Germany pauses AstraZeneca vaccinations as a 'precaution' (opens in new tab)

- 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.

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.

> 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+...).

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.

[0]: https://www.wsj.com/articles/astrazeneca-warns-europe-of-lar...

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.

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.

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.

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

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.

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!

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.theverge.com/2021/3/7/22318113/russia-intelligen...

'See, we were right not to vaccinate this fast'

For the downvoters: https://www.theguardian.com/commentisfree/2021/mar/15/eviden...

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.

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.)

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.

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.

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.

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.

I get that herd immunity won't occur if a significant proportion of population isn't immunized... but it still works on an individual basis.

[1]: https://www.francetvinfo.fr/live/message/604/f7f/da5/ff4/e9f... (in French)

I'm not saying the conclusion is incorrect, but it's driven by fear, uncertainty, and doubt -- not quite the same as a clear evidentiary basis.

That could be acceptable if the logic goes that AZN bears the burden of proving that every potential adverse side effect is extremely rare. However, by that logic the vaccinations will be paused several times and more people will suffer due to COVID.

Also, I'm pretty sure each regulator knows the pros and cons of this decision, and they know well the consequences of stopping the vaccination - it's not like they are all incompetent. I mean, imagine the odds of the amount of ignorance to have reached this level of decision making in several independent countries.

Not likely, at all.

It's not a "a case where a cautious ‘first do no harm’ approach will likely cost many lives.", it's them doing their job and follow the procedure that has worked pretty well, based in science. It's what builds trust in vaccines and medicines, knowing that regulators are there, aware, and if they think something is wrong they won't take a stupid risk out of pride or pressure.

https://mobile.twitter.com/politicsforali/status/13714790084...

EDIT: as pointed out elsewhere, the official press release gives us that there has been new data in the past few days with a specific concern, that's at least some info.

WHO say no evidence of any risk https://www.bbc.co.uk/news/world-europe-56404542

I've personally seen the waiver forms send to doctors, and none of the usual testing was done, including the effect on youngsters, pregnant women, etc.

There is a very good reason we had these regulations in place to begin with.

tl'dr: Governments have let AZ off the hook legally if side-effects or worse occur.

The summary of the experts' opinion in the UK is that those countries' decision to suspend the vaccine is "baffling".

You're criticizing EU commission for transparently expose the shortcomings of this private company, but you seem to forget what this wave of what apparently are thousands of "internet specialists" that know better then independent regulator bodies for medicines.

Yes, this isn't EMA (that British propaganda painted as a slow and incompetent agency) - it's each country own regulator that have been responsible for the safety of millions of citizens, and they have been doing a pretty good job for many, many years.

This isn't a joint operation. It's scientists expressing their concern about these cases which are anything but normal.

Or now, every single EU country regulator (including Norway) are all incompetent, including the doctors who reported these cases and are following closely their development? They're all in this conspiracy to put down AZ?

I mean people rightfully criticize anti-vaxxers, but trust me, this bullshit attitude is just the same as the anti-vaxxers. It's blind fanaticism towards a vaccine, that even science should be disregarded, exactly the extreme opposite of anti-vaxxes.

AZ was considered less trustworthy than Pfizer or Moderna vaccines several months before that due to irregularities in phase 3 clinical trials (original dosage leads to ~62% efficacy, while inadvertently given half-dose to a part of test subject leads to higher efficacy): https://www.thelancet.com/journals/lancet/article/PIIS0140-6...

Conflicts between AZ and EU commission seems silly compared to that and IMHO lead more to discreditation of Ursula von der Leyen.

source? Yes, there is some negative opinion about this, but at least in Germany it's much more based on media citing "government sources" and general FUD tactics than anything the commission has said.

The big impact is not a few days of delay. The big impact is the loss of trust in this vaccine in the general populace.

> I'm assuming that these decisions aren't political and are genuinely being taken for medical reasons. I mean, I sure hope so.

Obvious disclaimer: I'm not a medical expert.

However, I wouldn't be so sure it's a wise decision. I primarily trust Karl Lauterbach's [1] opinion on these matters, and he is actively criticizing the move on Twitter as an overreaction [2].

[1] Karl Lauterbach is the director of an institute for epidemiology at a German university and also a member of the German Federal parliament for the Social Democrats (who are part of the current coalition).

[2] Source (in German): https://twitter.com/Karl_Lauterbach/status/13714710614018949...

Not that I agree with the decision, but it's more complicated. People have to trust the vaccines to actually take them. There is already the fear that the process has been rushed, and particularly with AstraZeneca, there are some trust issues. Again, I don't want to argue that the concerns themselves are founded, just that they exists.

If that is the right measure to address those concerns is not purely medical or easily quantifiable. If you don't suspend it, would people still take the vaccine? Would they take the others?

Personally, since that is the case, I think one should stick with the facts. Be transparent about it, and try not to preempt whatever people may think. I would take it without a moment of hesitation, if I would be offered the opportunity.

One of the many unknowns about these vaccines is the length of time they give immunity, this can only be determined with confidence by looking at the data after a sufficient amount of time has passed. If the immunity only lasts for say 10-20 weeks, then getting it one week early, would mean the immunity goes away one week early as well. So in this case, I'm not sure there would be a major measurable impact. If the immunity lasts for say 50 weeks, that would be a different story.

> making it the latest of several European countries to hit pause

The article also cites the EMA, an EU institution, and notes:

> Several EU countries have called a halt to the AstraZeneca vaccine

Would you have them list each and every country individually? It seems, to me, that you're just complaining for the sake of complaining. Expect better of HN comments.

Romania hasn't, only for specific lot numbers that were reported by Italy and Denmark as problematic.

AstraZeneca: 13 Pulmonary embolisms Pfizer-BioNTech: 15 Pulmonary embolisms

Public health really hasn't been upfront with a lot, and their back and forth on a number of issues, while maintaining this air of authority is ultimately counter-productive to building trust.

On Monday Germany, Spain, Italy, and France were among those to suspend deployment of the vaccine, following similar moves made last week by Denmark, Norway, Ireland, and others.

Let me correct that understanding. The EU is absolutely short on doses. AZ has only delivered 10% of what they promised. There is no doubt if the EU had a greater supply the vaccine rollout would be going much better.

Interesting that Twitter and Facebook also not labeling the concerns about AZ as "Fake News" so likely there is some merit to the claims against AZ.

I am also against taking AZ as well. If HN folks are confident it is fine go ahead. I will choose what I'm comfortable with and Germans or anybody else for that matter should have a say.