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Medicine

US Health Officials Question AstraZeneca Vaccine Data and Efficacy (thehill.com) 171

whh3 writes: The NIAID issued a statement early Tuesday saying that they had concerns about the data that AstraZeneca included in their Monday-morning release touting the effectiveness of their Covid-19 vaccine. Slashdot reader phalse phace has shared additional information via The Hill. They write: U.S. health officials from the Data and Safety Monitoring Board issued an unusual statement that it was "concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial." This comes less than 24 hours after AstraZeneca said its vaccine had an "efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and hospitalization" and a week after several countries suspended dosing of the vaccine due to concerns of dangerous blood clots.

The Data and Safety Monitoring Board "expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data." As an oversight committee, the Data and Safety Monitoring Board helps regulate and evaluate clinical trials of new medicines to ensure accuracy and adherence to protocols. In a statement released early Tuesday morning, AstraZeneca said the interim results it announced on Monday were current as of Feb. 17. The latest development could throw a wrench in AstraZeneca's plan to seek the U.S. Food and Drug Administration's emergency use authorization for its vaccine.
Additional coverage: The New York Times
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US Health Officials Question AstraZeneca Vaccine Data and Efficacy

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  • by sonofbaal ( 7613728 ) on Tuesday March 23, 2021 @10:42PM (#61191526)
    Hey, youtube totally told me it was all okay! Are you questioning the ministry of truth?
    • Any scientist could see that the lack of cat-related pictures in the WaPo or WSJ was a good indicator that such media could not be trusted.
      I wonder if the people of the Democracy of Facebook already know?

  • Stop posting thehill.com and NYT/WaPo blog crap. As Fauci said: all COVID vaccines are effective in stopping the disease. Get vaccinated. Take the first vaccine offered. Listen to the science, not random blogs on the Internet (and yes, thehill is just another blog).
    • Stop posting thehill.com and NYT/WaPo blog crap. As Fauci said: all COVID vaccines are effective in stopping the disease. Get vaccinated. Take the first vaccine offered. Listen to the science, not random blogs on the Internet (and yes, thehill is just another blog).

      Don't you dare equate valid questions on a vaccine's effectiveness with antivax crazies. AstraZeneca is fairly effective at preventing serious disease, but has a relatively low relative effectiveness against getting the disease when compared against many of the others. It is completely well within people's rights to question what vaccine they are getting and its effectiveness. There is absolutely no testing right now on the efficacy and implications of mixing vaccines. Zero testing. We don't know yet i

      • Re: (Score:2, Interesting)

        by h33t l4x0r ( 4107715 )
        I'll take whichever one is offered first. Zero chance of severe disease should be good enough for anybody.
        • Maybe youâ(TM)re right, but dying of a brain blood clot sounds pretty serious to me. So you go ahead and take the first vaccine being offered, and I will see if I can get the one with the most consistent trial data behind it.
          • The experts have already said that the rate of blood clots are the same as they are in the general population. Take your shots, get your free krispy kreme and go home.
      • by jlar ( 584848 )

        Right now, in Canada, the AZ vaccine is considered poor enough that while it is approved, we don't give it to seniors or anyone who is vulnerable. They all get one of the better ones, generally the best one we have which is Moderna's.

        And France recommends the AZ vaccine only to people of age 55 and older. The reason is that the risk of blood clotting due to the vaccine (not yet scientifically settled) seems to be higher for younger people and the risk of dying or getting severely debilitated from Covid-19 is much, much smaller when you are young(er). This means that the risk-reward balance is much better for old people getting the AZ vaccine than it is for young people.

        I would tend to agree with France on this. Use the safer alternative

        • Re: (Score:3, Insightful)

          The reason is that the risk of blood clotting due to the vaccine (not yet scientifically settled)

          I find it strange, there is 0 correlation between vaccine and blood clotting. I mean there is as much blood clotting in AZ vaccinated population than in non vaccinated population but still blood cotting is indeed an open question. This is the current observation. Also why UK didn't panic? They are using this for longer than anybody else and nothing happened there.Total waste of time.

          • https://www.npr.org/sections/c... [npr.org] I'm a male. No problems. Could be associated to contraception and pregnancy. We also know the morning after pill is easy to get in Europe. The good news is that they can really zero in. The real question why were they too gutless to be politically incorrect - and say males only - for now.
          • by jlar ( 584848 )

            The reason is that the risk of blood clotting due to the vaccine (not yet scientifically settled)

            I find it strange, there is 0 correlation between vaccine and blood clotting. I mean there is as much blood clotting in AZ vaccinated population than in non vaccinated population but still blood cotting is indeed an open question. This is the current observation. Also why UK didn't panic? They are using this for longer than anybody else and nothing happened there.Total waste of time.

