covid-19

[RandBlade]

There are two separate concerns here:

1. We have no data on the duration and extent of efficacy between the first and second doses if the second dose is given late. The data is extremely thin in the brief period between the first two doses on a normal schedule (only a handful of events and no ability for long term followup), and nonexistent otherwise. They are using a booster dose for a reason.

2. We have no data on the duration and extent of efficacy of a second dose after an extended delay outside the scope of the original trial. Immunization boosters are not well understood and their timing can be critical depending on e.g. vector design.

So, not only might the people be vulnerable until their second dose is administered, they might be vulnerable after the second dose is administered. They might be fine, too, but we simply don't know. Without data it's speculation.

Indeed it is speculation, but it is well reasoned speculation. Just like emergency authorisation itself - the potential for saving tens of thousands of lives makes it seem worthwhile to try this route during the pandemic.

[wiggin]

There are data and empirical justification for an EUA. There are not for a substantial changes to dosing schedules.

[Khendraja'aro]

Indeed it is speculation, but it is well reasoned speculation.

Well reasoned speculation is still only speculation.

There are countless hypothesis which make a lot of sense. And which are then proven wrong. Especially in the areas of biology and medicine.

[Aimless]

Not entirely true. The data shows that there is negligible protection on the day you get the injection or the days after it, but that is not the case from about day 10 onwards.

[...]

The Pfizer vaccine from day 10 onwards gives close to 90% efficacy with just a single dose, not two doses. From Day 14 to Day 21 is virtually a flat line.

[...]

That chart is one of the most compelling pieces of evidence I have ever seen. My background is economics and business rather than epidemiology and medicine but that is a very clear chart to read.

[...]

the data shows extremely high efficacy from day 10 onwards - you have only got it down to 52% by including days 1-9 in the pool of days 1-21 which is distorting the data.

[...]

It does tell you something. It tells you that efficacy was over 90% for those 10 days.

No, it does not tell you that at all. The image you provided has been cropped, and lacks the most important part of the original image, which shows a very wide confidence interval for estimated efficacy between the first and second dose—roughly 30-70%. Most likely, some of the participants had relatively good protection, while others did not, but you cannot determine the extent to which protection was conferred on the basis of this figure. Moreover, you cannot determine the extent to which the most vulnerable people will be protected after a single dose, on the basis of this figure and this study.

Even without taking differences in baseline risk into account, this is problematic. There has been some simulation-based work done on the issue of single-dose vs. 2-dose regimes in the context of a hypothetical (influenza) pandemic, and it seems likely that the risks and benefits of either approach depends to a great extent on the magnitude and duration of the primary response—which is unknown for the interval that's now being discussed—and the transmissibility of the virus—which is unknown but probably rapidly changing, due to the new lineage. This is without taking rapidly shifting baseline risk into account, and assuming homogeneous transmission. The curently available data on the Pfizer vaccine and on covid do not clearly support the decision to greatly delay the booster dose; it's likely the experts involved have based their recommendation on at least some rudimentary modeling, but it's crucial that they show that work and let it be subjected to critical review by other experts.

Yes it is a gamble. But it is literally a gamble that could and probably will literally save tens of thousands of lives.

Conversely, it might be a gamble that will end up having the opposite effect. The basis for the gamble should be made clear and subjected to critical (external) appraisal.

[Flixy]

One interesting side effect of this pandemic is that suddenly everyone is an expert - from statistics to immunology, I find it amusing how lay people are correcting experts, even in this thread.

For what it's worth, at least I know enough to say that immunology is complex as shit so I will refrain from thinking I can make sound judgement, and leave it to experts. I hope the UK gets lucky with their gamble, but do realize it's not really based on much and that it could affect efficacy after the second shot as well. So, fingers crossed.

[Aimless]

Yes, that is certainly a popular talking point—one that has been weaponized in Sweden, the UK and, indeed, in the Netherlands, with the intent of stifling legitimate criticism of dubious contrarian policies. It has no place in a discussion forum. Nor does it confer any advantage to the broader public debate.

[RandBlade]

Conversely, it might be a gamble that will end up having the opposite effect. The basis for the gamble should be made clear and subjected to critical (external) appraisal.

The JCVI, MHRA and CMOs are independent extermal experts and not politicians. Providing critical appraisal is literally their job.

[Aimless]

The JCVI, MHRA and CMOs are independent extermal experts and not politicians. Providing critical appraisal is literally their job.

I have no idea how you failed to understand from my post that I was speaking of experts outside the group that developed the models and reasoning underlying this decision.

[RandBlade]

I have no idea how you failed to understand from my post that I was speaking of experts outside the group that developed the models and reasoning underlying this decision.

They weren't the ones that came up with the reasoning underlying this decision, it was proposed previously by others including former Prime Minister Tony Blair, for example this was produced 22/12.
https://www.independent.co.uk/voices...-b1777845.html

They are the independent experts who need to make approvals (MHRA) and advice (JCVI) and have independently reviewed the proposal made by others.

[Aimless]

They weren't the ones that came up with the reasoning underlying this decision, it was proposed previously by others including former Prime Minister Tony Blair, for example this was produced 22/12.
https://www.independent.co.uk/voices...-b1777845.html

They are the independent experts who need to make approvals (MHRA) and advice (JCVI) and have independently reviewed the proposal made by others.

Are you telling me Tony Blair develops complex epidemiological models on the side, RB?

[RandBlade]

No.

