CDC and FDA Against Johnson & Johnson Vaccine

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Michael Siegel

Michael Siegel is an astronomer living in Pennsylvania. He is on Twitter, blogs at his own site, and has written a novel.

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  1. Avatar Jaybird
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    Can they still give it to guys?

    Like, I read an article that said that J&J was the perfect shot for homeless people because of the one-and-done nature of the shot.

    This seems like it’d still be the preferred treatment for homeless men (even if it’s too dangerous to give to homeless women).

    Or is that sexist in a weird way that means that we can’t give it to guys either?Report

    • Avatar Marchmaine in reply to Jaybird
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      Public health is not worth running afoul of fraught topics.Report

      • Avatar Jaybird in reply to Marchmaine
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        says:

        I freaking hate post-science.Report

      • Avatar Pinky in reply to Marchmaine
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        Isn’t public health essentially off the table at this point? The vast majority of those in high-risk groups, probably everyone in those groups who wants a vaccine, has already gotten it. I don’t know whether the death count would be higher if we vaccinate the rest of the population in two months or in two years. (When I say “the rest of the population”, I mean up to more or less herd immunity levels.) In the meantime, barring some massive change, covid deaths will be coming from (a) the vaccinated who still get sick and die, (b) the unvaccinated in high risk categories who get sick and die, (c) the unvaccinated in the general population who get sick and die, and (d) the vaccinated who have side effects of the vaccine and die. It’s doubtful than any of those four groups will be significantly large. The best strategy for reducing deaths may well be extreme willingness to pull any questionable vaccine, and mainly because it will boost the confidence of those who haven’t been vaccinated.

        All of the above with the standard stipulation that I’ll get vaccinated as soon as I can, even with a more questionable vaccine, if it nearly eliminates my capacity to get anyone else sick.Report

        • Avatar Marchmaine in reply to Pinky
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          If I’m following you correctly, it seems we are nearing a point at which the risk of ‘overwhelming’ the health system is or nearly is past. That’s a thing, but not the only thing.

          My point (below) is that the FDA and CDC have publicly stated that they are attempting to navigate the ‘psychology’ of vaccinations, and honestly, they aren’t really that good at it… and that aspect of Public Health leadership is political not strictly bureaucratic in nature.

          The fact that you are using the term ‘questionable vaccine’ based on this data is sort of the point. Unless we want to start using the term ‘questionable birth control’ too. Or questionable every drug on TV that quite literally posts all of the nasty and potentially fatal side-effects on the screen.Report

          • Avatar Pinky in reply to Marchmaine
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            I’ll admit I don’t think conventionally on this issue. I’ve taken a lot of medications, and I understand that they all have potential side effects. I’m also a big enough fan of stats to know that these are in “the deaths by peanut allergy” range. So the phrase “questionable vaccine” isn’t meant as a pejorative. Anyway, to be questionable, a vaccine needn’t be dangerous; it need only be questioned.

            But I do think that a public health emergency is unlikely at this point. Of the four groups I listed above, the only one that concerns me is (b), the unvaccinated in high risk groups. Get as many of them vaccinated as we can, and for the rest of us the numbers should be comparable to the proverbial bad flu.Report

            • Avatar Michael Cain in reply to Pinky
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              Anyway, to be questionable, a vaccine needn’t be dangerous; it need only be questioned.

              That’s what I’m wondering about. So far this month, J&J has (a) tossed 15M or so doses due to manufacturing error; (b) due to (a), greatly under-delivered on what the states were expecting*; and (c) now the blood clot thing and suspension.

              * My understanding — possibly incorrect — is that an important consideration in my state’s decision to open up eligibility to everyone over 16 was that there was going to be a flood of the one-shot J&J vaccine delivered.Report

            • Avatar Marchmaine in reply to Pinky
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              Sure, but I think that’s more of a discussion around what to do when most, if not all, adults are vaccinated. Another area where the CDC/FDA seem to be failing the ‘psychology’ test.

              My guess is that the Biden-Harris administration has already signaled that it will curb-stomp the CDC come July 4 no matter where we are on vaccinations… or put another way, with approx 50% of the 18+ adult population already receiving 1-dose we’re already at the point where Biden will declare victory on July 4. The interesting question is where the final 18+ number lands… and whether it gets extended to 16+ or 12+.

