Does a Federal Statute Ban Requirements to Use Vaccine That's Under an Emergency Use Authorization?

|

No, says, a July 6 Memorandum Opinion of the Justice Department's Office of Legal Counsel:

Section 564 of the Food, Drug, and Cosmetic Act ("FDCA") authorizes the Food and Drug Administration ("FDA") to issue an "emergency use authorization" ("EUA") for a medical product, such as a vaccine, under certain emergency circumstances. This authorization permits the product to be introduced into interstate commerce and administered to individuals even when FDA has not approved the product for more general distribution pursuant to its standard review process. Section 564 directs FDA—"to the extent practicable" given the emergency circumstances and "as the [agency] finds necessary or appropriate to protect the public health"—to impose "[a]ppropriate" conditions on each EUA. Some of these conditions are designed to ensure that recipients of the product "are informed" of certain things, including "the option to accept or refuse administration of the product." …

[We conclude that] the "option to accept or refuse" condition in section 564 [does not] prohibit[] entities from imposing such vaccination requirements while the only available vaccines for COVID-19 remain subject to EUAs…. This language in section 564 specifies only that certain information be provided to potential vaccine recipients and does not prohibit entities from imposing vaccination requirements.

NEXT: Fixing Straight Quotes in Word Documents

Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time. Report abuses.

  1. Am I right in thinking that the EUAs for vaccines could be in jeopardy if a court recognizes that HCQ and Ivermectin were and still are available as alternative treatments for Covid (and therefore, whoever applied for EUAs lied by saying no other treatment was available)? And who would have standing to bring such a case?

    1. Neither are recommended or approved for that use.
      Below are quotes from the NIH website.

      There are insufficient data for the COVID-19 Treatment Guidelines Panel (the Panel) to recommend either for or against the use of ivermectin for the treatment of COVID-19.
      Results from adequately powered, well-designed, and well-conducted clinical trials are needed to provide more specific, evidence-based guidance on the role of ivermectin in the treatment of COVID-19.

      The COVID-19 Treatment Guidelines Panel (the Panel) recommends against the use of chloroquine or hydroxychloroquine and/or azithromycin for the treatment of COVID-19 in hospitalized patients (AI) and in nonhospitalized patients (AIIa).

      1. “Neither are recommended or approved for that use.”

        So what?

        So you’re claiming that because politically influenced administrators refuse to support the best available treatment for Covid https://stateofthenation.co/?p=51305 this empowers the administrators to force people to use a vaccine that hasn’t been through the standard vaccine testing protocols?

        That’s an interesting hypothesis

        1. There is no other approved treatment, much less one that have been as tested as the currently available vaccines.

          I was disputing that there are recognized alternate treatments.

          1. They are alternative treatments and are available. And the comment you replied to posed a hypothetical. “What if X . . ?” And your reply was, but X is not the case. *facepalm*

            1. They are alternative treatments in the same way that Trump having the biggest inaugural were alternative facts.

              1. https://stateofthenation.co/?p=51305

                The American Journal of Medicine now (Jan. 2021) recommends Hydroxychloroquine, Azithromycin, and Zinc for the treatment of Covid 19 outpatients.

                TDS is not your friend

                1. Is it entirely accurate to say that The American Journal of Medicine recommends those treatments?

                  https://www.newsweek.com/fact-check-did-american-journal-medicine-recommend-hydroxychloroquine-covid-1565459

                  1. No, that statement is misleading. The paper recommending that doctors consider such treatment was peer reviewed and published. The acceptance of a manuscript by a publisher does NOT mean that the publisher endorses or recommends the conclusion of the paper, only that the paper passed the journal’s standards for peer-review

                    1. For full disclosure, my statement is made as editor-in-chief of two well-established,international scientific journals

                2. It is true that State of the Nation says that The American Journal Of Medicine now recommends Hydroxychloroquine, Azithromycin, and Zinc for the treatment of Covid 19 outpatients. It is not true that the American Journal of Medicine now recommends Hydroxychloroquine, Azithromycin, and Zinc for the treatment of Covid 19 outpatients. (That’s even setting aside that “Jan 21” is not “now.”)

