12 ms·

AstraZeneca may have provided incomplete efficacy data NIAID

71 points by reddotX 6y ago

IfOnlyYouKnew 6y ago
It’s really a never-ending shit show with this company. Somehow, I’d still take the vaccine. I remain convinced that none of this is done with malicious intend. But that confidence is based mostly on a general trust of institutions and procedures in healthcare. It’s a deep reservoir of trust, built up over time. AZ is certainly taking from it more than it is contributing.
- happymellon 6y ago
  They use may have too many times in the article for me to take this seriously. It reads like a smear campaign.
  - ethanbond 6y ago
    It reads like scientists who have an entire career looking at this sort of data, have spotted something odd in the AZ data, aren’t sure what it’s coming from, and are asking for clarification.
    - ignoramous 6y ago
      > "AstraZeneca did not immediately respond to a Reuters request for comment." This wouldn't be the first I have seen News Agencies deliberately avoid carrying comments because the PR on the other side of the table happened to not respond "immediately" or "in time" etc;
      - gebruikersnaam 6y ago
        AZ admits they shared old data: https://news.yahoo.com/astrazeneca-share-latest-data-panel-115644244.html https://news.yahoo.com/astrazeneca-share-latest-data-panel-1...
    - happymellon 6y ago
      If it did, then there would be a reason for this position. > The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data [because... the data reviewed does not appear to cover the California varient, etc...] The fact that it is kept vague and not including a reason is not helpful and leads to speculation on how terrible AZ are for not being able to submit proper data. They do confirm that this question has nothing to do with the blood clots which this data helps disprove any proper link.
      - icegreentea2 6y ago
        The "may have" appears to come directly the NIAID's news release. If you think that NIAID or the DSMB is trying to smear AZ, then sure. Otherwise, keeping things vague provides maximum room for maneuver for both groups to resolve the issue without either group losing too much face. This way things can get chalked up to "mis-understandings" of what the requirements were, and AZ can reclarify their data in light of these new requirements.
      - refurb 6y ago
        AZ just released a statement that indeed, the data submitted was not the final analysis (interim data from Feb) and they promise to submit final data within 48 hrs. And the full data looks similar to the interim. What’s going on over at AZ? I’m not claiming conspiracy, but clearly there was a miscommunication somewhere. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html https://www.astrazeneca.com/content/astraz/media-centre/pres... “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
- sschueller 6y ago
  It's difficult. Do you trust J&J after what they did with their baby powder [1]? Or Pfizer [2], or Moderna who's vaccine is the most expensive and new to the scene [3]? [1] https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ https://www.reuters.com/investigates/special-report/johnsona... [2] https://en.wikipedia.org/wiki/Abdullahi_v._Pfizer,_Inc https://en.wikipedia.org/wiki/Abdullahi_v._Pfizer,_Inc. [3] - Oxford/AstraZeneca: €1.78 (£1.61). - Johnson & Johnson: $8.50 (£6.30). - Sanofi/GSK: €7.56. - Pfizer/BioNTech: €12. - CureVac: €10. - Moderna: $18.
  - yunohn 6y ago
    Wow, I’d never heard of the Pfizer case. Here’s a crazy snippet: “Pfizer argued that it was not required to obtain informed consent for experimental drug trials in Africa, and that any case should be heard in Nigeria”
    - juanani 6y ago
      >Wow, I’d never heard of the Pfizer case. From the Wiki article >Pfizer subsequently settled the case out of court with a $75 million settlement that was subject to a confidentiality clause. Does the confidentiality clause also suppress media or is that a separate payment to whoever is putting their nose into it? I'm curious how these stories get out, and are there others that don't ever reach Wiki articles?
  - spazrunaway 6y ago
    Conspiracy theorist. Trust the science! /s
    - sschueller 6y ago
      I'm definitely getting the Vaccine, just saying, it's not easy to just blindly trust anyone.
  - thehappypm 6y ago
