You do have to wonder if some of this is politically driven. Germany are losing hundreds of life's a day, while in the meantime the UK has administrated 23 million doses (not sure the ratio of those that were AstraZeneca) and not recorded a single fatality or adverse reaction and are seeing infection rates / deaths drop. I can understand caution under normal circumstances, but nothing is normal right now.
A problem with bureaucracies is that they often care deeply if people die from an action they are responsible for, but are fine if there are massive deaths due to inaction.
It's interesting because I feel the opposite as an acute care doctor in the US. If I give a medication, or get a scan, or whatever, and the patient has an adverse reaction, it's the medication/scan's fault. If I don't give the medication, don't get the scan, and something bad happens, it's my fault. At least that's how people see it for now. Leads to a lot of over-treatment and extra unnecessary testing in my opinion, especially around COVID (for example, I frequently see high-dose dexamethasone given for longer than 10 days or given to normoxic patients, despite the recommendation being for 6 mg daily for 10 days, and only for patients requiring oxygen).
Exactly. You care if people die on your lawn. So you give out medication, do scans, etc. so that if people die they do it on someone else's lawn. It's ass-covering all the way down.
I don't know how you know that. Given the significant time and effort required to become a doctor, isn't it at least as likely that they are motivated about people not dying on any lawn?
Or 42 000 people dead in traffic accidents (in the US year 2020), most of this preventable, eg by middle of the road separation barriers or separate bike lanes.
Most of the public doesn't care or understand, neither do the politicians. Not interesting to fix because no one intentionally did anything bad? And, spending time on this won't win any elections?
I mean, it doesn't actually say that, it says "I will do no harm" and "I will abstain from all intentional wrongdoing". That doesn't mean that doing nothing is fine, because you didn't do harm.
Feels similar to government IT risk aversion that I've seen. Folks are afraid to approve a new piece of software, or a new version, or a hotfix or whatever, because what if it goes awry and causes problems? But little weight seems to be put on "what if we keep running the same version we've been running for years and now that there's a known vulnerability, someone exploits it?".
Because you can very easily destroy public trust medicines if you approve something unsafe, even if in grand scheme of things, it was better for humans. Just look at antivaccination movement, and imagine how many more people would be there if their claims were actually supported by data.
Practically the last half year of Germany's corona policy is influenced by the anti vaccination movement. It's really annoying, on the other hand I think the anti vaxxers seemed to have stopped all major public appearances. So at least one positive thing.
The solution is simple though: politicians simply ask experts how many people die if they do X versus Y, and make sure it is recorded (e.g. by journalists) so they can refer to it later.
Why would any politician/regulator/expert willingly opt-in to accountability?
The best strategy (however cynical) is to not be quantitatively explicit about expectations so that you can frame it as though you succeeded no matter what happens.
Even assuming this utilitarian viewpoint is the correct one, you're putting a lot of faith in the general population to trust the experts / journalists and to be un-emotional when examining the facts.
I don’t think that beurocrats are supposed to be leaders. The elected officials should be pushing for the change, not the people who run the operations.
The cliché of the EU is that it's bureaucrats all the way up, though.
Of course this is an exaggeration, but there is a somewhat disturbing neglect of EU elections, functions and political appointments in the public view (it's seen as less prestigious than national/federal elections in many EU member states).
As a result, it's a climate that doesn't always attract and get the leadership it really needs (given that the EU formally and practically overrules legislation and jurisdiction of member states).
I’m not sure if it’s bureaucracy or human nature, as government procedures had been responsive to the pandemic, and pressure to urge inactions have been overriding the pre-pandemic determined actions.
Pretty much all the responses of the government that were done quickly were to prevent action (i.e. no going to restaurants, no flights to certain areas, etc) so I'd argue that that also represents "inaction", just in a roundabout way.
Right. They were playing it safe, as opposed to having to defend themselves some day in the future for not playing it safe.
This would explain why the Swedish state were so heavily criticised for not locking down. Also would explain the UK government arresting people for being outdoors (there's not really any data supporting outdoor transmission, that I know of).
