16 family members given vaccine

plodder

Bass Reeves wrote: »

I imagine that they are defrosted to refrigerator temperature before distribution. It would take special training for handling anything at a temperature of -75c. They are refrigerated to thaw and it takes 3 hours .

They come in trays of 195 vials which was 1k doses but is actually now transpiring to be 12-1400 doses. There are 5 trays in a box about 6.5k doses. While they can be transported in dry ice it's not ideal as it is a more specialised transportation method. It is easier to transfer refrigerated to hospitals.

It becomes awkward logistically to handle returns. You need to make sure they go out again next day and are used first. So generally boxes or trays will be batch thawed to send refrigerated to a vaccination center. In this situation Day two would be normal the earliest for distribution.
As I said special refrigerated transportation is used this may be doing 2-3 runs a day. Mess with dry ice leads to mistakes.

I hope not, as afaik they are supposed to be transported in a frozen state. Otherwise, how could you guarantee they weren't subject to excessive shaking?

The doc below suggests that they are transported frozen direct to the place of use in the US.

https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_distribution_fact_sheet

I presume if we are doing that then it has been cleared with the manufacturer.

Though I see both the CDC and EMA guidance imply that the vaccine is just stored in a regular fridge at the point of use. It's definitely assumed to be frozen when being transported, for fairly understandable reasons. Curious.

https://www.ema.europa.eu/en/documents/product-information/comirnaty-epar-product-information_en.pdf

https://www.cdc.gov/vaccines/covid-19/info-by-product/pfizer/downloads/storage-summary.pdf

Bass Reeves

plodder wrote: »

I hope not, as afaik they are supposed to be transported in a frozen state. Otherwise, how could you guarantee they weren't subject to excessive shaking?

The doc below suggests that they are transported frozen direct to the place of use in the US.

https://www.pfizer.com/news/hot-topics/covid_19_vaccine_u_s_distribution_fact_sheet

I presume if we are doing that then it has been cleared with the manufacturer though

Larger distances to transport often half a day. I think NY state/city was putting in a special freezer unit as there was none insitu to store it. It is indicated that regfrigrated transport is the norm fir short distances. As well it is easier to break up packs when thawed and target number of doses to projected recipients. As they go to smaller nursing homes number of recipients will be 50-100. Vaccination staff will be doing maybe two units a day. Much easier to handle at regrigeated temperatures. It much easier to run a no returns system than a multiple returns systems. As we get out to this stage there will be doses left at each site that may need to be used up.

wheresthebeef

I’m expecting delivery of 138 doses of Pfizer Vaccine tomorrow morning and will happily settle the bet on whether they arrive frozen or liquid.

plodder

Bass Reeves wrote: »

Larger distances to transport often half a day. I think NY state/city was putting in a special freezer unit as there was none insitu to store it. It is indicated that regfrigrated transport is the norm fir short distances. As well it is easier to break up packs when thawed and target number of doses to projected recipients. As they go to smaller nursing homes number of recipients will be 50-100. Vaccination staff will be doing maybe two units a day. Much easier to handle at regrigeated temperatures. It much easier to run a no returns system than a multiple returns systems. As we get out to this stage there will be doses left at each site that may need to be used up.

I found this document from Canada that looks relevant.

http://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/vaccine_storage_handling_pfizer_moderna.pdf

So, it's definitely preferable to transport when frozen but Appendix B describes how it is possible (if not ideal) to transport in more regular cool boxes. But, it really doesn't make sense to thaw the vials before sending them on.

plodder

wheresthebeef wrote: »

I’m expecting delivery of 138 doses of Pfizer Vaccine tomorrow morning and will happily settle the bet on whether they arrive frozen or liquid.

I don't recall any talk of bets ..

I'd say it will depend how far away you are. The protocol here seems to be to use cool boxes that behave like a regular fridge. So, if they aren't thawed when they leave, they definitely will be after a few hours traveling.

wheresthebeef

plodder wrote: »

I don't recall any talk of bets ..

