Mini-Throughput: The Reality of a 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 Brandon Berg
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    My takeaway from this is is that all the red tape the FDA puts around clinical trials for treatments for other diseases is in fact not as important for safety as we’ve been told. They’re planning to give an entirely new class of vaccine which has never been used in humans before this year to hundreds of millions of healthy Americans in order to stop a disease with an IFR of around 1%.

    If they can do that, why are there so many hoops that have to be jumped through to trial treatments for diseases with 100% fatality rates? The FDA seems to be happy to relax these requirements when it really matters; I guess the moral here is that people with other diseases don’t really matter.Report

    • Avatar Damon in reply to Brandon Berg
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      The first rule of a bureaucracy is to increase its size and limited it’s decrease. Of COURSE they put of hindrances to quick approval. That way when folks leave the organization, they can go work for the pharmaceutical companies with a rolodex of contacts they can lobby on their behalf. 🙂 It’s like guaranteed employment.Report

    • Avatar DensityDuck in reply to Brandon Berg
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      Eh. Yeah, the vaccine was developed very early in the situation. So was hydroxychloroquine.

      I’m not upset about the FDA requiring test data to confirm safety and efficacy. What does bother me is that they aren’t working twenty-five hours a day to review the data, that they aren’t calling for volunteers from universities and industries to work the issue. I’m pretty sure there are a bunch of people with PhDs in statistics and biochemistry sitting around with nothing better to do; why not put out a call and say “hey, we’ll deputize you to the FDA for the duration, check over these charts”…Report

    • Avatar InMD in reply to Brandon Berg
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      I don’t think this an accurate description of what happened. The ‘relaxing of requirements’ was to put the vaccines to the front of the line, not a change in requirements for approval.Report

    • Avatar Oscar Gordon in reply to Brandon Berg
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      Concur with both InMD (the relaxing was simply to put the vaccine to the head of the line and to the fast track the paperwork), and DD that despite putting the vaccine to the front of the line, the FDA did not pull out all the stops when it came to moving the ball.

      There has been quite a lot of criticism of the FDA regarding the time it takes them to do the statistical analysis that they do (they do not, TTBOMK, do any medical testing or biological testing). Like, professionals saying the the FDA takes weeks to complete a statistical analysis that a grad student can do in a day.

      Whether or not this is the bureaucracy being bureaucratic, or because Trump, et. al. has not specifically ordered the FDA to light a fire under their a$$es, or because the FDA is using old tools or techniques that should have been updated ages ago, I don’t know.Report

      • Avatar Kazzy in reply to Oscar Gordon
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        “Whether or not this is the bureaucracy being bureaucratic, or because Trump, et. al. has not specifically ordered the FDA to light a fire under their a$$es, or because the FDA is using old tools or techniques that should have been updated ages ago, I don’t know.”

        It is also possible that those saying it could be done by a grad student in a day are just wrong about that.

        Regardless, I do hope that there is a full, transparent, and independent audit of the FDAs process to identify if/when/how it could be more efficient, for both regular circumstances and emergency ones.Report

        • Avatar Oscar Gordon in reply to Kazzy
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          My understanding is that this is analysis the pharma researchers do already, then they submit everything to the FDA and the FDA re-runs the analysis to confirm the results.

          If I understand that correctly, then the FDA should be able to turn it around awful quick.Report

  2. Avatar Gabriel Conroy
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    And it’s for that reason that I’m sympathetic to people who don’t want to take it right away and think we should seriously consider not vaccinating the young. So far, side effects have been minimal. But there have been medicines such as DES, where effects did not show up immediately or until future generations.

    Thank you so much for saying that. I have a nagging concern, based on no facts, that these new vaccines might be something bad and that almost everyone is overlooking the potential bad because we really, really want a vaccine. (I don’t think I knew about DES–though I skimmed the wikipedia article–but yes, that’s the kind of thing I’m afraid of.)

    I have another nagging concern that those who express reservations about the vaccines will be tarred as “anti-vaxxers.” (And frankly, I don’t like the way anti-vaxxers are tarred as…..well, whatever they’re tarred as. I disagree with them, but the antipathy toward them seems to go beyond strident disagreement and into something pretty ugly. Of course, the effects of what they advocate would also be pretty ugly.)

