Looks like this may be a bit more relevant than many of the snarky comments would suggest - the relevant German authority on this said that they have seen a unexpected increase in a specific type of blood clotting issue that usually is very rare: https://www.pei.de/DE/newsroom/hp-meldungen/2021/210315-voru...
It's not a medically reasonable response that solicits snarky remarks, it's the complete retardation of the official covid response so far, and even reasonable decisions just are landing on a pile of steaming crap now.
- billions per week of half assed lockdown vs a few billion more for high quality timeley vaccine delivieries of the good stuff --- of course they chose the lockdown
- open schools as if nothing happens vs using UV-based air filtering machines and so on as a minimum level of precaution --- of course they choose to open schools with classrooms some of which even don't have windows that can be opened properly
- governing party members of parliament scamming the public out of money by selling overly expensive, low quality masks
- minister of health busy sueing newspapers for disclosing prices on his million dollar real estate purchases vs minister of health actually being busy 24/7 with fighting the crisis
the list goes "on and on and on", these are just the most popular ones right now. It's just a dumpster fire at this point and the positives will not be recognized divorced from said pile of crap.
Let's not forget that the German government resorts to "alternative facts" since the pandemic began just as they see fit. When we had nor masks available last march, they said "masks are useless" two months later they were mandatory "because they are the best thing we have". Recently, a post by the government on Facebook said "AstraZeneca gave us one of the best vaccines ever" just as people started to cancel their appointments when they saw that their vaccine was going to be from AstraZeneca. Now they pause vaccination with it. Yeah.
> - billions per week of half assed lockdown vs a few billion more for high quality timeley vaccine delivieries of the good stuff --- of course they chose the lockdown
This is not the issue. A few billion would not have magically solved the problems with vaccine deliveries. The EU has contracts with pharmaceutical companies which these companies are not honoring sometimes intentionally so.
AstraZeneca for example doesn't have the production capacity to supply what they promised to the EU even if the Belgian site was working properly. That's the result of the EU audit. These companies are betting that the consequence of them not fullfiling their contractual obligation will be insignificant compared to their benefits. As these companies remain hugely profitable, their production issue is not linked to difficulty accessing capital. It is naive to assume things would have gone differently if the EU was paying more. It would just have meant more profits for them.
The heart of the issue is that contraty to the USA or China the EU is weak so companies don't hesitate trampling it. If a Chinese company did to China what AstraZeneca is doing to the EU, the CCP would take control of it and its CEO would never be seen again. Meanwhile, the USA has little qualm using its legal system to punish companies defying the state to much. Congressional inquiries are not fun.
Your claims are off-topic and irrelevant with respect to the safety of this vaccine.
Any potential safety issues with vaccines must be investigated, otherwise there will be a huge problem with trust in vaccines and in the regulator. There's already a huge problem with vaccine skepticism, and vaccine fanatics are making things worse.
Suspending vaccinations for side effects that happen in 1 in 300000 cases is not medically reasonable. Even if all these cases are due to the vaccine, not vaccinating gives a worse result than vaccinating so it’s the dumb thing to do.
Which is what WHO and EMA are saying. But now that there’s panic, they’re not relevant anymore.
I'm very disappoint finding out that the minister of health is just a lobbyist with no medical background. He seems to care a lot about suing people who talk about his villa than doing actual work.
This is the best time for politicians to steal money, as people are unable to go to the street to do demonstrations.
Polititians are stuck between trying to make the free-for-all phase as long as possible, but still look as though they did everything to help, so that they can win the next election.
Compared to the status of 11.03.2021, additional cases (as of Monday, 15.03.2021) have now been reported in Germany. In the analysis of the new data status, the experts of the Paul Ehrlich Institute now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in conjunction with a deficiency of blood platelets (thrombocytopenia) and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine AstraZeneca.
Translated with www.DeepL.com/Translator (free version)
Yes, cerebral venous sinus thrombosis, exceedingly rare condition in the general population. It can cause permanent neurological disability and death if not diagnosed and treated.
Cerebral venous sinus thrombosis presents with nonspecific symptoms (eg headaches). It can only be diagnosed with cerebral imaging of specific modalities (CT or MR brain venogram, expensive and specialised tests). From speaking to colleagues in the UK, their hospital system is quite overwhelmed and doctors are repurposed outside their field (eg surgeons looking after internal medicine patients). It is quite possible in the throes of a pandemic to be underestimating the incidence of this condition in the UK.
> The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries.