I'd say it will depend how far away you are. The protocol here seems to be to use cool boxes that behave like a regular fridge.

I believe it’s coming from United Drug in Citywest, we’re less than 15 minutes drive away so might still be frozen.
I believe the Lipid Nanoparticles can be quite fragile so I’ll be happy to know they are frozen solid and won’t be bumped around too much in their little vials.

Bass Reeves

plodder wrote: »

I found this document from Canada that looks relevant.

http://www.health.gov.on.ca/en/pro/programs/publichealth/coronavirus/docs/vaccine/vaccine_storage_handling_pfizer_moderna.pdf

So, it's definitely preferable to transport when frozen but Appendix B describes how it is possible (if not ideal) to transport in more regular cool boxes. But, it really doesn't make sense to thaw the vials before sending them on.

Well if you are correct it more likely you have mass thawing. It takes 30 minutes to thaw a vial at room temp before mixing. It even a more likely reason for no returns as no guarantee that they will remain at -75 in a field situation.

They cannot be refrozen when thawed. Unless there is a suitable refrigerator they can only be thawed and used.

plodder

Bass Reeves wrote: »

Well if you are correct it more likely you have mass thawing. It takes 30 minutes to thaw a vial at room temp before mixing. It even a more likely reason for no returns as no guarantee that they will remain at -75 in a field situation.

They cannot be refrozen when thawed. Unless there is a suitable refrigerator they can only be thawed and used.

Sure, I was never saying returns should be contemplated. The less movement the better after they are thawed. Better to move people to the vaccine than the other way round. The whole discussion was around how much time you have to do that.

Bass Reeves

plodder wrote: »

Sure, I was never saying returns should be contemplated. The less movement the better after they are thawed. Better to move people to the vaccine than the other way round. The whole discussion was around how much time you have to do that.

And that gives you less time than refrigeration

plodder

Bass Reeves wrote: »

And that gives you less time than refrigeration

This looks like the HSE's plan:

https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/covidvaccinesop.pdf

Seems like up to 12 hours out of the 120 is allowed for transport. So, that should allow for 4.5 days in a fridge locally. But, it does presume that the vaccines are already thawed. Though, that's not the same as actually letting them thaw out first. I don't see anything in the doc related to protection from shock/shaking though. There are some simple things you could do to help with that (and measure it).

Bass Reeves

plodder wrote: »

This looks like the HSE's plan:

https://www.hse.ie/eng/health/immunisation/hcpinfo/covid19vaccineinfo4hps/covidvaccinesop.pdf

Seems like up to 12 hours out of the 120 is allowed for transport. So, that should allow for 4.5 days in a fridge locally. But, it does presume that the vaccines are already thawed. Though, that's not the same as actually letting them thaw out first. I don't see anything in the doc related to protection from shock/shaking though. There are some simple things you could do to help with that (and measure it).

Step 7 days the vaccines are thawed at the hub before transportation. This is supposed to be included in the 12 hour window. Therefore this should mean that they are taken out of the -75 freezer at or after midnight on day of distribution. May be impractical unless you have a Nightshift to do this.

The problem with shock is more of an issue when reconstituted. Transportation securely in trays should sort that. However the doc implies that there is a no returns policy/ use on the day in place as I assumed. It makes most sense

plodder

Bass Reeves wrote: »

Step 7 days the vaccines are thawed at the hub before transportation. This is supposed to be included in the 12 hour window. Therefore this should mean that they are taken out of the -75 freezer at or after midnight on day of distribution. May be impractical unless you have a Nightshift to do this.

It's ambiguous. They could be assuming cautiously that once taken out of the freezer they are thawed or thawing. But, if they are definitely thawed then wouldn't there be a stage, where they are put in a normal fridge for a number of hours before being transported?

The problem with shock is more of an issue when reconstituted.

