The article states the FDA wants it both ways. Yes, go ahead and mix vaccine from multiple vials into a single dose, and no, the practice leads to cross-contamination.
Clear as mud.
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Yes. Most vaccines these days are in single dose vials because of the concerns over the preservative needed for a multi-dose presentation. These would normally be slightly overfilled and no one would care. Though if they were underfilled that would be a serious problem.
Because of the global shortage of vials, stoppers, etc., the decision was made here (correctly) to use a multi-dose presentation. Again, you’d rather overfill than underfill, so the tolerances are set so that most vials will end up with a bit extra, often a full dose.
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No, they very clearly said not to draw from multiple vials. What they said is that if you can draw a sixth dose or even a seventh from a single vial you should do so.
And this is how the process with a new product should work. The users provide feedback and the FDA and manufacturers listen to that.
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AN article on this pretty much said the same. Nothing outside the norm. But these are desperate times and people are thinking outside of the box.
In the current situation, multi-dose presentations aren’t going to be a problem. The vaccine will be reconstituted, shipped to the vax clinic and the last dose will be drawn up and used within minutes of the first dose.
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Would these vials typically be ‘crash numbered’ consecutively-- or simply lot numbered?
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Good question. I don’t know the answer, because I mostly work on the R&D side. My guess (and it’s strictly a guess) is that the vials are individually numbered, and the trays are individually number. Any problems (and there are going to be some) have to be traceable at least back to the tray. It would be better if things could be traced back to the vial.
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Shall we share needles too?
Well, of course. It helps increase the bill to the patient! Oh, yeah - and something something about “avoiding potential contamination.”
Sure, it’s likely the medical professionals are most concerned for the life and health of the patient. But they’re not the ones who do the billing. That’s the green eyeshade squad, who will pile on any potential charge and a few extras.
It’s built into the system that if you want to make sure your process is 99.9% providing at least 5 fulldoses you are going to have a mean amount above 5.
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There is no problem with “dead space” or hub volume. Usually a 25 ga 5/8 needle is used which has very little dead space. After 5 does have been drawn all one has to do is continue drawing from the vial as long as a full 1 cc without air at the end is drawn.
Folks…there is NOTHING unusual about this. It’s done all day long all over the world.
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I saw this discussed last night by Biden’s incoming head of the CDC. It has to do with the design of the bottle and not the ability of Pfizer to measure. It only applies to some of the vials used by Pfizer. It happens all the time. Usually nobody pays any attention, but here we need to make sure we use every last drop.
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Thanx forr the clarification.
However, it still presents a contradiction, as both the CDC and FDA are on record that multi-dose vials should be patient-specific.
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There is also simple human error in the amount drawn out with each vaccination – the vials may be filled by a machine (with the volume caveats described elsewhere in this thread), but filling to the mark on the syringe is eye-balled by Bob the pharmacist, who hasn’t updated his near-sightedness prescription. The differences are small, but it’s not unusual for a five-dose vial to yield five when Bob administers it, and six when Barbara does.
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nope
I was being sarcastic.
but being my stepson and his wife ,which are both ER rn’s in a covid nightmare for the last 6 months, I have heard all the pros and cons wrapped around it. There is not much faith in how it all has been handled by anything attached to this administration.
so hence, my sarcasm
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Let’s say you have two vials, each with a half dose left. Can you draw up a half from each to make a full?
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Wow! There’s a host of comments here debating the legitimacy of what is essentially a FDA driven blame deflection exercise that has no basis in reality.
We are being made to believe that doses are being wasted without any evidence that this is happening at all, let alone by any degree of frequency. This FDA statement should be treated with the degree of seriousness it deserves, which is to say, none.
It’s called the SOROS-cut, where he collects all of the excess on the side for his secret stockpile of drugs for the coming nuclear winter. Nothing to see at all.
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It’s for the pharmacy he’s installing on Snowpiercer.
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You could but no one would. If you’re going to scavenge a dose an entire dose should be drawn. That means up to 1 cc with no air at the end. The problem with CoVax is it’s quite labile and if a second bottle is still on the stand it’s probably of reduced efficacy due to over temp.
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