Well, yeah. First, do no harm. It's not ethically acceptable to kill or seriously hurt a bunch of otherwise healthy people in order to plow on through with vaccination that'll save a bunch of other people. Especially since there are many other vaccine types, the issue with AZ could be a tainted batch instead of a fundamental problem with AZ per se, etc.
In Norway at least, where we have high compliance and relatively few corona deaths, one important point is to keep public trust in the authorities. The worst case scenario would be loss of trust in the vaccine and loss of trust in the health authorities. Then people would not get vaccinated even if the authorities were recommending it.
Also the symptoms are bizarre, the deaths and hospitalizations from blod clot have all been young health care workers in good health with onset of symptoms a few days after getting their first shot. They have all had low platelet count which is very unusual with blood clots and complicates treatment immensely because the standard thrombolytic treatment is then not safe to use.
Do I see this correctly that Norway has about 2 COVID-19 deaths per day on average recently? If so the governments is doing the absolutely right thing. Not halting vaccination with AZ would be highly irresponsible.
Norway is one of the few countries where it makes sense to be extra cautious, as they have excellent medical records and strong control over virus transmission.
It's absolutely mad for Italy, Austria etc.
But this is not a surprise: countries that handle the pandemic well (evidence based rather than populism or dogma) continue to manage the vaccine rollout well, and vice versa.
Yes, the US and the UK have done a good job ordering vaccine. The UK learnt a lesson about outsourcing and used the NHS for vaccine delivery. Delivery in the US is still shambolic, they just have an enormous supply.
I'm not sure at this point. When it was one suspicious death, countries suspending the vaccine definitely seemed like an overreaction, and unfortunately this particular vaccine has been something of a political football and subject of a lot of noise.
But as more blood-clot deaths emerge... you gotta think caution is wise.
OTOH yes, we in the UK have administered a lot of this stuff, and you'd think someone would have noticed a serious side effect like this. So far reports from the UK seem to show no greater incidence of blood clot problems than would be expected without the vaccine.
Difficult to call, but I hope it's all being investigated thoroughly.
> Difficult to call, but I hope it's all being investigated thoroughly.
Important point! I start to get anxiety that there might be some Chernobyl level incompetence building up in our bureaucratic countries.
I feel like we are getting to levels of a huge quantities of regulations, where then to unblock the process, relevant regulations are relaxed to be able to move forward, leaving us with a lot of regulations that make us feel safe, while the elephant in the room is building up through other valves.
I fell like the 737 max thing also more or less fits this framework.
So for the future: Let them incentives be aligned and them regulations work in the right direction!
> Difficult to call, but I hope it's all being investigated thoroughly.
We don't have time for that, we can't wait for some government panel to announce in 2025 "actually the blood clots were no more common than in the general population"
It actually will, considering a giant 3rd wave is starting in many of these countries. I saw some rough french analysis that stated that for every 100k doses that are delayed for a day, it will cost 15 lives.
Germany for example has nearly 2 million doses they are delaying, so that's ~300 deaths per day that are caused by these delays. If you delay by a fortnight that's more deaths than on 9/11.
I'm not so sure about that - vaccination efforts are just finally starting to ramp up, so 2 weeks of vaccinations lost can be hundreds if not millions of people who could have been protected from covid, not to mention the side effects of these people getting infected on the already overloaded hospitals.
> But as more blood-clot deaths emerge... you gotta think caution is wise.
Last I saw it's 30 blood-clot deaths. Given the number of people that have received the vaccine that's a tiny, tiny amount. Even if those 30 were directly linkable to the vaccine (and so far no such link has been proven) you could still make the argument that the benefits of mass vaccinations outweigh the concern.
I don't envy anyone in charge of making those choices, though.
Some anti baby pills cause 8-12 trombose cases in 10,000 women. And they are properly tested, approved and on the market.
Usually I don't read notes coming with meds, but I am almost sure that even everyday stuff has potentially deadly side effects in the ball park number of the blood cloths AZ is causing.
They're called contraceptives or birth control pills :-)
Yes, some drugs have pretty nasty side effects, but vaccines are rather special, because their acceptance affects the entire society and vaccine safety is a sensitive topic, especially in a climate of skepticism. Undermining the idea of vaccine safety will be much worse than Covid (at least at this time).
