Follow Slashdot blog updates by subscribing to our blog RSS feed

 


Forgot your password?
Close
typodupeerror
×
Medicine

Germany Suspends Use of AstraZeneca Vaccine, Along With Italy, France, Spain (dw.com) 184

Posted by msmash from the closer-look dept.
Germany on Monday halted use of the AstraZeneca coronavirus vaccine, the Health Ministry announced in a statement, with Italy, France and Spain following suit later in the day. Several other EU countries have stopped use of the vaccine because of the possibility of blood clots. From a report: The Health Ministry announced that use of the vaccine was "suspended as a precaution" on the basis of advice from the national health regulator, the Paul Ehrlich Institute (PEI). According to the Health Ministry, the European Medicines Agency (EMA) will decide "whether and how the new information will affect the authorization of the vaccine" pending an investigation. "After new reports of thrombroses of the cerebral veins in connection with the vaccination in Germany and Europe, the PEI considers further investigations to be necessary," the Health Ministry announced. German Health Minister Jens Spahn said "the decision is a professional, not political one," following advice from the PEI. Spahn said the risk of blood clots from the AstraZeneca jab is low, but could not be ruled out. "The most important thing for confidence is transparency," Spahn said during a briefing.
This discussion has been archived. No new comments can be posted.

Germany Suspends Use of AstraZeneca Vaccine, Along With Italy, France, Spain More

Germany Suspends Use of AstraZeneca Vaccine, Along With Italy, France, Spain

Comments Filter:

  • Confidence in Trials (Score:5, Interesting)

    by Thelasko ( 1196535 ) on Monday March 15, 2021 @02:02PM (#61161648) Journal
    Are they not confident in the clinical trials? Thrombosis is pretty common in the general population. The rate of thrombosis among the vaccinated population would have to be much higher than typical to warrant this action. Without a blind trial, it's impossible to tell if the vaccine is the cause, or it's a coincidence.

    If the vaccine is the cause, why didn't this show up in the trials?

    • Re:Confidence in Trials (Score:5, Interesting)

      by JaredOfEuropa ( 526365 ) on Monday March 15, 2021 @02:15PM (#61161690) Journal
      Problem is that they've seen a somewhat high incidence of a relatively rare form of thrombosis. Not enough to draw the conclusion that there is a statistically significant relation between the two, but it drew enough attention to warrant a closer look at what's going on. This might be rare enough to not show up during the trials.

      • Re:Confidence in Trials (Score:5, Insightful)

        by Thelasko ( 1196535 ) on Monday March 15, 2021 @02:58PM (#61161908) Journal

        This might be rare enough to not show up during the trials.

        Is it more common than dying from Covid-19? Suspending the vaccine distribution has it's own set of risks. At this point in the process, there needs to be some strong evidence to make this decision.

        • Yes, this seems to be really the wrong response. This is using the "precautionary principle" in exactly the wrong way. Rather than do an estimate of lives-lost v. lives-saved, they are just going with non-intervention being automatically better than intervention.

          • Re: (Score:3)

            by jabuzz ( 182671 )

            This is called the EU messed up the vaccination program, are not getting as many AstraZeneca doses as they hoped so let's divert attention away form that by saying the vaccine is "suspect".

            The main issue is that the UK paid AstraZeneca to set up new production facilities in the UK, with the first 100 million doses of the new production line reserved for the UK. The UK also paid for this several months before the EU got it's ass in gear and ordered. Then with less time to work out the kinks there where probl

            • Re:Confidence in Trials (Score:5, Interesting)

              by JaredOfEuropa ( 526365 ) on Monday March 15, 2021 @04:25PM (#61162264) Journal
              Not quite. The UK placed their order a few days after the EU did, under largely similar terms. However these contracts are enforced under quite different legal systems, which gives the UK a distinct edge over the EU if they want to threaten legal action. For AZ, it's a no-brainer who gets priority, regardless of which production facility got up and running first. Though as we've seen before, posession is 9/10th of the law sometimes.

              That's not to say that the EU screwed the pooch in a big way on the vaccination. Even though quite a few of the vaccines were actually developed here in the EU, every subsequent step, from production, logistics, ordering, to rollout, has been a day late and a dollar (euro) short. The numbers don't lie, and we are way behind the rest of the developed world when it comes to vaccination rollout.

              • Re: (Score:2)

                by jabuzz ( 182671 )

                Have a source for that because the reporting by reputable news sources in the UK (BBC, Channel 4 etc.) was that the UK signed their contract well before the EU did.