Maybe, but this (and other docs) say "Agitation of the vials should be minimised throughout this time." "Do not shake the vials" (before reconstitution)

Transportation securely in trays should sort that. However the doc implies that there is a no returns policy/ use on the day in place as I assumed. It makes most sense

Where does it say that? What would be the point of the 120 hour limit if that is the case?

Bass Reeves

plodder wrote: »

It's ambiguous. They could be assuming cautiously that once taken out of the freezer they are thawed or thawing. But, if they are definitely thawed then wouldn't there be a stage, where they are put in a normal fridge for a number of hours before being transported?

Maybe, but this (and other docs) say "Agitation of the vials should be minimised throughout this time." "Do not shake the vials" (before reconstitution)

Where does it say that? What would be the point of the 120 hour limit if that is the case?

It states it twice in the documentation once in part 7 of the doc and again in the process that vials are thawed before transportation . It also points to moving of thawed vials not thawing vials. They then allow up to 12 hours for transportation. As Irish journey tines are short generally on an international scale and vaccination scale small it makes more sense to thaw at hub. It eliminates the need foe specialist ultra cold handling training being required by vaccinator's .

It also states that vials should be transported in an upright position and minimise movement everything indicates that vials are thawed before insertion in cool box.

The sin is by omission. There is no returns process on the document. There is no overnight storage pattern. There is no returns documents which is critical to such a process

plodder

Bass Reeves wrote: »

It states it twice in the documentation once in part 7 of the doc and again in the process that vials are thawed before transportation . It also points to moving of thawed vials not thawing vials. They then allow up to 12 hours for transportation. As Irish journey tines are short generally on an international scale and vaccination scale small it makes more sense to thaw at hub. It eliminates the need foe specialist ultra cold handling training being required by vaccinator's .

It also states that vials should be transported in an upright position and minimise movement everything indicates that vials are thawed before insertion in cool box.

The sin is by omission.

Okay fair enough. I'm assuming you're not making this up and are involved in some way. They are thawed, but shouldn't the thawing process be documented then? For how long? Where? It looks like they are thawed centrally rather than at the hubs.

If the issue is the ultra-cold handling, then what are the risks versus the benefit of more stability of the product? Hospitals are already dealing with substances a lot colder than these vaccines.

There is no returns process on the document. There is no overnight storage pattern. There is no returns documents which is critical to such a process

We're agreed that there is no, nor a need for, a returns process, but that does not preclude keeping the vaccines over night.

Where does this idea that they have to be used the same day come from? Are they being kept in the fridges at the hubs for extended periods? The document clearly says the shelf life is 120 hours minus up to 12 hours of transportation time.

Does a country the size of Ireland really need hubs, when no part of the country is more than 6 hour's drive from Dublin?

lucernarian

If things are moved from a central hub already thawed, then why was the assertion made in the vaccines rollout thread that hospitals and logistics (the presence of -70 freezers) were the reason for some acute hospitals getting it long before nursing homes, that got it this week?

The vials appear to be constituted for administration at the start of the day (e.g. when the team arrives). They then have a shelf life of 6 hours.

Bass Reeves

plodder wrote: »

Okay fair enough. I'm assuming you're not making this up and are involved in some way. They are thawed, but shouldn't the thawing process be documented then? For how long? Where? It looks like they are thawed centrally rather than at the hubs.

If the issue is the ultra-cold handling, then what are the risks versus the benefit of more stability of the product? Hospitals are already dealing with substances a lot colder than these vaccines.

We're agreed that there is no, nor a need for, a returns process, but that does not preclude keeping the vaccines over night.

Where does this idea that they have to be used the same day come from? Are they being kept in the fridges at the hubs for extended periods? The document clearly says the shelf life is 120 hours minus up to 12 hours of transportation time.

Does a country the size of Ireland really need hubs, when no part of the country is more than 6 hour's drive from Dublin?

No I am not involved. But I worked in a technical area all my life. Because of this I can understand stand the issues with shelf life, processes and logistics.