If it only happened on the continent and there really is an issue, it might lie with one or more batches from the Belgian factory. My country has only halted the allegedly problematic batch. The UK has been using the domestically manufactured vaccine without issue.
> we in the UK have administered a lot of this stuff, and you'd think someone would have noticed a serious side effect like this
Apparently EU vaccines are produced in Europe, maybe there's something wrong in the local production facilities that's causing this. UK has only used AZ vaccines produced in the UK, afaik.
Millions of doses administered to mostly senior citizens, whose deaths may not arouse suspicion or further scrutiny, who are at greater risk from COVID than any vaccine side effect.
The equation changes when otherwise young and healthy individuals are at risk of serious complications, even if exceedingly rare.
> The [International Society on Thrombosis and Haemostasis] recommends all eligible adults continue to receive the #COVID19 vaccine, despite recent decisions by some countries to at least temporarily suspend the use of the AstraZeneca vaccine due to reports of thrombosis. Read the full statement here: https://isth.org/news/556057
> I would challenge the term "caution", as it implies giving the vaccine is more risky than not.
I suppose it depends on the alternative - if it's "not having the vaccine" clearly that's worse. If it's "controlling the death rate by prolonging lockdowns" then that's clearly not desirable either, but not quite as bad.
If it's just "give a different vaccine", then that would be no problem. Of course then there are the supply issues it's unlikely that simple.
While I'm not necessarily disagreeing with your idea, couldn't you make the opposite case as well? Namely that since the AstraZeneca vaccine is mostly British, the government of that country has an interest in hiding/downplaying potentially harmful side-effects?
As far as I know by now a bunch of European countries have already suspended vaccination with the AstraZeneca vaccine. These include France, Germany, Italy and the Netherlands - not really a politically homogeneous bunch.
Sure, but the EU is not a federation. There are still many divergent interests between these nations. Take the Netherlands and Italy for example - not a lot of agreement between those two, usually that is. They do seem to agree on AstraZeneca though.
This. I've lived in both Germany and UK and from my humble experience with both the government and the health standards, I think it's more likely the UK/AZ are downplaying this. It could be that they are right and the impact is minimal given that millions of people have been vaccinated. But I do believe the german version here more. The tory government can't be trusted.
I find so many of my British friends who are attacking the NHS-of-Germany (for being overly political in this scenario) while totally missing the point that British NHS could be doing exactly the same thing at the same time.
That being said a lot of Europeans who would come to the UK would be appalled by the quality of NHS compared to other European countries.
So I would argue that I would trust what German NHS says more than the British one.
Where did I mention the NHS?
I'm referring to the government downplaying the impact of the vaccine. Which could be true, because millions of people got the vaccine and only a few had the clot issue. But I would rather believe the german version on this.
Why do you believe there's a link to blood-clotting, and not to, say, broken dishwashers?
People (especially on HN) like to say "correlation doesn't equal causation", but there isn't even a correlation here. There are not higher rates of blood clots.
Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.
https://www.gov.uk/government/publications/coronavirus-covid...
I suspect it's probably "possible side effects and deaths within 28 days of administering a vaccine", in the same way that the UK records "deaths within 28 days of a positive COVID test". One does not imply the other was the cause. (edit) other commenter points to the official UK docs.
Even with that information, you need to know the non-vaccine incidence of the illnesses in that report to make any meaningful comparison and assessment of the efficacy of the vaccine. Which is what I rely on scientists to do.
From the horse's mouth:
Ann Taylor, Chief Medical Officer, said: “Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population. The nature of the pandemic has led to increased attention in individual cases and we are going beyond the standard practices for safety monitoring of licensed medicines in reporting vaccine events, to ensure public safety.”
Yup. In the UK when you get vaccinated they (should) give you paperwork that explains how to report any side effects. Obviously if your side effects are severe like you're struggling to breath or something your first action should be to seek medical assistance for the difficulty, not fill out a web form - somebody can do the paperwork later, but there's no reason any person who, for example, experiences otherwise unexplained dizziness for an hour the next day shouldn't write it up themselves if they don't feel they need to trouble a doctor.
