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.
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.
> "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;
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 The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data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.
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.
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.
“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.”
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]?
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”
>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?
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.
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.
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.
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:
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.
How is that relevant to the "Open Sourcing" of the vaccine?
In my eyes the fact that so much of vaccine production is in private hands is a classic example of "privatising profits" because everyone paid for the research with their taxes.
Gates is a super billionare only looking out for his bank account, through the good old "philantrophy PR" scheme. He is actively doing class warfare by close sourcing vaccines. Completely in line with the rest of his endeavours.
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.
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.
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.
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.
The concerns about Sputnik are geopolitical in nature
Not entirely. Their politicians boasted about it being the world's first "registered" vaccine a month before its Phase III trial started, that was an own goal completely of their making. It was only months later where they were able to finish their Phase III trial with very good results, but a few weeks behind the two mRNA vaccines.
So in other words exactly like Astra Zeneca. A good vaccine whose reputation was marred by nationalism-driven botched design of experiment and clinical trials.
That said, the effectiveness of Sputnik V has been established to Western standards now, so the only reason for the EU to refuse it when it is in crying need for vaccines is political, not scientific or medical.
AZ has genuinely fucked up a couple times. They accidentally gave some trial participants half the intended dose (https://www.bbc.com/news/health-55086927), and now appear to have made a mistake in reporting data.
They're procedural fuckups. Never should've happened, but neither one inherently says "the vaccine is unsafe".
This shouldn’t be downvoted it’s accurate. Several screw ups happened during the trials. AZ and Oxford are now paying the price for that lack of trust.
AZ has genuinely fucked up a couple times. They accidentally gave some trial participants half the intended dose
That was an Oxford fuck up, as were most of the other early clinical trial ones as far as we know. As others have explained, this is not a normal small organization plus Big Pharma arrangement, and after the EU went crazy I'll bet AZ is now regretting ever getting involved.
AZ's catastrophic fuck up from that testing mistake which should have burned a lot of their credibility was to use that data which in the long term didn't pan out to make a blended claim of higher efficacy than they could at that time legitimately support.
AstraZeneca has no experience developing vaccines. As a result they’ve massively screwed up multiple times before. Frankly, even the original approval they got from the UK should never have been given, considering how tainted their original trials in Brazil were.
Basically what seems to have happened is that Oxford university developed the vaccine, required that companies who wanted to manufacture and sell it should not make a profit, and therefore only got companies with little vaccine development experience, such as AstraZeneca, which probably due to their lack of experience has been making mistake after mistake.
That being said, we have seen that with COVID the vast majority of vaccines have been extremely successful (some like the Russian and Chinese ones were deployed without complete testing and were shown to have great results), and since we are confident the AZ vaccine is safe enough, ans we can see the impact in the UK, there’s a strong justification to authorize using it even without proper results.
Just not in the US, which already has access to enough vaccines for its population without needing the AZ zone.
This comment is a valuable contribution to the discussion wrt AZ's lack of experience & screw ups.
Although I disagree that there was any reason to hold up UK approval, there was clear safety and effectiveness evidence that overwhelmed any doubts about safety in spite of the screw ups.
But I have zero sympathy for AZ even if many, many people are compounding their errors.
Seems like anything made by this company should contain warnings like
"This manufacturer has never released an approved vaccine"
and
"This manufacturer is not allowed to make a profit on this product, so there is no monetary incentive to ensure quality after the product is authorized for emergency use"
I fully expect the same quality as soviet era cars.
AstraZeneca has staked their reputation as an extremely large firm that makes all sorts of pharmaceuticals on the safety and efficacy of this vaccine, the idea that they have no incentive to ensure the quality of the product is absolutely bonkers.
Hilariously Lada cars - the Soviet era cars being referenced I expect - were exported for the express purpose of making a profit!
They can fall back on the usual refrain. "We didn't know" "We couldn't have known" "We used the best data available at the time" and they also have a new out "Blame Oxford, it was their drug" etc.
What's Pfizer's reputation? Seems to be fine among the masses, despite decades of mismanagement and killing people.
Why don't we look at the actual data instead of supposing? Presumably because it wouldn't support your conclusion in the slightest. Please don't promote anti vaxxer misinformation.
Agree. Even the vaccine could have been done better - the spike protein RNA in the vaccine doesn't use the prefusion stabilization trick like the others.
Given the sheer amount of potential profit at stake, it's not surprising that some skullduggery is happening. However, given the speed of the rollout of the various vaccines, and the corresponding number of people injected with them, the companies invovled should be absolutely above reproach in these matters.
The fact that, even when lives are at stake, companies cannot resist temptation, is why there are regulations. Try complaining about the regulations that were relaxed to allow this all to happen, however, and suddenly I'm an anti-vaxxer.
