covid-19

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Originally Posted by RandBlade

Indeed. Though I'm assuming Reuters quoting their head of non-oncology research and development is a legitimate source.

Just remarkable to think a few weeks ago a 62% success rate would have been considered quite good for an initial vaccine, I believe it's better than the flu vaccine typically gets, but after the Pfizer study it would have seemed disappointing. But potentially if this article is right thanks to a "serendipitous" error it's now seemingly become 90%.

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It's not the legitimacy of the source I'm concerned about; we can't draw any firm or even somewhat mushy conclusions about what to expect from the real rollout wrt efficacy and safety, and we can't even form an opinion about what prominent gaps in knowledge might remain. Eg. did the two treatment arms differ from one another wrt subjects dropping out between doses? Who and where were the subjects? How did the subjects behave during the study wrt physical distancing? And so on. You can compare this to the situation with all the heavily promoted serological tests back in spring, where every single test seemed incredibly good, but, as soon as you examined the validation studies, they looked considerably less incredible to anyone interested in using them in the real world.

I'm cautiously optimistic that this and the other vaccine candidates will prove to be effective and safe, but I'm going to be completely agnostic wrt how effective and how safe until we can all see the detailed results :up: and I'd like to see whether the people behind the Oxford vaccine address previously (and recently) raised concerns about vaccines using an adenovirus vector—concerns that will be especially important to address if, as seems likely right now, that particular vaccine ends up being deployed on a massive scale in parts of the world where HIV is endemic.

Oh absolutely I agree that the devil will be in the details and I am sure bodies such as the MHRA here in the UK, the FDA in the USA, the EMA in the EU etc will know what to look for. I am cautiously optimistic but if the MHRA authorises the vaccine then I will be happy with that - that the scientists here are confident to report they are submitting it for approval to the MHRA is a good sign.

But yes its entirely possible the MHRA or the FDA/EMA etc will find some wrinkle.

Its worth noting that the safety data has been undergoing a rolling review from the MHRA already so while more data will no doubt need to be submitted its not starting from nothing.

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Originally Posted by wiggin

I can't stress enough how important it is to know details of the studies rather than press releases. Without confidence intervals and a lot of other information we cannot draw conclusions about relative efficacy. For now, let's be contented with what appears to be more good news and not stretch our analysis further.

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This.

Also I am curious if in this kind of study they usually include only healthy people or also people with comorbidities - e.g. being overweight can greatly influence your immune system and therefore presumably vaccine efficacy as well. So yes, it's good news, but I don't know how these "90%" press releases will compare to the real world.

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Originally Posted by Flixy

This.

Also I am curious if in this kind of study they usually include only healthy people or also people with comorbidities - e.g. being overweight can greatly influence your immune system and therefore presumably vaccine efficacy as well. So yes, it's good news, but I don't know how these "90%" press releases will compare to the real world.

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In these phase 3 trials, participants must be medically stable, younger than the oldest person to ever live, not pregnant, and not suffering from any severe underlying conditions or show any particularly worrying findings on exams & tests. No previous diagnosis of covid and no previous covid candidate vaccine treatment. Specific types of immune system disorders are usually grounds for exclusion. Overweight people are not excluded purely on the basis of being overweight; if they were, there wouldn't be enough subjects. People whose weight is so great that it's currently a severe and immediate medical problem might be excluded, but that level of detailed info about who have been excluded is not available r n afaict. They'll give a detailed account when they publish.

Due to extremely unsettling reports about ethically, er, fucked up treatment of frail, institutionalized elderly, Sweden's Health and Social Care Inspectorate launched a thorough review of all cases of probable covid-associated death in that group over the course of a couple of months in Spring. We all expected sharp criticism, but what they've concluded is absolutely devastating, irrespective of whether you focus on the purely ethical or the purely clinical aspects.

