Traub
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Africa probably too. But the hope is the one hit wonders (Johnson and Johnson) will be good enough given logistics.Which countries other than India?
Africa probably too. But the hope is the one hit wonders (Johnson and Johnson) will be good enough given logistics.Which countries other than India?
Which countries other than India?
There's something vaguely unsatisfying about that Oxford/Astra Zeneca report. I know some of it is inevitable in that it includes various protocol changes and rationalisations about how to combine/present data. It's also frustrating not to have a little more detail on the neurological incidents - I understand that I'm probably being unrealistic about that, but still - the reasons for discarding them may be clear to the neurologists, but I still feel the public defence in the report needed to be stronger, if only because of the bad PR.
I can't help but think the report, and maybe even chunks of the actual research/trial will need more work before approval in the US. I assume they're currently assembling/presenting more data and answering questions from the MHRA as well. It's unfortunate though, a lot of countries are banking on the Astra Zeneca vaccine for high volume in Q1 - and I do wonder if we're looking (at least) at a significant delay.
Based on a quick skim of the publication I’ll go out on a limb and say there’s not a hope in hell of that vaccine getting approved without more data. I don’t even know if they’ve got enough data to establish the optimal treatment regimen (either dose or timing).
I can see that paper turning up in “how not to do it” lectures on critical appraisal for future generations of med students!
The regime may be the main problem as the effectiveness is well.above minimal levels in either case.
Belgium should start at Jan 5th.Is there any set (or rough provisional) date as to when mainland Europe are starting to vaccinate?
There's something vaguely unfocused about the paper, which inevitably leaves the doubt that there was something similarly unfocused about the trial structure and maybe even its reporting. I'd have happily read the Brazil data presented in one section, then the UK trial (full dose/full dose - 3/4 weeks apart) presented separately. Then a nice straightforward argument bringing those two sets of comparable looking data together (despite changes in placebo use etc). Then bump the quirks, the odd dosing regime and the dose timing changes etc into a "further investigation" section of the report.Based on a quick skim of the publication I’ll go out on a limb and say there’s not a hope in hell of that vaccine getting approved without more data. I don’t even know if they’ve got enough data to establish the optimal treatment regimen (either dose or timing).
I can see that paper turning up in “how not to do it” lectures on critical appraisal for future generations of med students!
I wouldn’t say “well above”. The Confidence Intervals are wide and include a fairly marginal % of effectiveness. It’s a pity but you can really see how rushed this all was. If they had more time to really nail the optimal treatment regimen I suspect the results would look quite impressive. As it stands, they could end up paying a hefty price for (understandably) cutting corners. I’d say there’s a good chance they’ll either need a whole new Phase III or several months more data (and additional subjects recruited) before they’ll get a license. Which is fine really. That would be a good example of regulators doing their job.
Is there any set (or rough provisional) date as to when mainland Europe are starting to vaccinate?
It has a very low risk, but it is a risk that should never be taken. Among other things, they did the evaluation only on one lot, so they will have to do the same job again for the following lots. It is not a good idea to take the data that the industry gives you, put the stamp on and distribute it, even if there are all the conditions for it to be good and confirmed. That aspect of guarantee is missing. If there is only one thing that has been missed, that is not right, and it is very likely that two or three hundred EMA experts will find it or give more precise indications. For example, they might say who should and shouldn't use it. These things are of great importance in the long term, twenty days do not change anything if they then allow the campaign to be carried out effectively, continuously and quickly.
I could well be wrong but as it has been shown to be safe and to exceed minimum effectiveness standards I think we might well see it approved.
I still find the large difference of effectiveness between the two regimes odd and I 'd love to know why even if safety is already more than satisfyingly assessed.
A couple of incidents on Pfizer day 1 - triggering allergic reactions in NHS workers. Before you read the headline on twitter though, it's worth noting:
"They are understood to have had an anaphylactoid reaction - much milder than anaphylaxis - which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure.
Both NHS workers have a history of serious allergies and carry adrenalin pens around with them."
https://www.bbc.co.uk/news/health-55244122
Will this have any impact on the vaccine roll out and it's safety profile? Is it due to being rushed?A couple of incidents on Pfizer day 1 - triggering allergic reactions in NHS workers. Before you read the headline on twitter though, it's worth noting:
"They are understood to have had an anaphylactoid reaction - much milder than anaphylaxis - which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure.