    All that said, once it’s available for people like me, I’ll probably opt to get the vaccine.Report

    • Avatar Kazzy in reply to Gabriel Conroy
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      Re: anti-vaxxers

      I think it depends on which subset you’re talking about. The parents that quietly opt not to vaccinate their child? I have REAL issues with that but I won’t publicly tar them.

      The folks advocating for anti-vaxxing and pushing anti-vax propaganda and all that bullshit? They deserve whatever tarring they get.Report

      • Avatar gabriel conroy in reply to Kazzy
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        I certainly agree that if someone puts themselves out in the public sphere, they ought to expect a public response. RFK Jr., for example. Or Jim Carrey. Or Jenna McCarthy.

        I do think, though, that tarring is not very effective and probably is a detriment to the pro-vaccine argument. The tarring, depending on how it’s done, is more likely to solidify the anti-vaxxer contingent and enable them to get new(er) recruits.

        I also think they have something of a point. Vaccines are something both personal and public. We’re asking, often requiring, people to inject something into their bodies and re-calibrate their immune system. It’s for their good and the greater good, but it’s not entirely divorced from something that is very, very involved with one’s internal sense of being. And with parents deciding for their children, it involves another almost “primal” thing, a caretaker’s assessment of what they want their children to go through.

        By saying they have a point, I’m not saying they’re right. I do believe that we as a society and a polity have the prerogative and legitimate authority to engage in some sort of compulsion for many vaccines. But the personal/intimate aspect of it gives me pause before I unreservedly condemn them.Report

    • fillyjonk fillyjonk in reply to Gabriel Conroy
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      I admit I am slightly anxiousified by the “severe allergic reaction” news though I don’t know how much of this is “oh crap” and how much it’s the news reporting trying to get us all to collectively say “oh crap.”

      I have never had a bad reaction to a vaccine (worst I ever had was a seriously sore arm after an inexperienced person gave me a TDap int he wrong place) but I am allergic to nearly everything else, though not to the level of anaphylaxis (peanuts are questionable though; cut them out of my diet before I had a severe reaction).

      However – as long as I can find someone to sit with me for an hour or so after the vaccine and who is smart enough to call an ambulance if I start wheezing, I’m still getting the shot, because this locked-in thing I am doing now is no life, and some days I’ve said a fairly quick death of anaphylaxis (which I know is unpleasant, but still) is preferable to a lingering death from loneliness and loss-of-purpose.

      I just wish there weren’t an abundance of people ready and prepared to rain on everyone’s parade and make the vaccine sound less safe than it most likely is.Report

      • Avatar Oscar Gordon in reply to fillyjonk
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        I have a severe PCN allergy. It’s the only allergy I have, but I experience anaphylaxis.

        So I will get the shot. I will have my doctor give it to me, and I will sit in her office for a while afterwards.Report

      • Avatar gabriel conroy in reply to fillyjonk
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        The most recent time I got a vaccine was the flu vaccine this September. It was at a grocery store pharmacy. Usually, when I get it at the clinic that’s part of where I work, they make me sit down for 15 minutes to make sure I’m not having any reactions. But at the grocery store/pharmacy, it was in and out. I probably could have stayed if I had wanted to, but it wasn’t really encouraged or offered as an option. My wife, a couple weeks ago, got her flu shot at a CVS, and it was the same thing. No 15-minute wait.

        (I get a 1 or 2 days “feeling blah” from the flu vaccine, but it’s never been anything major for me–certainly not anaphylaxis or something that can be called a “reaction.”)Report

    • Avatar North in reply to Gabriel Conroy
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      The antipathy didn’t come all at once, IMHO, it evolved as our understanding of antivaxxers filled out. Initially antivaxxers were like vegans or goldbugs; they had odd quixotic fringe beliefs that seemed mostly harmless. Sure antivaxxers exposed their kids to a little heightened risk (which was mainly mitigated by herd immunity) but it was considered mostly harmless and the default assumption was that if they were better informed they’d change their views.

      Then we learned more about anti-vaxxers. Their numbers grew and they stopped being mostly harmless kooks and became growing gaps in herd immunity. Their quixotic beliefs stopped being only a mild risk to their own kids because as holes opened in herd immunity their own kids faced serious risk AND as they degraded herd immunity they exposed people who -couldn’t- be vaccinated to serious risk as well. On top of that they demonstrated an obduracy that was far more in line with genuine conspiracy theorists and grifters began to pop up like Andrew Wakefield who were obviously operating in bad faith.