                • AstraZeneca CEO Pascal Soriot made the argument that the U.K. had better vaccine supply because the U.K. signed an agreement for vaccines months earlier than the EU. Formally, this isn’t true: The U.K. contract was signed on August 28, while the EU’s was signed a day earlier on August 27. However, the key lies in an earlier agreement that AstraZeneca made back in May with the U.K., which was a binding deal establishing “the development of a dedicated supply chain for the U.K.,” an AstraZeneca spokesperson said.

                  So it depends a little on how you interpret things. From https://www.politico.eu/articl... [politico.eu]

            • Re: (Score:2)

              by AmiMoJo ( 196126 )

              The EU had stockpiles of the AZ vaccine just waiting to be delivered.

              The UK signed its contract with AZ the day after the EU signed theirs. Same terms, best effort. The EU invested a lot of money in new manufacturing facilities, far more than the UK.

              • Re: (Score:2)

                by ac22 ( 7754550 )

                You're parroting lies again, AmiMoJo. The EU invested more money in AZ manufacturing facilities than the UK?

                Prove it. Prove it, or stop lying. I don't normally get this angry about a post, but in this instance, AmiMoJo is deliberately trying to deceive you. The EU gave French Sanofi money for 300 million vaccine - heard anything about that vaccine?

          • >"Suspending the vaccine distribution has it's own set of risks. "

            Unfortunately, one of those risks is that people who were already suspect of vaccines are going to use this to reinforce their negativity towards ALL COVID-19 vaccines. Meaning, it will lead to lower vaccination rates, even in nations not using the AstraZeneca, like the USA.

            • Which of course is completely backwards since this just shows that the authorities takes any possible side effects from Vaccines very seriously so it should instead increase peoples trust in the system, but people decided to be stupid instead.

        • This might be rare enough to not show up during the trials.

          Is it more common than dying from Covid-19? Suspending the vaccine distribution has it's own set of risks. At this point in the process, there needs to be some strong evidence to make this decision.

          Possibly, but vaccines are given to healthy people, not sick people, so there's a fairly high standard for avoiding harmful side effects.

          In addition, AstraZeneca isn't the only vaccine. So the trade-off in suspension isn't between vaccinating and not vaccinating, it's between vaccinating now and vaccinating later.

          Finally, vaccine hesitancy is a serious issue, it's actually not a given that we'll be able to vaccinate enough people to achieve herd immunity. Not suspending AstraZeneca, especially if the blood

        • The vast majority of us are doing just fine with proper sanitation and social distancing. Vaccines aren't needed to be safe from the virus. If one of them is potentially causing life-threatening harm, then it's smart to investigate that while continuing with other vaccines and what's been working for over a year.

        • Re: (Score:2)

          by rtb61 ( 674572 )

          I like the implication, right now it is a toss up which is more dangerous, the vaccine or the virus, think about that. Hmm, not sure, so much for the Hippocratic oath (do no harm swapped with pharmaceutical profits first).

          How about his, all those who tested positive for the virus, do not need the vaccine, why take the risk for ZERO benefit. How about testing for antibodies prior to vaccinating, that wont kill or harm anyone and if they have already had the virus, zero benefit in the vaccine. It is not like

        • Is it more common than dying from Covid-19?

          Depends on where you are and who you are. Here in Australia we've had zero deaths this year. So for me, the vaccine is a higher risk.

          At this point in the process, there needs to be some strong evidence to make this decision.

          Do you think that the chief medical officers in these countries know less about this than you?

    • Re: (Score:2)

      by Tablizer ( 95088 )

      It sounds like they are not sure if the clot rate of testers is higher than normal. It's on the borderline between normal and suspect.

      why didn't this show up in the trials?

      These are generally "emergency trials" to speed things up. That's been stated up front. Ideally you want to test on millions of volunteers, but due to the rush it only started with thousands. As time goes on you get a bigger and more telling sample size.

      This kind of thing was and is expected with a rushed process.

      It's why multiple parall

      • These are generally "emergency trials" to speed things up. That's been stated up front. Ideally you want to test on millions of volunteers...

        You don't need a million volunteers. That would yield a confidence of +/- 0.1%. When battling a disease that kills >1% of those infected, that kind of confidence is just wasting time and resources. A trial size of 10,000 individuals in each group yields a confidence level of around 1%. It soundly proves the vaccine is safer than the virus it's designed to fight.

        The only thing rushed is the long term effects of the vaccine. Which historically appear within 120 days. We are beyond that point, and w

        • There is no reason this shouldn't have shown up in the clinical trials.
          Yes there is. Age distribution.