Both NHS workers have a history of serious allergies and carry adrenalin pens around with them."
https://www.bbc.co.uk/news/health-55244122
It's very unfortunate because this will definitely put some people off, even if they aren't people who carry Epipens - that will be ignored and people will just interpret it as "it's dangerous".A couple of incidents on Pfizer day 1 - triggering allergic reactions in NHS workers. Before you read the headline on twitter though, it's worth noting:
"They are understood to have had an anaphylactoid reaction - much milder than anaphylaxis - which tends to involve a skin rash, breathlessness and sometimes a drop in blood pressure.
Both NHS workers have a history of serious allergies and carry adrenalin pens around with them."
https://www.bbc.co.uk/news/health-55244122
It's very unfortunate because this will definitely put some people off, even if they aren't people who carry Epipens - that will be ignored and people will just interpret it as "it's dangerous".
Quite honestly, I can't really understand why those nurses put themselves forward so early on - if you're in any kind of "could have a problem" group, you need to wait until one of the other alternatives become available.
I was thinking more of the one that's being developed which actually gives you the antibodies, rather than provoking an immune system response. I'll have to wait for that, as I had a very severe reaction to Hep A and Typhim which caused spinal cord demyelination/plaque formation and 6 weeks off work.I don’t imagine any of the other vaccines will be any less likely to cause a similar reaction. Or any other vaccinations, period. The flu vaccine is well known to cause reactions like this in people prone to allergies. To be fair to the nurses, if they’re used to getting what sounds like a relatively mild atopic reaction then they may have thought it was worth the risk of another one to get vaccinated against a potentially lethal virus.
Who's gonna fix the computers if they die?Roll out programmes have begun in my hospital. First people in line to receive it? IT staff.
Classic NHS organisation.
Is it due to being rushed?
I've found a boot to the motherboard tends to resolve the issue with my NHS computer. Either that or shovel more coal into the back of it.Who's gonna fix the computers if they die?
I was thinking more of the one that's being developed which actually gives you the antibodies, rather than provoking an immune system response. I'll have to wait for that, as I had a very severe reaction to Hep A and Typhim which caused spinal cord demyelination/plaque formation and 6 weeks off work.
I do take your point about the nurses risk-assessing their individual situation, as they're frontline hospital staff. It just isn't good that this happened so early on in the roll-out, when many people will have (unfounded) reservations.
True, with 350m from Brexit, the NHS can finally upgrade to Windows 95I've found a boot to the motherboard tends to resolve the issue with my NHS computer. Either that or shovel more coal into the back of it.
I've found a boot to the motherboard tends to resolve the issue with my NHS computer. Either that or shovel more coal into the back of it.
No. The people who had reaction already had allergy issues for which they carried epipens so had elevated risk of other allergic reactions.
It is also really important to note they has an anaphylactoid reaction but did not gave anaphalaxis which is when your epipen is needed and were fine soon after.
I'm in that risk group as I'm highly allergic to paper wasps and am meant to carry an epipen (but usually forget) and I'd still take the shot without a second thought.
I truly appreciate the sentiment, Wibs. xhttps://www.google.com/amp/s/revcyc...g-codes-for-regenerons-covid-19-antibody-drug
And we should have a new slogan.
Get vaccinated or you might kill Penna you selfish bastards
I should be in marketing
How long would another Phase III take?I wouldn’t say “well above”. The Confidence Intervals are wide and include a fairly marginal % of effectiveness. It’s a pity but you can really see how rushed this all was. If they had more time to really nail the optimal treatment regimen I suspect the results would look quite impressive. As it stands, they could end up paying a hefty price for (understandably) cutting corners. I’d say there’s a good chance they’ll either need a whole new Phase III or several months more data (and additional subjects recruited) before they’ll get a license. Which is fine really. That would be a good example of regulators doing their job.
How long would another Phase III take?
India went all in on Novavax ... has there been update regarding it? I hear news just about Pfizer, Moderna and the Oxford one..An interesting snapshot of the way countries are pre-buying vaccines, and just how fundamental the other vaccines are. So far only Pfizer has approval in the UK (and now Canada). It also illustrates just how important some of the vaccines who haven't yet got/released Phase3 data (like Novavax) could turn out to be.
An interesting snapshot of the way countries are pre-buying vaccines, and just how fundamental the other vaccines are. So far only Pfizer has approval in the UK (and now Canada). It also illustrates just how important some of the vaccines who haven't yet got/released Phase3 data (like Novavax) could turn out to be.