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Medicine United States

FDA Panel Rejects Plan To Administer Pfizer's COVID-19 Booster Doses To General Public (cnbc.com) 151

An anonymous reader quotes a report from CNBC: An influential Food and Drug Administration advisory committee on Friday resoundingly rejected a plan to administer booster shots of Pfizer and BioNTech's Covid-19 vaccine to the general public, saying they needed more data. The panel, however, could still recommend the shots for other populations. Scientists continued debating the need for a third dose of the vaccines for people 65 and older and other vulnerable populations after their initial vote. "It's likely beneficial, in my opinion, for the elderly, and may eventually be indicated for the general population. I just don't think we're there yet in terms of the data," Dr. Ofer Levy, a vaccine and infectious disease specialist at Boston Children's Hospital, said after voting against the original proposal. The final tally failed 16-2.

In a paper published days before the advisory committee meeting, a leading group of scientists said available data showed vaccine protection against severe disease persists, even as the effectiveness against mild disease wanes over time. The authors, including two high-ranking FDA officials and multiple scientists from the World Health Organization, argued Monday in the medical journal The Lancet that widely distributing booster shots to the general public is not appropriate at this time. In outlining plans last month to start distributing boosters as early as next week, administration officials cited three CDC studies that showed the vaccines' protection against Covid diminished over several months. Senior health officials said at the time they worried protection against severe disease, hospitalization and death "could" diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. Before the vote, some committee members said they were concerned that there wasn't enough data to make a recommendation, while others argued third shots should be limited to certain groups, such as people over age 60 who are known to be at higher risk of severe disease. Some members raised concerns about the risk of myocarditis in younger people, saying more research is needed.

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FDA Panel Rejects Plan To Administer Pfizer's COVID-19 Booster Doses To General Public

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  • Doesn't matter (Score:4, Informative)

    by quonset ( 4839537 ) on Friday September 17, 2021 @04:06PM (#61805509)

    The stupid [imgur.com] will continue [imgur.com] to kill themselves. Meanwhile, some hospitals are in the process of creating death panels [marketwatch.com] while these same stupids insist there's nothing going on, even to their dying breath [imgur.com], while costing us billions of dollars [cbsnews.com]. But then, these people were never ones imbued with much intelligence [imgur.com] to begin with considering their arguments against getting vaccinated [imgur.com].

    • Re: (Score:2, Interesting)

      Cool story. Do smoking, obesity, and heart disease next.

      In all seriousness, this is the cost of a free society. People will make choices you don't like, but the good news is that you can get vaccinated and don't have to worry about it.
      • Re: (Score:1, Insightful)

        by quonset ( 4839537 )

        Cool story. Do smoking, obesity, and heart disease next.

        In all seriousness, this is the cost of a free society. People will make choices you don't like, but the good news is that you can get vaccinated and don't have to worry about it.

        Let us know when smoking, obesity or heart disease can be transmitted from person to person by breathing on them.

        I didn't say I didn't like their choices. In fact, I think their choices are great. By killing themselves they not only give me a laugh, they help to increase the overall IQ of the country. Even better, they don't get to vote any longer.

        • by ceoyoyo ( 59147 )

          Well, smoking can. That's why pretty much everywhere has laws against smoking inside public buildings.

          • Re:Doesn't matter (Score:4, Interesting)

            by Jfetjunky ( 4359471 ) on Friday September 17, 2021 @04:48PM (#61805627)
            Yup. Except by the time most every place stopped allowing smoking indoors in a public place, the majority of public favor had turned it anyway. But even then, smokers griped about it constantly (my parents were smokers). Here the battle of hearts and minds hasn't been won yet, so trying to force it is creating a lot of stir even though the evidence is pretty plain.

            It's actually a pretty interesting corollary now that I think about it. My parents and other smokers often clung to a very similar "baby with the bathwater" kind of sentiment to justify ignoring the facts. Something to the effect of "x person never smoked a day in their life and died of lung cancer, y person smoked their whole life and lived to be blank years old!". The key takeaway from that being, of course, that you can't predict your own fate, so why bother. Which of course is ridiculous on its face unless you're looking for a flimsy reason to not have to make the hard choice or confront your own beliefs/biases.