    Cost is by far the least interesting part of this for me. These are all astoundingly affordable vaccines. $18 is the cost of a big bottle of Claritin!
- addicted 6y ago
  The good thing is the actual vaccine development was done by Oxford University that has experience and done a good job with the vaccine itself. Unfortunately, it’s the related stuff, manufacturing, procurement, trials, contract signing, that was done by AZ and they have almost entirely done a horrible job.
  - Throwawayaerlei 6y ago
    The good thing is the actual vaccine development was done by Oxford University that has experience and done a good job with the vaccine itself. They failed for 8 years to get this particular vaccine platform to work, and read some of the other comments, they probably caused more of the infamous string of clinical trial screw ups than AZ.
- scotty79 6y ago
  Remeber that the only reason Astra Zeneca is involved in this is because Bill Gates told Oxford they should find commercial exclusive partner instead opensourcing their vaccine.
  - fmajid 6y ago
    No. AstraZeneca got involved at the request of the British government. They were not the first choice, GSK was (no 1. vaccine company in the world), but for whatever reason GSK passed, so AstraZeneca, as a British (and Swedish) national champion was chosen, even though they don't have vaccine experience. There is an excellent investigative report by Le Figaro (in French) that details the many issues the vaccine faced: https://www.lefigaro.fr/sciences/astrazeneca-le-laboratoire-ambitieux-qui-est-devenu-la-bete-noire-de-l-europe-20210317 https://www.lefigaro.fr/sciences/astrazeneca-le-laboratoire-... These include friction between AZ and Oxford, the latter insisted on retaining much more control than they would normally have, and this led to serious flaws in the design of experiments for the trials, including not having sufficient numbers of over-65. Furthermore, they mixed samples with different inoculation protocols, raising all sorts of red flags within the scientific community. It does seem the vaccine is effective and safe, but the unforced methodology errors did them no favors, and explain why the FDA and EMA are taking an exceptionally hard look at the data. Furthermore, production is outsourced to a number of companies with varying level of expertise, and they are poorly supervised by AZ, for instance EU commissioner Thierry Breton performed an inspection in the Belgian subcontractor that has been having problems that led to AZ not meeting its contractual commitments to the EU (and a diplomatic crisis between the EU and UK), and found production and quality control issues the AZ headquarters were unaware of.
    - moystard 6y ago
      The article is not accessible because of the hard paywall. Frustrating as it looks like an interesting read.
    - scotty79 6y ago
      That doesn't contradict what I said. Oxford wanted to opensource the vaccine before Bill Gates influenced them.
zpeti 6y ago
Is this the same data from like yesterday where the headline was US study says astrazeneca is 100% effective at preventing serious illness?
- gerdesj 6y ago
  "The European Union’s drug regulator said last week it was safe but an opinion poll on Monday showed Europeans remained sceptical about its safety." The above sentence, for me, sums up the quality of this article: What poll?
- anothernewdude 6y ago
  That was aimed at the public treating effectiveness as a tool for comparing vaccines. This current article seems to be based on further investigation coming out of the increased scrutiny.
sschueller 6y ago
I'm staring to think these are industry attacks on a company that is in competition with others. AZ's vaccine is quite similar to J&J but AZ is getting all the criticism. If AZ is so unsafe why has there not been huge issues in the UK where so many got AZ. Something fishy is going on. Either at AZ or from the outside.
- Neil44 6y ago
  The company licensing and distributing their vaccine at cost and many times cheaper than the others is getting lots of negative stories and comments in the media, who could possibly benefit from this.
- mantas 6y ago
  Don't forget geopolitics. Russia and China would looooove to come in with their vaccines and save the day.
  - sschueller 6y ago
    The negative press against the Russian Sputnik Vaccine is also quite dominant in the news.
    - mantas 6y ago