              My political bet is that Biden ignores the Covid-Hawks starting July 4.Report

  2. Avatar North
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    Man oh man I am glad I got my J&J shot before this came out.Report

  3. Avatar Michael Cain
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    How many J&J doses are there to give right now? They had to toss on the order of 15M doses back at the beginning of the month because their contract manufacturer messed up.Report

  4. Avatar Sam Wilkinson
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    The risk of blood clots for women taking birth control is 1 in 1000 and they’re stopping this vaccine because of a risk of 1 in 1,000,000?Report

  5. Avatar Marchmaine
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    says:

    Honestly seems like a situation where you update the ‘monitoring’ status with a note that (ultra-)rare Blood Clotting events have happened… and continue with the vaccinations.

    Abundance of caution would be to steer (younger) women towards mRNA, if concerned about risk.

    The weird confluence of CDC/FDA admitted attempts to manage public ‘psychology’ is precisely the area where political leaders should step in and override their ‘guesses’ which have proven mostly wrong.Report

  6. Avatar Jaybird
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    Nate Silver does some bar napkin math:

    Report

  7. Avatar LeeEsq
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    The tendencies for super-caution are coming to hit the CDC in the shins. They just stopped recommending hygiene theater even though we knew hygiene theater didn’t work.Report

  8. Avatar Oscar Gordon
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    Agencies that know better being overly cautious because the population, often thanks to poor journalism, is very bad at probability and risk assessment.

    Water remains wet.Report

  9. Avatar Doctor Jay
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    They are well aware that Frances Oldham Kelsey was lauded and given a medal for blocking the use of thalidomide in this country.

    I just wanted to point out that the FDC is very responsive to public opinion – which is the desired effect in a democracy.Report

    • Avatar dhex in reply to Doctor Jay
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      unless the public is unskilled when it comes to assessing risk, which the past year and change has shown us to be true a number of times and ways.

      one of the big institutional “losers” (in terms of public trust) from the pandemic has been public health orgs. this is not good stuff, but there’s a lot of unforced errors on top of the great difficulty* of navigating the waters trump chummed.

      * i do not underestimate this difficulty. i had a trumpian boss once and it made doing the right thing as onerous and difficult as possible with nearly every interaction. i sympathize, to a point.Report

    • Avatar Brandon Berg in reply to Doctor Jay
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      The desired effect of democracy is to give the masses the illusion of control while leaving the important decisions up to people who know what they’re doing.Report

  10. Avatar JS
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    I suspect if there weren’t two other major vaccines out there, they’d have limited this pause to “women with blood clotting risks” instead of everyone. But with two other vaccines in major production, I suspect the CDC and FDA simply feel there’s enough slack to go “better safe than sorry”.

    I do find it ironic that the newest, cutting edge mRNA vaccines aren’t the ones causing unexpected problems. They’re the ones plenty of people worried over, since the entire vaccine creation method was so new (although theoretically much safer and much faster to create).Report

  11. Avatar Kazzy
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    ““We are recommending a pause in the use of this vaccine out of an abundance of caution.”

    That right there: abundance of caution.

    How about: slight preference for doing what will save the most lives?Report

    • Avatar Pinky in reply to Kazzy
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      As I said (clumsily) above, it may be the case that the deaths from side effects of the J&J vaccine plus the deaths from people who will refuse to get any vaccine based on the J&J story will outweigh the number of deaths caused by delays. At least, it might not be a corner solution.Report

  12. Avatar Saul Degraw
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    I received the J&J vaccine on Friday. I was achey and sore and feeling rather weak on Saturday and sometimes had a low grade fever which came and went all day but was fine and dandy by Sunday morning.Report

  13. Avatar Mike Schilling
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    says:

    What seems to me to have happened is:

    * It was discovered that in rare cases J&J leads to blood clots.

    * These are unusual clots and need to be treated differently. The normal treatment of blood thinners like heparin is actually dangerous.

    * It was decided to recommended pausing J&J until this information can be disseminated.