The Yellow Card scheme and similar schemes are not useful for direct analysis, they're basically an aggregator for anecdotes. I had a mysterious craving for a kebab after the flu-like side effects from the Oxford vaccine subsided. Probably nothing. I'm not going to waste a doctor's time with a video appointment to report "I suddenly really wanted a kebab". But while musing about it I might as well fill out this web form (with the other boring side effects too), then it goes in the big pile and hey, maybe over the millions of shots given in this country they find 8000 people reported a craving for a kebab which is enough to be interesting even though it's unclear how that could happen or what you should do about it.
Medics are going to write a lot more of these. Patient comes in with unexplained back pain, can't recall any triggering incident, but they did get the Pfizer vaccine 10 days ago? It goes in a Yellow Card report. Again, probably nothing, patients turn up with unexplained back pain all the time, vaccine or not. But collecting these anecdotes gives us a better chance to spot real problems early, so long as we don't mistake them for serious data.
Not quite sure why I'm getting downvoted for publishing those two links, but hey :)
Anyway, here's the UK's disclaimer from the Yellow Card summary link you posted.
Part of our monitoring role includes reviewing reports of suspected side effects. Any member of the public or health professional can submit suspected side effects through the Yellow Card scheme. The nature of Yellow Card reporting means that reported events are not always proven side effects. Some events may have happened anyway, regardless of vaccination. This is particularly the case when millions of people are vaccinated, and especially when most vaccines are being given to the most elderly people and people who have underlying illness.
It can definitely be interpreted as CYA. They are following the recommendation of the Paul-Ehrlich-Institute, a federal regulatory body.
Imagine they went against this recommendation and it turns out there is indeed an issue with the vaccine. That would cause a shit storm of epic proportions. This way the "worst" that can happen is that there was a delay.
Now people could die during that delay because they weren't vaccinated, but it's much easier to sweep that under the rug as a politician, in my opinion.
The ethical issue is that the people dying from COVID and the people who might have an adverse reaction from the vaccination are not the same people.
If mostly old people die from COVID but the adverse reaction of the vaccine is independent of age, then for very young people the risk of an adverse reaction of the vaccination might outweigh the risk of permanent damage from COVID.
But if these reactions are a result of the vaccine, it has to be at an extremely low rate of people vaccinated. Even the small rate of death from COVID for young people is going to be higher than that risk.
> Even the small rate of death from COVID for young people is going to be higher than that risk.
But it doesn't mean that you will surely get COVID if you refuse to get a shot. Also, some people claim the vaccines are not very effective against some variants such as the South African one. So it means you can get vaccinated, suffer some serious side effects, and once you are recovered, get COVID.
Yeah. As someone not in any risk group I will prefer the Pfizer or Moderna one. I'll be happy to get the Janssen one or even the Sputnik, but if the vaccine they offer me is AZ then I will refuse.
And not just because of the obviously higher risk associated, but also because it appears not to be effective against the new strains. (Especially the new South Africa strain). Unlike for example the Janssen vaccine (goes by their parent company of Johnson and Johnson in the US) which was actually validated in South Africa or the rna ones which are just a technical masterpiece.
Keep in mind that the real shortage of vaccines is production locations right now. And the type of production of the Janssen, AZ and the Sputnik vaccine is all similar. So why even produce more of the worst vaccine in any of these locations.
> Yeah. As someone not in any risk group I will prefer the Pfizer or Moderna one. I'll be happy to get the Janssen one or even the Sputnik, but if the vaccine they offer me is AZ then I will refuse.
Maybe they won't let you know, to avoid people refusing to get the AZ "vaccine".
How long until you can buy it? This way it's not a (possibly corrupt) politician deciding which corporation will make the stuff that gets into your body.
Its unfortunate they felt the need to stop the administration of this vaccine, as this will only further slow down vaccine distribution in Germany/Europe. I think you've got it spot on there - it stinks of politically motivated attack, but I'm not clear how this could benefit Germany's politicians slowing down the administration of the vaccine? Maybe they can use this as an excuse for the poor administration rates???
BTW I literally just had the Astra Zenica vaccine here in UK - I have a sore arm, lets hope I don't get any of the reported side effects!