      Not so much after EU did 180... Here in my country PM claimed to never accept Sputnik. Wonder what will happen if EU confirms it :)
      - sschueller 6y ago
        Also interesting that a Swiss company is going to be producing Sputnik V [1] [1] https://www.handelszeitung.ch/unternehmen/schweizer-biopharma-firma-stellt-russischen-corona-impfstoff-her https://www.handelszeitung.ch/unternehmen/schweizer-biopharm...
    - fmajid 6y ago
      The Russian Sputnik V vaccine is as effective as the Western ones. Fr all its flaws the Soviet Union was a scientific, educational and health giant, and its successor Russian state still is. The Sinopec (Chinese) one is only about 60-70% effective, on the other hand, and unless given away for free, it's hard to understand why any country would want it. The concerns about Sputnik are geopolitical in nature (weakening the sanctions regime against Russia for its doings in Ukraine, and the persecution of Navalny), not sanitary ones.
Neil44 6y ago
As the issue of anti-vax sentiment is a big issue for many countries around the world and undoubtably is costing lives, I would think that questions like this need not be asked via the media.
- mantas 6y ago
  Better asked and discussed in media. Than discovered by anti-vax people and then discussed as a secret that media is hiding from The People.
- ppf 6y ago
  You appreciate that this attitude, that is, that things must be hidden or people might get worried, is exactly why some do not trust the new Covid vaccines?
  - ceejayoz 6y ago
    It's very much a damned if you do, damned if you don't scenario, yes.
    - ppf 6y ago
      I'd say that hiding potential issues with a vaccine, where regulations have already been eased to speed up its rollout, is about as damning as it can be.
      - ceejayoz 6y ago
        So's letting malicious actors permanently obliterate the reputation of one of the vaccines before we can get the data in to know if there's actually an issue. Media headlines are a really sucky way to do data science. There are serious issues in both directions here.
        curryst 6y ago
        I have yet to see any evidence of malicious actors. There are anti-vaxxers, but they have a genuine belief as far as I can tell. They're not just here to watch the world burn for fun. I also don't see a prevailing reason why one of the vaccine companies would want to sabotage AZ. They're all at maximum production afaict, and AZ had worse efficacy than Moderna already. If it were corporate sabotage, I would expect them to target one of the superior mRNA vaccines. AZ is also the one that screwed up here. If they can't submit correct efficacy data, people should be concerned. That raises serious doubts about their internal organization, and looks like we may be relying on government safety regulations to ensure the vaccine is safe. Which were relaxed for this vaccine. I didn't see a lot of people saying we should keep letting Boeing's MAX keep flying until we could be totally sure that it wasn't just an unlucky streak of drunk pilots. I also don't see a lot of people saying that we should give Boeing lead time to get a PR spin on their latest disaster. > Media headlines are a really sucky way to do data science. I agree. They're also the only way that most people are going to encounter this information, which I would argue they have a right to know. I hope that they'll make rational decisions based on the evidence available, but I'd rather they made poor choices with the evidence than good choices without it.
mortehu 6y ago
AstraZeneca did respond a few hours ago saying that they included data only up to the interim analysis cutoff point. I don't think this makes any sense; the point of the cutoff is to prevent too many analyses of the same data, not to limit the amount of data. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html https://www.astrazeneca.com/content/astraz/media-centre/pres...
- Mvandenbergh 6y ago
  Once again reinforcing that while their science may be solid, their management of the regulatory process is awful. If this was a disagreement they had with their DSMB and the results are basically the same including the new data (as they claim in that press release) then surely they should have just included that in the press release originally? Instead they've now caused another round of noise.
  - mchusma 6y ago
