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- Multiple production sites. - A portfolio approach to the vaccines procurement. Relevant to remember that AstraZeneca was and is selling the vaccine to the world on a non-profit basis too. |
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Is Europe's AstraZeneca jab decision-making flawed?
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You are right that there would be little by way of mitigation that they could engineer - but then they shouldn't have been so "how wonderful we are" if they couldn't know that the hoped for result might not materialise. To my mind the term "best reasonable efforts" was the clue and I, as a project manager, would report major risks to my sponsors unless the assurances were satisfactory. But you know all this, of course. Yes? ---------- Post added at 18:36 ---------- Previous post was at 18:34 ---------- Quote:
The portfolio approach yielded little as well. Why are you defending those fools (again)? ---------- Post added at 18:38 ---------- Previous post was at 18:36 ---------- Quote:
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Jonbxx has neatly explained the processes. I hope that when you have had time to reflect upon his posts, you will be able to adjust your your perspectives to fully appreciate his insight. (But we'd both better avoid going backwards and forwards too much as we'll bore the forum. :D) |
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It's the same problem as MMR. One dodgy study undermined faith in vaccines for over a decade purely because its findings were promoted by papers like the Daily Mail and Private Eye who portrayed the efforts of regulators and the NHS to ally fears as part of an establishment stitch-up. |
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As long as the UK doesn't jump on the stupid suspension bandwagon before the end of the week - I'm booked in at 9:10 am on Thursday and will be pretty fed up if the wheels drop off before then.
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It's looking good for over 50s soon - https://inews.co.uk/news/politics/ov...-jabbed-915170
Got my sleeve rolled up already! |
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Really don't get the EU mentality of, Germany makes a certain decision, so everybody else has to follow suit. How about France, Italy, etc looking after the interests of their own people, rather than having to follow Germany.
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But you're right - I'm convinced it's a politically driven situation aimed at two fingers to the UK. Well I would, wouldn't I? What do the Remainers think? |
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I’m just enjoying the Schadenfreude. They are just gluttons for flumping themselves up the asp.
The attempts to discredit the AZ vaccine have been front and centre, why? Who knows, petulance? The issue is science and data is absolute and as before you will be made to look stupid. We’ll just keep rolling on here and get the job done. |
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Again, had we not been in a pandemic, the precautionary principle would absolutely favour the cautious approach shown by some national regulators. However, there is a very strong argument for saying these regulators have failed to adjust their decision-making processes to allow for the fact that we are in a pandemic in which significant numbers of people are getting very sick and dying. Even in the face of weaker efficacy data there was ample phase 2 data that amounted to indirect evidence of efficacy - the UK regulator's approach was that in these circumstances, the indirect evidence was sufficient. The broo-ha-ha in many European countries now appears to be an unholy combination of inadequate decision making processes (still sticking doggedly to the precautionary principle, despite evidence that slowing the vaccination programme will kill more people) and regulatory over-caution thanks to the calculated political vandalism perpetrated by a few very well-placed politicians like Emmanuel Macron, a few weeks ago when the UK's successful programme needed taking down a peg or two because it was showing up the EU. As Damien observed earlier, once you let the anti-vax genie out of the bottle it is very difficult to get it back in, and I think some politicians and regulators are now over-thinking every step as they try to persuade their populations that getting vaccinated is safer than not doing so. |
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I see Mr Trump is now recommending his believers get the jab. Probably worried about them not surviving to the next election...
Tbh you'd have to be quite thick not to get the jab and even thicker to change your mind because Donny says so ! |
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I see Northern Ireland which completed (both doses) to care homes at the start of February have had a reduction in deaths as a proportion of all deaths and recorded 0 in w/e 5th of March.
Meanwhile in England/Wales care home deaths stick doggedly to around 22% of all deaths every week since January to the same date. When is that expected to come down based on the dosing strategy? Will it be after the second dose I wonder... |
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Vaccinations now available for everyone over 50 now! Fill your boots my middle aged friends - https://www.nhs.uk/conditions/corona...s-vaccination/
Booked my jab for a week on Monday with a second dose in June. Could have had the jab next week but the parking at the centre offered is really bad |
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They finally got round to the young people :)
A drop of the dodgy AZN stuff for me, I am a shareholder so they need my support ;) |
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Von der Leyen throwing her toys out the pram again, all over a vaccine that no one in the EU wants............................................. .......
The problems in the EU are all down to AZ. From Sky News: Quote:
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Her butt is on the line and she’s desperately trying to deflect attention from the mess she has presided over - including the slackly worded contract with AZ. She has by now accepted she has no contractual right to AZ vaccines from the UK and is trying to turn it into a governmental issue. I.e. the UK government could, and should, be doing something to see vaccines shipped to the EU. This is of course based the fact that Pfizer vaccines are being shipped to the UK from the EU - though Von Der Lying appears to want to give the impression that this is down to EU largesse rather than a commercial supplier fulfilling their contract. There is no basis in contract, in law or in treaty for what she’s demanding.