I am saying others have made proposals and the appropriate, statutory, independent regulatory bodies have done their job.

Are independent regulatory bodies supposed to outsource their work to others?

[Aimless]

No.

I am saying others have made proposals and the appropriate, statutory, independent regulatory bodies have done their job.

Are independent regulatory bodies supposed to outsource their work to others?

Is hugely important scientific work supposed to be conducted unsystematically, by a small group of people, in secret and without scrutiny? Please re-read what I wrote a little more carefully so that you can understand why your response about Tony Blair missed the mark.

[RandBlade]

No. The work has been done by Pfizer and AZN etc and they are scrutinising it and coming up with the best response. They are the scrutiny.

Plus all their reports will I believe be put into the public domain.

[Aimless]

No. The work has been done by Pfizer and AZN etc and they are scrutinising it and coming up with the best response. They are the scrutiny.

That is incorrect. Pfizer has not modeled this public health policy. Moreover, Pfizer has explicitly stated that the evidence does not support the proposed deviation from their protocol. AZN has tested a protocol not too different from this proposal, but they have not produced any applicable epidemiological work. I'm not sure how you managed to get so confused about this, but what's at issue here is the decision to delay the second dose by three months, and it's that decision that must be based on evidence and models that can withstand scrutiny. That is why your comment about Tony Blair missed the mark—Blair has not produced any scientific results that can answer this question. Presumably, the group of experts that have decided to support this decision have developed models that they believe show the tradeoff to be worthwhile. That work needs to be able to withstand scrutiny—now, not when it's too late. Such models are often sensitive to changes in key parameters or reliant on key assumptions. Some of the most likely key parameters are not known, and it's important to see how they've dealt with that limitation—the range of assumptions and scenarios under which the decision to greatly delay the second dose results in a net benefit. What is happening here is the exact opposite of scrutiny. They're making guesses based on eg. the data from the Pfizer trial; those guesses must be seen to be able to withstand critical appraisal by other experts.

[Aimless]

Lol

Twitter Link

[Khendraja'aro]

Oh God. Frankensteining vaccines and making it up as they go along?

Seriously?

[Steely Glint]

the fuck are they doing

[Timbuk2]

Reports of GPs ignoring the Clown Circus and administering the second dose as scheduled to those who'd made second appointments.

What a joke this has quickly become.

[Loki]

At this point, anyone advising the British and Swedish governments about Covid needs to be kept away from hot stovrs let alone life and death decisions.

[RandBlade]

At this point, anyone advising the British and Swedish governments about Covid needs to be kept away from hot stovrs let alone life and death decisions.

Well let us see in 3-4 months, and this time next year.

Currently over a million people have been vaccinated. If by the Spring tens of millions have been and it works then good.

The French are surely handling vaccinations far, far worse yet that doesn't get a look in from you Anglophobe obsessives.

[Aimless]

the fuck are they doing

Unsanctioned human trials.

[BalticSailor]

What the actual fuck.
Even the initial plan (single dose for more people) is a gamble, there's no other way putting it. And it is not "well reasoned" - though, to be fair, it can't be called outright stupid, either, IMO. It's a desperate move, which in best case scenario, provides reasonably good immunity to large parts of population quickly enough to significantly limit the pandemic, and in worst case scenario, renders the whole immunization effort moot. And there is no solid data to suggest with any level of confidence which of these outcomes is more likely.

The "mix and match" lunacy, though, is not too far from "those who are afraid of needles will be allowed to just drink the contents of the vial and hope for the best".

[Flixy]

The Dutch government's stance of 'we may be slow, but we want to make sure we do it right' is starting to look less idiotic.

[Aimless]

The French are surely handling vaccinations far, far worse yet that doesn't get a look in from you Anglophobe obsessives.

Because slowness isn't as interesting to discuss as a govt. sloppily conducting unsanctioned medical experiments on millions of people.

[Loki]

Well let us see in 3-4 months, and this time next year.

Currently over a million people have been vaccinated. If by the Spring tens of millions have been and it works then good.

The French are surely handling vaccinations far, far worse yet that doesn't get a look in from you Anglophobe obsessives.

That's not how science works. And it certainly shouldn't be how science works when tens of thousands of lives are at stake.

[Aimless]

Seeing a number of colleagues and other HCWs across the country saying that we/they should be prioritized over nursing home residents when it comes to initial vaccine rollout. They do not seem to understand that the Pfizer trial data do not permit us to rule out asymptomatic transmission. They do, however, let us assume that we can protect nursing home residents from symptomatic illness by vaccinating them. There's no way in hell all nursing home staff will accept the vaccine, so the risk of getting covid into our nursing homes will remain very high. We can, however, vaccinate almost all nursing home residents, protecting them from symptomatic illness. Disappointing moment in Swedish healthcare.

[Loki]

2020 is the year we found out how people really feel about grandma.

[Aimless]

2020 is the year we found out how people really feel about grandma.

For sure, but I think this might (partly) be chalked down to not knowing what the Pfizer trial actually showed vs. did not show.

[Aimless]

Reports of GPs ignoring the Clown Circus and administering the second dose as scheduled to those who'd made second appointments.

What a joke this has quickly become.

Not surprising. The govt. is asking them to violate core principles of medical & research ethics.

[Ominous Gamer]

Florida just reported 31k+ plus new cases today. The previous record was 17k, which happened earlier this week.
Universal theme park hit capacity 10 minutes after opening.


We are so fucked.