In a situation like this KISS is the solution. Keep It Simply Simple. The more complicated you make a process the more likely you are to have mistakes and waste. While 5 days may seem a lot when you start returning and reissuing mistakes are more likely to happen. Human error is more likely

Why thaw and not send it to centers in dry ice. The reason is obvious IMHO. It takes 30 minutes to thaw at room temp. But what to has the room to be at. You would have batch thawing as especially with hospitals you cannot have staff hanging around for 10-20 minutes for a few vials to thaw. Then they have to be used within 6 hours and cannot be moved. A vaccination team arrives at a nursing home, the nurse that was out last night picks up the wrong paperwork for the nursing home they are doing in the afternoon that has 150 residents and staff not the one here that has 70 residents and staff. As well you would have to train an inordinate amount of people in ultra cold handling. This is going to nursing homes as well as hospitals . KISS, KISS KISS take the human element out as much as possible it easier to use a thawed process because of this.

What fridge do you store over night in. It supposed to be stored in an alarmed fridge set to 5C+/-3. In most cases vacination staff will not be there the following day to administer. What happens in a nursing home where there is 4 doses left in a vial when the process is complete. Do you start ringing the local guard station or SuperValu to get a few people to trot up. In theory you can have a reserve but it will not be half a dozen Gardai or LIDL staff hanging around a nursing home on the off chance there may be a few extra doses.much easier when you arrive on site to assertain the number on site and ask the manager of the home to get a few elderly relatives to stand by.

KISS

plodder

wheresthebeef wrote: »

I believe it’s coming from United Drug in Citywest, we’re less than 15 minutes drive away so might still be frozen.
I believe the Lipid Nanoparticles can be quite fragile so I’ll be happy to know they are frozen solid and won’t be bumped around too much in their little vials.

Did they arrive?

plodder

Bass Reeves wrote: »

No I am not involved. But I worked in a technical area all my life. Because of this I can understand stand the issues with shelf life, processes and logistics.

In a situation like this KISS is the solution. Keep It Simply Simple. The more complicated you make a process the more likely you are to have mistakes and waste. While 5 days may seem a lot when you start returning and reissuing mistakes are more likely to happen. Human error is more likely

Why thaw and not send it to centers in dry ice. The reason is obvious IMHO. It takes 30 minutes to thaw at room temp. But what to has the room to be at. You would have batch thawing as especially with hospitals you cannot have staff hanging around for 10-20 minutes for a few vials to thaw. Then they have to be used within 6 hours and cannot be moved. A vaccination team arrives at a nursing home, the nurse that was out last night picks up the wrong paperwork for the nursing home they are doing in the afternoon that has 150 residents and staff not the one here that has 70 residents and staff. As well you would have to train an inordinate amount of people in ultra cold handling. This is going to nursing homes as well as hospitals . KISS, KISS KISS take the human element out as much as possible it easier to use a thawed process because of this.

What fridge do you store over night in. It supposed to be stored in an alarmed fridge set to 5C+/-3. In most cases vacination staff will not be there the following day to administer. What happens in a nursing home where there is 4 doses left in a vial when the process is complete. Do you start ringing the local guard station or SuperValu to get a few people to trot up. In theory you can have a reserve but it will not be half a dozen Gardai or LIDL staff hanging around a nursing home on the off chance there may be a few extra doses.much easier when you arrive on site to assertain the number on site and ask the manager of the home to get a few elderly relatives to stand by.

KISS

I'd agree with respect to nursing homes and not keeping stock over night there, but not big hospitals. They are more than capable of dealing with this.

What I question is thawing the stuff out before being transported anywhere. You can be sure that the clinical trials didn't do that, and to get the same levels of efficacy we should try to replicate the same conditions as the trials as closely as possible.

The more I think about it, the more I think they should be delivered still frozen, even to nursing homes. The person delivering can put them in the fridge and they just have to be left for three hours there to thaw, completely stable, no risk caused by bumpy roads or sudden braking. No need for ultra cold training at the receiving site either if it's a nursing home.