                  It is good to know where you get your “news” from, though. The next post on State of the Nation explains: “BIDEN REGIME: It’s really a Judaeocratic administration working for Jewish interests and Israel.”

            2. “They are alternative treatments and are available.”

              Leeches were good enough for Washington, they’re good enough for you.

          2. “I was disputing that there are recognized alternate treatments.”

            And I was pointing out that the lack of “recognition” is due to political factors, not scientific ones.

            And that the politically motivated administrators who are refusing to “recognize” those effective treatments are the same ones pushing the vaccine.

            1. ” I was pointing out that the lack of “recognition” is due to political factors, not scientific ones.”
              Just how do you KNOW that?

              1. Because we’ve got solid studies showing that HCQ + Zinc significantly imp[roves outcomes for Covid patients

                And we’ve got a bunch of other “studies” where they took the effective HCQ protocol (give it with Zinc, give it as early as possible), and violated it in every way they could (give it without Zinc, give it to people who are in the ICU), and them presented the studies as “proving” that HCQ was useless.

                This would be roughly equivalent to “proving that soap doesn’t block transmission of infections” by doing a study where a 2nd person rubbed a dry bar of soap on a doctor’s neck in between each patient, and then showed that this protocol didn’t prevent doctors from passing infections from one patient to the next.

                1. “Because we’ve got solid studies showing that HCQ + Zinc significantly improves outcomes for Covid patients”
                  In other words, Greg, you do not KNOW that. It is your personal opinion. Moreover, studies with a few thousand patients are hardly dispositive, although they may be suggestive of possible ‘off label” uses of a drug.

                  1. The thing is, it’s very hard to argue with people about things they just KNOW.

                    Try pointing out that Mr. Trump was heavily invested in hydroxychoroquine and to COVID anyway, and as soon as he did, he rushed off to the hospital to get useful treatment(s).

                    1. things they just KNOW.

                      Like your zealous belief that it is entirely UNpossible! that this peer reviewed study in a respected journal is, in fact, a data point that is being provided as evidence of the statement being made, rather than just a random guy on the intertubez screaming, “but you just KNOW!”

                      Stellar as always James.

                    2. But I know he’s an idiot, as are you, based on earlier interaction.

            2. ” the politically motivated administrators who are refusing to ‘recognize’ those effective treatments are the same ones pushing the vaccine.”

              Then Biden should have replaced them when he became President.

              Or, we could ignore the conspiracy theory and note that effective treatments are ones that actually work, unlike HCQ as prophylaxis for COVID-19.

        2. You know he’s not claiming that at all. You know he’s claim is that there is a substantial amount of scientific evidence (from controlled clinical trials) supporting the safety and effectiveness of the vaccines, while there’s no such evidence for Ivermectin and the HCX evidence says it’s unsafe.

          We all know that if you actually didn’t know what he was claiming, you would never have phrased your reply that way. By phrasing it that way, you are signalling loud and clear that you know perfectly well your claim that it’s all “politically influenced administrators” and there’s no science involved is complete bullshit. Howdy-Doodying your bullshit into somebody else’s mouth and bullshitting that it’s what the other guy is claiming isn’t helping you either. Why fuck with us? Maybe you’re hoping to snare a sucker. Or maybe you just like to fuck with people.

          1. “while there’s no such evidence for Ivermectin and the HCX evidence says it’s unsafe.”

            Well, those of us who actually have a clue, and know how to read a scientific paper, know that both of your claims are entirely false.

            Did you not read the link I gave? Or are you just so ruled by politics that no dissenting information is allowed in your brain?

            1. Anyone stupid enough to continue suggesting hydroxychloroquine as a COVID treatment or cure is an instant-mute, and not worthy of being recognized as an intelligent member of our species.

              JFC you people need to stop getting your information from your fellow idiots.

              1. I’ll take Yale epidemiologist Harvey Risch over noted imbecile Jason Cavanaugh.

                1. Even the Yale faculty says he’s full of shit.

                  I’ll go with the rest of the epidemiologists – you can have your one discredited idiot.

                  https://academic.oup.com/aje/article/190/4/491/5898696

                  I’d post more links, but then the comment wouldn’t show up, and frankly – you’re not worth anyone’s time.