I was responding to the parent comment that such headlines are just competing vaccine compaines attempting to destroy the reputation of their competitors. Assuming that is the reason behind this headline (which, is not a given), I'm just pointing out that would not be surprising.
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.
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?
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.
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.
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.
Ah, OK. I wouldn't characterize the use of a preexisting regulatory channel that is present exactly for this purpose as "easing" but it is a perfectly fair position to take. Thanks!
At least where I am (UK), yes. They added to article 174 of the Human Medicines Regulations, allowing an unlicensed vaccine to be advertised in some circumstances, as well as allowing a broader range of people to administer the vaccine, and provided legal protection in law to the developers of the vaccine in case of any issues.
This is in addition to the existing powers of article 174, which allows an unlicenced medicine to be rolled out in exceptional circumstances.
No, not silly, but potentially justified, in the case of a pandemic. However, these changes obviously increase the risk to the recipient of the vaccine. There's a higher chance of something going wrong with the actual injection, as a broader spectrum of people are administering it (where I live, there was a call for volunteer vaccinators in the local paper), and also very little legal recourse if something is found to be harmful with the vaccine itself.
For those reasons, along with the lack of any information as to whether the vaccine has a meaningful effect on reducing transmission, I have decided that the risk (relative to the reward) to me is too high.
"Data analysis in a study by the Israeli Health Ministry and Pfizer Inc found the Pfizer vaccine developed with Germany’s BioNTech reduces infection, including in asymptomatic cases, by 89.4% and in syptomatic cases by 93.7%."
"More research is needed to draw a definitive conclusion, but the studies are among the first to suggest a vaccine may stop the spread of the novel coronavirus and not just prevent people getting ill."
At least do me the favor of reading the link; "two Israeli studies" is in the very first sentence, and the second study is published:
> A separate study by Israel’s Sheba Medical Center published on Friday in The Lancet medical journal found that among 7,214 hospital staff who received their first dose in January, there was an 85% reduction in symptomatic COVID-19 within 15 to 28 days with an overall reduction of infections, including asymptomatic cases detected by testing, of 75%.
> As shown in Figure 1A, the percentages of persons who became infected differed according to vaccination status, with infections in 234 of 8969 nonvaccinated employees (2.61%; 95% confidence interval [CI], 2.29 to 2.96), 112 of 6144 partially vaccinated employees (1.82%; 95% CI, 1.50 to 2.19), and 4 of 8121 fully vaccinated employees (0.05%; 95% CI, 0.01 to 0.13) (P<0.01 for all pairwise comparisons).
> The effect of vaccination on the preservation of our workforce has been dramatic. We observed a greater than 90% decrease in the number of employees who are either in isolation or quarantine.
On its face the UK has administered doses to over 25MM people thus far I believe (remarkably hard to find the exact number to date from an official source with a simple google!) and unless you are among the oldest on HN or in remarkably poor health most of those people would likely be at much high risk of complications than you would. If complications were anything but extremely rare there would be many, many cases by now.
Additionally, perhaps you are better equipped than I to know, but I believe you could control for any risk you perceive (which I think is ridiculous, but to each his own) from having someone inexperienced administering the vaccine by getting it from your GP.
As for the transmission of COVID-19, if you require absolute proof that vaccination will prevent all transmission then you are setting your bar far too high and your position is indefensible.
To start the presumption is that it is very likely that vaccination will at the very least reduce the likelihood of transmission because while there are viruses like Measles that can still be transmitted in such circumstances those cases are the exception to begin with.
Furthermore evidence is building that vaccination against COVID-19 prevents people from carrying loads of the virus that can be transmitted, if you are quite as committed to this line of argument as you seem to be I am sure you can find the published and pre-pub studies out there. I am confident that if you went about booking yourself an appointment for a month from now by the time your appointment were actually up you'd have lots more evidence to avail yourself of - and you'd always have the option of declining at the time!
> 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?
People don’t trust the vaccine because a lot of them are scientifically illiterate and paranoid. That someone on the Internet sees benefit in hiding something doesn’t factor into the equation. It’s an emotional response, not a fact-based one.
I’m not sure what you mean by this sentiment. If there were issues, questions need to be asked. Anti-vax is a problematic issue, but you can’t solve that with hiding facts or causing doubt.
You trust experts to lie to the public (at the very least through omission) for their own good.
No thanks. Your attitude is a significant part of our current political dysfunction. Public servants have been replaced by self-promoters and technocrats who share nothing except contempt for the man on the street.
In the tech world, we've got responsible disclosure for security holes. That's essentially what's being proposed here - let AZ have 24h to at least come up with a response. The article includes a line saying "AstraZeneca did not immediately respond to a Reuters request for comment", which sure sounds like "we sent their PR an email, then hit publish an hour later".