The headline findings are that decisions about transitioning to end-of-life care instead of considering even basic supportive treatment were, in most cases, taken in a manner that is not compatible with our ethical and legal obligations; only a small minority of decisions were taken on the basis of a current, individualized medical assessment—let alone a physical exam by a physician—and with the support of either patients or their relatives. To the extent that there was an individualized assessment of any sort, the documentation of that assessment was extremely deficient—or impossible to find—in most cases.

Just a couple of weeks ago, the director of one regional healthcare authority confidently dismissed such concerns, based on a cursory look at some "quality assurance system". My dad works at that hospital, and has been pushing for recognition of this problem for a long time, only to be dismissed as being a naive, alarmist immigrant. Alarmist or not, at this point, I think it's not out of bounds to start thinking of this as systematic gerontocide.

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Originally Posted by Aimless

In these phase 3 trials, participants must be medically stable, younger than the oldest person to ever live, not pregnant, and not suffering from any severe underlying conditions or show any particularly worrying findings on exams & tests. No previous diagnosis of covid and no previous covid candidate vaccine treatment. Specific types of immune system disorders are usually grounds for exclusion. Overweight people are not excluded purely on the basis of being overweight; if they were, there wouldn't be enough subjects. People whose weight is so great that it's currently a severe and immediate medical problem might be excluded, but that level of detailed info about who have been excluded is not available r n afaict. They'll give a detailed account when they publish.

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Thanks. I only have experience with clinical tests for heart valves, where it was a problem that almost all patients had comorbidities (comes with the territory of congenital heart disease I suppose), and for obvious reasons it's not ethical to implant those on healthy people.

And I've seen ads for drug tests, which generally specify things like non-smoking, and other health related requirements, which always makes me suspect performance in real life will be less good than during trials.

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Originally Posted by Flixy

Thanks. I only have experience with clinical tests for heart valves, where it was a problem that almost all patients had comorbidities (comes with the territory of congenital heart disease I suppose), and for obvious reasons it's not ethical to implant those on healthy people.

And I've seen ads for drug tests, which generally specify things like non-smoking, and other health related requirements, which always makes me suspect performance in real life will be less good than during trials.

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Designing clinical studies from the perspective of exclusion criteria is a real art. On the one hand, you want your data to be as widely applicable as possible (and you want to have the widest label with fewest contraindications as possible). On the other hand, having too messy of a cohort will add lots of confounding variables that will muddle your story and potentially obscure real, good results. In theory you can expand indications later, as well as rely on clinical case reports of off-label use to leverage more broad usage of your technology. Also, if your patients have lots of comorbidities your adverse events will be higher and you'll need to do more fancy footwork with regulators to justify that the patients was going to have the problem whether or not they got your therapy.

Of course, if your criteria are too restrictive (or you have an awful control arm) it might take forever to enroll your study. So it's a real balancing act.

This is very, very hard.

The Oxford/AZN team's communications are an absolute mess. Several red flags. They need to come clean and be much more transparent about what happened—and why—so that their work can be scrutinized properly.

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Originally Posted by Aimless

The Oxford/AZN team's communications are an absolute mess. Several red flags. They need to come clean and be much more transparent about what happened—and why—so that their work can be scrutinized properly.

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Yep it does seem a bit ad hoc / haphazard.

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Originally Posted by Aimless

The Oxford/AZN team's communications are an absolute mess. Several red flags. They need to come clean and be much more transparent about what happened—and why—so that their work can be scrutinized properly.

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The full report of what happened will have to be made public before they can submit their MHRA submission won't it?

The MHRA won't be giving approval based upon a press release alone.

As a happy side effect; covid-19 made a populist party implode upon itself over the last couple of days. I wish you guys could read dutch because some of it is almost too good to be true. It seems the straw that broke the camel's back was a table thumbing conclusion to the description of the leader (Thierry Baudet) of how he'd gotten tears in his eyes seeing a caged lion. "And that is exactly what I feel like". From there on it only went down hill. We've had covid-19 being a plan to re-populate Europe (by Soros of course) , a rant about how fighting Islam was useless as 'these niggers will be kicked out anyway by the new rulers of Europe', and then the statement that he didn't understand why he should bother about anti-semites in the party, because 'everybody I know is an anti-semite anyway'. This man of the people, who showed his anti-elities credentials by hauling a full sized grand piano into his parliament office is tearing down the house.