                  1. https://stateofthenation.co/?p=51305

                    The American Journal of Medicine now (Jan. 2021) recommends Hydroxychloroquine, Azithromycin, and Zinc for the treatment of Covid 19 outpatients.

                    Jan 2021 trumps Aug 2020. At least, it does if you’re not a politicized idiot

                2. ML,
                  Yours is a reasonable opinion re: Jason–who knows no medicine and a Yale epidemiologist.

            2. Greg I did download the paper.
              The abstract says: ” In the absence of clinical trial results, physicians must use what has been learned about the pathophysiology of SARS-CoV-2 infection in determining early outpatient treatment.”
              The manuscript does not argue that such experimental treatment is a substitute for vaccination

              1. The OP claimed there were no treatments for Covid.

                The OP is wrong.

                That is the point I’m addressing.

                I chose to get the Covid vaccine the first day I could. I’m glad I made that choice.

                But I’m not such a thug that I would bully everyone else to make the same choice I did

                1. The OP is not wrong. There are no proven treatments for COVID-19.
                  There is suggestive evidence, which in the absence of alternatives may be useful.
                  But as the experience of the UK shows, widespread vaccination is so effective in reducing case fatality rates that one should NOT avoid vaccination hoping for a miracle cure ifs/he gets sick.

                  1. “There are no proven treatments for COVID-19.”

                    Bleach injections? Did you forget about the bleach injections?

                    1. Bleach injections? Did you forget about the bleach injections?

                      You got yours early in development apparently.

                    2. You, too. But you went back for seconds.

            3. Well, those of us who actually have a clue, and know how to read a scientific paper, know that both of your claims are entirely false.

              Well, that leaves you out on two counts. Turns out you’re almost as good a scientist as you are a legal scholar.

          2. HCQ has safely been used as a prophylactic and as a treatment for malaria for more than fifty years, and as a treatment for lupus and other disorders for a shorter time that is still measured in decades; recommended (and safe!) doses are well-established. If you look at those studies that claim HCQ is unsafe, you will find that they administered more than twelve times the recommended dose, to patients already critically ill. If you use a pressure tank to administer a twelve-times overdose of air, it will kill the victim from oxygen poisoning.

            As I read the Helsinki accords, those study-authors have committed crimes against humanity.

            1. “HCQ has safely been used as a prophylactic and as a treatment for malaria for more than fifty years”

              Which is a great argument that it is safe and effective to treat exposure to malaria. COVID is not malaria.

              1. Which is a great argument that it is safe and effective to treat exposure to malaria. COVID is not malaria.

                Is there an echo in here?

                1. That’s the hollow sound of your head you’re hearing.

    2. jdgalt1 : And who would have standing to bring such a case?

      I’d say find a person ranting about the “stolen election” on some street corner and he’s your man. After all, the HCQ people & Stolen Election people probably share a sizable common membership, venn-diagram-wise. A search for the latest study finds this from Norway :

      https://www.uspharmacist.com/article/more-evidence-that-remdesivir-hcq-not-effective-against-covid19s

      1. “I’d say find a person ranting about the “stolen election” on some street corner and he’s your man.”

        Just make sure he’s ranting about the 2020 election and not the 2016 election, the 2004 election, or the 2000 election. And make sure he’s ranting about stolen a election and not stolen supreme court seats.

        1. ” make sure he’s ranting about stolen a election and not stolen supreme court seats.”

          Exactly. Make sure they’re ranting about something that didn’t actually happen, before you treat them like they’re ranting about something that didn’t actually happen.

      2. Coincidentally, the same group is ALSO very likely a plaintiff group for a class-action about lead exposure during childhood.