            Queue all the "but this study (that's super dubious, cherrypicked, or outright fradulent or forged) says bleahblahbhbhbhalbhblablhalbh" responses.
            • by ceoyoyo ( 59147 )

              Hasn't it? Even famously anti-vax France has a very strong majority of eligible people fully vaccinated. In Canada, a strong majority of the population supports *mandatory* vaccination. There's a very tiny but very vocal minority who constantly make the news, but they're finding increasingly hostile public reception. Just like smokers did.

              The US is the black sheep, but still with a majority of eligible recipients vaccinated. As the choice between restrictions or medical rationing grinds on, I expect even th

        • Re: (Score:1, Troll)

          by ravenshrike ( 808508 )

          As shown by Israel with a 61+% total population vaccination rate(And they're not giving the vaccine to children) the idea that there is a significant difference in spread rate between vaccinated and unvaccinated is bunk. As such, pissing and moaning about unvaccinated people being responsible for spreading the disease is naught but performance theater. Which means that it once again breaks down to personal risk.

          • Re:Doesn't matter (Score:4, Insightful)

            by cusco ( 717999 ) <brian@bixby.gmail@com> on Friday September 17, 2021 @05:42PM (#61805771)

            Why do you think that over 95% of the people dying of COVID right now are unvaccinated? Coincidence?

            • To which I nod and say, "Yes, you understand."

              The vaccinated and unvaccinated spread the virus as similar rates - this is pretty well establish now. However, the immune (whether by vaccine, surviving exposure, or natural immunity) are far less likely to die of covid. The non-immune have chosen their risks, just the same as the smoker chooses his risks or the overeater chooses her risks.
              • by ceoyoyo ( 59147 )

                Exactly. I see you support vaccine passports. No unvaccinated indoors, just like we don't allow smoking in public buildings.

                • I think you missed the point. If the immune and non-immune spread the virus at the same rate, then vaccine passports are useless. There is no difference in rate of spread for vaccinated vs unvaccinated according to the latest research, so vaccine passports are pure theater
                  • by ceoyoyo ( 59147 )

                    I didn't miss your silly point.

                    I doubt your premise is true, but even if it is, it's important to mange the unvaccinated's risk of getting infected because they take up critical care resources at a much higher rate. If we were being sensible we would either a) confine them until there's no shortage of resources or b) triage them to the field out back of the hospital to either survive or die on their own.

          • the idea that there is a significant difference in spread rate between vaccinated and unvaccinated is bunk. As such, pissing and moaning about unvaccinated people being responsible for spreading the disease is naught but performance theater.

            Yes, we had hoped the vaccines would reduce spread like the vaccines for some other diseases do. Unfortunately they don't. This means that the unvaccinated gain no benefit from the majority who do get the shot. No herd immunity of others to protect you. Ha ha.

            On the bright side though, the vaccines work very well at preventing the infected from requiring hospitalization. So long as we can keep the unvaccinated from clogging the health care system, it's all good. Just need to spread it out a little

      • Re:Doesn't matter (Score:5, Insightful)

        by ArchieBunker ( 132337 ) on Friday September 17, 2021 @06:12PM (#61805855)

        None of those things are contagious.

      • Re:Doesn't matter (Score:4, Insightful)

        by Gravis Zero ( 934156 ) on Friday September 17, 2021 @06:29PM (#61805887)

        In all seriousness, this is the cost of a free society. People will make choices you don't like,

        Bullshit. This is a public health issue. Everyone eligible should be required to be vaccinated if they are going to use any publicly funded facility/resource or have a negative PCR test.

        but the good news is that you can get vaccinated and don't have to worry about it.

        Not everyone can get vaccinated. This (currently) includes those under the age of 12 as well as those who are immunocompromised. At this point, I'm in favor of denying care to the unvaccinated with covid-19. The reason for this is people who need medical care are being turned away because of all the covid-19 patients.

      • Even ignoring the possibility of a breakthrough infection or a new variant people not getting vaccinated is crushing our healthcare system and slowing down the economic recovery we desperately need. I'm going to guess that most people on slash dot managed to hold on to their jobs, but if the economy keeps being crap that's not going to last.