It's 3 big buckets of popcorn entertainment.

Ah, i missed the covid related bits in that saga. But the self destruction has been amusing to watch. And if I'm not mistaken, it can lead directly to them losing a seat in parliament to a competitor right? :D

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Originally Posted by Hazir

As a happy side effect; covid-19 made a populist party implode upon itself over the last couple of days. I wish you guys could read dutch because some of it is almost too good to be true. It seems the straw that broke the camel's back was a table thumbing conclusion to the description of the leader (Thierry Baudet) of how he'd gotten tears in his eyes seeing a caged lion. "And that is exactly what I feel like". From there on it only went down hill. We've had covid-19 being a plan to re-populate Europe (by Soros of course) , a rant about how fighting Islam was useless as 'these niggers will be kicked out anyway by the new rulers of Europe', and then the statement that he didn't understand why he should bother about anti-semites in the party, because 'everybody I know is an anti-semite anyway'. This man of the people, who showed his anti-elities credentials by hauling a full sized grand piano into his parliament office is tearing down the house.

It's 3 big buckets of popcorn entertainment.

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Oh yeah, I'm enjoying the show alright. It's almost as if Baudet was envious about all the attention Trump was getting for his fuckups and went: I also want attention for my fuckups!

Wish granted.

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Originally Posted by Flixy

Ah, i missed the covid related bits in that saga. But the self destruction has been amusing to watch. And if I'm not mistaken, it can lead directly to them losing a seat in parliament to a competitor right? :D

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Yep, unless Otten refuses to take the vacated seat he'll be sworn in. It's a difficult choice for him I guess. It would mean a switch from the senate to the chamber which of course is a step up, but that's only till the elections march next year, in which he'll be running for the (new) Future Party afaik

Baudet believes covid-19 is part of a plan by the Jewish investor Soros to decimate the population of Europe in order to more effectively rule over them. It's all very X-files and I don't exactly understand the dynamics of the plan.

* maybe I should have posted this in the Zionuts thread.
* full disclosure; I call Baudet 'the MP for the Kremlin"

COVID vaccine could be approved tomorrow in the UK.

Health Editor of the Economist with a teaser Tweet.

Twitter Link

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YES! :D Just what was needed! :D

To quote the great Murray Walker: "Go! Go! Go!"

Aimless still hearing mixed reports from Sweden. Some people here still claiming that we should be more like Sweden and that Sweden is coping with the second wave better than the rest of [non-Scandinavian] western Europe like the UK, France, Italy, Spain etc - others saying that Sweden is struggling and turning away from their old scientific advice. The problem here is that the name Sweden has almost become code for what people want to be right that its hard to see truly neutral reports, most people mentioning Sweden here have an agenda.

From your position at the coalface are you noticing major changes?

Also much of the Swedish logic seemed to be that this was a virus that needed to be lived with for years and potentially no vaccine could arrive for years. Does the arrival of a vaccine change the arithmetic?

For me people catching the virus and dying from it now, with a vaccine imminently available, is like those who went over the top in November 1918. If there is a vaccine imminently available that's all the more reason to be ultra cautious until the vulnerable at least are vaccinated.

We're not exactly nearing the end of this mess, RB. In the rich world we might start to have decent coverage by summer, especially if JNJ's effort works. Even that is optimistic. It's going to be years before we get much of the world vaccinated, and we may need boosters. We are not near the end; at best, it's halftime.

I'm more optimistic than you, at least domestically. I believe the Pareto Principle will apply here to our favour.

Since a key element of spread happens in a few locations (eg care homes and hospitals) vaccinations can have an immediate impact just by vaccinating the staff of those sectors. Since the overwhelming majority of all cases of hospitalisations from this virus comes from a relatively small sector of the population then vaccinating them will have an immediate impact too.