    You seem to imply it's AZ's fault, when in fact it's clearly a systemic FDA issue here. AZ's vaccine has been proven safe and effective multiple times in multiple studies. The FDA has banned banned everyone from choosing to voluntarily get it if they wish. It's not based on ANY bona-fide scientific concern, it's ban is solely based on red tape. This event proves it. If the FDA was in the business of helping people, they would find a way to lift this ban.
    - Mvandenbergh 6y ago
      Part of AZ's job is to manage their relationship with their DSMB (which is not the FDA). Even if they've done the science correctly and developed a good vaccine (I happen to think the evidence supports this view) they are also supposed to manage these relationships to stop this kind of disagreement becoming public. Either one of two things has happened: 1) Their independent DSMB have conspired to screw them for reasons unknown - I think this is pretty unlikely. 2) They have mismanaged the communications with the DSMB and released results which it was their job to know the DSMB did not agree with. Something not being approved is not the same thing as a ban. You and I might think there is enough evidence, given the context of the pandemic, to have started using this vaccine in the US but I am not qualified to assess that.
Hypocritelefty 6y ago
Approved in India, UK, EU and a lot of countries yet Fauci goes public with some missing data. He could have asked them instead but no. More than 100m have already taken it across the globe but that is not good enough for some elite countries.
freebuju 6y ago
> The vaccine, developed with Oxford University, was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation, and posed no increased risk of blood clots. Am no super smart virologist but my brain immediately pinged when I started hearing the news from AZ quoting ... 100% effective against Xxxxx... Only thing that came to me was the good ol' adverts from bug sprays and disinfectants claiming to be 99.9% effective against bugs/bacteria
- ceejayoz 6y ago
  > Am no super smart virologist but my brain immediately pinged when I started hearing the news from AZ quoting ... 100% effective against Xxxxx... This is an illustration of why lay people applying "common sense" to data sets and statistics can be a problem. The efficacy stats are based on small numbers, but with sound stats behind them. For example, from https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html https://www.nytimes.com/interactive/2021/03/03/science/vacci...: > What’s more, all the vaccines look as if they have a high efficacy against more serious outcomes like hospitalization and death. For example, no one who got Johnson & Johnson’s vaccine had to go to the hospital for a Covid-19 infection 28 days or more after getting an injection. Sixteen people who got the placebo did. That translates to 100 percent efficacy, with a confidence interval of 74.3 percent to 100 percent. Expanding from the trials (with tens of thousands of people) to billions of people will mean that number can't stay at 100% forever in real-world use. It's still a great number to see.
  - freebuju 6y ago
    100% effective against hospitalization is 100% obvious BS. I don't need to be a statistician to make this conclusion.
    - thehappypm 6y ago
      The real-world data they have shows 100% protection compared to placebo in the trial. That's all the number means. Would you prefer they round down to 99% for you?
Mvandenbergh 6y ago
The story says "outdated" data but it's not clear what that could be in this context and why including older data would be bad? Something to do with not accurately capturing the current mix of variants, maybe? So the issue is that they've included too much data leading to (in the DSMB view) inaccurate efficacy rather than incomplete data. Nonetheless this is a management failure on their part because any disagreement with the DSMB over which data to include should have taken place privately before publication of the results. For all I know they have good reason for including this older data but it's not a good look to have your DSMB disagree with you in public now.
- IfOnlyYouKnew 6y ago
  They reported earlier numbers that showed about 79 % effectiveness even though more data had come in in the meantime and overall effectiveness had dropped to about 69 %.