        We really need to do something about this whole "I am an island in and of myself" belief that Americans have gotten drilled into their heads. The decisions of other
      • If I'm hit by a drunk driver, people like that may leave me without a hospital bed to go to.

        That's on top of what I'd expect to be obvious, that I can still get a case from someone who chooses to stay fully vulnerable. I know the difference between 95% and 100%, and it's not 95% any more.

        Plus, you know, I care about the other people they're going to kill.

      • Hospitals are actually well sized to deal with smoking, obesity and heart disease. Two thirds of people die from cancer or heart disease.

        COVID patients can still fill up the ICUs so quickly there is no room for those people though. Personally I think they should continue to offer the same service level to everyone that they provided it to pre-pandemic, and treat COVID patients only when it does not hinder that goal.

        People should not be having cancer surgery postponed because others did not believe i
      • I would agree with you that it doesn't matter, except that it does still. It matters because the transmission rate of COVID-19 is over 1, meaning for each person that gets infected, more than 1 person is affected (i.e. they go on to infect someone else).

        This might not be an issue either IF they couldn't infect my niece or nephew who arn't old enough to be able to get a vaccine, or the millions of people who can't be vaccinated because of medical reasons, or the billions around the world who still have yet
      • Cool story. Do smoking, obesity, and heart disease next.

        In all seriousness, this is the cost of a free society. People will make choices you don't like, but the good news is that you can get vaccinated and don't have to worry about it.

        Amen, and it's paid in Herman Cain Awards. When you start to feel the smallest amount of pity, remember, they died for your freedom. Wait no, they died for their freedom. That's still not right, they died with their freedom? Let's go with that one. They definitely died doing what they love, no, shit. They died with the thing they love, freedom! And a bunch of tubes and forced oxygen in a hospital bed, shit, fuck. They definitely died knowing that they chose freedom. YES! ... and that's why we don't

      • "this is the cost of a free society. . People will make choices you don't like, but the good news is that you can get vaccinated and don't have to worry about it."

        Public health is non-excludable and non-rivalrous, the very definition of a public good.

        I cannot be free of someone else's poor public health choices.

  • What will this decision do to the spread of COVID? It seems like you are more likely to spread COVID if you have symptoms, so by allowing more people to get COVID and become symptomatic it seems likely it will increase the spread of COVID in the population (especially among the idiots who refuse to get vaccinated and the unfortunate who are unable to get vaccinated). It also seems to have economic effects as well, whereas even if you aren't afraid of becoming hospitalized with COVID if you have been vaccina
    • What will this decision do to the spread of COVID?

      We don't know, that's why we need more data.

    • by tlhIngan ( 30335 )

      In a word, nothing much.

      The thing is, booster shots are good for those who may not have been able to produce enough antibodies - like those with compromised immune systems (either through disease, transplant, old age, whatever).

      What happened is the FDA rejected the plan to give EVERYONE booster shots. Basically the data that says booster shots are good in the immunocompromised and elderly people don't really apply to 16 or 17 year olds who have healthy immune systems. Likewise, the data we do have from say,

  • I am certainly no expert in this field, but given the rapidly decreasing efficiency against new variations of the COVID virus, it seems to me that rather than pumping everyone full of the same vaccine we rushed to market to at least make a step in the right direction, any booster that is added should not target the same original strain the vaccines were originally designed for, but instead should be tailored for the new strains.

    If I understand the technology correctly, a new vaccine capable of fighting new
    • I am certainly no expert in this field, but given the rapidly decreasing efficiency against new variations of the COVID virus

      It doesn't rapidly decrease in efficiency against new variations. There was a preliminary study that showed a large reduction of efficacy, but since then we have more data and the vaccine is largely effective against delta.

      In my local area, most hospitalized people are those without the vaccine. The people with the vaccine in the hospital are mostly people who got the vaccine after being exposed (ie, their family member got covid so they got the vaccine), or people who have a weakened immune system, from ot

    • Re:Idiocy? (Score:5, Informative)

      by mark-t ( 151149 ) <markt AT nerdflat DOT com> on Friday September 17, 2021 @05:54PM (#61805801) Journal

      The vaccine wasn't rushed, it was prioritized. There is a difference. "Rushed" would imply that there was some kind of sloppiness in the COVID vaccine's development, or that steps that might otherwise get taken for other vaccines were not done or glossed over for the COVID vaccines. This is not the case.