"The decision today is purely precautionary..." given this level of signal. We don't have details on the age groups involved and the normal rates expected but I can hazard a Fermi Estimate that the risk is minuscule compared to COVID-19 itself. I look forward to seeing the actual data in coming days/weeks. Precaution without downside is acceptable; this is not one of those cases, IMO. YMMV.
> the risk is minuscule compared to COVID-19 itself
You don't know this at all - we don't know what age groups are affected here, and COVID is pretty much negligible in many younger age groups. It's best to wait for more data to come in before drawing any conclusions.
1. If holding off AstraZeneca vaccine does not affect vaccination rate during the investigation period, it is a prudent thing to do.
2. If vaccine rate is expected to drop, number of expected increase in death per day due to covid vs blood clog should be compared, if we were to minimize short term death.
3. More concerning is unknown effect that could take a long time to materialize. This is a tough call to make since any effect is only theoretical at this point.
British Columbia's Dr. Bonnie Henry discusses [1] (5min YouTube clip up until 28m37s) the decision process surrounding Adverse Events Following Immunization (AEFIs) [2] within the context of the EMA decision involving the AstraZeneca vaccine. Her explanations tend to mirror her refrain "Be Kind, Be Calm, Be Safe".
For those jurisdictions like the UK, India, and Canada that continue recommending AstraZeneca, I'd suggest that COVID-19 vaccines are like beer; the best one is the one in front of you.
It's 0.0015% compared to 4%, so at least a 2.6·1e3 difference. Given less than 0.004% chance to catch the disease in my city, the odds are 10 fold in favour of not getting vaccinated. I'll still get vaccinated regardless, because I am sick and tired of this pandemic and want to go on vacation instead of into an another lockdown this year.
Surely more people will die from COVID than from blood clotting, due to this delay?
Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society).
> Birth control pills can also cause thrombosis. So why is there all
the fuss about the COVID-19 Vaccine AstraZeneca?
It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on
prescription. Every woman must be informed of this risk by the prescribing
physician. For the COVID-19 Vaccine AstraZeneca, there is currently a
suspected very rare side effect of sinus vein thrombosis with accompanying
platelet deficiency, sometimes fatal. It is not listed in the SmPC.
The consideration of whether the vaccine can continue to be used even
though it may cause this very rare side effect (if necessary, after this risk has been added to the SmPC) will be made at the European level by the
European Medicines Agency (EMA) and at the national level by politicians.
The procedure has been initiated.
Which sounds pretty clearly like bureaucratic CYA instead of an actual cost/benefit analysis that takes into account the excess deaths that are now being caused due to pausing the vaccine rollout.
I'm set to take the oxford d vaccine, but I could also take the pfizer vaccine.
I've had elevated blood markers for clotting during covid-19, and now I hear of this.
I'm thinking of taking 75 mg aspirin, before and after the vaccine. On the other hand, the issue is the patients have low platelet count and I understand that this is the way aspirin reduces blod clotting.
So, do these patients have low platelet count because they had blod clots, or the other way around?
Afik, in the case of COVID-19, clotting is an autoimune issue, so perhaps the clotting is not something related to the astra Zeneca vaccine, but something about the immune response itself.
Talk to your doctor before making decisions. Taking aspirin right before a vaccine might not be a good idea as it can blunt your immune system response, but the whole point of a vaccine is to elicit a strong immune response that builds memory. I know acetaminophen is specifically mentioned as something not to take right before the COVID-19 vaccines (and afterwards, if you can deal with the immune response naturally).
According to a high-ranking doctor on the German TV today, the observed effect isn't normal thrombosis but a brain related thromboses, where prophylactic treatment is not possible.
Okay, so they looked for correlations with a million conditions and when they found a vaguely significant one they automatically suspended the vaccination campaign prolonging by days or weeks the national lockdown.
Is that the real reason? In times of crisis one must be wary of propaganda. AstraZeneca has recently announced they'd deliver even less to the EU because of Italy's interception of the delivery headed to Australia [0]... Europe having to halt the vaccinations with AstraZeneca due to none being in stock makes europe lose far more face than halting them because of quality concerns...
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).
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.
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.
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.
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.
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.
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"
> 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.
> 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
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.
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.
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.
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.
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.
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!
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.
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.
I've mentioned it in a comment in the previous thread but it's not completely unexpected and with no causal link. Adenovirus induced blood coagulation problems are known:
Adenovirus-induced thrombocytopenia: the role of von Willebrand factor and P-selectin in mediating accelerated platelet clearance
You can see the number of reported cases across Europe in the EUDRA Vigilance database (if you manage to get through the Oracle BI interface and if it doesn't error out)
I don't understand why AstraZeneca doesn't just say: yeah blood clots are a risk, incidence 1/100,000 and everyone can move on. Why does everything needs to be so politicized with this vaccine.