    3. I’ve been hearing there’s quite a bit of evidence for ivermectin as a promising treatment.

      That’s all interesting enough. What’s incredible, though, is the censorship, suppression, authoritarianism and corruption running rampant through the institutions of “science” and the internet and social media, all of which for some reason gets directed at suppressing ideas and information such as ivermectin as a COVID-19 treatment.

      https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8088823/

      Conclusions:
      Meta-analyses based on 18 randomized controlled treatment trials of ivermectin in COVID-19 have found large, statistically significant reductions in mortality, time to clinical recovery, and time to viral clearance. Furthermore, results from numerous controlled prophylaxis trials report significantly reduced risks of contracting COVID-19 with the regular use of ivermectin. Finally, the many examples of ivermectin distribution campaigns leading to rapid population-wide decreases in morbidity and mortality indicate that an oral agent effective in all phases of COVID-19 has been identified.

      1. The linked American Journal of Therapeutics was published 2021 Apr 22. From the same article

        Currently, in the United States, the treatment guidelines for COVID-19 are issued by the National Institutes of Health. Their most recent recommendation on the use of ivermectin in patients with COVID-19 was last updated on February 11, 2021, where they found that “there was insufficient evidence to recommend for or against ivermectin in COVID-19.” For a more definitive recommendation to be issued by major leading public health agencies (PHA), it is apparent that even more data on both the quality and quantity of trials are needed, even during a global health care emergency, and in consideration of a safe, oral, low-cost, widely available and deployable intervention such as ivermectin.

        There is nothing I’m aware of preventing any MD from prescribing the drug “off label”.

        1. “There is nothing I’m aware of preventing any MD from prescribing the drug “off label”.”

          malpractice liability.

      2. ML,
        The manuscript looks interesting. It is pretty recent. The statistics are limited to a few thousand patients.
        However, your claim of ” the censorship, suppression, authoritarianism and corruption running rampant through the institutions of “science”… is just a political assertion. Even these smallish trials cost money and most likely a government at some level is funding them.

      3. Get your shots, and you are much less likely to need to care about how they treat severe COVID. Alas, they probably won’t be able to fix your gullibility problem at this stage of development.

        1. Get your shots, and you are much less likely to need to care about how they treat severe COVID. Alas, they probably won’t be able to fix your gullibility problem at this stage of development.

          Very few people under the age of 65 even need to get the shot before they stop worrying about severe COVID. That’s not a very compelling argument for getting vaccinated, or ignoring possible medications that could be used to reduce the severity of COVID in places where vaccines are not as available. Why do you hate nations where vaccines are less available James?

          1. “Very few people under the age of 65 even need to get the shot before they stop worrying about severe COVID. ”

            True enough, those humans who lack lungs or hearts need have no fear of COVID. And those lacking brains have made their opinions known.

      4. “I’ve been hearing there’s quite a bit of evidence for ivermectin as a promising treatment.”

        Swell. Are you hearing that from someone who’s qualified to tell?

  2. I continue to be puzzled why we are still operating under an EUA anyway. The first, best, argument to get hesitant people vaccinated it to get the vaccines officially approved, safe and effective. At this point, over 160 million people have been vaccinated, we have ample data.

    1. The only answer I can suggest is that we have ample short-term data but next to no long-term data.

      However, that’s an exceedingly weak argument since there is such a high fraction of the population already vaccinated that any long-term negative impacts are going to be widespread regardless of the official approval.

      1. Since every flu season we get a different flu vaccine, with different strains, and unknown long term effects, I fail to see how thats a good argument.

        1. The annual flu vaccine is a lot more alike than different from year to year so the risk of unknown effects within the annual variation is very, very small.

          That said, I didn’t say that it was a good argument. In fact, I specifically said that it was “an exceedingly weak argument”, though for different reasons than you suggest.

          1. I thought it was EUA because the FDA has a “standard” review process that usually takes 10-15 years.

            But the two of you are discussing an “argument” for why it should or shouldn’t be fully approved. Not sure what that’s about.

        2. You’re both wrong.

          https://www.scientificamerican.com/article/how-are-seasonal-flu-vaccines-made/

          “Another factor that can determine which strains of the flu will be included in the current flu shot is the ability to produce a working vaccine against that particular strain. Every vaccine must be thoroughly tested and approved by the FDA before it is made available to the public. If for any reason the production process is particularly slow for a given strain, that strain will not be included in the World Health Organization’s list.”