We've already seen issues in recent weeks with the blood clots issue, where the initial breathless media coverage gives way to "the regulators took a look and it seems fine, it's about the normal level of them, and the pause probably killed many more than the clots ever did".
Lay people - including reporters - are really bad at teasing apart normal "how the sausage is made" from "there's an actual issue here", especially with anti-vax propagandists ready to leap on anything with even a hint of confusion.
The reason there's so much skepticism of public health authorities is because they repeatedly mislead the public.
Right now, for example, Dr Fauci tells people who have been vaccinated to wear two masks. That's because he wants the unvaccinated to keep wearing theirs, lest they see others without masks. But it's nonsense and lay people know it. So they see this and think Fauci is mad, deceptive, or something else that can't be a reason to trust him. And that's how public health figures lose the trust of the public and create millions of skeptics of vaccines, masks, social distancing, etc.
No, the double masking recommendation comes from studies performed that demonstrate a better fit, especially with the cloth masks that are in widespread use.
You missed the point. Why does Fauci care about the fit of his masks if the vaccine he took is effective?
It's not about what the CDC recommends: if Fauci has faith in the vaccine, why is he personally walking around with two masks on? He should take them off to inspire confidence in the vaccine but... Something must be stopping him. Either there's something he doesn't trust about the vaccine or he thinks there's some other reason he and others should go on wearing masks after being vaccinated. Little people like me must not be privy to that info.
Because while we have conclusive data that states "the vaccine will keep you out of the hospital", we do not yet have the data that lets us conclusively say "you can't get and spread the virus if you're vaccinated".
Wrong, according to Fauci when pressed by Dr Rand Paul MD on this, Fauci said it's because we don't know how well the vaccine works against variants
So no that's not why he's wearing two masks, he obviously doesn't trust the vaccine to protect him, said it himself.
It was a rhetorical question that I posed. Get informed about what your insane leaders are telling you to do and why. You want to lecture me about CDC guidance or being uninformed and you don't even know the incident I was referencing in my original post.
Fauci will probably never stop wearing the masks because there will always be something he could catch. There will always be more variants.
> The findings of these simulations should neither be generalized to the effectiveness of all medical procedure masks or cloths masks nor interpreted as being representative of the effectiveness of these masks when worn in real-world settings.
I think complaints are justified when CDC officials turn around and do exactly what their report says not to do: interpret the findings as being representative of real-world settings. A year in and with trillions spent, our evidentiary standard should be higher.
How, exactly, are you proposing we get the data on "real-world settings" without trying out the approach that's been lab-validated? Barring evidence in the "this might be dangerous" direction, those lab results certainly appear to support recommending people adopt the practice.
Turning this sort of CYA language that's standard in medical research into a scary gotcha is exactly the sort of propaganda the anti-vax folks engage in all the time.
I believe clinical trials are the gold-standard mechanism by which specific questions about interventions may be answered. I’m not pointing out a “scary gotcha.” I’m pointing out an omission identified in the linked work.
Lab confirmation of double masking can be performed in an afternoon. A clinical trial is going to take tens of thousands of self-reporting "I wore two" people for months or longer, plus difficulties with all sorts of confounding variables.
I'm very comfortable with a tentative recommendation based on the lab data for a non-dangerous intervention. If we get observational data a year from now confirming it, even better.
Let's make a distinction between "the tech world" and some substance we're injecting into people en masse.
In all likelihood the AstraZeneca vaccine is perfectly fine. But we should have this conversation in public. If people "come to the wrong conclusions," that's fine. It's the price we pay for an open society.
1. If there's a serious issue with the vaccine and we kept it quiet, the consequences would be catastrophic. Not only in terms of public health but also in terms of public trust. Even a small chance of this outcome far, far outweighs the number of people who will die due to people wrongly deciding not to get the AZ vaccine.
2. We have a moral obligation to have conversations in public that involve the safety of injecting substances into people. Regardless of "cost benefit analysis," people simply have a right to be privy to these conversations. It's better for things to go worse and respect this right than for things to go better and not respect it.
You expressed concern about anti-vaxxers, correct? If it turns out the AZ vaccine doesn't work very well, that's a boost to them, especially if the conversation occurred in private. Perhaps that will result in more people dying in the long run due to decreased trust in institutions.
When you play this utilitarian game, you can kick the consequences can down the road forever, which is why it's better to think of these arguments in more immediate terms.
That's not "in more immediate terms". It involves peering into the future and it implies the belief that we can perform a cost benefit analysis and therefore remove the moral and political elements from decision making.
