Skip to content

AstraZeneca Can’t Catch a Break

So what's the deal with the AstraZeneca vaccine? It's been given to nearly 20 million people around the world with no reported efficacy problems, and after a brief panic it appears that it doesn't cause blood clots either. On Monday, AZ issued a press release describing the results of its US testing, which it said were very good.

But then a funny thing happened: NIH issued a statement saying that the agency that oversees test results in the US informed it that AZ's test data "may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data." Shazam!

But what's the unforced error? That AZ issued a press release that might be slightly wrong? Or that NIH decided to publicly call out something that could easily have been handled internally within a day or two? [UPDATE: Fauci's full quote makes it clear he blames AZ.]

I feel like there must be something going on behind the scenes that we're not privy to. NIH issued its statement after midnight, which certainly suggests someone was in a helluva rush to reprimand AZ publicly. Someone with sources should try to report this out. Is there ongoing bad blood between AZ and NIH? Is AZ a serial bad actor? Or what?

My prediction: AZ will update the data and it will make only the slightest difference. At that point, the NIH statement will look a little shabby. It could be that NIH felt like they needed to issue a strong statement in order to send a message to the entire vaccine community, but it still seems shortsighted. Why cast even more doubt on the AZ vaccine when it would take only a day or two to find out if there's really a problem?

Alternatively, I suppose it might turn out that AZ really was deliberately fudging the data for public consumption and deserves everything it gets in return. I can hardly imagine why they'd bother since the official report data is going to have all the detailed test information, but who knows? I guess we'll find out shortly.

30 thoughts on “AstraZeneca Can’t Catch a Break

  1. Brett

    I'm starting to wonder if there's some weird nationalist thing going on here, facilitated by their initial screw-up last year. AstraZeneca is not an American pharma company, unlike Pfizer, Moderna, J&J, and Novavax.

  2. royko

    I suppose it's possible (but probably unlikely) that one of the competitors friendly with NIH is pushing them to spread FUD. I suppose it's also possible (but also unlikely) that we're throwing AZ shade to help give cover to political allies in Europe.

    Could just be someone at NIH with a bee in their bonnet, though you would think institutional barriers would make this less likely. But it's probably more likely that there's been some sort of behind the scenes tension that caused NIH to (rightly or wrongly) lash out. We may never know.

    1. dausuul

      If Pfizer or Moderna or J&J were sticking a knife in AZ's back, I would expect them to do it quietly through the bureaucracy.

      A noisy dust-up like this is the last thing any vaccine maker wants to see; it shakes public confidence in *all* vaccines.

  3. rick_jones

    Come now Kevin, shirley you do not think the United States would send a bad vaccine to its two closest neighbors?
    A press release sent just after midnight certainly sounds fishy. One definitely wonders about motivation with that.

    Does the tinfoil make my head look fat, or, might Donald Trump have not been the only one in the US government kompromised in some way? ...

  4. MarkedMan

    Something has been a little off about the AZ vaccine registration from the start. It was very odd they delayed so long in attempting to register it in the US, months after it had been cleared and used in Europe. I spent 15 years in the medical device business and know that you can reach out to the FDA prior to submission and ask specific questions, and that way you are more likely to have submissions ready and approved quickly (there are downsides, too). Once it became obvious AZ was delaying submission I've suspected that via this pre-submission procedure, or through something else, the FDA felt there were problems with the data or the records or something similar. And this latest spat has the feel of the FDA questioning some data, AZ sending it to the press without amending it, and the FDA getting pissed off and showing they won't be railroaded.

    The fact that they still haven't submitted as of today, despite releasing this study, is odd. The other vaccines were submitted in Europe and the US within a few weeks of each other, this one has been dragging out for months.

    And I doubt politics is at play. After all, it was part of Operation Warp Speed, as was J&J's vaccine, and the J&J had no problems with approvals or delays in submission. On the other end, Pfizer was not part of OWS and also had no problems.

  5. MarkedMan

    I should have been clear above that I don't suspect there is anything wrong with the vaccine, but that their submission materials might be inadequate. They are still in the "will be submitting soon phase", so maybe we will know once they submit.

    1. Crissa

      There's been lots of problems adapting to the no-in-person work, and some people don't seem to get it. It would only take one key person failing to delay the entire project.

  6. dausuul

    The impression I've had for a while is that AstraZeneca's vaccine technology is fine--maybe not quite as good as Pfizer or Moderna, but solid--but when it comes to running vaccine trials and reporting the results, they are sloppy and cut corners. And that is a big problem where vaccines are concerned. Trust and confidence are absolutely vital.

    The blood clot thing wasn't their fault, but the rest of their troubles appear self-inflicted. And now, of course, regulators and health authorities are primed to second-guess them any time something seems the least little bit off.

    1. MarkedMan

      This makes sense. I was fortunate enough never to get in the FDA's crosshairs but can think of others who have. It almost always involves trying to put one over on them. I know of two people who actually went to prison. It wasn't for what they did, which resulted in no patient harm, but for lying to the FDA and falsifying documents. The entire company came within a hair's breadth of literally having its doors padlocked shut by the Feds.

    2. Maynard Handley

      Well, that's one way to look at it.
      Another way to look at it is that AZ prioritized "get a vaccine out" unaware that a bunch of journalists, officials, and the usual do-gooder types were prioritizing procedure over common sense.

      And so we get a drip drip of "scandals", like AZ completed the form using blue ink not black, and submitted the data on Tuesday when the rules clearly said Wednesday.