          The flu shot is made up of a mix of previously approved vaccines. The mix is changed each year in an attempt to target what’s currently going around

          But all the vaccines used are “FDA approved”.

          1. Sort of. Just because a vaccine is 69% effective does not mean its 69% effective in a mix with other strains. We don’t know the long term effects of that particular permutation.
            How, exactly, do we know a particular mix of strains is as effective as each strain individually. The short answer, we dont.

            Now some of this is pedantic. The intellectually honest answer is that the FDA does magic hand-waving of clinical trials for various permutations of flu strains, hand waving that they would not tolerate for other drugs.

            And I am ok with that. But the corollary is that the arguments, at this point, for not fully approving Pfizer or Moderna are exceedingly weak.

            1. Nope.

              Those individual vaccines against the various strains have all gone through the whole FDA approval process.

              The Covid vaccines, for good reason, have not.

              Because Trump wanted to help people as soon as possible, not as “soon” as the FDA bureaucrats wanted (which, generally speaking, is “never”).

              Are you working in an old age LTCF? Then you should have to get vaccinated to work there.

              Anyplace else?

              No. Absent being in a place where you routinely have close access to old people in bad health who don’t really have a choice about being there, there’s no legitimate argument for requiring people to get a Covid vaccine.

              There’s a lot of behaviors that are far riskier than not getting a Covid vaccine, that people are allowed to chose to do. No one, neither the US government, a State or local government, or any company, should have the right or power to ban such activities, or any equivalent ones

              1. Crackpot pandemic management tips are always a treat — and increasingly and remarkably featured at a blog that ostensibly is related to academia.

                1. I’m curious, Rev, did you get the “Trump vaccine”?

                  You know, the one that Harris and Biden were warning about before the election?

                  1. I am a reasoning, educated, sensible adult who attempts to be a productive member of society. I am not an anti-social, disaffected, backwater, superstitious, science-disdaining clinger. Take a wild guess concerning my vaccination status.

                    1. Well, we know you’re a liar, since you’re neither reasoning, educated, sensible nor adult.

                      So I’m going to guess that you lied to yourself, and got teh Trump vaccine, while pretending it was the Biden vaccine

                    2. But, but, but there might have been a gay person who worked on developing the vaccine.

                      Are you going to get the gay vaccine? What if it makes you suddenly decide that same-sex couples can get married if they want to?

              2. “Absent being in a place where you routinely have close access to old people in bad health who don’t really have a choice about being there, there’s no legitimate argument for requiring people to get a Covid vaccine.”

                Except it can mutate. Say, into a strain that can kill younger, healthier people.
                Fortunately, the disease is now highly selective, and mostly only kills stupid people now.

                1. Except it can mutate. Say, into a strain that can kill younger, healthier people.
                  Fortunately, the disease is now highly selective, and mostly only kills stupid people now.

                  Why the hell would it deviate from millions of years of evolutionary tactics to become more, instead of less, lethal?

                  You’re lucky the vaccines were available so quickly.

                  1. “Why the hell would it deviate from millions of years of evolutionary tactics to become more, instead of less, lethal?”

                    You’ll have to ask the virus about its motivations. You seem about par, intellectually, so I’m sure the conversation will be scintillating.

      2. Flu vaccines just have their strain swapped out from season to season. I don’t believe they need to undergo a lengthy reauthorization process like a novel vaccine. They also rely on long-established vaccine technology whereas mRNA is brand new.

        1. mRNA has been around for millions of years.

          1. Context, how does it work?

            1. Context has also been around for millions of years.

      3. I suspect that your reason is the FDA’s excuse. But they damage the case for universal usage by leaving only an EUA order in place

        1. If you watch the news, you’d have seen that the Pfizer and Moderna vacines are expected to gain FDA approval this year. The current delay has to do with whether or not children can get it. They have some pretty big trials running with 6-to-11-year-olds.

      4. This is the first mRNA vaccine, as well, so it may not compare well to our experience with vaccines that use different methodologies.

      5. However, that’s an exceedingly weak argument since there is such a high fraction of the population already vaccinated that any long-term negative impacts are going to be widespread regardless of the official approval.