      Animus of antivaxxers didn’t spring full formed from the forehead of Zeus- it has accumulated to its current level one maimed kid, one killed immunocompromised victim, one grasping charlatan and one circular ignorant bad faith argument at a time. One can argue about the efficacy of anti-vax animus but I don’t think one can seriously claim it us unearned.Report

      • Avatar InMD in reply to North
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        Evangelization of the anti-vaxx movement is what has rightly IMO created widespread negativity towards them. That said, and to Gabriel’s point, I’m not sure viciousness is the solution even if they kind of deserve it. We need to pull as many of them back as we can and prevent people with innocent curiosity from being hardened then falling down the rabbit hole.Report

        • Avatar North in reply to InMD
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          We don’t disagree at all- I’m very doubtful that anti-vax animus is productive but I do think it’s well earned.Report

        • Avatar gabriel conroy in reply to InMD
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          I take the position I do mostly because of the fact (I’ll assume it’s a fact) that anti-vaxxer animus is counter-productive.

          However, I do feel something like sympathy for their position. You all can see my response to Kazzy above for more detail. But I’ll add one more thing. All of (or most of us, or many of us) believe crazy things. Usually, our belief in those things doesn’t harm others, so we get a pass (or we get mocked by internet commentators, but that comes with being on the internet). And while North is right to say that anti-vaxxers or their spokespersons have “far more in line with genuine conspiracy theorists and grifters,” I wouldn’t want to be too quick to judge.

          That said, I also realize North’s point is that while the animus (for lack of a better word) might not be productive, it is indeed “earned.”Report

    • Avatar Jaybird in reply to Gabriel Conroy
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      Eh. I generally trust the vaccine people to be putting together something in my best interest.

      But then I remember Tuskegee way back when and, more recently, the CIA agreeing to no longer use vaccine programs as cover. Like, they said this in 2014.

      That’s a strawman, I can imagine someone saying. They wouldn’t use vaccines as cover for nefarious stuff against Americans!

      And I point out Tuskegee again.

      “White Americans”, they clarify.

      Again, I generally trust the vaccine people to be putting together something in my best interest.

      But there is a lot of baggage when it comes to this sort of thing.Report

      • Avatar Kazzy in reply to Jaybird
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        Was Tuskegee the government or a private company or both? Maybe I’m naive but the vaccines being developed by private companies inspires faith in my in these particular circumstances. If they botch it — regardless of the reason — that’s it for them. They’re kaput. NO ONE wants to be the company that fucked up the Covid vaccine and made things worse. Or to even be perceived as such. If they’re putting it out, I imagine they’re as confident as they can be in it. The government funding them and facilitating distribution doesn’t concern me. If this was developed in a government lab under the auspices of the Trump administration, I’d feel very differently.Report

        • Avatar Jaybird in reply to Kazzy
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          From the Wikipedia:

          The Tuskegee Syphilis Study, also known as the Tuskegee Syphilis Experiment, Tuskegee Study of Untreated Syphilis in the African American Male, U.S. Public Health Service Syphilis Study at Tuskegee, or Tuskeegee Experiment, was a clinical study conducted between 1932 and 1972 by the United States Public Health Service (PHS) and the Centers for Disease Control and Prevention.

          That was a long time ago, of course.Report

      • Avatar Pinky in reply to Jaybird
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        We don’t talk about it much on this site, but a lot of the anti-vax and anti-mask stuff I’ve seen comes out of the black media.Report

      • Avatar gabriel conroy in reply to Jaybird
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        With the covid vaccine, I’m afraid that 30 or 40 years from now, introduction to biology textbooks will have a one-page excerpt about “science in history” where they talk about that one time, 30 or 40 years ago, when everybody was onboard with a vaccine, but they neglected obvious factor X because so many people really, really, really wanted a vaccine.

        Or, maybe the excerpt would be in introduction to psychology textbooks. Maybe in a chapter on confirmation bias.

        We’ll see.Report

  3. Avatar DensityDuck
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    Some people might point to Vioxx here.

    The response to that is that Vioxx was studied in a hospital setting under constant care and monitoring by professionals. And that’s how it was expected to be used. In reality it was just “here’s some pills, try to remember not to take ’em all at once”, and people went home and took them all at once and had heart attacks.