And, of course, the real problem in the EU right now is member states bizarre, ongoing refusal to use the AZ doses they already have. |
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Perhaps we can trade 1 million does for 2 years' grace extension period.
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Ursula Von der Leyen is doing more to discredit the EU in four minutes than Farage has done in 40 years!
Now that Jeremy Corbyn has stepped down as BoJo's useful idiot, she seems to have stepped into his shoes and made it her own! |
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https://www.bbc.co.uk/news/uk-politics-56435549
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Honestly, I think this sort of thing will re-occur, as it’s a new complex process, and bumps on the road are to be expected - here’s hoping it won’t delay inoculation to the under-50s by much. |
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Apparently the EU have loads they don't want, mebbe we can have that :p:
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Leaked figures in January pointed to the UK getting around 11 million AZ and 4 million Pfizer in April. Be interesting to see what the actual outputs are.
If you were as cynical as I am, and you wanted to suspend the vaccine rollout for safety reasons except to people who have already not had an adverse reaction to the first dose, I’d maybe suggest this is a mechanism to do it. ;) |
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Meanwhile. https://pbs.twimg.com/media/EwshS5UX...pg&name=medium https://pbs.twimg.com/media/EwshS5bW...pg&name=medium |
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I don't know whether it's still the case, but it should be pointed out to the EU that a key component of the Pfizer vaccine is produced in the UK. They are dependent on us.
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The big wrinkle in the whole thing is the US Defence Production Act and Operation Warp Speed stopping export of raw materials from the US if they might be needed for vaccine production domestically. It's causing some real headaches in the industry out side of the US |
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Last I checked although it was a few weeks ago the total numbers of vaccines not administered (Vs delivered) in Germany was about 4 or 5 days worth (and some of these are likely to be being held back for second doses). I'd be surprised if we didn't have a few days stock lying around somewhere. |
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This link from the FT might work or hit a paywall. If it hits a paywall, Google 'Shortage of giant plastic bags threatens global vaccines rollout' |
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1. China will win again! 2. Who wanted to get rid of plastic? |
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Not recyclable either.... * there are some very good reasons why single use plastics are the way forward including higher productivity, lower water use and carbon footprint especially if you look at energy from waste power stations. It's not a good look though... |
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This morning I booked my Covid-19 vaccination, only took a few minutes, its local and 9:20am Monday.
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https://www.bbc.co.uk/news/live/uk-56440055
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Interesting point on today’s BBC 1pm News - part of the reasoning behind Germany being cautious about the AZ/O vaccine (waiting for the EMA review) was that the blood clotting issue was specifically about a rare form of blood clotting on the brain, which for the number of people who had the vaccine should have been 1, and was in fact 7.
I’ll look for a link. https://www.telegraph.co.uk/global-h...e-says-german/ Quote:
https://www.reuters.com/article/heal...-idUSL8N2LE66B |
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Ah, using statistics which can prove anything you want. Forget science, just use statistics.
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Statistics are what the efficacy of the vaccine and impact of side-effects are based on, so I’m not sure what your point is?
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On the raw materials shortage, it looks like the US exports ban on those big plastic bags and filters might be the cause of the delays - https://economictimes.indiatimes.com...4.cms?from=mdr |
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Not to worry, I'm sure the Government are currently pushing through a lucrative deal with the CEO of the Cornish tin miner association to deliver thousands of perfectly safe and sterile plastic bags with filters ;) |
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Statiscally how safe is the AZ vaccine in your opinion??? |
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Well, I had the AZ vaccine, so there's my opinion...
re your questions - that may be why the EMA is reviewing the incidents, to obtain answers... |
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I think some are missing the point that it's entirely appropriate and their role to investigate such matters.
While side effects are extremely rare. Why only women? A very good question. Were they on any other medication? Another good question. If we could narrow such things down deployment can continue in a safer manner than now around the world. Surely something everyone would want given we have another 60 million or so doses to issue ourselves plus any "new variant booster" launched in the autumn. |
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There are two parallel questions really. 1. Should they investigate? (Obviously yes) and 2. Should they halt use while they investigate? (Depends).
In the present circumstances the precautionary principle is liable to kill more people than it saves. The number of people suffering these clots is vanishingly small. The number of people dying from them is even smaller. Covid itself is clearly the far greater and deadlier threat. Some national regulators seem to have inadequate investigative procedures for pandemic situations. Their basic premise (that it is safer to do nothing) is flawed. The MHRA's far more sensible pandemic operating principle has been to allow use of the vaccine to continue while a thorough review of the evidence was conducted. It has now concluded that review and is unequivocal. There is no evidence of a causal link between the Ox-AZ vaccine and the cerebral thromboses reported to it (five of them, one fatal, from the 11 million vaccinations reviewed). https://www.bbc.co.uk/news/health-56447367 What will be interesting to see now, is how quickly those national regulators that have ordered suspensions, will lift them. The MHRA has shown how quickly this sort of work can be done when an emergency situation demands it. Somehow, I suspect the regulators in some other countries still haven't twigged that this is a public health emergency and that they need to start behaving accordingly. |
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But what is the benefit in continuing to issue it for the EU?
