BREAKING: Pfizer vials appear to contain a sixth dose per some pharmacists. But the EUA allows five

[Nevilledog]

Link to tweet

Tweet text:
Andy Slavitt @ 🏡🇺🇸
@ASlavitt
BREAKING: Pfizer vials appear to contain a sixth dose per some pharmacists. But the EUA only allows for 5.

We may be wasting valuable vaccine.
11:12 AM · Dec 15, 2020

[Bleacher Creature]

1. What does that even mean?

Do they use the same vials for more than one patient?

[genxlib]

3. Yes

Five inoculations drawn from one vial. Different syringes and needles obviously.

They obviously put a little extra in there as a margin of error so the 5th shot doesn't get left short. The people administering the shots are just noticing that there is some left.

It is a shame but fully expected and likely unavoidable.

[Bleacher Creature]

7. Ah, that's super helpful.

Thanks!

[qazplm135]

10. sounds smart to me

not necessarily "wasteful." You don't want 20 percent of the public getting an insufficient dose.

[unblock]

4. With a fresh syringe for each patient, of course

[RockRaven]

5. Yes, the vials are multi-dose. Not uncommon. Every time you draw a dose out of the vial a

different new needle/syringe are used.

[Massacure]

9. Yes.

The vaccine is diluted with 1.8ml of sterile 0.9% sodium chloride solution (essentially salt water) and that is used to give five 0.3ml doses of vaccine.

Pfizer and/or the FDA may be allowing a certain margin of error for for providers. I don't know how accurate a human eye and hand are, but it's possible that they may permit a margin of error of say 0.05ml on the dilution (ie 1.75 to 1.85ml) and or 0.03ml on the vaccine dosage (ie 0.27ml to 0.33ml)

https://www.fda.gov/media/144413/download

[JanMichael]

24. Thank you. I didn't understand either. nt

[Dem2]

48. Seen this story several times in the past couple days

Each time I think that same thought "what the fuck does that even mean?"

[WhiskeyGrinder]

2. There's often some extra in a vial like this to account for loss. Much more fun to FREAK THE FUCK

OUT, though.

[FSogol]

6. +1 n/t

[Peacetrain]

8. +1000

[USALiberal]

20. who is freaking out???? nt

[Disaffected]

11. If so, why not simply

combine the leftovers into more doses? Is there some reason more than 5 withdrawals can't be made from a single vial?

Tossing as much as 17% of your vaccine allotment seems unnecessarily wasteful.

[LisaL]

29. Possible contamination.

You do not want to be combining multiple vials.

[Disaffected]

35. Not if it's done properly.

Eg. limit the collection to a few vials only per batch. Or, move continually from one vial to the next (while drawing all the contents from each vial; there then is only one double needle entry per vial). I realize the possibility of contamination is greater than not combining residual doses but, since there is and will be a vaccine shortfall and the need is so high, non-wastage may be warranted until supplies improve.

[LisaL]

39. Once they diluted the vaccine they are not adding anything else to the vial.

Do you want to get a nasty infection with your vaccine shot? I don't. If the company is pressured to cut corners there is not going to be a short fall because people will refuse to take it.

[Disaffected]

40. I don't follow.

They are not adding anything else besides sticking a needle in vial #1 (to draw the remainder) and immediately, I would think, sticking the same needle in the next vial (to top off the dosage).

As I mentioned before, the risk of contamination would be greater than the normal method but the increased risk might well be justified in the initial stages of the program due to limited supplies. As well, current procedure is to stick the vial with five separate needles so the incremental stick would seem pretty unlikely to cause a contamination problem.

In any case, I note from other posts that Pfizer has apparently applied to draw a sixth dose from a vial so it may be a moot question.

[LisaL]

42. It is a moot point, but combining multiple vials is a horrible idea because of contamination issues.

This practice would not be allowed.

[Disaffected]

44. I'll leave at this point

simply by pointing out that argument by assertion is not usually very convincing.

[LisaL]

47. Is FDA saying don't combine multiple vials convincing enough?

“At this time, given the public health emergency, FDA is advising that it is acceptable to use every full dose obtainable (the sixth, or possibly even a seventh) from each vial, pending resolution of the issue. However, since the vials are preservative-free, it is critical to note that any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one.”

https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-12-16-20/h_5921a8cd0146649db84e3b631374984c

[Sympthsical]

12. And this is why random Twitter people shouldn't be used as news

The extra is normal. This Twitter person doesn’t know this. But let’s get a frothy panic going.

Social media are making us dumber as a people. Twitter. Is. Not. News.

[Nevilledog]

13. You think a health care official from the Obama administration is a "random" person?

[Klaralven]

14. Administrator type, started at Goldman Sachs as a banker, started a healthcare company.

https://en.wikipedia.org/wiki/Andy_Slavitt

[Sympthsical]

15. And he's deeply wrong

My partner is a head honcho in the pharmacy division of a major health group. I told him about this and he said, and I quote, “That guy is a fucking moron.”

[Nevilledog]

16. You're entitled to your opinion.

[Sympthsical]

18. My partner's life for the past two months has been preparing vaccine distribution

For millions of people.

I’m going to trust his opinion, because it’s not his opinion. It is a fact.

We’re not entitled to our own facts.