>Why does everything needs to be so politicized with this vaccine
It is politicized because it effects more or less everyone on the planet and people are setup to take popular things and turn them into polarizing issues for political power in politicians and social capital for ordinary people. This is how a whole lot of people seek out happiness, by being "right" in their social circles, especially in a way that shows them as superior to large groups of others who are "wrong".
Social media preys intentionally or unintentionally on this human psychological vulnerability (can we get a CVE on the human psyche?) and every bit of media wants to sell you a compelling story so they stoke the flames of A/B conflicts.
The mass psychology/mythology/philosophy of the day is based around this crap and will turn anything into a "political" issue and people just generally aren't well educated enough to think independently or evaluate situations rationally on their own so they allow their reason to be driven by systems which are evolutionarily dependent on preying on addictive human behavior.
Agreed. I add that the 24-hour news cycle is in it for the clicks, and they get lots of clicks selling fear. Risk assessment isn't one of our stong suits, either (human nature being what it is).
The pandemic has made me believe we need to be greater consiquentalists in our polices. It's pretty obvious that on the whole the AstraZeneca vax will save more people than are killed from the side effects. We don't not live in a 0 risk existence.
In the US, ~160,000 people over the age of 85 have died while 216 people under the age of 18 have died. Covid represents a proportion of deaths from all causes of 13.5% for 85+ and 0.58% under 18. The trend in between the age group extremes continues in an expected way.
You can't make the same decisions about risks when you have one side so skewed by age. There is absolutely no guarantee that side effects from vaccination would be a preferable risk for younger populations or that vaccination side effects would have comparable age-related effects.
Covid response isn't a religion, it's not "we have to do everything" or "we shouldn't do anything", responses need reason not gut reactions.
0.58% is an order of magnitude higher then 30 out of 17 million. Going by these numbers, AZ is still better than COVID. And I doubt any worse than other vaccines.
Yes, but those are different people that might be killed, which makes it an ethical dilemma.
Depending on the type of adverse reaction, it might be safer for young people to not get vaccinated at all or with a different vaccine. (For example if the adverse reaction affects mostly young people, while COVID affects mostly older people.)
Thats why everyone should be free to chose to get vaccinated. It is not fair to transfer the disease risk from old/risk groups to (longterm) side-effect risks for young/healthy people
No one is forcing you to get the vax. I would have personally taken the Moderna vax months before the FDA approved it because I was following the research closely.
Agreed, and the same argument can be applied _against_ lockdowns (meaning measures such as mandatory stay-at-home orders that go beyond usual NPIs). I think it is slowly emerging that hard lockdowns have done more harm than good. There is no zero risk in life.
There's a big difference here though - when it comes to a vaccine, we have hard stats to define the risk/reward ratio.
I believe it's likely that lockdowns may cause some deaths, or possibly even lots of deaths. However, they certainly help prevent the spread of deadly disease too and hence prevent many deaths. We can probably get fairly definite numbers on how many deaths lockdown prevents in a large population. I don't think we can get similar numbers on how many they cause. My gut says they probably prevent a lot more than they cause, but I'd like to see any studies on this, if anyone has a link to share.
As we have learned over the last year, doing a cost benefit analysis on anything related to covid is the equivalent of drowning your grandmother in a bathtub.
And not just financial costs, but quality of life costs. One to two years of restrictions, quarantine, and/or lockdown is a sizeable fraction of everyone's lives.
I feel bad for people in countries where people are even restricted from being outdoors, despite hearing again and again that outdoors is the safest place to be.
In EU at least plenty of Pfizer and Moderna vaccines are still incoming, so there are actually alternatives to AZ.
Do not forget that these vaccines are still very new, plus there's the possibility of a production issue with the AZ vaccine that affects only part of the production; I wouldn't say it's "politically-motivated" or a dumb idea to pause AZ vaccinations until one does a deeper investigation; I personally chose to avoid AZ due to a history of strokes in my family, I preferred to reserve a spot on the Moderna list. Better safe than sorry.
Ummmm....we can wait and get another vaccine? The vaccine is done on HEALTHY people, we're not talking about meds on terminal stage cancer patients with nothing to lose.
Ummmm... I already have been vaccinated and it feels amazing not having a fear of death over me. Guess what. I'm going on vacation to a beach in a few weeks because you know, science.