          Clinical trials are usually done on rather young and healthy people. In the real world people are overweight, old whatever ...

          • Clinical trials are usually done on rather young and healthy people. In the real world people are overweight, old whatever ...

            Where did you get this information? Doing that would be negligent. Clinical trials should be performed on randomly selected individuals, or stratified sampling with stratifications that accurately represent the general population.

            • No, a trial should start with young and healthy volunteers, to minimise the risk if something doesnâ(TM)t work as expected. Once you know young and healthy people are fine, you should proceed with people that are more at risk.

              I read they want to extend vaccinations to kids. To do that youâ(TM)d do a trial for 16-17 year olds, when thatâ(TM)s fine 14-15 year old etc.
      • No, this was not expected and the trials weren't rushed or under-scaled for any of the other vaccines. It's just AstraZeneca/Oxford specifically that has been bumbling along from one problem and inadequacy to another.

        • Re: (Score:2)

          by jabuzz ( 182671 )

          Not true there are people taking the Pfizer vaccine getting blood clots too. This is political crap to divert from a borked EU vaccine procurement program.

          Remember if I where to get millions of people to come in special seating rooms and sit down for 15 minutes. The next day a whole bunch of them would drop down dead from heart attacks and strokes.

          It is only relevant if more people than you would expect are afflicted and the evidence with the blood clots is that this just normal rates. Even if it was slight

        • Re: (Score:2)

          by Cederic ( 9623 )

          That's odd. AZ have been quietly and efficiently delivering millions of safe vaccines that have been used across many countries with no issues.

          That's not bumbling. That's not inadequacy. You must work for the EU, whose bumbling inadequacy has led them to demean and blame AZ for all the EU's vaccine failures.

      • You're too optimistic on the sample size [wikipedia.org]. The vaccines were tested on more people than a typical approved drug.

    • Re: (Score:2)

      by sjames ( 1099 )

      It's not that uncommon for side effects of a drug to be discovered after approval. It's a combination of a much larger sample size and often sub-populations that weren't included in the pre-approval trials.

      It is also possible that this is a correlation without causation. That's why use is only suspended at this time while they figure that out.

    • The depends heavily on how you define "common"

      The first numbers I could find were for Spain*, which saw an average of 16,000 patients per year admitted with DVT from 2001 to 2003. With a then-population of 41M that's only about 0.039%, or 1 in 2,500

      Testing only ran for a few months - call it 4 to be generous. Which means you'd only expect about 1 in 7,500 patients to be admitted for DVT normally. And I'd expect most of those cases actually occur in the elderly - who were not included in the COVID tests.

      • All of which combine to mean you'd need a test population in the hundreds of thousands to have any hope of detecting a doubling or tripling of the DVT rate with any degree of statistical significance.

        You don't need to detect doubling or tripling of DVT. You only need to understand if the risk of death from the vaccine is higher than without it. With a fatality rate of >1%, a trial size of 10,000 participants per group will do that.

        DVT is an understood and treatable disease. Highly effective treatments have been around for over 70 years. Covid isn't well understood, and there are few treatments. Even with treatment, the risk of death is high. At this point there would have to be extraordinary

        • Re: (Score:2)

          by DarkOx ( 621550 )

          DVT is an understood and treatable disease.

          You think that holds up when the DVT is possibly some kind of autoimmue thing related to MRNA vaccines never used in humans before?

          The fact is there IS a lot we don't know and these were approved with abbreviated process. Just because we all really really want these to be safe so we can all put our covid worries behind us does not make them so.

          • You think that holds up when the DVT is possibly some kind of autoimmue thing related to MRNA vaccines never used in humans before?

            TFA is about the Oxford-AstraZeneca vaccine that uses ChAdOx1 technology. [nytimes.com]

            • TFA is about the Oxford-AstraZeneca vaccine that uses ChAdOx1 technology.

              All four vaccines Pfizer/Moderna/AZ/JJ do the same shit in the end.

              Pfizer/Moderna deliver RNA directly to make spikes.

              AZ/JJ get into the nucleus and screw with DNA to get it to deliver RNA to make spikes. At the end of the process you end up with a cell full of covid spike analogue thingis sticking out of it /w all four of the vaccines.

              • That's absolutely correct, they are all mRNA therapies not approved for anything much before now but were fastest ways to make the covid19 vaccines that could be produced in large volumes. They all get your own body/cells to produce something similar to the corona virus and then your immune system attacks it and gets trained. The traditional vaccines use an actual inactivated corona virus, like Covaxin from Bharat Biotech.