When I say immediate, I'm talking about this:
> 2. We have a moral obligation to have conversations in public that involve the safety of injecting substances into people. Regardless of "cost benefit analysis," people simply have a right to be privy to these conversations. It's better for things to go worse and respect this right than for things to go better and not respect it.
I would rather have more people die in an open society than less people die in a closed one.
Remember that many public vaccination programs are relying on healthy people taking on risks to protect others. Right now, more people are being harmed by polio vaccinations than by wild polio: https://www.the-scientist.com/news-opinion/polio-vaccination...
I think that is a perfectly acceptable trade-off given the the long-term goal of eliminating polio entirely. I also think it's totally ok to ask people to bravely face a risk to help others (a fairly small one in this case). I even think it can be ok to ask minors, and parents, to take on those risks in some circumstances, and I think polio elimination is one of them. But it's a trade-off that must be done openly, with consent.
> Lay people - including reporters - are really bad at teasing apart normal "how the sausage is made" from "there's an actual issue here", especially with anti-vax propagandists ready to leap on anything with even a hint of confusion.
Exactly this. Journalists and laypeople are specialists in making mountain out of molehills
But it's said when specialists also do that (with the suspension of the vaccine when the thing it is preventing has a 1000x chance of causing the same problem)
> "DSMB externalisations of concerns are deeply unusual for multinational pharma companies and suggest an extraordinary high level of friction between the DSMB and the sponsor,' Citi analysts said in a note."
It sounds like they're not getting the type of collaboration they want from AZ, so they've raised the stakes.
Which is why I at least take pause when I see the entire liberal sphere drop their characteristic distrust of the healthcare industry in the US and the whole "profiting off healthcare is evil" line, to suddenly standing in solidarity with Big Pharma.
I don't think experts are lying to the public, I think they have questions and it's correct they should ask them. But you can do that with a phone call or an email. When you make a press release you're not asking a question you're making a statement. And the statement the media makes and then the statement the public choose to hear are beyond your control. To use the old analogy, there are consequences to yelling fire in a crowded theater.
The backlash from people finding out about a quiet discussion can be just as bad. If they favor openness then they don't lose points for secrecy.
And it's clear enough that literal anti-vax people don't need a real reason. It's hesitancy that is the addressable issue, which is going to be better addressed by building trust than by saying what sounds right.
As someone who had been a part of FDA interactions, it’s not being communicated via the media. I have no doubt there were conversations between the FDA and AZ prior to the press release.
I assume that whatever the discussion, it wasn’t going to get resolved quickly so the FDA informed AZ they could not sit on the information and would have to make a public statement.
The actual final data analysis isn’t done (AZ mentioned this in their press release). It sounds like they did an initial analysis of the final data, it looked similar to the Feb interim data, so they said “good enough, go with 79% in the press release” and the FDA was like “wait a second, that wasn’t the agreed upon final data”.
yes we should unquestionably accept everything told to us by the holographic spokespeople of corporations on the tv, after all they always have our best interests in mind
I'm a huge proponent of vaccinations but this attitude is very concerning. I see it too with J&J, where we have data showing lower efficacy rates and no data on long term avoidance of chronic side-effects of COVID (such as chronic pain and fatigue, organ damage, clots, etc), only data on hospitalization rates (which yes, are on par with other vaccines). And if you dare question any of this, you're immediately shut down and told to shut up. It just makes me trust J&J even less. I'm young and healthy, my biggest risk is not hospitalization but the long term side effects, do not suppress this and do not act like it's wrong to question these things in an informed and intelligent manner.
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.
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.
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.
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.
They have found a way to "lift this ban". The company simply has to conduct a well run trial, submit the trial data to the FDA, and ask for an emergency use authorization. Once they do that, it takes two or three weeks for the FDA to processes it. That two or three weeks is not red tape--it is the FDA having their own scientists and independent scientists go over all the data and do the safety and efficacy calculations themselves.
This worked fine for Pfizer, Moderna, and Johnson & Johnson.
> 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
> 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.
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?
I'd prefer they focus on doing research with actual data & figures that actually matter. And getting it right while at it.
IMO the 100% effective xxx was absolutely unnecessary. It becomes easy for anyone to tear down this report. AZ aren't helping themselves with such claims.
Also prefer they round off nothing. Report your data as-is. Majority of the people aren't stupid. They don't need your loose interpretations nor any nudges. Certainly not from the vax manufacturer.
That’s, like, your fault, then? Because the data does show 100% effectiveness. And I do trust the data, because (a) explicit, deliberate lying just doesn’t make any sense, for any of the people involved here. And, (b), all the vaccines have been 100% effective. Not a single fully vaccinated person across all the trials has been hospitalized or died from COVID.
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.
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 %.
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.
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