Is that obvious? If you have the choice between self quarantining and trying to avoid contracting a virus that, if contracted, has a low percentage of killing you, vs choosing to get a vaccine that also has a low percentage of killing you, why would you choose the vaccine?
Maybe because one probability is significantly lower than the other. Maybe because you just can't self quarantine because you cannot work from home. Maybe because you need to take care of other family members and don't want to put them at risk.
There's a lot of good reasons for choosing a vaccine even if the risk isn't strictly zero. And you also need to remember that receiving vaccination isn't mandatory. If you personally aren't comfortable with the risks you don't have to get vaccinated.
This makes me skeptical of the suspension, but I'm not an export on these matters and haven't done enough research to claim to have done my due diligence, so I'll refrain from either advocating for or against this step.
Three weeks ago I was debating someone here on HN, defending the FDAs choice to deny approval of the AZ vaccine. I pointed out that while the FDA can be conservative compared to the EU, they have a strong track record of being right.
Thalidomide is the most well known example, but there are many others:
Given that some amount of alternate vaccines are available, governments are doing the right thing by "deferring" deployment of this vaccine for a short while, because this move has the highest chance avoiding direct harm to people from medicine (which is often perceived worse than harm that would have befallen people without medicine) and highest chance of avoiding an increase of brand-agnostic vaccine mistrust from the public.
As news about some countries pausing its deployment spread, the pressure rises on other countries to follow suit, as they weigh the risk of public mistrust.
If in the near future, public mistrust about this brand of vaccine climbs higher but confidence in other vaccines does not drop as much, then governments will benefit from having deferred deployment of this vaccine, and they may benefit further by suspending deployment of this vaccine entirely, even if the vaccine is entirely vindicated to be safe.
This outcome would be unfair for the manufacturer, but it would sacrifice this brand to preserve public trust. Public trust is a key factor in healthcare policy in societies where some healthcare participation is voluntary and elections can significantly influence policy priorities.
Thank you temp-dude for this viewpoint.
I did not think about it in this way before. Weighing the possible deaths of barring one of the vaccines against the possible deaths of a rise in mistrust towards vaccines seems like an impossible task.
However, the findings of blood clotting alone would not have sufficed for this argument as they really should be no cause for concern at this point in time. The knee-jerk response of other countries on the other hand makes this reasoning much more valid. Something something self-fulfilling prophecy
>Given that some amount of alternate vaccines are available, governments are doing the right thing by "deferring" deployment of this vaccine for a short while, because this move has the highest chance avoiding direct harm to people from medicine
I think so too, especially since AZ is one of the least effective ones available.
Sounds like a real world case of the trolly problem. Either take no action (by giving out no vaccine) and let hundreds die each day, or give out the vaccine and kill a few people each day (assuming the vaccine is causing the deaths, which likely isn't the case anyways).
That trolly problem is a one off. Having a major vaccine lead to serious issues puts all of vaccines into question, creating a far larger problem spanning time. It's already the case that various sub-communities are hesitant to get the vaccine based upon previous experimentation on their populations long ago, such as the Tuskegee Study.
> Having a major vaccine lead to serious issues puts all of vaccines into question, creating a far larger problem spanning time.
Is pulling the vaccine (with minimal evidence that it's causing issues) worse? How many people are going to turn down the AZ vaccine now, even if there's not actually an issue?
> Having a major vaccine lead to serious issues puts all of vaccines into question
This is false. Problems with AstraZeneca has little to do with any other vaccine. They're engineered entirely differently and mechanisms of action are wildly different.
Using the Tuskegee Study is a bad example. The African American community has among the lowest rates of vaccine hesitancy, it’s about half of what Republican males report.
Maybe AZ should have charged €3 per shot instead of €2 and spent the extra € on a PR agency. They just seem to be constantly taking a hammering in the press, unfairly I’d say.
I believe AZ have said they will not profit off the vaccine until the pandemic ends. The interesting thing is that they may get to decide when that happens.[1]
It was totally deserved, the EU helped fund the vaccine with a €336 million grant and what they did was stopping the exports from the UK plants to the EU while still exporting from the EU to the UK.No wonder that they didn't delivered the promised doses since their best efforts were being allocated to the UK.
This is false. The €336m was a down payment to AZ for 400m doses, not funding for development. It was agreed in August after protracted negotiations as the EU demanded a lower price.
Please provide some evidence for that claim. I've get to see even one bit of confirmation that this happened, just unfounded speculation by politicians playing political games (at the expense of their citizens' own health). The EU even went to raid the Belgian production facility to look for evidence this happened, and I've yet to see any further action after than. Want to bet it was completely made up?