            Two independent research teams have identified the cause of the blood clotting (which had very unusual characteristics): https://www.ibtimes.com/scient... [ibtimes.com]

            So there seems to be little to no doubt that it is indeed caused by the vaccine. The question is more if the prevalence and risk is high enough to offset the benefits of using the vaccine. And it seems like the risk can be mitigated by taking specific precautions if you get symptoms related to the blood clotting. But I guess we will know more about this in

          • by fwad ( 94117 )

            It's all politics. The Oxford/AZ vaccine is seen as a British vaccine. Therefore the UK will roll it out on large scale (and hasn't had a significant numbers of issues reported). The EU is hurting over BRexit and the fact that there vaccine campaign is way behind and are looking for things to blame. Sadly for them all they are doing is making their populations not trust *any* vaccine. In the US the Oxford/AZ vaccine is 10x cheaper that the alternatives so big pharma is campaigning against it.

            The simpl

            • In the US the Oxford/AZ vaccine is 10x cheaper that the alternatives so big pharma is campaigning against it.

              Its not a biggie for the US, in any case. Allegedly, the USG has already prepaid for enough Pfizer, Moderna, and J&J vaccine to innoculate all 335 million Americans. The FDA should just approve AZ and giveaway some of the stockpile to Mexico, (and in secret to the news media) inoculate the people in border detention.

              As for big pharma campaigning against AZ, Pfizer & Moderna can only sell their vaccine to 1st world nations; its that expensive to produce. J&J is only one shot, so I bet its as c

          • German news reports indicated 7x higher incidence in the az cases then in the regular population.
      • by fwad ( 94117 )

        It's good that you want to know the facts. You do know that the testing for the Moderna and Biontech vaccines was different to the AZ? The AZ testing was frankly the most honest - hence the results of the tests make AZ look like it's not as good.

        You also need to do is look at the evidence from where the AZ vaccine has been rolled out (i.e. the UK) to notice that it's far outperforming the trial results (which is expected as the trial picked up asymptomatic cases but real life generally won't)

        You also ne

      • I fully support vaccinations. I will happily take a Moderna or Biontech vaccine. I haven't decided yet if I will actually refuse the AZ vaccine if offered to me,

        Just remember (in the US) there is also a one shot Janssen (J&J) vaccine, which has come out. Its having problems ramping up production, but it should be available in large quantities by summer (which is only a couple months away). It has slightly better efficacy than AZ, with no gotchas. Also, summer is not as conducive to spreading coronavirus. With precautionary measures, waiting a couple of months for a better vaccine is a plausible strategy.

        • "With precautionary measures, waiting a couple of months for a better vaccine is a plausible strategy."
          For many, waiting a couple of months for _any_ vaccine is plausible.

    • TheHill is just reporting a press release from www.nih.gov.

      Take care that your opposition to antivaxxers is rooted in reasonable argumentation, not in culture war bullshit.

    • If you are going to trust Science then you should be happy that officials are questioning each Vaccine for its data and efficacy.

      If it gets approved, I want to be assured that it is Safe and Effective. And not just some guy who had Covid sneezed into a bottle of distilled water, then sells it as vial of Covid Vaccine.

      From my understanding AZ didn't give us all the data that we wanted to see, so we are questioning them to get some more detail. So they just need to get us more data, when we have it. Then t

      • AZ gave us the data up to a certain date. They did not give us all the data they had. It is unclear whether that was in adherence to a prior plan for compiling data (after all, stats do take time to run if you want to compile it pretty and have PhDs checking the work) or was done because late breaking data was exceptionally bad for them. So they requested all the data they had up to now to resolve that question. AZ said it would take a day or two to compile/format and they would get it right over.

        I will

  • Oxford made a lot of PR mistakes and manufacturing errors, but so did everyone else given the rapid nature of development. There are side effects. Some people go into anaphylactic shock. On the Oxford vaccine, it does appear that there is a path that it causes blood clots, but it is not appear to be statistically significant. What we do know is the vaccine has saved the UK with few side effects

    The best way right know is to send all vaccine out of the US as a gesture of good faith. Sorry about approval w

    • The US has started shipping its AZ vaccines to other countries.

      • by fermion ( 181285 )
        I believe we are calling it a loan. We seem to have enough, many states are allowing all eligible adults to request vaccination. We have done 3 million a day. If we can keep it up that is 90 million a month. Just release the vaccine and allow those who want to use it.
  • Remember back in November, they released some results? One group had been given the wrong dosage (1/2 dose, followed by full dose), and was inexplicably limited to under age 55? And they combined data from different trial groups? How the 1/2 dose worked better than the full dose? How a single does was said to be more effective (76%) than two doses give less than 6 weeks apart (55%)? It's like a homeopathic vaccine! Then, completely different excuses from different parts of AZ. Turns out, there were multiple
    • by fwad ( 94117 )

      The issues with the AZ studies aren't unusual. There were issues with the other studies as well. Notably the AZ study tested everyone on the study for Covid on a regular basis; on lots of other vaccine studies they only tested people with symptoms.