71 points by reddotX 6y ago

It’s really a never-ending shit show with this company. Somehow, I’d still take the vaccine. I remain convinced that none of this is done with malicious intend. But that confidence is based mostly on a general trust of institutions and procedures in healthcare. It’s a deep reservoir of trust, built up over time. AZ is certainly taking from it more than it is contributing.

happymellon 6y ago
They use may have too many times in the article for me to take this seriously. It reads like a smear campaign.
- ethanbond 6y ago
  It reads like scientists who have an entire career looking at this sort of data, have spotted something odd in the AZ data, aren’t sure what it’s coming from, and are asking for clarification.
  - ignoramous 6y ago
    > "AstraZeneca did not immediately respond to a Reuters request for comment." This wouldn't be the first I have seen News Agencies deliberately avoid carrying comments because the PR on the other side of the table happened to not respond "immediately" or "in time" etc;
    - gebruikersnaam 6y ago
      AZ admits they shared old data: https://news.yahoo.com/astrazeneca-share-latest-data-panel-115644244.html https://news.yahoo.com/astrazeneca-share-latest-data-panel-1...
  - happymellon 6y ago
    If it did, then there would be a reason for this position. > The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data [because... the data reviewed does not appear to cover the California varient, etc...] The fact that it is kept vague and not including a reason is not helpful and leads to speculation on how terrible AZ are for not being able to submit proper data. They do confirm that this question has nothing to do with the blood clots which this data helps disprove any proper link.
    - icegreentea2 6y ago
      The "may have" appears to come directly the NIAID's news release. If you think that NIAID or the DSMB is trying to smear AZ, then sure. Otherwise, keeping things vague provides maximum room for maneuver for both groups to resolve the issue without either group losing too much face. This way things can get chalked up to "mis-understandings" of what the requirements were, and AZ can reclarify their data in light of these new requirements.
    - refurb 6y ago
      AZ just released a statement that indeed, the data submitted was not the final analysis (interim data from Feb) and they promise to submit final data within 48 hrs. And the full data looks similar to the interim. What’s going on over at AZ? I’m not claiming conspiracy, but clearly there was a miscommunication somewhere. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html https://www.astrazeneca.com/content/astraz/media-centre/pres... “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
sschueller 6y ago
It's difficult. Do you trust J&J after what they did with their baby powder [1]? Or Pfizer [2], or Moderna who's vaccine is the most expensive and new to the scene [3]? [1] https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ https://www.reuters.com/investigates/special-report/johnsona... [2] https://en.wikipedia.org/wiki/Abdullahi_v._Pfizer,_Inc https://en.wikipedia.org/wiki/Abdullahi_v._Pfizer,_Inc. [3] - Oxford/AstraZeneca: €1.78 (£1.61). - Johnson & Johnson: $8.50 (£6.30). - Sanofi/GSK: €7.56. - Pfizer/BioNTech: €12. - CureVac: €10. - Moderna: $18.
- yunohn 6y ago
  Wow, I’d never heard of the Pfizer case. Here’s a crazy snippet: “Pfizer argued that it was not required to obtain informed consent for experimental drug trials in Africa, and that any case should be heard in Nigeria”
  - juanani 6y ago
    >Wow, I’d never heard of the Pfizer case. From the Wiki article >Pfizer subsequently settled the case out of court with a $75 million settlement that was subject to a confidentiality clause. Does the confidentiality clause also suppress media or is that a separate payment to whoever is putting their nose into it? I'm curious how these stories get out, and are there others that don't ever reach Wiki articles?
- spazrunaway 6y ago
  Conspiracy theorist. Trust the science! /s
  - sschueller 6y ago
    I'm definitely getting the Vaccine, just saying, it's not easy to just blindly trust anyone.
- thehappypm 6y ago
  Cost is by far the least interesting part of this for me. These are all astoundingly affordable vaccines. $18 is the cost of a big bottle of Claritin!
addicted 6y ago
The good thing is the actual vaccine development was done by Oxford University that has experience and done a good job with the vaccine itself. Unfortunately, it’s the related stuff, manufacturing, procurement, trials, contract signing, that was done by AZ and they have almost entirely done a horrible job.
- Throwawayaerlei 6y ago
  The good thing is the actual vaccine development was done by Oxford University that has experience and done a good job with the vaccine itself. They failed for 8 years to get this particular vaccine platform to work, and read some of the other comments, they probably caused more of the infamous string of clinical trial screw ups than AZ.
scotty79 6y ago
Remeber that the only reason Astra Zeneca is involved in this is because Bill Gates told Oxford they should find commercial exclusive partner instead opensourcing their vaccine.
- fmajid 6y ago
  No. AstraZeneca got involved at the request of the British government. They were not the first choice, GSK was (no 1. vaccine company in the world), but for whatever reason GSK passed, so AstraZeneca, as a British (and Swedish) national champion was chosen, even though they don't have vaccine experience. There is an excellent investigative report by Le Figaro (in French) that details the many issues the vaccine faced: https://www.lefigaro.fr/sciences/astrazeneca-le-laboratoire-ambitieux-qui-est-devenu-la-bete-noire-de-l-europe-20210317 https://www.lefigaro.fr/sciences/astrazeneca-le-laboratoire-... These include friction between AZ and Oxford, the latter insisted on retaining much more control than they would normally have, and this led to serious flaws in the design of experiments for the trials, including not having sufficient numbers of over-65. Furthermore, they mixed samples with different inoculation protocols, raising all sorts of red flags within the scientific community. It does seem the vaccine is effective and safe, but the unforced methodology errors did them no favors, and explain why the FDA and EMA are taking an exceptionally hard look at the data. Furthermore, production is outsourced to a number of companies with varying level of expertise, and they are poorly supervised by AZ, for instance EU commissioner Thierry Breton performed an inspection in the Belgian subcontractor that has been having problems that led to AZ not meeting its contractual commitments to the EU (and a diplomatic crisis between the EU and UK), and found production and quality control issues the AZ headquarters were unaware of.
  - moystard 6y ago
    The article is not accessible because of the hard paywall. Frustrating as it looks like an interesting read.
  - scotty79 6y ago
    That doesn't contradict what I said. Oxford wanted to opensource the vaccine before Bill Gates influenced them.