      The reason we got a vaccine so fast is two-fold. First, the technology is always improving, and they are simply getting better at creating vaccines quickly. But secondly, because there were a whole lot of people pouring a whole lot of money into getting a vaccine for this novel coronavirus as quickly as possible, far in excess of what vaccine development ordinarily gets, many steps that are usually performed sequentially to accommodate a more typical rate of funding could actually be done in parallel.

      • There was a huge head start from SARS 1.0 and MERS. One vaccine developer said that as soon as they got the sequence for our new enemy, they knew exactly what to do.

        Or just look at the results. Read https://berthub.eu/articles/po... [berthub.eu] and anyone who's done engineering will recognize a refined product.

        The closest thing to "rush" was deliberately overlapping steps, which could have cost money if earlier steps had failed while later ones were already started.

        • by mark-t ( 151149 )

          The closest thing to "rush" was deliberately overlapping steps, which could have cost money if earlier steps had failed while later ones were already started.

          This is my understanding as well. Fortunately, there was enormous amounts of money being poured into it that made such overlapping financially feasible.

  • I miss the pre-science, let's-follow-the-data, there's-no-evidence days.

    I don't need a bunch of people to make recommendations from existing data. I can do that all by myself. There's no trick to making decisions AFTER you already have the data.

    What I need, are experts that can make decisions with incomplete data, missing evidence, and, oh, I don't know, EXPERTISE?

    I get that we need more data, more time, more tests, and more evidence. I hereby stipulate that we don't have that.

    It's a given that by the ti

    • The question today is not "is there evidence that we need a booster".

      Of course it is.

      The question today is "should we get a booster today".

      The answer is no because there is no evidence to support saying yes.

      Stop showing me the data. Grow the four organs that we link with courage, stick your neck out (okay, that makes five), and prove that your expertise is worthy of others to follow.

      Ignorance is not courage its just dumb.

      Otherwise, you're useless. I don't need you to read the data for me.

      What else is new? Useless is what government agencies do.

      • So, if I show you a mushroom, and you don't have a laboratory available to you, there's no evidence that the mushroom is poisonous.

        Are you going to eat it?!

        Utilizing your expertise isn't ignorance. It's experience. Putting your name to your experience is the courageous part.

        I hope you've never gone to a doctor. Your family doctor doesn't tend to run laboratory tests for every patient. A quick examination, and your doctor might say: "you've likely got a blah blah. try doing yada yada. if it doesn't go

        • So, if I show you a mushroom, and you don't have a laboratory available to you, there's no evidence that the mushroom is poisonous.

          Are you going to eat it?!

          No, I don't like mushrooms and I don't eat or inject things without affirmative evidence.

          Utilizing your expertise isn't ignorance. It's experience. Putting your name to your experience is the courageous part.

          Experience is no substitute for knowledge. It isn't like the necessary evidence to support boosters is unknowable, unobtainable or requires unreasonable effort to obtain. Being courageous with other peoples lives is not a virtue. Neither is being courageous with whatever public trust the federal government has left.

          When world renowned experts wing it and rely on "courage" over reality you end up with Quebec bridges w

    • I'd actually rather prefer to keep future-seeing witch-doctoring away from my medical experts, thanks.

      One thing all the studies agree on is that if you've had your second dose of the vaccine any time in the past six to nine months, which everyone in the general population has, then you're still fine; you're protected. There's no point in getting a third shot too soon; it's not going to boost immunity if you get yet another shot too closely on the heels of the first two shots.

      In fact, it is almost certainly

      • You've actually sold me on the now-is-not-the-time for a booster.

        But that wasn't the discussion.

        I want those FDA wimps to do exactly what you just did. To say, quite plainly: "our expertise says that it's better to wait". That's what you did. That's what I want them to do.

        I don't care what their advice is (for this conversation). I just want their advice. "there's no evidence to support" is not advice. That's tantamount to saying "we haven't done our job, so we can't tell you". That's not to say that

  • Sheesh (Score:5, Informative)

    by RyanFenton ( 230700 ) on Friday September 17, 2021 @04:41PM (#61805613)

    This article must have been written in the few minutes they had between that vote and the one for folks over 65 - which was unanimously approved to get the booster.