    So, the issue here will be the people who swear up down and sideways that they’ll take the vaccine, and they sign the paper and nod along with the doctor who says “you HAVE TO COME BACK, you HAVE TO GET A SECOND DOSE, this WILL NOT WORK WITHOUT A SECOND DOSE,” and they get the shot and feel awful for the next couple days and then when it’s time to for the second appointment they…”forget”.Report

    • Avatar Philip H in reply to DensityDuck
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      Strong national leadership can mitigate some of that . . . bully pulpits and allReport

    • Avatar Kazzy in reply to DensityDuck
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      If people are getting dose 1 in waves, that may help. With regular vaccines, everyone is on a different schedule. For some reason, I never got a HepB vaccine and my doc recommended me for it. I have to remember of my own accord when to return for doses 2 and 3. CVS sure as hell ain’t gonna call me and even the doc never followed up on his recommendation (he made it over a year ago).

      But if 20M people get vaccinated in January and dose 2 is needed in 6 months, than in July we can hit ALL those people with a reminder. “HEY!!! IF YOU GOT STUCK IN JANUARY, IT’S TIME TO COME BACK!!!”Report

  4. Avatar Kazzy
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    My girlfriend is one of those people with hesitations about the vaccine. I asked her when she’d feel comfortable taking it and she said in a year. That flummoxed me. But maybe that is my own ignorance. I don’t imagine we’ll know much more about the “safety” of the vaccine than we know now. And it seems impossible to know the long-term effects of anything that hasn’t existed long-term. This is true of both the virus itself and any potential cures/vaccines/etc. To some degree, we simply have to hope that the long-term effects are nil to minimal. We can’t wait 50 years to find out what happened to the test subjects.

    But maybe I’m being wrong-headed about this. Maybe I’m too cavalier about trusting the science. I keep saying I’d be first in line for the vaccine. And not because I’m concerned about my risk exposure* or I feel special and deserving. Rather, someone has to be first in line and if my being willing to helps move the process along, I’m game to do it. SOMEONE needs to take those first 100M doses. If any go unused, that is bad. We need to get 60% or whatever of the population immunized and I want to be part of achieving that, not preventing that. I’m very encouraged to hear that there is more demand than doses at this time, since it means we are more likely to get to herd immunity sooner than later. I’m okay with production limitations being a bottleneck; I’m less okay with reluctance being so.

    But, again, that is my not-very-well-informed opinion. Curious to hear other thoughts, including those offered already.

    * I have a hunch of I have some degree of inherent immunity. As I mentioned before, my sons’ mom was diagnosed with Covid back in March. Her exposure date was likely 3/9. We celebrated our son’s birthday together on 3/11 and the boys were with her until 3/16. Her diagnosis was confirmed on 3/19. The boys and I remained quarantined together until 3/30. We never developed symptoms and were unable to be tested at that time; NJ considered us “the worried well”… reason to be concerned but not sick and thus not qualifying for the limited tests available at the time. Antibody tests in May for all three of us were negative. Since things have returned to normal-ish, I’ve had pretty consistently high exposure risk, never developed symptoms, passed every test, and no one around me has gotten sick (making it unlikely I was an asymptomatic carrier). Anyway, all that to say, I’m not super worried about getting it: I think if I was going to get it, I would have gotten it already. But I’m not so confident in that that I won’t get vaccinated.Report

    • Avatar Pinky in reply to Kazzy
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      Hey – I hope you get through it fine, but don’t get too lax in the meantime.Report

      • Avatar Kazzy in reply to Pinky
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        Thank you. I have not been lax but the nature of my life simply put me at risk. I’m a single dad with two active kids, so while summer camp for all three of us wasn’t a MUST, it felt pretty darn important. But it upped our risk. Returning to work — as a masked teacher with mostly unmasked students — upped the risk. Commuting upped the risk. The boys returning to school carries risk. Etc etc etc. I was not so positioned that I could hunker down for weeks into months into a year.

        I’m not assuming I am immune… just suspecting I’m less susceptible. But I’ll get vaxxed all the same because we only get out of us if ALL of us get out of it and that means banding together for mass vaccinations. Regardless of my personal risk, this is a “we” problem so I fully support a “we” solution. So if folks are hesitant, I’ll step up.Report

        • Avatar gabriel conroy in reply to Kazzy
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          I probably have something like the same view of my own risk. I’m hopeful that if I do get it, it would be a mild case. I think that’s kind of like denial. (In my case–I’m not speaking to yours.) That said, I don’t really know.

