Coronavirus

Is the FDA Too Cautious in Its Approach for Approving COVID-19 Vaccines?

Yes, but the Trump administration's politicization of the hunt for a vaccine is undermining public trust.

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"The vaccines are coming momentarily," asserted President Donald Trump in his post-hospitalization video yesterday. The same day the White House reportedly first blocked and then scrambled to approve under pressure the Food and Drug Administration's (FDA) proposed guideline that COVID-19 clinical trial vaccine recipients be followed for two months to evaluate vaccines' safety before they can be approved for inoculating millions of Americans. The justification for first blocking the FDA guidance appears to be that that timeline would make it essentially impossible for a COVID-19 vaccine to be approved by the agency prior to Election Day.

Generally, it has taken 10–15 years for a new vaccine to be developed, tested, and approved. However, vaccines for COVID-19 are being developed and put into clinical trials in less than a year, an unprecedented speed. Given how the pandemic is evolving, is the FDA being too cautious?

An August 31 op-ed by two Harvard researchers in the Journal of the American Medical Association urged that the FDA stick to strict approval standards requiring that the COVID-19 vaccines show clinical benefit, not just pass some biomarker threshold such as producing a certain level of antibodies, before they are deployed. The authors warned:

Some have argued that extreme clinical need warrants backing away from the FDA's historical standards requiring clinical benefit. This trend coincides with increasing political popularity of the libertarian "right to try" movement for medications, which advocates that patients should be able to access treatments not approved by the FDA. This approach was likely reflected in the presidential reasoning about unproven COVID-19 treatments: "Try it; what do you have to lose?"

The researchers conclude that "the nation's health will be far better served by reliance on the usual rigorous approach to vaccine evaluation. Premature rollout before the planned trial data are even collected would not be a medical breakthrough; it could represent a major public health misstep."

A strongly contrary view arguing for the immediate release of many current COVID-19 vaccines was expressed by Harvard biotechnologist George Church and his colleagues in an August 14 op-ed in Rejuvenation Research. "For this pandemic, open the gates and release the vaccines," the researchers urge. They specifically suggest, "nucleotide vaccines are ready. They should have virtually zero safety issues."

These innovative vaccines use coronavirus messenger RNA (mRNA) sequences to induce our cells to produce viral proteins that provoke the immune system to develop antibodies to fight off infections from future coronavirus exposures. Moderna and Pfizer mRNA vaccines are already in Phase 3 efficacy clinical trials. "The extremely rapid scaling of RNA vaccine makes it the superior method for mass deployment," assert the researchers. They further argue that modern biotechnology makes other types of vaccines also safer to develop and deploy nowadays.

"Foot dragging and wild misjudgment of vaccine risk are not acceptable. Likewise, withholding vaccines because of bureaucracy when a pandemic is raging," argue Church and his colleagues. "Nothing is absolutely zero risk. But risk must be weighed against certainty of doing nothing, which here and now is too extreme." They ominously conclude, "When nations are at risk of serious economic disruption or overwhelming health care facilities, there is no justification for current policies that leave no alternative but mass death and severe economic damage. It is worth remembering that the last global depression was ended by world war and a new world order."

The argument for the rapid rollout of COVID-19 vaccines by Church and his colleagues would be greatly strengthened through establishing a robust regime of post-deployment safety surveillance to detect and react to any serious side effects that might crop up.

An even better and faster way to assess the safety and efficacy of COVID-19 vaccines would have been human challenge trials. Researchers would have recruited some healthy young people, injected them with various experimental coronavirus vaccines, and then exposed them to the virus to see if any of them worked. But it's too late now to use this alternative given how far down the Phase 3 clinical trial path vaccine makers are now.

If a fall or winter wave of the pandemic is building, then effective vaccines should be made available to the public sooner rather than later. People of goodwill can differ on which approach toward COVID-19 vaccine deployment they think is appropriate. For my part, I think that Church and his colleagues make the stronger argument. However, the Trump administration's transparently self-interested political motivations to rush the approval of COVID-19 vaccines has undermined public trust in them. As an unfortunate result, millions of Americans may hesitate or even refuse to avail themselves of safe and effective vaccines that would protect themselves, their families, and their neighbors from the COVID-19 plague.