  7. Jimbo

    AZ f'd this up from the get-go. Their press release was a CYA stunt. The US FDA, with guidance from NIH and other advisory sources, will make the decision. AZ has f'd this up further if they think they can pressure the FDA. HUGE MISTAKE. As for all of the data on 20 million people, whonis that data being reported by? AZ? Their lackeys? Submit the recent data to the FDA for review. But they should be making their case to the FDA, not the news media, not without peer-review. The US has 3 reliable vaccines. We don't need AZ's shitshow.

  8. Liam3851

    I think Kevin's missing the history here. When AZ originally reported results, they chose to publicize their (accidentally tried, statistically insignificant, small-sample) half-dose-first result of 90% accuracy to the media, rather than their (pre-specified, statistically significant, but weaker) result of 62% accuracy of the original specification, or even the (possibly justifiable) weighted average result of 70% accuracy combining both specifications.

    So basically AZ has a history of unscientific cherry-picking of results for the media that look good, rather than the full results of their pre-specified trials that don't look as good.

    That history should put them in the penalty box. No cherry picking, only release your pre-specified trials. It sounds like they failed to do that AGAIN. Hopefully the difference here isn't a 28% difference in efficacy like the first time, but jeebus.

    1. dausuul

      Exactly. If you screw up once, it happens; but you need to show that you've learned from it and that you're being extra vigilant about not repeating your mistake. Nobody is going to give you the benefit of the doubt the second time.

    2. Rattus Norvegicus

      It seems to me as though their press office is treating the releases about this vaccine as though they were TV ads for their latest overpriced drug. It is probably worth noting that AZ does not have a lot of experience with vaccines, with only a nasal flu vaccine in their portfolio.

  9. azumbrunn

    Another thing about AZ's handling of the vaccines: They appear to have made wildly inflated projections for the production. They promised tons of shots to European countries. Then they said sorry, we can only delver a small fraction.

    Many European countries seem to have planned their vaccinations based on those promises and this is major reasons for the massive vaccination-setbacks over there.

    Boris was smart (but selfish like he always is) and made sure the UK was first in line.

  10. KenSchulz

    It does appear that AZ’s production capacity is limiting them. Not much point in getting approved for use in a nation of a third of a billion people if you can’t meet the demand you already have. But they must have known this for a while; why not work out licensing deals?
    I don’t think there is anything unexpected in the NIH action — given rampant misinformation and disinformation around vaccines of all kinds, anything less than total transparency by governments will be viewed with suspicion. There is no working through issues quietly, behind the scenes.

    1. MarkedMan

      There is an AZ facility being built in the UK specifically for this vaccine. I know a vendor who is supplying clean room equipment and back in December he said it was scheduled for commission in May. If that is the date they actually complete validation, then that should significantly boost production. But that is a long way off.

  11. Special Newb

    DSMB asked them this weekend not release the interim results and wait for the full report in 2 days because there was more recent data included there than the interim (Feb.17 cutoff) which is probably less favorable but should not effect too much. AZ flat out ignored them, hence the quick statement.

    1. dausuul

      Ouch. Yeah, that definitely belongs in the "unforced error" category.

      It's maddening. All indications are that AZ has a pretty good vaccine; fairly effective, cheap, easy to transport and store. But they keep acting like hustlers trying to offload a used car, and so it's impossible to ever really trust them.

      1. Special Newb

        To update: AZ was asked by DSMB not to release data that showed 79% efficacy because more comeplete data (data that examined more probable and possible cases) showed efficacy of 69-75%. Above the low 60s showing in the other trials.

        AZ ignored them. So DSMB had NIH fire back because it knowingly released misleading data. For what reason I have no idea but it is clear AZ released incomplete data that overstated their vaccine.

  12. Silver

    There is no doubt AZ has messed up a lot in this whole business, including failure to deliver according to contracts. However, authorities in Sweden have for some time now made observations regarding propaganda from “foreign powers” against AZ in particular. Their statements in this matter have been unusually clear (for Sweden), all but pointing directly to Russia and China. I haven’t heard about this other than in Swedish media, but wouldn’t be surprised if this is happening elsewhere as well.

  13. D_Ohrk_E1

    You're too quick to dismiss the blot clot issue. If there is a clear pathway from vaccine to blood clot, wouldn't you want to know about it and therefore know how to address it properly?

    Outright dismissing the blood clot issue can hamper deeper scientific inquiries and understanding of how things work.

    I have no problem accepting the use of statistical analysis to ascertain correlative values, but, wouldn't you prefer to let the science play out?

    If you're being honest with yourself, you don't know if there's a direct pathway or not.

    1. dausuul

      If *you're* being honest with yourself, you don't have any reason to suspect the existence of such a pathway. It is on those claiming such a thing exists to supply evidence for the claim.

  14. Paul

    If I have understood the position correctly AZ is selling vaccine at cost. Its rivals are not. So ask ourselves, when the EU and the US combine to criticise one vaccine provider again and again, cui bono? Is it a series of bizarre and hard-to-explain, but independent, decisions by governments and agencies, or can we see a reason why that one vaccine provider may be getting its arse kicked on the hour every hour?

  15. dmcantor

    Yes, AstraZeneca is definitely a serial bad actor. Their original analysis, the one that got them approval in the UK was filled with statistical no-nos, and was disseminated to investment analysts and investors before being made public. Reporting clinical trial results in a press release is simply a terrible idea, since there's no view into how they crunched the numbers.

    I've read that the conclusion that the vaccine is 100% effective against serious disease was based on the observation that 5 people in the placebo arm got serious disease, and none in the treatment arm. Five people. Doesn't seem very statistically robust, does it?

Comments are closed.