        “Don’t worry, people. If there are fatal long-term side effects, it might affect 100s of millions, or maybe even billions of people. But, we’re safe from a possible extra million of so COVID deaths. Cheers!”

        “Confirmed” “cases”: 200,000,000
        “Confirmed” deaths: 4,000,000
        Vaccines administered: 1,000,000,000 people

        What could possibly go wrong?

        1. Dead people don’t have long-term health effects… the decomposition is pretty much a short-term process.

    2. Well, the groups most concerned about missing studies are those who have not been studied. Fertile women, infection survivors with natural immunity. The young. Everybody if you want an actual long term study.
      You know, the standard of testing applied to every other vaccine.
      So we definitely do not have ample data at all.
      You can bet your last bought vote that the FDA is pushing every envelope as hard as they can to get “real” approval, but the fact remains that we are not there.
      Get over it.

      1. The only ones needing to get over it are the ones like you hiding behind bs reasons for not getting it.

        Just admit you’re like a petulant toddler and won’t get it regardless. At least then you’d wouldn’t be hiding like a coward behind artificial reasons. And somehow I rarely hear any of you wondering about long term effects of covid compared to the vaccine but here you are just peddling more bullshit anyhow.

        1. BUT I DON’ WANNA!!!! WAAH!

      2. Almost all medicines in your cabinet were authorized based on at least two orders of magnitude fewer people.

        I am sure that there are “fertile women” among the 160+ million people who are vaccinated.

        Also, if “natural immunity” works the way you think it does, there is no downside to getting the vaccine, which would run headlong into your pre-existing natural immunity.

    3. dwb68 : I continue to be puzzled why we are still operating under an EUA anyway.

      There has been several articles on this and the consensus is the FDA has their plodding process and refuses to accelerate it. In a way that’s almost reassuring – given the magnitude of their responsibility – but it definitely feeds into some toxic narratives in this case. I’ve seen it suggested final approval is plus-minus two months away.

      It was suggested in one account that final approval is

      1. At this point its just silly. Name another drug tested on 160 million people before being authorized.

        1. On 16 July, FDA accepted Pfizer’s application “under priority review”—meaning it will move faster than during standard reviews, which typically take at least 10 months; the agency now has until January 2022 to review the materials. That seems like a long time, but last week an FDA official told CNN that the decision is likely to come within 2 months. “The review … has been ongoing, is among the highest priorities of the agency, and the agency intends to complete the review far in advance of the [January] Date,” an FDA press officer confirmed to Science in a statement.

          https://www.sciencemag.org/news/2021/07/when-will-covid-19-vaccines-be-fully-approved-and-does-it-matter-if-they-are

        2. Another quote from the same article :

          What’s the difference between full approval and an EUA?

          It’s one of scale. FDA will review much more data, covering a longer period of time, before granting full approval. “It’s not a huge difference, but it is a real difference,” Goodman says. The agency will analyze additional clinical trial data and consider real-world data on effectiveness and safety. It will inspect manufacturing facilities and make sure quality control is very strict. “It’s an exhaustive review,” Goodman says. FDA is already familiar with much of the data, however, for instance on the very rare side effects caused by the J&J and Pfizer vaccines that didn’t show up in clinical trials.

          1. “very rare side effects … that didn’t show up in clinical trials.”

            This could be said of literally any application. If you test 1000 people, side effects that only happen in 1 of 10,000 people wont show up. If you test 30,000 people, rare side effects that happen in 1 in 100,000 people wont show up.

            And yet, they approve medicines (like the recent Alzheimer one) on far less safety data.

          2. Thank you very much. I’d been having a hard time getting good information about what was in full approval that wasn’t in the EUA. A bit confused, though, they must already be inspecting factories because they caught the failures at the J&J plant.

        3. “Name another drug tested on 160 million people before being authorized.”

          Tetrahydracannabinol.

          1. You win the internet.

          2. THC, a chemical in a plant which has been used for thousands of years, and even has receptors in the human brain/body specifically for uptake. Versus a very new (10-15 years) process of man-made attempts to “play God” with natural processes (piss off with your anti-vax responses, I got my second Pfizer shot early in May), and ignoring our own internal, governmental processes of acceptance.