                • Re: (Score:2)

                  by jabuzz ( 182671 )

                  Rubbish the Oxford AstraZeneca and Sputnik V are traditional modified virus vaccines just with modern technologies it is much much easier to modify a virus. The Johnson & Johnson is a DNA vaccine.
                  Stop spouting factually incorrect quack science.

          • You think that holds up when the DVT is possibly some kind of autoimmue thing related to MRNA vaccines never used in humans before?
            That does not make any sense. How should that be possible?

            • You talk as though we understand biology.

              We're still discovering whole new organs we didn't know existed. Our understanding of the details of cellular biology is still in its infancy. When we can design and build a living cell from scratch, then we can start acting like we really understand things. We'll probably still be wrong, but at least our hubris would have some justification. For now, we're just barely scratching the surface, and unexpected side effects are the rule rather than the exception.

              • You talk as though we understand biology.

                We're still discovering whole new organs we didn't know existed. Our understanding of the details of cellular biology is still in its infancy. When we can design and build a living cell from scratch, then we can start acting like we really understand things. We'll probably still be wrong, but at least our hubris would have some justification. For now, we're just barely scratching the surface, and unexpected side effects are the rule rather than the exception.

                What's the difference between saying this and saying we don't know its not aliens?

                • Do we have any reason to believe it's aliens? Do we understand the system well enough to be able to reasonably predict what would happen if there were no aliens involved? Then so long as it's within the error bars of the prediction, and there's no specific reason to believe aliens are involved, then it's silly to assume they were.

                  With biology, the error bars in our understanding are so large that whole fleets of aliens could be effing with us and we'd never know - and so it's silly to blame them unless we

        • Let me preface my comment by stating that I'll take a vaccine when it's offered to me. I'm in the UK so we don't get a choice of which, but I'm hoping this AZ situation is resolved so I can take whichever with confidence.

          I think it's more nuanced than simply comparing death rate from vaccine vs covid. I'll use myself as an example: healthy male in 30s with good weight. I'm struggling to find some stats I have complete confidence in but it looks like the CFR for 30-39 is somewhere in the region of 0.3%. IFR

          • Re: (Score:2)

            by jabuzz ( 182671 )

            What you haven't factored into that is the very very real risk of long COVID. So your chances of dying from COVID are low, your chances of suffering long term debilitating complications are many times higher. People your age who used to run marathons that can now barely get up the stairs, for which this might be a life long side effect. There are people your age who got sepsis that have had hands and feet amputated which is definitely a life long side effect.

        • This is the reason so many people distrust vaccines. Vaccine maximalists say shit like "it's perfectly safe" and "in trials, more people survived with the vaccine".

          The first is a blatant lie. Doesn't stop the medical community from spouting it occasionally, or others to do so ad nauseum. People do die of vaccines. None of them is perfectly safe. And those who claim they are perfectly safe lose all credibility after a single linked death.

          The second statement is more subtly problematic. It may be true. But th

    • Re: (Score:2)

      by pesho ( 843750 )
      In addition to the other replies, you have to consider that this could be a manufacturing problem or quality control problem that was not present during the trails. AZ/Oxford already has one documented incident where they don't seem to have taken sufficient care of QC. This was during the clinical trials when it turned out that a number of people were vaccinated with half of the intended dose. The reason is that the virus from one supplier had more additive (polysorbate 80) than the formulation specified. T
    • The results are not definitive. In analyzing the current vaccination patients there seems to be something worthy of investigation. As for why it did not show up in the trials, that is why it is an investigation.
    • The trials only tell you if the vaccine design is ok, they don't tell you anything about quality control problems that might happen after the trials are done. This problem sounds a lot like bad batches being mixed in with otherwise ok vaccine. On the other hand, thrombosis is pretty common as a baseline, but this particular case seems to be a weird type of thrombosis... it's pretty hard to tell if this is a real problem or not, but a little pause to figure things out doesn't cost too much

    • Thrombosis is actually lower than the general population ... and lower than the otherwise vaccinated population ..if anything the data shows that the Oxford/AstraZenica vaccine prevents it ... mostly because one one the symptoms of Covid-19 is Thrombosis ...