Bass Reeves

plodder wrote: »

I'd agree with respect to nursing homes and not keeping stock over night there, but not big hospitals. They are more than capable of dealing with this.

What I question is thawing the stuff out before being transported anywhere. You can be sure that the clinical trials didn't do that, and to get the same levels of efficacy we should try to replicate the same conditions as the trials as closely as possible.

The more I think about it, the more I think they should be delivered still frozen, even to nursing homes. The person delivering can put them in the fridge and they just have to be left for three hours there to thaw, completely stable, no risk caused by bumpy roads or sudden braking. No need for ultra cold training at the receiving site either if it's a nursing home.

You have no understanding of process's and risk. Somebody in a nursing home or a nurse get frostbite the solicitors line up. You have to train 4-500 people in ultra cold handling. There no way you can.

Maybe you should send you submission to NPHET, the HSE and the Minister. I sure they have plenty of bins for rubbish.

On this thread we have people questionings the integrity of nurses and doctors. We have idiots posting about trotting down to the local LIDL or SuperValu with excess doses. We have people on about staff that may have put in a 10-12 hour shift should be ringing Tom, Dick and Harry who may be higher on a list than another Tom, Dick or Harry.

KISS is the answer follow the instructions, do not complicate the administration of a fairly complex product.

As a friend of mine says be getting on with it.

A load of rubbish posted by people why want to be outraged because someone managed to use up 120 extra dose 104 of them very efficiently and 16 fairly efficiently

plodder

Bass Reeves wrote: »

You have no understanding of process's and risk. Somebody in a nursing home or a nurse get frostbite the solicitors line up. You have to train 4-500 people in ultra cold handling. There no way you can.

Come on. Even in nursing homes they have people who are clinically trained. They aren't stupid and can do it in other countries. Put a notice on the package to not open it until three hours have passed. We trust them to hand out medication to the right people at the right time.

Maybe you should send you submission to NPHET, the HSE and the Minister. I sure they have plenty of bins for rubbish.

On this thread we have people questionings the integrity of nurses and doctors. We have idiots posting about trotting down to the local LIDL or SuperValu with excess doses. We have people on about staff that may have put in a 10-12 hour shift should be ringing Tom, Dick and Harry who may be higher on a list than another Tom, Dick or Harry.

Ok, you've run out of road, so it's down to the ad hominen stuff now! Carry on .. :rolleyes:

jill_valentine

We have idiots posting about trotting down to the local LIDL or SuperValu with excess doses.

In fairness, the Challenge Anneka strategy does appeal to me for entertainment value.

lucernarian

Bass Reeves wrote: »

A load of rubbish posted by people why want to be outraged because someone managed to use up 120 extra dose 104 of them very efficiently and 16 fairly efficiently

And I thought replies were supposed to be constructive. There is a lot of faux outrage, but that doesn't excuse the HSE for not anticipating this most obvious scenario in the rollout and leaving frontline staff in the lurch and making their own judgement calls.

Also, your wider approach has some pretty obvious drawbacks if you thought about it. If the guidance is to "just find people asap to get leftover doses" without extra oversight on this, for better or worse people involved in the rollout might be subject to undue influence from friends and family - even to the point of bribes being offered or other nefarious shenanigans on a localised level. Even if the proximal risk is small, the consequences for the plan would be disastrous.

A simple strategy was to have a standby list of higher priorities on standby, and the first come first served principle applies then. Airlines do something similar for decades, with overbooking and standby seats on planes. I see some of your points but the conclusion seems better at baiting for reactions.

steddyeddy

Bass Reeves wrote: »

You have no understanding of process's and risk. Somebody in a nursing home or a nurse get frostbite the solicitors line up. You have to train 4-500 people in ultra cold handling. There no way you can.

Jesus where are you getting this rubbish from? This is how they deal with vaccine "surplus" in the UK and US.

Wessex local medical committee chief executive Dr Nigel Watson, the clinical lead for the Covid-19 vaccination programme in Hampshire - representing just over 3m patients - said: “Across our 40 sites vaccinating, we are being really careful and there has been virtually no wastage.

