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Thread: covid-19

  1. #2041
    Quote Originally Posted by RandBlade View Post
    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%.
    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 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.
    “Humanity's greatest advances are not in its discoveries, but in how those discoveries are applied to reduce inequity.”
    — Bill Gates

  2. #2042
    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.
    Quote Originally Posted by Ominous Gamer View Post
    ℬeing upset is understandable, but be upset at yourself for poor planning, not at the world by acting like a spoiled bitch during an interview.

  3. #2043
    Senior Member Flixy's Avatar
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    Quote Originally Posted by wiggin View Post
    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.
    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.
    Keep on keepin' the beat alive!

  4. #2044
    Quote Originally Posted by Flixy View Post
    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.
    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.
    “Humanity's greatest advances are not in its discoveries, but in how those discoveries are applied to reduce inequity.”
    — Bill Gates

  5. #2045
    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.
    “Humanity's greatest advances are not in its discoveries, but in how those discoveries are applied to reduce inequity.”
    — Bill Gates

  6. #2046
    Senior Member Flixy's Avatar
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    Quote Originally Posted by Aimless View Post
    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.
    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.
    Keep on keepin' the beat alive!

  7. #2047
    Quote Originally Posted by Flixy View Post
    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.
    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.
    "When I meet God, I am going to ask him two questions: Why relativity? And why turbulence? I really believe he will have an answer for the first." - Werner Heisenberg (maybe)

  8. #2048
    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.
    “Humanity's greatest advances are not in its discoveries, but in how those discoveries are applied to reduce inequity.”
    — Bill Gates

  9. #2049
    Quote Originally Posted by Aimless View Post
    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.
    Yep it does seem a bit ad hoc / haphazard.
    Quote Originally Posted by Steely Glint View Post
    It's actually the original French billion, which is bi-million, which is a million to the power of 2. We adopted the word, and then they changed it, presumably as revenge for Crecy and Agincourt, and then the treasonous Americans adopted the new French usage and spread it all over the world. And now we have to use it.

    And that's Why I'm Voting Leave.

  10. #2050
    Quote Originally Posted by Aimless View Post
    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.
    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.
    Quote Originally Posted by Ominous Gamer View Post
    ℬeing upset is understandable, but be upset at yourself for poor planning, not at the world by acting like a spoiled bitch during an interview.

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