vanillabean

Would you happen to have a link handy?

nacho

I saw that on a page called "Your Danish Life" on FB yesterday: Today the page has an update: There shouldn't be anything tomorrow - maybe next week.

GUWonder

Denmark wants to go in for enforced quarantine on air passenger arrivals and some other things.

Regional commuters of sort will have an exemption to the quarantine on arrival.

CPH-Flyer

It is not just the label, it is the usage instructions (specifics on syringes) , so yes I am pretty sure that this is going via EMA before Pfizer changes the count.

GUWonder

Changing the number of doses included in a package type is an adjustment to usage instructions? That sounds off to me.

Without touching them, I looked at the physical labels affixed to the Pfizer vaccine vials and other containers in the US that mention 5 doses. The labels attached to the two kinds of packaging I saw holding those Pfizer-BioNTech COVID-19 Vaccine don't have a mention on the specifics of the syringes to be used to extract the doses from the vials. They do say that USP is not supplied.

When it comes to the labels' usage instructions for storage (pre-dilution storage and post-dilution storage) and for dosage+administration, I would be surprised if the US has a prohibition on the vials' included quantity of doses on the labels being replaced in ways as long as the labeling for the contents is accurate for the vial contents and the label and packaging is representative of the storage, dosage and administration requirements that were agreed to by the government and meet other routine standards. I would be surprised if the US told Pfizer that we only approved their vaccine if "all vials must be limited to 5 doses in each bottle" and that everything else is prohibited until future government approval.

I have put out feelers to contacts in compliance matters for some pharmas in the US and Europe to find out more as this is not an area that usually has any relevance to me, except as an investor at times.

CPH-Flyer

The usage guideline as published by EMA

https://www.ema.europa.eu/documents/...mission_en.pdf

GUWonder

As of the 28th of January, Sweden's reported Covid-19 running death total is 11,521 people
As of the 27th of January, Sweden's reported Covid-19 running death total was 11,425 people

As of the 28th of January:

Norway's reported 557 Covid-19 deaths in total.
Finland's reported 664 Covid-19 deaths in total.
Denmark's reported 2071 Covid-19 deaths in total.

Sweden has lost more people with Covid-19 since around December 14, 2020, than Denmark+Finland+Norway have collectively lost with Covid-19 since December 14, 2019.

And that is for the 6 dose version. The 5 dose version was rescinded by the EMA, or it never existed?

It doesn't prohibit or even advise against the use of standard syringes/needles; it says that to get the sixth dose out it may need a low dead-volume syringe.

Apparently some authorities in Sweden should have considered the divergence that happens between using low dead-volume syringes or using more standard syringes. But I would place responsibility for this issue on the desk of Pfizer and the EMA as well, since they didn't prominently advise against the use of standard syringes and the near certain consequences of using standard syringes.

It's more like less than 6 doses (i.e., 5 doses) in a vial when using some standard syringes but 6 doses when using low dead-volume syringes. If Pfizer pulled this stunt in the US and labeled it as 6 doses without limiting the usage instructions exclusively to low-dose syringe use, I would be first in line to say that Pfizer deserves the litigation coming its way for that. It's probably why Pfizer decided to just label the vials in the US for 5 doses when it did.

nacho

So there is a press conference today after all in Denmark.

GUWonder

Danish young adults who couldn't go skiing in Sweden headed to ski in Austria on pretenses of looking for work in Austrian ski areas. Some of their Swedish buddies went to Austria too under the same kind of pretenses. And apparently they are partying together with British skiers in Austria.

Causing a stir in Austria:

https://www.tt.com/artikel/17776043/...rn-in-st-anton

Denmark's closing to flights from the UAE has had some consequences for people wanting to travel to and from Sweden.

CPH-Flyer

The FDA has approved the 6 doses per vials as well, with the same caveat to use low dead volume syringes and needles. In the US the vials are now counted as six doses as part of the contract fulfiment, even retroactively in some cases.

​​​​​​It is not a matter of Sweden being ripped off, it is a matter of Sweden complaining about a condition that the responsible authorities approved and issued guidance for. I don't see Denmark or Norway complaining....

GUWonder

The EMA initially approved just 5 doses per vial and then was asked in late December to approve it for 6 doses per vials. Even as the liquid volume inside the vials was to remain the same. Italy had already approved 6 doses for the vials even while the EMA approval for those same vials was just for 5 doses at that point.

Given how Sweden handles things around Christmas-New Years' peak vacation period, I can see how the doses per vial situation may have come as a surprise to the involved Swedish authorities. Even if that weren't a contributing factor, it should be quite clear by this point that Sweden's ways during this pandemic are all about "going cheap" and Sweden is stingier than its Scandinavian neighbors when it comes to taking on costs during this pandemic. And so of course it would show up in disputes over invoices/prices per dose.

At one point, I had assumed that maybe I would have a higher chance of getting vaccinated sooner with one of the mRNA Covid-19 vaccines in Sweden than in the US. But at this point I expect it's likely to be the other way around. And that's saying something given the mess that has been going on with the vaccines in the US.

vanillabean

I take it that you out of curiosity may want to take an antibody test before getting vaccinated, as the result might otherwise be positive. Meanwhile around here, it would appear you are vaccinated earlier in "north suburban" San Francisco than in north suburban Chicago, where an elderly Danish-American living in a retirement home told me she had just gotten her first shot with the second coming in a couple of weeks.

GUWonder

I've had the antibody test a few weeks back, and its findings were still such that I probably had not been hit by Covid-19. I've not had symptoms of any sort of communicable infectious disease at all during this pandemic period across the world.

None of the elderly Swedes in my family have been vaccinated yet in Sweden; and the first of them scheduled for a vaccine has it scheduled for next week. And that is for a relative who is closer to 100 than 90 years old. How old does someone need to be in Sweden to get a birthday card from the Swedish king? My guess is that due to the pandemic in Sweden, the Swedish king will be less busy signing birthday cards for ordinary Swedes whom he doesn't know personally than would have otherwise been the case were it not for the pandemic in Sweden.

CPH-Flyer

I am learning a lot about health care operations in Denmark and in Sweden these days.

In Denmark there has been a incessant drive for efficiency, systems, KPIs, measurements, digitisation, etc. over the last many years. The front line staff has been complaining that it has been too much about efficiency and bureaucracy, and not enough about care. But it turned out on this that it has created a system that is very efficient in managing care, and making sure that information in a pandemic is flowing effectively. So not entirely bad after all.

nacho

The Danish government even have measurements like "undervisningseffekt" for schools - and my kid's school scores really low on that, Mr told me what it is then I know why the school scores low. The healthcare system in DK seems more organized compared to Sweden, especially regarding vaccinations. I have no record of when my kids were vaccinated after they were done with BVC and the vaccinations were pushed multiple times (change of staff) at their school and it's impossible to keep track of them because there is no communication whatsoever (certainly no record in their medical journals).

The restrictions in DK is prolonged until the end of February.