We can get 80% of the benefits of vaccinations relatively quickly. The final 20% will be challenging and could take a long time, but we shouldn't need lockdowns etc for that final 20%.

I suspect that by Valentine's Day we should be starting to see a lifting of lockdowns enforcing closures of restaurants etc and by Easter a lifting of most damaging restrictions.

Face masks may be with us for years to come.

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Originally Posted by RandBlade

I'm more optimistic than you, at least domestically. I believe the Pareto Principle will apply here to our favour.

Since a key element of spread happens in a few locations (eg care homes and hospitals) vaccinations can have an immediate impact just by vaccinating the staff of those sectors. Since the overwhelming majority of all cases of hospitalisations from this virus comes from a relatively small sector of the population then vaccinating them will have an immediate impact too.

We can get 80% of the benefits of vaccinations relatively quickly. The final 20% will be challenging and could take a long time, but we shouldn't need lockdowns etc for that final 20%.

I suspect that by Valentine's Day we should be starting to see a lifting of lockdowns enforcing closures of restaurants etc and by Easter a lifting of most damaging restrictions.

Face masks may be with us for years to come.

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You may be right, but there are so many things we don't know yet - how good will the vaccine protect the most vulnerable patients? Do we need herd immunity to really protect them? How efficiently and quickly can we roll out vaccination, especially with all of the transport and timing logistical issues with the first round of likely approvals? How long will immunity last? How quickly can scarce production be ramped up?

You're right that to get some resumption of normal activity we probably don't need 90+% vaccination. I wouldn't be shocked, however, that we might need 60+%. And getting to there is going to take a hell of a lot longer than Valentine's. Whether that will be reflected in public health policy is another question entirely given the political pressures involved.

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Originally Posted by RandBlade

I'm more optimistic than you, at least domestically. I believe the Pareto Principle will apply here to our favour.

Since a key element of spread happens in a few locations (eg care homes and hospitals) vaccinations can have an immediate impact just by vaccinating the staff of those sectors. Since the overwhelming majority of all cases of hospitalisations from this virus comes from a relatively small sector of the population then vaccinating them will have an immediate impact too.

We can get 80% of the benefits of vaccinations relatively quickly. The final 20% will be challenging and could take a long time, but we shouldn't need lockdowns etc for that final 20%.

I suspect that by Valentine's Day we should be starting to see a lifting of lockdowns enforcing closures of restaurants etc and by Easter a lifting of most damaging restrictions.

Face masks may be with us for years to come.

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I doubt we'll hit a vaccination rate of more than 20-30% by Valentine's Day. Do you think people in your age group will act like everything is fine at that point? Yes, the death rate will go down dramatically by then. But the number of cases? Probably not. Which means the likelihood of catching it won't decrease much either. I'm hoping things will be mostly back to normal by the summer, and even that's not a guarantee.

Here in the US, Atlas resigned. Small steps. Get the incompetents out.

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Originally Posted by Loki

I doubt we'll hit a vaccination rate of more than 20-30% by Valentine's Day. Do you think people in your age group will act like everything is fine at that point? Yes, the death rate will go down dramatically by then. But the number of cases? Probably not. Which means the likelihood of catching it won't decrease much either. I'm hoping things will be mostly back to normal by the summer, and even that's not a guarantee.

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20% of the US population is about 65 million people, or 130 million doses. You'd need to have deployed 65 million doses in the US by mid January to have the follow-up injections happen by Valentine's. Between the three vaccines that have released results, we expect maybe 65 million doses worldwide by end of December for the two that are likely to get US regulatory approval (scuttlebutt I'm hearing is that the FDA may wait for more clarification on the data in the Astrazeneca trial, though that's unclear). AZN will have another ~200 million doses.