Get them to look at https://yellowcard.mhra.gov.uk/ and report their side effects. That's the UK system for reporting side effects in medications of any form.
Just because we are at a medical topic and you are mentioning pomelos: they contain a substance (naringin) that can interfere with certain drugs. Just fyi
Germany has high rates of vaccine hesitancy. One way to tackle that is to be extra cautious. So, as soon as there's information about problems the vaccination programme is halted, an investigation is carried out, accurate and clear information is then presented showing rates of harm in unvaccinated and vaccinated people, and the programme is restarted.
Historically interesting: In the Soviet GDR there was a 95%+ vaccination rate and people trust Russian/Soviet vaccine science (I am from the region). Introducing Sputnik V to Germany may boost vaccine acceptance in the East.
The majority of the vocal deniers is localized around Munich btw, same with homeopathy advocates. Not sure why that is but I suspect 1888's medicine book by Eduard Bilz, which was extremely popular in Germany, could play a role (https://de.wikipedia.org/wiki/Bilz-Buch).
Europe is paying the technical debt from years of unquestionably devouring mumbo jumbo cures like homeopathy, organic everything ('bio') and diminishing respect for science.
It's going to be interesting to see if western europe doubles down on the anti-vax beliefs or they swing round to be more like the Ossis.
I never considered that angle. I wouldn't mind if Sputnik V would be certified in the EU as well. The more vaccines the better. And the faster we get out shit together here, the faster poorer countries can get their doses as well. Which was the EU plan anyway, at least initially.
We will at some point have vaccinated the true believers and be left convincing the rest of the population to get their shots. From that perspective, taking action to demonstrate that we are being absolutely rigorous on the safety of the vaccines might be the global optimal in terms of minimizing time to herd immunity. Especially if we keep manufacturing the shots while studying the data.
It seems like a dumb move to me. Like you said hundreds (thousands!) are dying daily and they get a few blood clots out of 17 millions doses and they stop completely and panic, even though this stuff has been out for months now.
When you plot the infection and death rates of the vaccinated vs the unvaccinated population, the rates in the vaccinated group drop like a stone. The effect is highly significant.
The vaccination strategy is highly effective and is absolutely a major contributor (if not the primary contributor) to the decline.
If someone would say this about COVID, they would be downvoted into oblivion for spreading unfounded conspiracy theories. It's already 6 countries in the EU that reported issues until now.
Yeah, and I rightly so if you ask me. AZ seems so to get all the heat in the press. I really wonder why, but as soon as you start looking at the numbers, there never seems to be something to it.
First it was efficiany with elderly in the study, were the numbers were totally misunderstood. Then it was overall effectiveness, then prevention of severe cases. The list goes on. In the meanwhile, the press is reporting every single rash people get with AZ.
EDIT: Just checked, they found 7 cases of thrombosis in the brain, out of 1.6 million vaccinated people. Well, we'll see how that develops.
So we've been in a 5 month lockdown already in Germany, all of it to stop the spread of the virus with huge costs to the country, and now the comment that I replied to is saying that "I think this is part of political cover for the failing". Meaning that Germany and the EU, which have been doing everything that they can to stop this, are now somehow involved in a political cover to get some sort of revenge on the UK/AstraZeneca at the cost of the people that would be affected by COVID?
But they did not do everything they can. They did not expedite AZ vaccine approval, they are messing up the rollout, they tried to negotiate prices instead of securing vaccines at all costs. They made a whole theatre about AZ deliveries and almost created an international crisis around Ireland..but no, no political aspect to it, none at all..
I don't think they are trying to get revenge. They are trying to cover for their own failings. By any reasonable means, the vaccine rollout in continental Europe in relation to the wealth and logistics available compared to US/UK is a complete failure.
so how does further slowing vaccine progress, making it even less likely they'll meet the adjusted goals and anouncements, "cover for their failings", especially if there is a good chance it'll turn out it was unnecessary? At least right now people's reaction for sure isn't "oh too bad then, not your fault".
Well, as of early January the EU ordered almost twice as many doses as needed. They, and by that I mean the member states more than the EU, screwed up the distribution and vaccination campaigns.