            Yeah, totally, same same.

            You win the internet

            You’ve set a really low bar. As far as jokes go, that only registered a 0.1/10 on the “I chuckled” scale.

            1. “As far as jokes go, that only registered a 0.1/10 on the “I chuckled” scale.”

              But you’re too stupid to get it, so that proves nothing.

      2. The FDA has their plodding process because thalidomide, that’s why.

        1. And the first polio vaccine.

    4. My experience is that there are very few “hesitant” people, and rather there are a large number of people who have decided they will not get this vaccine and latch onto whatever justification they need for that position. I don’t think official approval will change many minds

      1. One less excuse (at least)

      2. The science mag article above suggests as much as 30% are waiting for FDA approval (based on a Kaiser Foundation study).

        idk if its really 30%, but even half that would make a serious dent.

        The FDA dragging its feet certainly gives the appearance that there is not enough data, or they know something not public.

        And the FDA is its own worst enemy. From the article: “Regulatory rigor is especially important for messenger RNA vaccines, which use an entirely new technology, he adds”

        Well now you tell us lol, after over 100 million people have had it. lmao. This quote sounds like something from an Alt-right conspiracy page.

        The same article says that FDA is not considering the Moderna application because all the materials were not submitted.

        I feel like at this point they are merely justifying their own overbearing bureaucracy.

        1. The only thing “entirely new” is the scale and the approval for medical use.
          mRNA vaccine trials go back to a cancer vaccine experiment in 2008. It was safe then.

        2. “The science mag article above suggests as much as 30% are waiting for FDA approval”

          No, it says that many people chose that option on a survey, which is not quite the same thing.

          The fact is, a substantial portion of the American public have decided that they can resolve the COVID pandemic via the simple remedy of wishing it would go away. At one point, it looked like this might actually work, if enough other people got their shots, but now it seems that the virus can mutate enough to still be a threat even if half the population has gotten their shots. Bummer.

          Alas, there doesn’t seem to be a way to resolve the ongoing problem of people who don’t want to treated any differently, just because they refuse to protect themselves (and others) from a readily communicable disease.

          1. This is a situation that may (hopefully) self-resolve. The more people who die, the more will get the vaccine. If the majority of those people became vaccinephobic because of a FOX News addiction, then there will be fewer FOX News viewers which will reduce the impact of their BS. It’s morbid, but eventually they’ll either: 1) cease to be a large portion of society, or 2) develop a vaccine-resistant version and take everyone else out with them.

            1. The problem is that while they’re incubating the virus, they’re giving it an opportunity to change into a new variant that can infect people who ARE vaccinated. So “stay out of their way and let them improve the gene pool by self-selecting out of it” doesn’ t only threaten them.

          2. No, it says that many people chose that option on a survey, which is not quite the same thing.

            The fact is…

            Ladies and gentlemen, I present to you, The Amazing, Mind Reading, James Bollocks.

            *crickets*

            1. Let me offer a performance of my amazing talent.
              Here is what’s currently happening within the mind of one VinnithegayMarine:

              “*crickets*”

      3. I think you are very right. They will just attach to another conspiratorial and ridiculous reason.

      4. That seems true. Vac hesitant are 99.9999% likely to not get vaccinated at this point. To call that hesitant is wish casting. They are going to change their minds at this point.

        1. You can’t reason with superstition, bigotry, or belligerent ignorance. It is pointless to try.

    5. Phase III trials have not yet completed. This mainly tells researchers about longish-term effects from the vaccine.

      More time needs to pass.

  3. I’m curious

    Is anyone stupid enough to think that the Democrat controlled OLC will release an “opinion” that contradicts the desires of the Democrat Administration?

    Or, to put it another way: Does anyone believe that the DoJ that refuses to prosecute FBI and DoJ members who clearly violated the law WRT FISA investigations is possessed of any professional ethics?

    1. Yeah, not sure what useful information this opinion conveys, if any.

      Only thing will matter is circuit appeals court opinions as lawsuits are filed.