    The whole reason they rejected the under 65 population is because the data hadn't been reviewed by the larger community of experts yet for that group. Which is absolutely fair.

    Just like with the original vaccine rollout, there's just going to be staging steps.

    Unless this article was only pushed to give the false impression that the FDA was against boosters... that would be pretty lame.

    Ryan Fenton

    • Re:Sheesh (Score:4, Informative)

      by fafalone ( 633739 ) on Friday September 17, 2021 @08:01PM (#61806087)
      They didn't just approve them for 65+. They also approved them for people under 65 with factors that make them at high risk; the language isn't final but they'll probably defer to the existing categorization, which includes being overweight and having high blood pressure. They took an additional straw poll requested by the FDA (Dr. Marks) on additional populations, after he reminded them the FDA can reject or modify their proposal, and they unanimously voted to include healthcare workers and those whose occupation exposes them to a high risk of infection.

      It's likely the large majority of the population will be eligible. They're substantially understating the strength of the evidence for need, because they're rejecting that mild infections are important to control at all.
  • Nobody is doing a double blind, randomly controlled trial on a third dose. Without data to that standard, I don't see the FDA approving anything.

    There are tons of field studies with noisy data, that are poorly controlled. There is even some published literature (Provincetown study) that is simply anecdotal. Good quality research is scarce.
    • by Whibla ( 210729 )

      Nobody is doing a double blind, randomly controlled trial on a third dose.

      It is almost certain that such a trial at this stage would be considered unethical. We already know that the outcome of the intervention would be positive (on balance, ignoring any rare individual side effects), so denying that intervention to the control group would not fly with the trial regulators.

      Without data to that standard, I don't see the FDA approving anything... Good quality research is scarce.

      While there is no doubt that double blinded rct's are the gold standard for clinical research they are not the be all and end all of trials: perfectly good data can be obtained without using them. And, as previ

  • by Thelasko ( 1196535 ) on Friday September 17, 2021 @04:51PM (#61805633) Journal
    CNN Reports: [cnn.com]

    Advisers to the US Food and Drug Administration on Friday voted unanimously to recommend emergency use authorization of Pfizer's booster shot six months after full vaccination in Americans 65 and older as well as those at high risk of severe Covid-19.

    That vote came after the group had first voted and rejected a broader application: to approve the third shot in all Americans 16 and older six months after they were fully vaccinated.

  • If two shots gives us enough protection, then is should be fine to drop mask indoor mask mandates for fully vaccinated individuals. Same with schools - teachers and students who are vaccinated should no longer be required to wear masks. Same with in medical settings.

    Two shots gives us enough protection. No need for a third shot. No need for masks.

    • by cusco ( 717999 )

      Thank you for your expert opinion Doctor. /s

  • I got a Pfizer booster. Not everyone has that opportunity but I did.

    No side effects for me.
    Does it improve my immunity? Who knows. It was my decision. I'm glad I did.

  • Why did this make me think it was initiated by politicians?

    Scientist: "A single dose of the vaccine is only 30.7% effective against COVID Delta (B.1.617.2)"
    Politician: "Well why don't you give everyone three shots so they'll be 92.1% effective?"
    Scientist: "I don't think it works that way."

    https://www.nejm.org/doi/full/... [nejm.org]

  • The drug companies love to make drugs that we need to buy over and over again, rather than drugs that actually cure something. This is especially true of Pfizer, the people who brought us Viagra and Lipitor, two big money-makers for them. This wold be even better: The government would force everyone to take a booster of their proprietary vaccine over and over again. Think of the revenue! Their board must be very unhappy with the government board's decision.

    • given that a Pfizer dose is worth about $20, I say it's money well spent. It's nothing compared to the cost of the pandemic. Good job Pfizer, good job BioNTech, good job Moderna.

  • Once the FDA granted full approval for the Pfizer shot, it effectively lost any regulatory enforcement authority with respect to that vaccine. As physicians read more about the data coming out of Israel, more of them will be willing to prescribe a third shot off label. If you have a patient who had no issues with the first two shots, it's a negligible risk. Up to 1/5th of all scripts in the US are off label. These vaccines will just join the club if the FDA insists on being left behind.

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