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Post by Ton ⓉⓞⓃ on Nov 16, 2020 20:46:37 GMT
Am I right in thinkng that 95% effective is twice as good as 90% (as in you are half as likely to contract the virus)? Not of contracting the virus, but of developing symptoms. But yes, 90% means that if e.g. 100 people show Covid-19 symptoms in the placebo group then 10 will do in the vaccine group, while with 95% effectiveness that would be 5, which is technically half. Then again these are interim results, I wouldn't pay too much attention to small differences in the percentages.
My bold. I understand with another phase 3 trial a new drug is not being given to elderly to start with unless it's appears safe with the first 1000 younger participants, so you can guarantee real world figures will be different from trail results.
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ilmoro
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'Wondering which of the bu***rs to blame, and watching for pigs on the wing.' - Pink Floyd
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Post by ilmoro on Nov 18, 2020 11:22:27 GMT
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Post by bracknellboy on Nov 18, 2020 12:01:04 GMT
Brilliant, just brilliant.
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cb25
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Post by cb25 on Nov 18, 2020 12:45:19 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose"
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agent69
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Post by agent69 on Nov 18, 2020 12:53:03 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose" Equally effective for over 65's
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benaj
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Post by benaj on Nov 18, 2020 13:29:10 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose" I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical?
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Greenwood2
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Post by Greenwood2 on Nov 18, 2020 13:36:11 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose" I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical? So give everyone the real thing and if one or more of them dies due to bad reactions... But I would want the real thing. Or give them all the real thing and expose them to the virus, shortens the trials enormously but with greater risk, but may save huge numbers of lives if the drugs reach the market a few weeks or months earlier. Ethics is tricky.
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registerme
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Post by registerme on Nov 18, 2020 13:46:20 GMT
I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical? So give everyone the real thing and if one or more of them dies due to bad reactions... But I would want the real thing. Or give them all the real thing and expose them to the virus, shortens the trials enormously but with greater risk, but may save huge numbers of lives if the drugs reach the market a few weeks or months earlier. Ethics is tricky. I'm no expert but I believe that there are protocols in place such that, just with halting a trial if something goes wrong, if things go much better in the non-control group than expected the trial is similarly halted with a view to giving whatever the treatment is to the control group.
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mrk
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Post by mrk on Nov 18, 2020 13:47:42 GMT
I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical? So give everyone the real thing and if one or more of them dies due to bad reactions... But I would want the real thing. Or give them all the real thing and expose them to the virus, shortens the trials enormously but with greater risk, but may save huge numbers of lives if the drugs reach the market a few weeks or months earlier. Ethics is tricky. It's just very difficult to measure effectiveness without a control group (i.e. giving half the participants the placebo).
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Post by dan1 on Nov 18, 2020 13:48:36 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose" I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical? Provided the participants are fully informed and capable of understanding of the information they're provided then I don't see ethics being an issue. Those involved shouldn't do anything differently than if they hadn't been involved - half get placebo and the other half get a vaccine that may not even work. Ethics does play a part in emergency use authorisation because it's considered ethical to offer the vaccine to those participants who received the placebo. The problem is that you immediately cut short the long term data that would have been gained if EUA hadn't been granted.
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Post by dan1 on Nov 18, 2020 13:54:21 GMT
A study on the longer term immune response hasn't received the same publicity as the vaccine efficacies but may be just as important IMO. Immune response was measurable for 90% of participants at >= 5 months.... They say good news always come in threes
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Post by bracknellboy on Nov 18, 2020 14:07:35 GMT
Pfizer/BioNTech press release "Pfizer and BioNTech Conclude Phase 3 Study of COVID-19 Vaccine Candidate, Meeting All Primary Efficacy Endpoints ... Primary efficacy analysis demonstrates BNT162b2 to be 95% effective against COVID-19 beginning 28 days after the first dose" I wonder how many of those received the dummy jabs are over 65 and confirmed positive with COVID. If one of them dies due to not receiving the real dose and infected by COVID, is this kind of trial even ethical? Of course it's ethical. If you don't do the trials, you don't know what the outcomes are which means you don't have a basis to decide it should be given to everyone. Blind trials are pretty much the gold standard for measuring efficacy, which is why there are done. There comes a time with trials like this where at the time you do the unblinding, the results are so significant that it does become unethical to continue as is with a placebos group You then have an option - if you are continuing the trial - of giving to all and then comparing to the general population. But that is more tricky, arguably esp so with a disease like this. The behaviours of your volunteers may be considerably different from the general population, and comparison with the general population is a very geographic sensitive measure (given the huge geo differences in population infection rates).
What is more likely I would suggest is that the evidence of efficacy becomes so overwhelming that you simply stop mass trial and turn to deployment.
The situation here is also ethically different from a trial of a drug to treat patients who already have a known medical condition. In that case, you might decide to unblind earlier*, and switch to all having the treatment. That is because your test group already have "the disease"; you have a greater ethical reason to give the treatment to all; and you have a more solid basis for a comparison baseline based on historic outcomes for that condition without the treatment. *You would no doubt face this dilemma when it became clear that the results from your total blinded sample implied siginificantly better outcomes than would be the case outside of the trial.
In this case, the whole population can benefit from the outcome if it is an effective drug: QED those that were in the placebo group are at no disadvantage compared to everyone else in the general population who are not receiving. There is therefore no ethical objection to not having given it to those in the placebo group, or arguably continuing to do so until such time as its able to made available to the general population: at which point it would patently unethical to continue giving some a placebo.
At this point, if trials do continue (as opposed to simply ongoing analysis of data for the existing participants), then you would expect they would need to shift so that all in the trial receive it.
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r00lish67
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Post by r00lish67 on Nov 18, 2020 15:27:02 GMT
Whilst we're in Vaccine basic ed...how are the risks of issues that might arise years down the line after taking a particular new drug addressed by the trials? Or Is that just a risk we have to take? This vaccines page says " Every licensed and recommended vaccine goes through years of safety testing..", which, err, isn't very reassuring in this case. edit: Obviously the rollout would be monitored, but it sounds like they're planning to go great guns to roll these bad boys out as fast as possible..
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mrk
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Post by mrk on Nov 18, 2020 15:55:02 GMT
Whilst we're in Vaccine basic ed...how are the risks of issues that might arise years down the line after taking a particular new drug addressed by the trials? Or Is that just a risk we have to take? This vaccines page says " Every licensed and recommended vaccine goes through years of safety testing..", which, err, isn't very reassuring in this case. edit: Obviously the rollout would be monitored, but it sounds like they're planning to go great guns to roll these bad boys out as fast as possible.. Well, until somebody invents a time travelling machine the only way to know for sure if there are any issues years down the line is obviously to wait a few years. So in that sense it's a risk that we have to take, given that the alternative risk is catching a virus whose long term effects are also unknown. (E.g. One in five COVID-19 patients develop mental illness within 90 days - study.) That said, it usually take years to develop a vaccine because normally the various steps are done sequentially, for financial reasons. You don't want to spend money starting further tests before you know the results of earlier tests. With this pandemic the incentives are so big that many steps are being done in parallel. But they're not being skipped.
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registerme
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Post by registerme on Nov 18, 2020 18:23:14 GMT
With this pandemic the incentives are so big that many steps are being done in parallel. But they're not being skipped. Not just that, the various main regulators like the FDA and the EMA are actively working with the various drug development programmes to expedite processes. So what was once, passive, serial, and stop start, in terms of long drawn out development / test stages / review / approval processes has become as parallelised as possible, and incredibly streamlined compared with what used to be normal practise.
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