    • Re: (Score:2)

      by prefec2 ( 875483 )

      Current figures show that 7-11 (depends on the source) thrombosis cases are on record to 1.2-1.6 mio does. Birth control pills sold to women starting at age 16 have a 1:10 000 risk of thrombosis. This reaction of some EU countries is insane. I am totally disappointed in our governments. Most likely they are just afraid of the nutters who "think" Corona is fake. They are close allies of qanon and Nazis. Esp. in Germany. They only have approx. 10% of the population behind them, but politics are not doing anyt

  • First the US was being stingy (Score:5, Insightful)

    by WoodstockJeff ( 568111 ) on Monday March 15, 2021 @02:03PM (#61161652) Homepage

    Because we wouldn't let AZ send the vaccine stored in the US (but hasn't been approved here yet) to the EU. Reportedly, we haven't approved it because of the problems discovered in the EU.

    Now the EU doesn't want it anymore. At least, this week.

    • Re: (Score:2, Funny)

      by thegarbz ( 1787294 )

      Now the EU doesn't want it anymore. At least, this week.

      This may come as a shock to an American, but the EU is more than 4 countries. I mean I get it though we all know America consists of Texas, Washington (which is somehow on the east and west coast at the same time), and Dakota though for some reason you act like there's two states called Dakota which is confusing to us all.

      • This may come as a shock to an American, but the EU is more than 4 countries.

        And the French. And the Germans. People from Italy and Spain might raise an eyebrow at that.

  • I have it on very good authority that this is fake news and a Q-Anon conspiracy theory. I demand a moderator remove this comment or tag it as being untrue. I would be all for letting the stupid kill themselves but if they aren't getting this vaccine then they're killing us! You will take the vaccine and you will like it, even if it kills you!

  • I'm not talking about this vaccine itself, but any news like this clouds all of the vaccines and inclines people to stay away from them that are on the fence about taking them.

  • I've heard from a reliable actress that the Pfizer vaccine causes autism. At least I think.

    Seriously, you put this in the arms of millions of people, you're gonna have some issues.

  • politics (Score:3)

    by Tom ( 822 ) on Tuesday March 16, 2021 @01:11AM (#61163632) Homepage Journal

    Note that the German minister of health is a failure who desperately needs to distract from his multiple fuck-ups in handling the crisis. Before Corona, his name was in a hat as a potential future prime minister of Germany after the September elections. Those days are over.

    So yeah, there's the real reason. He needs to be seen "doing something" instead of simply fucking everything up. (it didn't help that in the middle of last year he bought a villa that he cannot possibly have paid for from his salary as a minister)

    It's all politics and has very little to do with health, side effects or anything. It just happens to be very convenient timing, as the company behind Astra Zeneca had just announced that they can only deliver a bit less than half the amount promised by summer - so a ban like this will cover up that as well (the idiots at the EU level failed to negotiate a contract properly, so there are no actual targets for the delivery and no consequences if they fail to deliver... oopsie...)

  • Press release (Score:3)

    by Artem S. Tashkinov ( 764309 ) on Tuesday March 16, 2021 @02:45AM (#61163756) Homepage

    Following a recent concern raised around thrombotic events, AstraZeneca would like to offer its reassurance on the safety of its COVID-19 vaccine based on clear scientific evidence. Safety is of paramount importance and the Company is continually monitoring the safety of its vaccine.

    A careful review of all available safety data of more than 17 million people vaccinated in the European Union (EU) and UK with COVID-19 Vaccine AstraZeneca has shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country.

    So far across the EU and UK, there have been 15 events of DVT and 22 events of pulmonary embolism reported among those given the vaccine, based on the number of cases the Company has received as of 8 March. This is much lower than would be expected to occur naturally in a general population of this size and is similar across other licensed COVID-19 vaccines. The monthly safety report will be made public on the European Medicines Agency website in the following week, in line with exceptional transparency measures for COVID-19.

    Furthermore, in clinical trials, even though the number of thrombotic events was small, these were lower in the vaccinated group. There has also been no evidence of increased bleeding in over 60,000 participants enrolled.

    Ann Taylor, Chief Medical Officer, said: âoeAround 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.â

    In terms of quality, there are also no confirmed issues related to any batch of our vaccine used across Europe, or the rest of the world. Additional testing has, and is, being conducted by ourselves and independently by European health authorities and none of these re-tests have shown cause for concern. During the production of the vaccine more than 60 quality tests are conducted by AstraZeneca, its partners and by more than 20 independent testing laboratories. All tests need to meet stringent criteria for quality control and this data is submitted to regulators within each country or region for independent review before any batch can be released to countries.

    Source: https://www.astrazeneca.com/me... [astrazeneca.com]

    In short: much ado about nothing and vaccinating is still ~1000 times safer than getting the COVID-19.

Slashdot Top Deals

Understanding is always the understanding of a smaller problem in relation to a bigger problem. -- P.D. Ouspensky

Close