          For the vaccine, if it were offered me today or tomorrow, I almost definitely would take it. Whether I’ll do so whenever it becomes available to someone like me, I’m a cautious “yes,” but I won’t guarantee it. (I do think your girlfriend might be on to something. I presume–maybe wrongly–that the risk profile in a year will be much more reliable than the two-month or so profile we have now.)Report

  5. Avatar Philip H
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    Let’s be clear that these vaccines have had large clinical trials (something on the order of 500K people across the three major vaccines). They don’t have long term tests yet however.

    But the biotech they are based on has been around a while. As mRNA vaccines they are building on genetic techniques that are decades old, so the likelihood they will cause problems is actually minimal. The reporting on the initial side effects are what I’d expect from an mRNA vaccine targeted at a virus. There will be people with adverse reactions, ad those reactions are known and have been discussed in the public sphere and media.

    Given the hospitalization rates that come with this thing unchecked, and given what we are seeing in terms of long lasting after effects of COVID, deploying the vaccine with the knowledge we have makes sense. The alternative is to shut the whole thing down again for longer time periods so it can dies out due to lack of spread, but clearly we as a nation don’t want to turn our collective wealth to that approach. Hell we can’t even get our neighbors to put on the damn mask because mumble mumble freedom mumble mumble.

    So I’ll take it when offered. I’ll have my kids vaccinated. and I’ll urge other to get vaccinated.Report

  6. Avatar North
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    I would not only go first in line to get a vaccine, I’d probably pay a significant fee to do so and whistle happily all the while. Vaccines are like flying buttresses of medical science and herd immunity is a cathedral of the modern era- an achievement of medical and social effort that strikes one dumb in awe and joy.Report

    • Avatar James K in reply to North
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      I strongly agree, I can’t wait to get it myself.Report

    • Avatar Michael Cain in reply to North
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      The last CDC guidance I saw on priorities put my wife and I pretty far back in the line. The guidance issued by our state has us much closer to the front of the line. And I know that some of the authorities have been practicing moving simulated vaccine around the state. What I haven’t heard anything about is how things are going to work for individuals. Will we get a choice of vaccine? Assigned locations? Scheduled? Do we just go stand in the weather and wait, properly socially distanced? Are they just going to announce, “We have a half-million doses this month. Best of luck.”Report

    • Avatar gabriel conroy in reply to North
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      I’d probably pay a significant fee to do so

      I’ve been thinking about this for a couple of weeks. I’d (probably) pay a fee, too, if it meant that my paying it would mean someone else could get it for free or at reduced cost. I’m not sure I’d pay it if paying was the principal thing that puts me in line before another person.

      That’s the ethical side of me, of course. I don’t always live or act ethically.Report

  7. Avatar Pinky
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    I wouldn’t rush to get the vaccine, but only because I’m not in a high-risk group, and I have limited exposure to those in high-risk groups. There are others who need it sooner. When we have a bunch lying around, I’ll take it without concern.

    Odds are very low I’ll suffer from Covid-19. Odds are very low I’ll suffer from side-effects from a vaccine. I mean, if I spent three days in bed because of their one, that’s just how life goes. Every vaccine, virus, or car ride has an element of risk. I’ll do what I can to minimize the damage I might do others, and that means letting the higher-priority people go first, then doing my part for the herd.Report

  8. Avatar Kazzy
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    Stupid question: Does everyone need to get the same vaccine? I understand there are 2 or 3 different viable ones out there. Does it matter if half of us get one and half the other?Report

    • Avatar InMD in reply to Kazzy
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      Not as a population but maybe somewhat on a personal level. Do you want to be in the half that continues living normally but with a microchip in your brain or the half turned into alien replicons?Report

    • fillyjonk fillyjonk in reply to Kazzy
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      It seems that “no” is the answer, as long as the person is blocked from getting sick (and especially transmitting it, which is still a big unanswered question, sadly).

      I suspect most of us won’t have a choice; it’ll be “what’s available where you are when you can get vaccinated” though possibly if some of the vaccines cause a higher likelihood of adverse reactions in some groups, maybe the less-reaction-causing ones will be held back and used on people in those groups. Though I’m not even sure how they could DO that logistically, short of telling people in those groups “okay you have to go to Hospital X in Big City Y if you want that particular vaccine, otherwise, good luck and God bless”Report

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