Thanks for this Camy. I do hope you are right. I find it astounding though that the Germans, for whatever reason, think its acceptable to play such high stake feckwittery. You just know the anti vaxxers out there will be frothy over this and if doubt in this vaccine takes hold, it could easily pass to the others
SARS CoV-2 coronavirus / Covid-19 (No tin foil hat silliness please)
- Thread starter Don't Kill Bill
- Start date
Of course there would have been plenty of asymptomatic and potentially infectious patients. So you are right. But if your clinical end point with regards to efficacy is preventing severe manifestation of the disease (and in real terms thats the most significant for preventing health systems becoming overwhelmed) then its good news that no body in the vaccine side/arm got really unwell.
Also. Absence of evidence isn’t evidence of absence. I’m sure that was rammed into you in med school!
Just because they haven’t adequately proved it works in elderly people doesn’t mean it won’t work in elderly people. If there are doubts about efficacy in the elderly it doesn’t help that the number of elderly people in the study is so low. 97%+ in primary analysis 69 or younger. They only started recruiting 70+ yo’s late in the day. So there’ll be more and data on this age group in the weeks/months ahead.Yep yep, definitely rammed into my head! I was just using my own thoughts physiologically.Also. Absence of evidence isn’t evidence of absence. I’m sure that was rammed into you in med school!
I remain confident there'll be good data/more reliable coming out for them. What worries me is that articles like this can erode public trust very quickly. Until statistically significant evidence is available, these stories don't help with the relief effort!
Had a work meeting with someone based in Israel. 40 years old, fit as a fiddle, first dose received and second scheduled for 2 weeks time.
I know their population is way smaller, and they've only got 3 health bodies which means coordination is way easier, but they've done so well to avoid all the BS bureaucracy which is just infuriating here. I mean, you currently have King's College in London throwing away doses on a daily basis because they're only permitted to give it to people affiliated to the university in some way. It's actually grotesque.
I know their population is way smaller, and they've only got 3 health bodies which means coordination is way easier, but they've done so well to avoid all the BS bureaucracy which is just infuriating here. I mean, you currently have King's College in London throwing away doses on a daily basis because they're only permitted to give it to people affiliated to the university in some way. It's actually grotesque.
AZ didn't have sufficient case numbers amongst the over 55s to quote efficacy, and even less for the over 70s. They did however do tests for antibodies produced, which they used to suggest that they were expecting similar results across agegroups.
From the December AZ report:
We have reported immunogenicity data showing similar immune responses following vaccination with two
doses of ChAdOx1 nCov-19 in older adults, including those older than 70 years of age, when compared with those
younger than 55 years.6 As older age groups were recruited later than younger age groups, there has been less time for cases to accrue and as a result, efficacy data in these cohorts are currently limited by the small number of cases, but additional data will be available in future analyses.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
If there's new data with EMA, then that will be quite a revelation. Hopefully the story in Bild is a misrepresentation.
From the December AZ report:
We have reported immunogenicity data showing similar immune responses following vaccination with two
doses of ChAdOx1 nCov-19 in older adults, including those older than 70 years of age, when compared with those
younger than 55 years.6 As older age groups were recruited later than younger age groups, there has been less time for cases to accrue and as a result, efficacy data in these cohorts are currently limited by the small number of cases, but additional data will be available in future analyses.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32661-1/fulltext
If there's new data with EMA, then that will be quite a revelation. Hopefully the story in Bild is a misrepresentation.
If the rumour in Bild is true then either the EMA is insisting on hard clinical endpoints to demonstrate efficacy in the elderly or they’ve seen a more recent dataset.
When you take a step back, it is quite a big ask to license this for use in the elderly based on such scanty data.
The small number of test subjects in the over 70s group is worrying in itself. When you combine it with the relatively small number of test subjects in the over 55 group it seems even worse. Especially as almost all those over 55s come into the trial quite late (and the over 70s later). Only 5 cases included in that report from the over 55 cohort.
I can believe that the trial ran for long enough to pick up safety data from the over 55s, but there's no actual efficacy data in the December paper. It all seems to rely on the antibody data.
The data in the December publication will have come from an analysis done several weeks before that. So it’s likely that the EMA submission included a more recent analysis, which none of us have seen yet. I agree it’s probably too soon to have generated any solid evidence of efficacy in the elderly. Which may be the sticking point.
Day 4-6(?) today. No noticeable effects at all so far, slight headache and tiredness maybe but that’s a bit of a reach as I’m prone to both. Hoping I’m one of those that’s naturally handled it well but not getting complacent yet
That seems like a far bigger drop off than you would normally expect.
Best of luck with it.