AZ in the EU are miles behind in terms of deliveries and the bloc are months away from being in a position to meaningfully ease restrictions. Right now the biggest (only?) real weapon in their arsenal is lockdown and other non-pharmaceutical interventions. A delay in issuing the AZ vaccine of a week to two weeks is neither here nor their for the vaccination programme as a whole. The UK regulator isn't in the same boat, it's weighing up the ongoing availability of a large number of doses with inadequate contracts to meaningfully continue the vaccination programme as a whole. We'd be doing about 25% of the vaccinations throughout April if we were relying on Pfizer only. That puts the UK back months, hence the "it's safer to use it than not" is closer to black vs white. |
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Well they've signed it off now, so safe to use - until they find another reason not to use it.
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Unless you're suggesting that politicians in those countries are implementing decisions, and then using their regulators as cover to give an entirely different set of justifications? The regulators are not (or should not be) concerned with supply levels or other infection control measures. They should be concerned only with safety and efficacy. Incidentally the EMA has also concluded its own review of the data, and states that the Ox-AZ vaccine is 'safe and effective.' https://www.bbc.co.uk/news/world-europe-56440139 |
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Now it gets interesting. A newspaper somewhere will do the XS deaths maths arising from the vaccine pause. |
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I'm not sure how, in a pandemic, a regulator is supposed to isolate supply from their decision making. The whole point is surely to reduce both prevalence and transmission across the population. A drug where supplies are unable to significantly do either must factor into whether the benefits outweigh the risks because the benefits and risks are intrinsically linked to what non-pharmaceutical are required.
As for politicians and regulators my cynicism knows no geographic bounds. |
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The third question is who are we going to give this to given the data of safety, effectiveness, side effects, costs, quality of life, etc. This is more a clinical decision. In the UK, NICE usually makes this decision though JCVI will in the case of vaccines. My feeling is that the separation of these strands is important. With the safety and effectiveness being 'blind' and scientific and the clinical application being the more 'human' side. Say for example, that the findings were that there was a slight increase in clotting issues. Then the Marketing Authorisation would be adjusted to state this and then the clinicians would take the risk/benefit decision. For example, if you have clotting issues, then the AZ vaccine is not the one for you. ------------------------------------------------------------------------------------------------------------------------------ Just to add, investigating this was the right thing to do in my opinion. In vaccine sceptic groups, saying 'nah, it's fine' probably doesn't wash. Saying let's stop, have a look, check and act on the results is more likely to get past vaccine sceptics. Of course, it's not ideal as it slows down the roll out but one reports were out, it needed to be done |
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Like they forgot to order it;) |
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I can prove anything by statistics except the truth.George Canning https://en.wikiquote.org/wiki/George_Canning |
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34.38% of us hate statistics
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80% of all statistics are made up - Vic Reeves.
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So 5x higher risk of disseminated intravascular coagulation, DIC and just under 10x higher risk of cerebral venous sinus thrombosis, CVST in vaccinated under 50s. However, the conclusion is; Quote:
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Maybe aspirin for a few days after the vaccine?
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France daily cases continue to spike, nearly 7 times that of the UK. France entered 3rd wave territory and extra measures are being implemented considered to be their THIRD lockdown.
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'Eat out to kill some people', what a wonderful initiative... |
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Starting to look like Paris in springtime is out
Caravan at Cleggy it is then :D |
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Good news.
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The irony of herd immunity Sweden not wanting to take the risk.
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So much for statistics over science, |
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Indeed I'm not sure the UK is well placed to blame decision making elsewhere resulting in excess deaths when each lockdown we went into came a week, or more, after scientific advice was calling for it.
I know we aren't statistics fans but tens of thousands of deaths have been attributed to poor decision making. A few days delay in a vaccine rollout that's running behind schedule is neither here nor there by comparison. |
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No need for statistics or science, just use common sense.
Majority of people given the vaccine are over 50. People over 50 are 'probably' more at risk of developing a blood clot naturally KISS |
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Stats are always fun but especially where the numbers are small within larger sets.
So and increase in vaccine issues from 2 to 5 is a more than doubling but is still small compared to the numbers vaccinated. Same with the increases in infections, as the numbers come down a small change gives a big percentage change. |
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Monsieur Macron has sent his prime minister out to get an AstraZeneca jab on live TV. I'm pretty sure their German friends have a word for how I'm feeling right now. :rofl:
https://www.bbc.co.uk/news/live/uk-5...ost_type=share |
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Macron himself said a few weeks ago he would take it if offered as well. He has been very weird on the whole thing going back from saying some of the most outrageous statements on it to be one of the few prominent supporters of it in the EU. Unlike Germany who have seemed to just to have had a constant low-scale negative attitude to it.
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You couldn't make this up!
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That's actually magnificent decision making by France, someone under 55 is extremely unlikely to die of Covid-19.
It's almost as if they're genuinely weighing up the risks vs benefits and moving their decision making with the evidence. |
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