The UK and EU supply chains are completely separate to the best of my knowledge. The UK manufactures and packages its supply, and the EU manufactures and packages its supply.
Not that unfairly. They keep reducing vaccine deliveries on short notice in the EU and have been opaque in general. I think they have delivered about 10% of what they agreed to for Q1.
Indeed they promised 120M doses in Q1 and so far delivered 12.3M, out of which about 70% has been administered. While delivering basically exactly as promised to the UK and having a stockpile of 30M doses waiting in a warehouse in the US because they paid a higher per dose price.
The feeling I am getting is that AZ is being less cautious with their promises. What I fear is that they did the same with their fase 3 trials.
I read an unsourced claim on HN a few weeks ago that they did 9 phase-3 trials, and applied for approval on the basis of only 2. Which would be rather bad if true. Moreover, it is clear that their 1.5 dose regimen was a mistake in trial execution.
Meanwhile, the FDA still hasn't approved AZ.
It seems possible that AZ was overeager to present good results, and thus was less cautious than they should have been.
It's only a possibility, but its one that worries me.
Anyone here have an source to confirm / debunk the rumor that AZ did 9 trials, and only applied on the basis of 2 trials?
edit:
I just looked at the stats in the UK, and it certainly seems like since they started vaccinating cases have dropped off, and deaths have dropped of even faster. Since vaccines are probably targeted at the more vulnerable, it certainly seems to show that the vaccine has very positive net effects.
I really don't understand the "unfairness" about how AZ is being treated. This isn't an NGO that's doing their best with limited resources, it's a private company that is getting funded to expand their operations - this isn't charity, and I doubt anyone asked for charity.
EU is buying vaccines with profit margins, and those are delivering.
If that cost structure is proving to not be enough for AZ, then they shouldn't have accepted it, because clearly what they are doing now is borderline criminal, all while hiding behind a "best effort" clause in a contract, that's being stretched far beyond what is acceptable.
They messed up the trials, they set up production infrastructure that would have never worked to begin with (because of the UK contract not allowing exports of vaccines), giving notice of failed deliveries on short notice, and still make new promises of deliveries that are showing yet again not to be true. They are yet to file approval for other production facilities in EU that should have been working for MONTHS.
Now they dare to question independent regulators from different countries by saying their vaccines are fine - when they didn't seem to even have bothered to investigate any of the cases - it's like they looked at a spreadsheet and said "this anomaly is within these intervals", completely disregarding the type of cases, their local incidence, time window and age group. Ignoring the fact that these occurrences are 4x greater then the ones in the UK.
I understand that the EU doesn't want to file a lawsuit because it's counter productive, but at this point I think it's the only path - pull the funding, place it on other candidates, sue AZ. It's too much incompetence for such an endeavor, which makes you question if they are not simply cutting corners. Again, they seem to be pushing "best effort" to what is acceptable.
Readit News
- billions per week of half assed lockdown vs a few billion more for high quality timeley vaccine delivieries of the good stuff --- of course they chose the lockdown
- open schools as if nothing happens vs using UV-based air filtering machines and so on as a minimum level of precaution --- of course they choose to open schools with classrooms some of which even don't have windows that can be opened properly
- governing party members of parliament scamming the public out of money by selling overly expensive, low quality masks
- minister of health busy sueing newspapers for disclosing prices on his million dollar real estate purchases vs minister of health actually being busy 24/7 with fighting the crisis
the list goes "on and on and on", these are just the most popular ones right now. It's just a dumpster fire at this point and the positives will not be recognized divorced from said pile of crap.
This is not the issue. A few billion would not have magically solved the problems with vaccine deliveries. The EU has contracts with pharmaceutical companies which these companies are not honoring sometimes intentionally so.
AstraZeneca for example doesn't have the production capacity to supply what they promised to the EU even if the Belgian site was working properly. That's the result of the EU audit. These companies are betting that the consequence of them not fullfiling their contractual obligation will be insignificant compared to their benefits. As these companies remain hugely profitable, their production issue is not linked to difficulty accessing capital. It is naive to assume things would have gone differently if the EU was paying more. It would just have meant more profits for them.
The heart of the issue is that contraty to the USA or China the EU is weak so companies don't hesitate trampling it. If a Chinese company did to China what AstraZeneca is doing to the EU, the CCP would take control of it and its CEO would never be seen again. Meanwhile, the USA has little qualm using its legal system to punish companies defying the state to much. Congressional inquiries are not fun.