zpeti 6y ago

Is this the same data from like yesterday where the headline was US study says astrazeneca is 100% effective at preventing serious illness?

gerdesj 6y ago
"The European Union’s drug regulator said last week it was safe but an opinion poll on Monday showed Europeans remained sceptical about its safety." The above sentence, for me, sums up the quality of this article: What poll?
anothernewdude 6y ago
That was aimed at the public treating effectiveness as a tool for comparing vaccines. This current article seems to be based on further investigation coming out of the increased scrutiny.

sschueller 6y ago

I'm staring to think these are industry attacks on a company that is in competition with others. AZ's vaccine is quite similar to J&J but AZ is getting all the criticism. If AZ is so unsafe why has there not been huge issues in the UK where so many got AZ. Something fishy is going on. Either at AZ or from the outside.

Neil44 6y ago
The company licensing and distributing their vaccine at cost and many times cheaper than the others is getting lots of negative stories and comments in the media, who could possibly benefit from this.
mantas 6y ago
Don't forget geopolitics. Russia and China would looooove to come in with their vaccines and save the day.
- sschueller 6y ago
  The negative press against the Russian Sputnik Vaccine is also quite dominant in the news.
  - mantas 6y ago
    Not so much after EU did 180... Here in my country PM claimed to never accept Sputnik. Wonder what will happen if EU confirms it :)
    - sschueller 6y ago
      Also interesting that a Swiss company is going to be producing Sputnik V [1] [1] https://www.handelszeitung.ch/unternehmen/schweizer-biopharma-firma-stellt-russischen-corona-impfstoff-her https://www.handelszeitung.ch/unternehmen/schweizer-biopharm...
  - fmajid 6y ago
    The Russian Sputnik V vaccine is as effective as the Western ones. Fr all its flaws the Soviet Union was a scientific, educational and health giant, and its successor Russian state still is. The Sinopec (Chinese) one is only about 60-70% effective, on the other hand, and unless given away for free, it's hard to understand why any country would want it. The concerns about Sputnik are geopolitical in nature (weakening the sanctions regime against Russia for its doings in Ukraine, and the persecution of Navalny), not sanitary ones.

Neil44 6y ago

As the issue of anti-vax sentiment is a big issue for many countries around the world and undoubtably is costing lives, I would think that questions like this need not be asked via the media.

mantas 6y ago
Better asked and discussed in media. Than discovered by anti-vax people and then discussed as a secret that media is hiding from The People.
ppf 6y ago
You appreciate that this attitude, that is, that things must be hidden or people might get worried, is exactly why some do not trust the new Covid vaccines?
- ceejayoz 6y ago
  It's very much a damned if you do, damned if you don't scenario, yes.
  - ppf 6y ago
    I'd say that hiding potential issues with a vaccine, where regulations have already been eased to speed up its rollout, is about as damning as it can be.
    - ceejayoz 6y ago
      So's letting malicious actors permanently obliterate the reputation of one of the vaccines before we can get the data in to know if there's actually an issue. Media headlines are a really sucky way to do data science. There are serious issues in both directions here.
      - curryst 6y ago
        I have yet to see any evidence of malicious actors. There are anti-vaxxers, but they have a genuine belief as far as I can tell. They're not just here to watch the world burn for fun. I also don't see a prevailing reason why one of the vaccine companies would want to sabotage AZ. They're all at maximum production afaict, and AZ had worse efficacy than Moderna already. If it were corporate sabotage, I would expect them to target one of the superior mRNA vaccines. AZ is also the one that screwed up here. If they can't submit correct efficacy data, people should be concerned. That raises serious doubts about their internal organization, and looks like we may be relying on government safety regulations to ensure the vaccine is safe. Which were relaxed for this vaccine. I didn't see a lot of people saying we should keep letting Boeing's MAX keep flying until we could be totally sure that it wasn't just an unlucky streak of drunk pilots. I also don't see a lot of people saying that we should give Boeing lead time to get a PR spin on their latest disaster. > Media headlines are a really sucky way to do data science. I agree. They're also the only way that most people are going to encounter this information, which I would argue they have a right to know. I hope that they'll make rational decisions based on the evidence available, but I'd rather they made poor choices with the evidence than good choices without it.

mortehu 6y ago

AstraZeneca did respond a few hours ago saying that they included data only up to the interim analysis cutoff point. I don't think this makes any sense; the point of the cutoff is to prevent too many analyses of the same data, not to limit the amount of data. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2021/update-following-statement-by-niaid-on-azd1222-us-phase-iii-trial-data.html https://www.astrazeneca.com/content/astraz/media-centre/pres...