As I said, no idea whether or not something is wrong with the AZ vaccine.
And yes, governments are doing everything they can. And the screw up with vaccinations. No idea why, because I don't have all the details, but maybe AZ is just coming in time to have been 1) a good scape goat early on when one was needed during the frustration with vaccine deliveries 2) bad at PR 3) earned a bad rep and now everybody is over cautious. And public / media pressure isn't really helping.
The difference being that there is no evidence yet to point towards vaccinations causing these, while there is plenty evidence for covid. Further, there is plenty of evidence for the lost lives by NOT vaccinating faster.
> Nearly 60 years ago thalidomide was prescribed to treat morning sickness in pregnant women. What followed was the biggest man-made medical disaster ever, where over 10,000 children were born with a range of severe and debilitating malformations.
> The thalidomide scandal may have led to 10,000 miscarriages, stillbirths and infant deaths in Britain, according to the former director of the trust that oversees payments to hundreds of people disabled by the drug taken by their pregnant mothers.
> The thalidomide scandal may have led to 10,000 miscarriages
So, over an entire century, the worse drug approval mistake caused fewer birth defects than the number of Covid per day. Deaths that at this point could be easily prevented by faster vaccine approval.
What rational person could possibly look at that state of affairs and not conclude that our drug approval process is trading off far too many type II errors relative to type I errors.
How do you know that before the cautious testing and approval procedure?
The EU recently approvied and has bought 200M J&J vaccines, I don't remember numbers of the other vaccines. If that vaccine were about as harmful as thalidomide, about 3000 babies would die during birth, and a considerably larger number would be born without an arm or similar.
Without hindsight we can still see that countries differed in approval timelines by a month even though they should have the same information available at the same time. Which means either one is taking more risks than necessary or another one is wasting time (and thus lives).
And that's just approval, then there's the whole issue with the EU taking too long to negotiate lower prices instead of pre-paying for faster production ramp-up.
Vaccines are not that different just because they are for different sickness. And there are no vaccines with any of these side effects, so there is no reason to believe the COVID vaccines will cause anything even close to that. Besides the normal stuff every drug has.
Contagan, which is part of the reason why we have the drug approval process we have. And ever since, we didn't have anything comparable. At least not that I remember.
I don't think that answers the question. The question was "for which kind of…". Naming one specific past product doesn't answer that, because surely you don't mean that no future candidate warrants can pose similar risk.
Contergan (thus spelt) is thalidomide, BTW. Thalidomide is the name of the active agent, which is used in products named contergan (as well as several other names).
this is awful first order thinking. If public authorities are perceived as untrustworthy on the safety of vaccines, there's a very high chance there will be widespread rejection of vaccination altogether in the population.
People aren't utilitarian machines, trust in drugs is very easily broken, vaccines in particular. Showing neglect and lack of precaution may harm vaccination efforts for decades.
There are large swathes of the world, where significant fractions of the population refuse vaccines out of fear of witchcraft and voodoo.[1]
Do you think we should add an FDA phase five stage, where exorcists and witch doctors carefully study Covid vaccines for evidence of black magic and evil spirit? Because it's perfectly sensible to let rational people die to satisfy the whims of whoever holds the most irrational beliefs? Because you're making the exact same argument, except just substituting out Western anti-vaxxers for folk superstitions.
There's no evidence to indicate that anti-vaxxers are sensitive to clinical evidence whatsoever. A third of American adults are considering foregoing the vaccine[2], despite it being the most extensive and sophisticated safety trial in vaccine history.
Why would you believe that the minutiae of the FDA approval process would have any effect on anti-vaxxers, when the vast majority of their beliefs come from wholesale fake news.[3]
sorry, but this is an abysmal straw-man. In this case the vaccine distribution has been paused because of reports of blood-clotting. Even if that turns out to be spurious, it has to be investigated and precaution has to be used.
This stop in Germany comes from Germany's federal vaccine authority, which as far as I know, does not employ witch doctors.
If it turns out that a vaccine actually has harmful side effects (which is possible, this is not some conspiracy but a risk of all drugs), and the administration would have ignored it, you have eroded trust far beyond anti-vaxers.