Any potential safety issues with vaccines must be investigated, otherwise there will be a huge problem with trust in vaccines and in the regulator. There's already a huge problem with vaccine skepticism, and vaccine fanatics are making things worse.
Which is what WHO and EMA are saying. But now that there’s panic, they’re not relevant anymore.
Polititians are stuck between trying to make the free-for-all phase as long as possible, but still look as though they did everything to help, so that they can win the next election.
Compared to the status of 11.03.2021, additional cases (as of Monday, 15.03.2021) have now been reported in Germany. In the analysis of the new data status, the experts of the Paul Ehrlich Institute now see a striking accumulation of a special form of very rare cerebral vein thrombosis (sinus vein thrombosis) in conjunction with a deficiency of blood platelets (thrombocytopenia) and bleeding in temporal proximity to vaccinations with the COVID-19 vaccine AstraZeneca.
Translated with www.DeepL.com/Translator (free version)
Cerebral venous sinus thrombosis presents with nonspecific symptoms (eg headaches). It can only be diagnosed with cerebral imaging of specific modalities (CT or MR brain venogram, expensive and specialised tests). From speaking to colleagues in the UK, their hospital system is quite overwhelmed and doctors are repurposed outside their field (eg surgeons looking after internal medicine patients). It is quite possible in the throes of a pandemic to be underestimating the incidence of this condition in the UK.
"The decision today is purely precautionary..." given this level of signal. We don't have details on the age groups involved and the normal rates expected but I can hazard a Fermi Estimate that the risk is minuscule compared to COVID-19 itself. I look forward to seeing the actual data in coming days/weeks. Precaution without downside is acceptable; this is not one of those cases, IMO. YMMV.
You don't know this at all - we don't know what age groups are affected here, and COVID is pretty much negligible in many younger age groups. It's best to wait for more data to come in before drawing any conclusions.
1. If holding off AstraZeneca vaccine does not affect vaccination rate during the investigation period, it is a prudent thing to do.
2. If vaccine rate is expected to drop, number of expected increase in death per day due to covid vs blood clog should be compared, if we were to minimize short term death.
3. More concerning is unknown effect that could take a long time to materialize. This is a tough call to make since any effect is only theoretical at this point.
For those jurisdictions like the UK, India, and Canada that continue recommending AstraZeneca, I'd suggest that COVID-19 vaccines are like beer; the best one is the one in front of you.
[1] https://youtu.be/xbLJCh9XHl0?t=23m42s
[2] https://en.wikipedia.org/wiki/Vaccine_adverse_event
Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society).
https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoel...
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca? It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC. The consideration of whether the vaccine can continue to be used even though it may cause this very rare side effect (if necessary, after this risk has been added to the SmPC) will be made at the European level by the European Medicines Agency (EMA) and at the national level by politicians. The procedure has been initiated.
Which sounds pretty clearly like bureaucratic CYA instead of an actual cost/benefit analysis that takes into account the excess deaths that are now being caused due to pausing the vaccine rollout.
"This potential side-effect is not listed in the SmPC so we need to pause vaccinations", ignoring the fact that hundreds of people are dying every day in Germany (https://www.google.com/search?q=germany+covid+case+fatality+...).
Dead Comment
I've had elevated blood markers for clotting during covid-19, and now I hear of this.
I'm thinking of taking 75 mg aspirin, before and after the vaccine. On the other hand, the issue is the patients have low platelet count and I understand that this is the way aspirin reduces blod clotting.
So, do these patients have low platelet count because they had blod clots, or the other way around?
Afik, in the case of COVID-19, clotting is an autoimune issue, so perhaps the clotting is not something related to the astra Zeneca vaccine, but something about the immune response itself.
https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/al...
[0]: https://www.wsj.com/articles/astrazeneca-warns-europe-of-lar...
Of course they are influenced by what they see in the news and questions by the government, but aren't a political player.
https://en.m.wikipedia.org/wiki/Paul_Ehrlich_Institute
Humans aren’t rational.
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.
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.
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.
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.
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!
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"
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.
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.
The equation changes when otherwise young and healthy individuals are at risk of serious complications, even if exceedingly rare.
> I don’t know anyone in pharmacovigilance who thinks what is happening now in EU states is rational based on known information.
> EMA had this right last week. We are seeing panic spread at EU state level.
https://twitter.com/isth/status/1370424157947752452
> 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.
> Difficult to call, but I hope it's all being investigated thoroughly
I agree there. But rather not for medical reasons.
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.
Litterally all members of the same economic and political Union. The EU.