      My guess is the govt. hopes mandates can last long enough to improve vax numbers before being struck down (and, of course, they may not be struck down).

      1. The thing is, the virus doesn’t care WHY you aren’t vaccinated.

  4. Circular logic.

    You don’t need to look any further than the FDAs recent approval of the new alzheimer drug to know that the process appears far more scientific than it really is.

    1. That approval certainly appears extremely suspect.

      1. Of course, how it looks is all that matters.

  5. The Washington Post reports that the Veterans Administration has imposed a vaccination requirement for healthcare employees.

    To the ramparts, law-talking clingers!

    1. The American Medical Association has called for all employers to require vaccination with respect to workers providing health care or personal care.

      This sounds like a coordinated effort by credentialed, educated, professional, reasoning, modern America to try to save lives — even the lives of those who seem to be too stupid to live.

      1. Obviously, medical professionals such as doctors and nurses would benefit from a larger pool of sick people who need professional medical care, either for acute COVID, long-haul COVID, or COVID-related heart problems, so we should completely ignore them when the recommend not getting vaccinated. It’s totally self-serving and abjectly transparently obvious.

  6. The majority of U.S. counties are inhabited by a majority which has and continues to be “hesitant” to accept a CoViD flu shot. This same “hesitant” population produces the majority of food, energy, and raw materials for the temerarious. That majority is (a) wrong both to refuse the flu shot and to produce for others, (b) wrong only to refuse the flu shot, (c) wrong only to produce for others, or (d) absolutely correct. I’m not certain that any OLC blather — or FDA blather, for that matter — changes the outcome.

    Pride is the never-failing vice of fools. The flu shot temerarious certainly have their pride… but they also have human needs which can be filled only by the hesitant.

    Since it’s Poetry Monday, how about Alexander Pope’s 1711 poem “An Essay on Criticism”?https://www.poetryfoundation.org/articles/69379/an-essay-on-criticism

    1. “The majority of U.S. counties are inhabited by a majority” – this is only true because of the incredible sparsity of population in most of those counties. However, the more spread out the population of an area is, the less important the vaccine is anyway.

      Sounds pretty rational to me (and I speak as somebody who is vaccinated and regularly wore masks without complaint).

    2. “The majority of U.S. counties are inhabited by a majority which has and continues to be “hesitant” to accept a CoViD flu shot.”

      So, as they die off, what happens to their majority?

  7. “a CoViD flu shot”
    There is no such object and COVID-19 is very far from influenza in every respect except that both are respiratory diseases that can lead to pneumonia.

  8. So Eugene, any comments on this?

    https://www.documentcloud.org/documents/21015571-cruisescdcca11order072321

    BEFORE: WILSON, JILL PRYOR and BRANCH, Circuit Judges. PER CURIAM: The panel sua sponte VACATES its order of July 17, 2021, and substitutes the following order in its place:

    The appellants’ “Time-Sensitive Motion for Stay Pending Appeal and Administrative Stay” is DENIED because appellants failed to demonstrate an entitlement to a stay pending appeal. See Nken v. Holder, 556 U.S. 418, 434 (2009). USCA11

    This is the case where the 11th Circuit panel initially blocked the District Court ruling against the CDC’s Cruise Line Covid rules, but has now reversed themselves

  9. So…. “Government has to tell you X. X does not have to be true.” So the law requires the government to lie to the people. Great.

    1. The FDA (which is who the law applies to) has to give you information about the status of the vaccine so you can choose whether to get vaccinated or not. Also various entities, including other parts of the govermnet, are free to require you to get vaccinated before you participate in certain activities. Then you can make an educated decision about whether it’s worth it to get the vaccine in order to participate in those activities.

      It’s really not that hard.

      1. BUT BUT BUT I don’t think it’s fair for people to treat me like a plague carrier just because I won’t take steps to reduce the chance that I might have plague. NO FAIR!!!!

    2. “So the law requires the government to lie to the people.”

      Why not cut out the middleman? Various Republican states have passed laws requiring doctors to lie to people regarding the effects of D&C abortions.

Please to post comments