The CDC and Pfizer both recommend against that, but I be some will be tempted.
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They’re ER docs and opposed to extra dosing?
All because they want to keep pandering by refusing to use the defense production act amd hurt big pharma’s fee fees.
Up next: “this proves the liberal scientists and medical people are trying to make this worse to hurt Trump. They weren’t even going to use all the vaccine to get as many people as possible!!!”
Azar and Hahn have nothing to do with this. This is exclusively a manufacturing and control problem at the industrial operations level.
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WRT dead space/hub volume I’m only repeating what I heard on NPR on the way into the office this morning. It sounded plausible to me. You clearly know more than whoever was talking on the radio.
Everything is identified at the very smallest unit of production - vials are serialized as well as the product put into each vial. Serialization is matched and recorded in the system, in the event of product recall and other issues.
I’m working now on a FDA-related implementation for contact lenses. Same thing there - everything is batched and serialized. Product recall rules from the FDA require that level of documentation (for the vaccine industry, it’s 21CFR11).
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The article implies that the variability isn’t caused at the manufacturing end, but at the user end. Different gauge needles, different size syringes, different eyeballs judging exactly when the right dose has been drawn up – that sort of thing.
Addendum: I should have put this on the list, because unless they use carefully calibrated machines in a completely automated process, reconstituting the vaccine is going to add another source of variability. Use a bit more or less saline than you should, and the vial has more or less volume than it should.
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Or one slightly less. It is, as you say, an average, but I would imagine they’re going to err on the side of heavier than lighter. But those weighing mechanisms are generally pretty precise.
Now, the question I have is, are the other manufacturers showing the same variability of weight? If they aren’t, and five dose vials have only five doses, NOW we have an issue with the process at Pfizer.
I’d be a little suspicious (and only a little) that the users are drawing a bit less than they need to from a vial that would create enough ‘left over’ to create another dose.
On this part of it, I’m not as savvy, but that sounds a little weird to me.
It’s probably not due to any superior ability I have. Let me clue you in. Science and medicine are actually easy stuff. That makes them attractive to empty egos that want to proselytize out of a need for self aggrandizement. To be contrarians. Sounds like PBR had one on. The hub volume of a standard syringe 0.05 cc. The needle volume of a 25g 5/8" needle is to little to talk about. But why are we talking about any of this shit? Because it sounds good. If you stick a needle in the bladder of a CoVax vial and draw up 1 cc and there’s still residual vax in the bottle what difference does “dead space” make. There was syringe / needle dead space in the first volume drawn too.
“Sorry you’re dying of COVID sir but I was concerned about dead space and did not vaccinate you”
Shit.
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It’s too bad that no one could have predicted that the vaccines scientists were feverishly working to produce for the past year would need to be stored in vials when they were done.
If only there was some large organization with the responsibility to think about things like this and authority to compel manufacture of critical supplies.
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Desperate times, desperate measures, etc.
That is not the issue. Nor unknown. The issue is doses in a vial
There can be same amount in each vial. However, how the doses are withdrawn & size of needles will determine #doses obtained per vial, independent of amount in vial.
Encouraging the attempt to withdraw “more” vs leave the residual is nothing but recipe for contamination.
Are they suppose to force out what remains in needle into new vial in an attempt to gain more doses?
This is unwise, the manufacturer should not have advised this.
Public health hazard.
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“you wouldn’t buy something before you knew it works if you had six opportunities to have one provider provide you with what you needed.”
We went around till we found someone willing to kick back a little to us!
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Mix some bleach with it too!
Actual heard on the news last night that other respiratorily spread disease rates like cold and flu were down.
https://www.nature.com/articles/d41586-020-03519-3
Apparently old news and probably not unexpected, but first time I remember hearing this.
Are you suggesting that 5 doses be withdrawn with initial use of vial?
Then administering a full dose to 5 patients or 3 patients receive full & remaining 2 patients a half/dose?
Are you saying to re-draw to get remaining 1cc for next dose🤔
We already have a public trust issue with the vaccine.
This stems partly from how quickly it was approved, by an FDA not obviously insulated from the whims of a demented president. Such concerns are hardly ridiculous, but are not justified, because knowledgeable people not under Trump’s control agree that the studies done on the thing make it easily pass a risk/benefit analysis.
There is also concern that this vaccine is based on a novel design, being the first mRNA vaccine approved for mass distribution. Maybe there are no immediately obvious substantial side effects, but who knows what long-term effects might lie months to years in the future? This also isn’t ridiculous, and unlike the efficacy and side effect profile of the vaccine, cannot be tested by any means short of the experience of years to decades of the thing being given to millions of people and not making them sprout a second head, or whatever novel side effect is feared from a vaccine produced with a novel technique. The thing is, though, that the benefit of being protected from COVID is very proven, while the risk that you’re going to sprout a second head from the vaccine is breathtakingly hypothetical.
So, great, add to these concerns, which are not ridiculous, but aren’t substantial either, the concern that the person who draws up your dose of the thing is going to not give you quite enough of it so that there will be another substandard dose or two left at the bottom of the vial after the standard five have been drawn. Wonderful.
Absent further studies that substantiate the idea that a lesser dose performs as well as the dose that was studied, it is not a good idea to try to stretch the supply by underdosing. Even if a lesser dose works, until that’s proven we really, really need to back off a sufficient distance from the immediate need for more doses to include in the analysis the further loss of trust in vaccinations that will result if we allow underdosing intentionally, on a systematic basis. The risks of such an approach seem to me to outweigh the benefits.
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Question for the medical types. It is my understanding that the vaccine needs to be diluted with saline before administering. Is this done on a per dose or per vial level? That is, does the nurse draw up [n] ml of saline and then [m] ml of vaccine and stick it in your arm, or do they draw out 5m from the vial, mix it with 5n ml saline in a beaker and then draw individual doses out of the beaker?
Whole vial dilution would reduce the impact of variability in the draws of individual doses, but increase the importance of the diluter’s accuracy
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Does this mean that depending on the needle you might NOT get a full dose of the vaccine? Or is it again the difference isn’t a concern?
The volume in the needle is NEVER part of the dose. The little markings on the syringe is the dose.
Do you see why there has to be ‘extra’ in the vial? Drug company cannot dictate what size needle or syringe gets used, but that excess is going to be left in the shoulder and the barrel of the needle. Drug company is messaging that if the smallest needle and syringe is used, there is enough left over for more doses.
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This morning, on social media, I entertained concern over a story that someone in Alaska had an allergic reaction to the vaccine.
I countered, accordingly:
Ok, I’m prepared to take the same tack as many COVID deniers are willing to take:
That was one allergic reaction out of how many doses administered in the period. It’s only one; just like it’s only 2% that die from the virus.
If we’re going to accept that the virus isn’t serious because only 2% die from it, then we need to accept that 1 allergic reaction out of hundreds of doses administered doesn’t constitute an emergency.
Carry on with the vaccination process.
Story of the allergic reaction here:
Alaska health care worker had severe allergic reaction to Pfizer Covid-19 vaccine (nbcnews.com)
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