Pfizer: https://assets.publishing.service.gov.uk/government/uploads/...
AstraZeneca: https://assets.publishing.service.gov.uk/government/uploads/...
Disclaimer from UK.gov:
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...
Edit: Added disclaimer from UK.gov
Slightly different reporting periods but I'm pretty happy with the odds and I'd take either if offered.
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.”
https://www.astrazeneca.com/media-centre/press-releases/2021...
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.
Can we please fucking stop the downvotes?
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.
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.
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.
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!
Make sure to get plenty of water and rest :)
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.
Just a thought with zero data behind it...
Twitter thread with some commentary & sources:
https://twitter.com/Martin_Moder/status/1371033872046166025
The Irish reasoning for suspending AZ wasn't just because of blood clots but blood clots in the brain which have a completley different severity.
https://www.astrazeneca.com/media-centre/press-releases/2021...
https://www.theverge.com/2021/3/7/22318113/russia-intelligen...
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.
'See, we were right not to vaccinate this fast'
For the downvoters: https://www.theguardian.com/commentisfree/2021/mar/15/eviden...
Am I missing something, how's that supposed to help ?
The alternative Pzifer jab is 10-20 times as expensive.
That is a lot money, some of which may find its way to work the media and the decision makers.
https://www.ft.com/content/c474f9e1-8807-4e57-9c79-6f4af145b...
AstraZeneca vaccine document shows limit of no-profit pledge
Company has right under contract to declare pandemic over by July 2021
Dead Comment
Dead Comment
Dead Comment
Adenovirus-induced thrombocytopenia: the role of von Willebrand factor and P-selectin in mediating accelerated platelet clearance
https://www.sciencedirect.com/science/article/pii/S000649712...
You can see the number of reported cases across Europe in the EUDRA Vigilance database (if you manage to get through the Oracle BI interface and if it doesn't error out)
https://www.ema.europa.eu/en/human-regulatory/research-devel...
I don't understand why AstraZeneca doesn't just say: yeah blood clots are a risk, incidence 1/100,000 and everyone can move on. Why does everything needs to be so politicized with this vaccine.
It is politicized because it effects more or less everyone on the planet and people are setup to take popular things and turn them into polarizing issues for political power in politicians and social capital for ordinary people. This is how a whole lot of people seek out happiness, by being "right" in their social circles, especially in a way that shows them as superior to large groups of others who are "wrong".
Social media preys intentionally or unintentionally on this human psychological vulnerability (can we get a CVE on the human psyche?) and every bit of media wants to sell you a compelling story so they stoke the flames of A/B conflicts.
The mass psychology/mythology/philosophy of the day is based around this crap and will turn anything into a "political" issue and people just generally aren't well educated enough to think independently or evaluate situations rationally on their own so they allow their reason to be driven by systems which are evolutionarily dependent on preying on addictive human behavior.
- Johnson & Johnson (USA)
- Sputnik V (Russland)
- CanSino (China)
You can't make the same decisions about risks when you have one side so skewed by age. There is absolutely no guarantee that side effects from vaccination would be a preferable risk for younger populations or that vaccination side effects would have comparable age-related effects.
Covid response isn't a religion, it's not "we have to do everything" or "we shouldn't do anything", responses need reason not gut reactions.
Depending on the type of adverse reaction, it might be safer for young people to not get vaccinated at all or with a different vaccine. (For example if the adverse reaction affects mostly young people, while COVID affects mostly older people.)
I believe it's likely that lockdowns may cause some deaths, or possibly even lots of deaths. However, they certainly help prevent the spread of deadly disease too and hence prevent many deaths. We can probably get fairly definite numbers on how many deaths lockdown prevents in a large population. I don't think we can get similar numbers on how many they cause. My gut says they probably prevent a lot more than they cause, but I'd like to see any studies on this, if anyone has a link to share.
I feel bad for people in countries where people are even restricted from being outdoors, despite hearing again and again that outdoors is the safest place to be.
Do not forget that these vaccines are still very new, plus there's the possibility of a production issue with the AZ vaccine that affects only part of the production; I wouldn't say it's "politically-motivated" or a dumb idea to pause AZ vaccinations until one does a deeper investigation; I personally chose to avoid AZ due to a history of strokes in my family, I preferred to reserve a spot on the Moderna list. Better safe than sorry.
Deleted Comment
Deleted Comment
Dead Comment
There's a lot of good reasons for choosing a vaccine even if the risk isn't strictly zero. And you also need to remember that receiving vaccination isn't mandatory. If you personally aren't comfortable with the risks you don't have to get vaccinated.
