whatever they can to remove barriers here whilst ensuring safety of the vaccine is still considered. I don't want us to to all UK on this like, but there's a happier middle ground than that imo.

This was the same argument used when Ireland didnt start vaccinations on the same day that they arrived and we can see what difference it makes now (i.e. very little)

I think rushing experts to approve something that you are going to inject into hundreds of millions of people is not a good idea.