    This is smart and responsible.Report

  14. Avatar Dark Matter
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    says:

    Decent odds J&J’s vac is just as good as the others, it was just tested in much worse conditions (mutant strain, different stage of the pandemic).

    https://www.youtube.com/watch?v=K3odScka55AReport

  15. Avatar Michael Cain
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    Random factoid… Of 3.29M doses administered in Colorado so far (2020 population estimated at 5.84M), only 122K were J&J. On various media’s graphics, well, J&J is somewhat more than noise, but not a lot. I admit to being surprised.Report

  16. Avatar Jaybird
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    says:

    Report

  17. Avatar DensityDuck
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    says:

    This is something that the FDA can do something about. So they’re doing something about it. Because the people who run the FDA did not take college through the terminal post-graduate level and get hired as a GS-5 and work all the way up to a GS-13 and not really understand the numbers that the industry people were pushing across the table at them and occasionally wonder whether their position was due more to personal merit or more to ticking the boxes for “black, disabled, female” in order to not do things.Report

  18. Avatar Jaybird
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    says:

    I had a handful of thoughts about risk and whatnot but I am not a doctor.

    So here is a doctor that has a handful of thoughts about risk and whatnot that I pretty much entirely agree with.

    Report

    • Avatar DensityDuck in reply to Jaybird
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      says:

      An important thing to remember, when asking “why does the FDA and CDC do what they do”, is that these organizations do not see COVID-19 deaths as preventable. They consider them natural occurrences, like, well, being hit by lightning.

      They do not say “vaccines prevent so-many COVID deaths per thousand, versus causing so-many-fewer deaths per thousand from side effects”. They say “vaccines cause so-many deaths per thousand from side effects, is that an acceptable number, by the way any number greater than ‘zero’ is not acceptable”.Report

  19. Avatar Kristin Devine
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    I’ll stick my thumb out here and point out that there’s a difference between something that is a known factor (the rate that birth control causes blood clots, very well studied and understood) and is treatable (the type of blood clots the birth control pill causes, which can be treated fairly easily if caught in time) and what is happening here.

    We don’t know about the J and J vax – remember it was hurried to market under the EUA without the rigorous scrutiny we normally do – at what rate this side effect will ACTUALLY occur if everyone continues getting the shot, and if there are any lesser effects yet that haven’t been discovered, or effects that will begin to appear over time (many of the people getting the side effects had them 5 or more days after the vaccine).

    It seems to me like the idea that “well this is it, this is the stable rate of side effects, now we know absolutely everything there is to know about this” is a hell of an assumption to make.

    The women who are experiencing this side effect, some of them are still in the hospital and apparently not getting better. Clots are continuing to form. One of the women who developed this condition after the Astra Zeneca shot had to lay in bed and not move because if she did she started bruising over her entire body – EVEN as she had clots forming. I can’t find the article I read now but at least two of the six are still in critical condition as of yesterday. One woman is dead. For all we know, this is irreversible for some of them.

    To some extent, and I know this was no one’s intent, but there’s a little bit of a “sacricficial lamb” vibe here that I don’t much care for. “it’s just a few women, it’s for the good of the nation”. Um, ok, well, as a woman I take issue with that. It is obvious we shouldn’t be giving it to women with low blood platelets (I have low blood platelets and I’m not going anywhere near it and my doctor agrees). But maybe we shouldn’t be giving it to women at all until we understand the mechanism. Maybe we shouldn’t be giving it to anyone until more is known. May I repeat – you are assuming this is the final rate of side effects and that nothing more will be discovered, but that is a leap not supported by the facts.

    Maybe the CDC is right (and I think they are) and the sudden appearance of a weirdness we do not understand in a brand spanking new vaccine that has not been tested to the level we are used to, warrants a bit of caution. We are talking about the ability of the blood to clot properly which is a massively complicated system that can kill you both if blood is too sticky and if it’s too thin, and maybe it’s just not something we should all be shrugging and saying “whatevs” to.Report

    • Avatar Jaybird in reply to Kristin Devine
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      says:

      I am 100% down with the argument that this is too dangerous to give to women. Great! No more women get the J&J. Pfizer and Moderna only.

      Why can’t guys get it?Report

      • Avatar Dark Matter in reply to Jaybird
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        says:

        If J&J were the only thing on the market, or even the vast majority of the market while the other two had production issues, then that would make the argument of it staying a lot stronger.

        However, J&J is a bit player. Pfizer has 107 million doses in the US. Moderna has 91 million. J&J has 8. https://covid.cdc.gov/covid-data-tracker/#vaccinations

        They were late and have enjoyed serious production issues. Kicking them off the market doesn’t mean “no vaccine for you”, it means “take the Pfizer vaccine a few weeks later than you would otherwise”.

        We are rapidly moving to the point where vaccine reluctance will be a bigger problem than lack of vaccine.Report

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