This makes me skeptical of the suspension, but I'm not an export on these matters and haven't done enough research to claim to have done my due diligence, so I'll refrain from either advocating for or against this step.
Dead Comment
Thalidomide is the most well known example, but there are many others:
https://en.wikipedia.org/wiki/Lumiracoxib -- Approved in Europe, not the USA. Withdrawn from sales due to side effects.
https://en.wikipedia.org/wiki/Zimelidine -- Same.
https://en.wikipedia.org/wiki/Tolrestat -- Approved in Europe, failed stage 3 clinical in the USA
https://en.wikipedia.org/wiki/Rimonabant -- Approved in Europe, failed in the USA, withdrawn worldwide because the side effects were so bad.
As news about some countries pausing its deployment spread, the pressure rises on other countries to follow suit, as they weigh the risk of public mistrust.
If in the near future, public mistrust about this brand of vaccine climbs higher but confidence in other vaccines does not drop as much, then governments will benefit from having deferred deployment of this vaccine, and they may benefit further by suspending deployment of this vaccine entirely, even if the vaccine is entirely vindicated to be safe.
This outcome would be unfair for the manufacturer, but it would sacrifice this brand to preserve public trust. Public trust is a key factor in healthcare policy in societies where some healthcare participation is voluntary and elections can significantly influence policy priorities.
However, the findings of blood clotting alone would not have sufficed for this argument as they really should be no cause for concern at this point in time. The knee-jerk response of other countries on the other hand makes this reasoning much more valid. Something something self-fulfilling prophecy
I think so too, especially since AZ is one of the least effective ones available.
Is pulling the vaccine (with minimal evidence that it's causing issues) worse? How many people are going to turn down the AZ vaccine now, even if there's not actually an issue?
This is false. Problems with AstraZeneca has little to do with any other vaccine. They're engineered entirely differently and mechanisms of action are wildly different.
Source: https://www.axios.com/concern-republican-coronavirus-vaccine...
The number of people who got sick equals the base rate, so I really don't see how this could be the case.
So they are only technically allowed to adjust the price to take into account the different operational costs depending on the manufacturing site.
[1] https://www.fiercepharma.com/pharma/astrazeneca-puts-a-time-...
I do think people aren’t giving AZ enough credit for doing it at cost though. Especially compared to the €50 per dose Pfizer initially quoted the EU!
The UK and EU supply chains are completely separate to the best of my knowledge. The UK manufactures and packages its supply, and the EU manufactures and packages its supply.
Dead Comment
I read an unsourced claim on HN a few weeks ago that they did 9 phase-3 trials, and applied for approval on the basis of only 2. Which would be rather bad if true. Moreover, it is clear that their 1.5 dose regimen was a mistake in trial execution.
Meanwhile, the FDA still hasn't approved AZ.
It seems possible that AZ was overeager to present good results, and thus was less cautious than they should have been. It's only a possibility, but its one that worries me.
Anyone here have an source to confirm / debunk the rumor that AZ did 9 trials, and only applied on the basis of 2 trials?
edit: I just looked at the stats in the UK, and it certainly seems like since they started vaccinating cases have dropped off, and deaths have dropped of even faster. Since vaccines are probably targeted at the more vulnerable, it certainly seems to show that the vaccine has very positive net effects.
EU is buying vaccines with profit margins, and those are delivering.
If that cost structure is proving to not be enough for AZ, then they shouldn't have accepted it, because clearly what they are doing now is borderline criminal, all while hiding behind a "best effort" clause in a contract, that's being stretched far beyond what is acceptable.
They messed up the trials, they set up production infrastructure that would have never worked to begin with (because of the UK contract not allowing exports of vaccines), giving notice of failed deliveries on short notice, and still make new promises of deliveries that are showing yet again not to be true. They are yet to file approval for other production facilities in EU that should have been working for MONTHS.
Now they dare to question independent regulators from different countries by saying their vaccines are fine - when they didn't seem to even have bothered to investigate any of the cases - it's like they looked at a spreadsheet and said "this anomaly is within these intervals", completely disregarding the type of cases, their local incidence, time window and age group. Ignoring the fact that these occurrences are 4x greater then the ones in the UK.
I understand that the EU doesn't want to file a lawsuit because it's counter productive, but at this point I think it's the only path - pull the funding, place it on other candidates, sue AZ. It's too much incompetence for such an endeavor, which makes you question if they are not simply cutting corners. Again, they seem to be pushing "best effort" to what is acceptable.