[Nevilledog]

19. Random

[Sympthsical]

22. Your post is irresponsible and should be deleted

I’ll stick with science. My information is coming from a highly trained pharmacist with 25 year experience who is responsible for vaccine distribution in a major metropolitan area.

You’re quoting a business administrator with no medical training.

Do as you will. But I’m going to speak up for truth and science here, especially when I have an impeccable source literally five feet away from me.

[Disaffected]

38. So, why then is the source cited in the OP

"deeply wrong". Not saying he isn't, just wondering why...

[Nevilledog]

46. ....

Link to tweet

[DeminPennswoods]

21. Skepticism should abound

when it comes to Slavitt.

[Sympthsical]

17. He literally has it wrong

There is extra in every vial to ensure the fifth shot is just as good as the first. This is standard for all vaccines that come in multi-dose vials (not all do. Depends on the formulations).

He is spreading alarm where none is warranted. We need people to trust this process, to trust the science.

This alarmism is deeply irresponsible. I don’t care who the guy is. He spoke out of ignorance. Problem is, ignorance can spread, as it is here.

[ProfessorGAC]

25. I'm With You On This

I was on betaseron for many years.
The prefilled syringe had nearly 1ml of saline that was pushed into the attached vial.
When the vial was snapped off, the needle became the flow path.
When one drew the 0.8ml into the syringe before vial removal there was ALWAYS liquid left in the vial.
This virtually guaranteed that one would get the required 0.8ml injection, even after assuring no air bubbles.
I'm guessing the loss anticipated in purging air from the needle is part of the design.
I seriously doubt that there are lost doses involved here.

[Sympthsical]

26. Apparently Pfizer is being pressured to apply for a sixth dose

I'm literally listening to a Zoom call my partner is having with his co-workers as I post this, and none of them seem happy about it at all. They think this is political pressure intruding on medical thoroughness and caution. These are some seriously grumpy people. They're worried about that sixth shot.

Kind of a funny story related to this. I just glanced over at the spreadsheets a bit ago, and the Astrazeneca efficacy has this very strange hiccup. In many cases, they accidentally gave people less of the vaccine than intended. Those people ended up with 90% efficacy. In people who received the full two doses, it was a mere 62% efficacy. That's where the final 70% number comes from.

They're still trying to figure that one out. Is there a problem in the methodology? Is the lower dose actually better? Who knows at this point. But we won't be seeing that one on the market for a bit. Not until they sort that one out.

[ProfessorGAC]

32. I Saw That

I'm not pleased with this because I think the risk of under dosing some of those "sixth patients" far outweighs the 20% maximum short term supply gain.

[Sympthsical]

33. That's the concern being expressed

I have to say, because we are both working from home during Covid, I've been privy to a lot of the conference calls and Zoom meetings of a lot of high level pharmacy people in a major hospital system for the past few months. It's fascinating to hear their thoughts on all matters vaccine-related.

It's also nice, because I don't get my information filtered down through journalists who may not entirely understand what they're talking about. Just today, I wanted to see something about one of the vaccines. I just reached over and glanced through one of the billion spreadsheets that's open on the computer next to me. A lot of unfiltered scientific information. So much more assuring.

[Klaralven]

41. Next thing will be the pharmacists doing the diluting will add a tad more diluent to ensure 6 shots.

It must also screw up the accounting. Previously you had 5 dose vials packed 195 to the tray, 5 trays to the carton. That's 4875 doses per carton and all the shipping schedules are worked up with that number. Now you have 5850 doses per carton, and new shipping schedules.

[ProfessorGAC]

43. The Logistics Are Hard Enough

Changing the plan this early into execution could be a major problem.

[herding cats]

28. I don't see how this spreads alarm.

The extra is in case of overdrawing in the previous vaccines. It's to ensure the last one is as much as is required. It's good practice and sound science to do such.

In this case, where we're in a pandemic and there's an issue meeting demand for the vaccine, it would make sense to use the extra after the 4 doses were administered I would think.

[Sympthsical]

30. It doesn't work that way

For a variety of reasons. You can just go rummaging around for scraps of vaccine to make up a full dose.

But the pressure seems to be working.

This isn't good science. I'm already listening to pharmacists bitching among themselves about it.

[Nevilledog]

45. ...

Link to tweet

?s=21

[Agschmid]

34. +1

[herding cats]

23. Waste not want not during a pandemic.

Link to tweet

BREAKING: Pfizer now to submit new paperwork to allow the 6th vaccine to be used!!

The world is already 20% better.

Thanks to all...

[LisaL]

27. Well, Mr. Slavitt should be the one getting that sixth shot.

None for me, thank you very much. There is not going to be enough left to allow for a full dose as far as I can tell.

[herding cats]

31. He didn't discover this.

It was something being mentioned in the medical community. The VA uses the extras from doses, and it was something some medical professionals wondered if could be done here as well. As it turned out it couldn't without authorization.

[Nevilledog]

37. I didn't see you had already posted this. TY!

[LisaL]

49. FDA approved getting six, or possibly even seven doses.

They are instructed to make enough for six doses (and use five). But how could there be seven doses?
https://www.cnn.com/world/live-news/coronavirus-pandemic-vaccine-updates-12-16-20/h_5921a8cd0146649db84e3b631374984c