So we have enough to vaccinate maybe 130 million people worldwide by the end of the year, spread out over a billion or so rich people (and that's not even counting India and China that each have money and leverage to get a chunk of that). Even with tens of millions of more doses coming out in January (maybe 100 million!), we still won't have enough distributed in time for 20% coverage in the rich world.

I expect that production is ramping up very quickly, and certainly I would expect to see hundreds of millions of doses each month; theoretical dose production capacity for the three sets of vaccines with trial data is around 5 billion for 2021, though much of that will likely be back-loaded in the year. With the addition of potential vaccines from JNJ, Novavax, and Sanofi (of which at least JNJ only requires 1 dose, making it more than doubly effective on a manufacturing basis), we could even have upwards of 8 billion doses by end 2021. That's a hell of a lot of doses and I suspect we'd have good vaccination coverage in the rich world by summer or fall, with a concomitant improvement in infection numbers, deaths, and an opening of the economy. But I would be very surprised if vaccines coming out now will make a substantial dent in this year's Covid season until it's already largely petering out.

In 2022/2023 we'll likely see broader distribution of vaccines to the general populace of poor countries as well as potential re-vaccination campaigns in the rich world if we see waning immunity. By then I wouldn't be surprised if we could see sustained production of 500+ million doses every month, if not more.

The vaccine has been officially approved. Well done to Pfizer and BioNTech for developing the vaccine and both of them and the MHRA for the successful rolling review. Rollout begins next week.

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Originally Posted by Loki

I doubt we'll hit a vaccination rate of more than 20-30% by Valentine's Day. Do you think people in your age group will act like everything is fine at that point? Yes, the death rate will go down dramatically by then. But the number of cases? Probably not. Which means the likelihood of catching it won't decrease much either. I'm hoping things will be mostly back to normal by the summer, and even that's not a guarantee.

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To be clear I'm not suggesting a return to normal by Valentine's. I said an end to restaurant closures. Currently in the UK we have a Tier system and my city is in Tier 3 (the worst tier) which means all hospitality is closed except for takeaways. Tier 3 is for if the NHS might collapse in that area without the Tier.

Tier 2 is restaurants etc can be open but only one household per table. No household mixing indoors.

Tier 1 is relatively normal with social distancing and the "rule of 6".

Currently nearly a quarter of England is Tier 3, 1% Tier 1 and three quarters Tier 2. I am hopeful the vaccine rollout in the next two months hitting priority areas first could take the edge off the virus enough to end the need for Tier 3.

You're right that for the young the virus will continue to spread but R will go down with partial herd immunity and for the young this is comparable to the flu, it is the risk of spreading it to the old that is the worry. Once the old are vaccinated then case numbers become less relevant.

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Originally Posted by RandBlade

The vaccine has been officially approved. Well done to Pfizer and BioNTech for developing the vaccine and both of them and the MHRA for the successful rolling review. Rollout begins next week.

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First western country to officially and formally approve rollout of a Covid 19 vaccine. First jabs for the most vulnerable and the front-line start next week. :up:

I was surprised - thought other countries would be pushing sooner than the UK.

The MHRA has a lot of expertise and has been undergoing rolling reviews throughout the process.

Without wanting to spark a political debate, a small but noticeable bonus from having left the EU.

MHRA doing a press conference where they're making it clear that they've cut no corners, been working in parallel and seven days to get this done ASAP. Well done them, and well done Pfizer and BioNTech for getting everything cleared.

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I bet it won't take long for "lockdown skeptics" to magically morph into antivaxxers now.

Florida joined texas today with 1 million recorded infections :rolleyes:

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Originally Posted by RandBlade

The MHRA has a lot of expertise and has been undergoing rolling reviews throughout the process.

Without wanting to spark a political debate, a small but noticeable bonus from having left the EU.

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For once on Brexit, I may be inclined to agree with you.

It seems that lunatics on all sides are happy to be lunatics on other issues. Expected it but depressing - Toby Young and Carole Codswallop both coming out with antivax bullshit today.

After this year if we never heard of either of these morons again it would be too soon.