I'm around a week in, not been too bad either. Had light coughing that mostly stopped after 2 or 3 days. Mild headache the whole time, still there now. Eyelids are sensitive to touch. Stiff muscles over the weekend, still slightly there now but easing. Developed a bit of a runny nose the past day or two, can sort of feel it on my chest but not much.
Last Friday was the worst day so far, shivers and feeling dizzy on top of some of the above.
AZ were told in no uncertain terms that the December data was not enough for EMA approval. There is new data but what it contains is as yet not public.
I’ll admit that I only just realised the Lancet publication had basically zero efficacy data in the elderly. It looks as though they’re trying to justify use in this cohort based on phase II studies showing an increase in antibodies but with no clinical endpoints. That’s a very big ask. Would be unprecedented.
There surely must be some proper phase III results in >70s by now. It’s just that nobody has seen it apart from AZ and the EMA.
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Good luck to you also pal. Hopefully we’re both over the worst
-The article credits Handelsblatt as the first to report this. The supposed source are "goverment circles".
-Unlike Bild, Handelsblatt ("trade paper") is not a tabloid
-They ("goverment circles") supposedly calculate with an efficacy of 8% in over 65 year olds, Bild reported that it looks like EMA will only license the vaccine for under 65 year olds
-German goverment is supposedly re-evaluating their age centered vaccine rollout strategy.
-A final result regarding efficacy of the A/Z vaccine is not possible at this point, because studies barely featured older people. MHRA themselves objected that reliable results couldn't be derived from those studies.
so who is liable IF it’s proven that AZ has not been tested enough on the older population and if it goes pear shaped?
Then why didn't you say as such
I was thinking why you didn't say something similar whilst reading your bicker as it looked like you were prioritising the lives of nhs over other sectors and that's what he was getting at.
I'd expect them to give any data like that to the MHRA - and I'd expect the MHRA to insist on it. Of course that might just be an ethical not a legal requirement.
My guess is that the numbers in the over 70 are still too low to narrow the efficacy error margin, and someone is waiting the worst case (and AZ will quote the best)
Anyway, AZ have got some explaining to do today.
That will definitely be happening. And the MHRA can change the license accordingly.
Is this just going to turn out that the lower confidence interval on their data for the small number of >65s is 8% and someone's got over excited?
An English journo has tweeted that the 8% references the % of over 55 yo’s in the study. And the German article is completely wrong.
Oops.
If this pandemic teaches us anything, it should be to check our numbers before speaking.
AZ & Pfizer have received biliions & billions of subsidies from the EU and are now suspected of breaching agreements with the EU and prioritizing the supply of the subsidized vaccins to non EU countries. Great!!
Hardly need this pandemic to teach us that, people just don't learn or choose not to. This 8% stat will still be quoted for eternity by those that want to watch the world burn and those that haven't seen it debunked or know how to research properly themselves will wonder whether or not its true.
I'm hearing that the government is going to effectively close the borders to all air travelers with this enforced 10 hotel stay applying to anybody flying into the UK.
BBC seems to think it will only apply to those coming from high risk areas like South America.
It's all about 6 months too late.
Does this shit worry anyone else? Why are they now after a year suddenly implementing these measures?
Ireland's coronavirus lockdown is being extended until 5 March
I'm guessing to have some control over the variants. By the time the discussion was had on initial controls like you mentioned below, the damage was well and truly done. Whilst a year too late, I don't think it's a worrying sign of enforcing a quarantine. I'm more worried that it's taken a year to come to the conclusion.
The Uk has crossed 100k deaths today.
Boris on at 5pm
It’s so so sad
20k cases and 1631 deaths, 3341 hospital admissions
Some good news about cases coming down at least.
Regarding flights, it's about the new variants in South America and South Africa. If you keep allowing people in carrying certain variants it becomes tricky to control and trace so there's good reason to do it now.
Back in March April Uk had millions of people abroad. In 2019 we made 19 million visits to Spain alone so I don't think quarantining was on the cards. Incidentally the cases swamping the UK were nearly all linked to people coming home from mainland Euopean hotposts in France Italy Spain and ski resorts. Blocking China wouldn't have made a difference for the UK, the virus was already spread from China to mainland Europe's big tourist spots.
Some good news about cases coming down at least.
Regarding flights, it's about the new variants in South America and South Africa. If you keep allowing people in carrying certain variants it becomes tricky to control and trace so there's good reason to do it now.
Back in March April Uk had millions of people abroad. In 2019 we made 19 million visits to Spain alone so I don't think quarantining was on the cards. Incidentally the cases swamping the UK were nearly all linked to people coming home from mainland Euopean hotposts in France Italy Spain and ski resorts. Blocking China wouldn't have made a difference for the UK, the virus was already spread from China to mainland Europe's big tourist spots.
Another 1631. Those daily deaths are tragically and persistently not dropping.
So is this British variant more transmissible or not? I've heard it's not actually.