“I know some sites have put care home staff on notice that if we have spare vaccine left over, we’ll call them to come in and be vaccinated.”

hynesie08

jill_valentine wrote: »

In fairness, the Challenge Anneka strategy does appeal to me for entertainment value.

"Random spar cashier, you have 30 minutes to clear the shop, cash up, close up, race to the Coombe and give informed consent.

Win and you get the vaccine and a brand new sticker.... Lose and *animated coronavirus appears on screen*"

I'd watch it......

steddyeddy

plodder wrote: »

Come on. Even in nursing homes they have people who are clinically trained. They aren't stupid and can do it in other countries. Put a notice on the package to not open it until three hours have passed. We trust them to hand out medication to the right people at the right time.

Ok, you've run out of road, so it's down to the ad hominen stuff now! Carry on .. :rolleyes:

The argument of those defending all this has been either ad hominin or strawmen (you want to throw in the bin or delivery to supermarkets). It's embarrassing that other countries have strategies for excess vaccines in place and there's people here laughing at the possibility that it could have been done any differently than in our HSE.

lucernarian

steddyeddy wrote: »

The argument of those defending all this has been either ad hominin or strawmen (you want to throw in the bin or delivery to supermarkets). It's embarrassing that other countries have strategies for excess vaccines in place and there's people here laughing at the possibility that it could have been done any differently than in our HSE.

Even worse personally when a number of posters last week dismissed my annoyance about the plan that was being changed on the hoof and a lack of details for how frontline workers could get extra doses, and in the communities with the highest transmission rates. Not many have put their hands up about their assertions since this news broke.

steddyeddy

lucernarian wrote: »

Even worse personally when a number of posters last week dismissed my annoyance about the plan that was being changed on the hoof and a lack of details for how frontline workers could get extra doses, and in the communities with the highest transmission rates. Not many have put their hands up about their assertions since this news broke.

Exactly. Worse still this "extra" vaccine problem had been flagged by the UK on the 17th of December 2020.

It couldn't have taken them by surprise that they'd have more doses.

plodder

steddyeddy wrote: »

Exactly. Worse still this "extra" vaccine problem had been flagged by the UK on the 17th of December 2020.

It couldn't have taken them by surprise that they'd have more doses.

Interesting.

GPs have been told to try to keep wastage of the vaccine for other reasons - such as missed appointments or error - down to five per cent, a huge challenge considering that they have just 3.5 days to deliver each batch of 975 vaccines.

I guess they allow up to a day for transportation, leaving 3.5 days to administer with storage in a fridge overnight. More evidence that each batch doesn't have to be used in a single day.

Hotblack Desiato

looksee wrote: »

I would much prefer to see front line workers - even to the people in the supermarkets - actually, especially people working in supermarkets, get the vaccine first.

Yeah, especially the junior manager in my local Dunnes who keeps his mask around his chin when the senior managers aren't around... :mad::mad:

steddyeddy

The Coombe are having an independent review and removing the master who gave his kids the vaccine from the vaccination procedures.

A review is good but the review should also be with the HSE that didn't even have an IT platform in place for vaccinations.

he board of the Coombe hospital in Dublin has ordered an independent review into how family members of employees received Covid-19 vaccines.

In a statement issued on Wednesday night, the board of the maternity hospital said it had met to discuss how 16 relatives of employees had been vaccinated on the night of January 8th.

The decision to vaccinate relatives of hospital employees was taken by the master of the hospital, Prof Michael O’Connell, after the hospital had vaccines left over following the inoculation of more than 1,100 hospital employees, local GPs and community healthcare workers.

The family members vaccinated included two of Prof O’Connell’s children.

“Given the serious nature of the matter, the board has made the decision to commence an independent review. It expects this review will be completed within a number of weeks,” the board of the hospital said.

Prof O’Connell will not be involved in the follow-up vaccinations of the second dose of Pfizer-BioNTech which are to be administered three weeks after the first dose.