      The real life figures from the AZ vaccine are very, very impressive (the test populations for all the vaccines were really too small to get good numbers). I believe the real life figures from the other vaccines are also equally as good.

  • I'm in desperate need of a dose of AstraZeneca for my vaccine bingo [mfbc.us] card. My arm's a little sore, and a bit tired from a busy day, but I have only managed to get Moderna, J&J, and Pfizer.
  • Disinformation (Score:3, Interesting)

    by clickclickdrone ( 964164 ) on Wednesday March 24, 2021 @05:00AM (#61191962)
    It seems rather curious that the one vaccine which is sold at cost price is getting slated on the basis of very little or at best marginal evidence compared to other far more expensive options which are also far from risk free. You'd almost think it was a coordinated disinformation campaign
    • Considering that the manufacturer is only able to deliver a quarter of the promised (and paid for in advance) amount anyway and has been caught lying not just once, one'd almost think that you are spreading conspiracy theories.

      • by Cederic ( 9623 )

        Nonsense, AZ has delivered all of its promised volumes so far.

        To which alleged lies are you referring? It's just that Macron has lied about it, German newspapers have lied about it and Ursula Fond of Lying has been wittily renamed because of her constant stream of bullshit on the matter.

        The damage to the EU from this one simple contract is entirely self-inflicted and the constant attacks on a company delivering effective vaccines at cost are doing more to push countries to leave the EU than even Brexit.

        • Ah, Cederic Pants On Fire strikes again, trying to be a cheap knockoff of his idol de Piffle Johnson.

          The EU export ban is imminent and since AstraZenaca won't even be able to deliver enough to the UK from India the next quarter and since the UK never had any stock for the required second jab in the first place in order to appear being great at vaccinating people, that vaccination program will suddenly run into a wall in a 6 weeks or so.

          • by jabuzz ( 182671 )

            That is a super dangerous game for the EU to play. Critical components of the Pfizer vaccine (the bit that makes the lipid vesicles) are manufactured in the UK.

            The EU where very late signing a contract for the AZ vaccine so basically the first batch of vaccine they got was the first batch they grew in the manufacturing plants in the EU. Guess what having the recipe is not enough it takes practice and yields where lower than anticipated. The contract the EU signed says "best effort" for that very reason. The

        • Nonsense, AZ has delivered all of its promised volumes so far.

          Why do you lie? Just like flat out lie? They have not met the delivery schedule for a single delivery period to date. Are you being paid by them, or are you just really that fucking dumb?

          I mean they themselves are telling the EU they'll miss the second quarter deliveries https://www.dw.com/en/coronavi... [dw.com]
          They didn't deliver in Ireland 2 weeks ago https://www.thejournal.ie/vacc... [thejournal.ie]
          They failed miserably to deliver to the UK last year https://www.ft.com/content/6cc... [ft.com]
          They have actively reduced the target for the

          • by Cederic ( 9623 )

            Sorry, I was talking only of AZ's commitments to the EU.

            The ones that said 'best efforts', and that they've brought people from the UK over to Holland to try and fix the production line there.

            Obviously AZ haven't delivered everything to everyone. For instance, they failed to deliver 250,000 vaccines to Australia. Because Italy supported by the EU blocked them.

            Now the EU want to prevent AZ meeting contractual obligations again, in a move guaranteed to have diplomatic repercussions. Meanwhile people in Irelan

    • by AmiMoJo ( 196126 )

      Maybe, although the AZ vaccine is different to the others so it's not all that surprising that one type is more effective than the others.

      The AZ vaccine is more "traditional", in that it it relies on cells to do the transcription to mRNA. The BioNTech vaccine skips that step and actually contains the mRNA molecule. I'm not a biologist but as an engineer removing one step that relies on the patient's body working properly seems like it would increase reliability. Maybe someone who knows more can comment.

      Of c

    • You'd almost think it was a coordinated disinformation campaign

      There was. https://www.wsj.com/articles/r... [wsj.com] Fortunatley most health agencies took the correct approach:
      1. Briefly suspend vaccine rollouts
      2. Investigate
      3. Quickly resume after reassuring the people that what they heard was false. (Norway, Sweden, and Denmark are the holdouts, everyone else has resumed)

      This was a preferable course of action than simply saying "No they are wrong, trust me we're from the government!" because we all know how well Antivaxxers receive that.

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