Mvandenbergh 6y ago
Once again reinforcing that while their science may be solid, their management of the regulatory process is awful. If this was a disagreement they had with their DSMB and the results are basically the same including the new data (as they claim in that press release) then surely they should have just included that in the press release originally? Instead they've now caused another round of noise.
- mchusma 6y ago
  You seem to imply it's AZ's fault, when in fact it's clearly a systemic FDA issue here. AZ's vaccine has been proven safe and effective multiple times in multiple studies. The FDA has banned banned everyone from choosing to voluntarily get it if they wish. It's not based on ANY bona-fide scientific concern, it's ban is solely based on red tape. This event proves it. If the FDA was in the business of helping people, they would find a way to lift this ban.
  - Mvandenbergh 6y ago
    Part of AZ's job is to manage their relationship with their DSMB (which is not the FDA). Even if they've done the science correctly and developed a good vaccine (I happen to think the evidence supports this view) they are also supposed to manage these relationships to stop this kind of disagreement becoming public. Either one of two things has happened: 1) Their independent DSMB have conspired to screw them for reasons unknown - I think this is pretty unlikely. 2) They have mismanaged the communications with the DSMB and released results which it was their job to know the DSMB did not agree with. Something not being approved is not the same thing as a ban. You and I might think there is enough evidence, given the context of the pandemic, to have started using this vaccine in the US but I am not qualified to assess that.

Hypocritelefty 6y ago

Approved in India, UK, EU and a lot of countries yet Fauci goes public with some missing data. He could have asked them instead but no. More than 100m have already taken it across the globe but that is not good enough for some elite countries.

freebuju 6y ago

> The vaccine, developed with Oxford University, was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation, and posed no increased risk of blood clots. Am no super smart virologist but my brain immediately pinged when I started hearing the news from AZ quoting ... 100% effective against Xxxxx... Only thing that came to me was the good ol' adverts from bug sprays and disinfectants claiming to be 99.9% effective against bugs/bacteria

ceejayoz 6y ago
> Am no super smart virologist but my brain immediately pinged when I started hearing the news from AZ quoting ... 100% effective against Xxxxx... This is an illustration of why lay people applying "common sense" to data sets and statistics can be a problem. The efficacy stats are based on small numbers, but with sound stats behind them. For example, from https://www.nytimes.com/interactive/2021/03/03/science/vaccine-efficacy-coronavirus.html https://www.nytimes.com/interactive/2021/03/03/science/vacci...: > What’s more, all the vaccines look as if they have a high efficacy against more serious outcomes like hospitalization and death. For example, no one who got Johnson & Johnson’s vaccine had to go to the hospital for a Covid-19 infection 28 days or more after getting an injection. Sixteen people who got the placebo did. That translates to 100 percent efficacy, with a confidence interval of 74.3 percent to 100 percent. Expanding from the trials (with tens of thousands of people) to billions of people will mean that number can't stay at 100% forever in real-world use. It's still a great number to see.
- freebuju 6y ago
  100% effective against hospitalization is 100% obvious BS. I don't need to be a statistician to make this conclusion.
  - thehappypm 6y ago
    The real-world data they have shows 100% protection compared to placebo in the trial. That's all the number means. Would you prefer they round down to 99% for you?

Mvandenbergh 6y ago

The story says "outdated" data but it's not clear what that could be in this context and why including older data would be bad? Something to do with not accurately capturing the current mix of variants, maybe? So the issue is that they've included too much data leading to (in the DSMB view) inaccurate efficacy rather than incomplete data. Nonetheless this is a management failure on their part because any disagreement with the DSMB over which data to include should have taken place privately before publication of the results. For all I know they have good reason for including this older data but it's not a good look to have your DSMB disagree with you in public now.

IfOnlyYouKnew 6y ago
They reported earlier numbers that showed about 79 % effectiveness even though more data had come in in the meantime and overall effectiveness had dropped to about 69 %.