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  1. Yes, but the Trump administration’s politicization of the hunt for a vaccine is undermining public trust.
    Is the new issue of the Lancet out?

    1. Bailey’s politicization of every “the science” article he writes is also undermining public trust.

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    2. Thats right its all Trump undermining not the lefts undermining accusations that trump is undermining. There is politics on both sides of the isle in this one and hopefully everyone will realize the real undermining is by Reason and msm.

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  2. Are you literally making the argument that “The government too slow, but Trump shouldn’t be calling for it to go faster”? Really?

    1. I don’t know about you, but I think the timeline and criteria for vaccine approval should be left up to populist politicians into whom the people have placed their trust, rather than career scientists that graduated from Marxists indoctrination camps.

      1. On my part, I would prefer that the government have as little say as possible in what people are allowed to put in their bodies. Any politician, populist or other, who is advocating to those ends is doing yeoman’s work imho.

      2. March: Trump go too slow! All coronavirus his fault!

        October: Trump go too fast! All coronavirus his fault!

        It’s almost like you’re a retarded cunt or something.

    2. “Do something!”

      “What?”

      “I dunno. Not nothing!”

    3. Anytime the gov is involved at all the whole process is by definition politicized.

    4. Well, how else could he have come up with material to fill the Trump criticism quota?

      I don’t know. Is it just TDS, i.e. specific to Trump? Or would it be the same with any other mostly libertarian office holder: that when they finally do the things we’ve been calling for, we’re so used to not getting what we want that we conclude it must be a trap, and find reasons to oppose it?

  3. let’s kill a bunch of healthy people with vaccine experiments instead of the cold virus that doesn’t kill healthy people.

    1. Can I pick the people?

      1. for you other-Rev, absolutely.

  4. I think that Church and his colleagues make the stronger argument. However, the Trump administration’s transparently self-interested political motivations to rush the approval of COVID-19 vaccines has undermined public trust in them.

    This seems like an awfully contorted way of describing the situation. Was, for instance, the HIV crisis in the 90s heavily politicized while activist groups wanted to rush vaccines to market?

    for instance, did this undermine anything:

    ACT UP forced the government and the drug industry to radically change how they conducted drug research. On September 14, 1989, ACT UP took over the New York Stock Exchange to protest Burroughs-Wellcome’s pricing of the first AIDS drug AZT — the most expensive drug ever. ACT UP activists blew fog horns to drown out the opening bell. Within weeks, and after intense media shaming, Burroughs-Wellcome reduced the price of AZT.

    1. Fauci is a fucking murderous attention whore and if this was a just world would be the clown comic relief in a circus act.

    2. It is a bizarre formulation. Ron wants the government out of the drug approval market. There are millions of people who disagree with this and believe that the FDA ought to be MORE careful in approving what companies sell to us. And then there is Trump who is trying to give Ron what he wants.

      We shouldn’t kid ourselves: Both sides are playing politics here. If Trump is moving too fast, the Democrats are whipping up lots of baseless fear mongering. Ron could just as equally blame the Democrats for making things harder, because they don’t want Trump to succeed. Where is the vitriol for them?

      1. This can’t be said enough: Within weeks, and after intense media shaming

        A tacit admission that the media was squarely on the side of the activists. And maybe the activists were right. Here’s a photo caption on the article:

        Marchers at the Pride Parade, Sunday, June 25, 1989 in New York, New York, carry signs ‘9 years of AIDS, One drug approved for HIV.’

        Essentially, ACT-UP was bemoaning the foot-dragging at the FDA for delaying potentially life-saving treatments for AIDS off the market because they might cause cancer in rats.

        Say what you will about comparisons between the diseases, but AIDS was, at that time, a death sentence. COVID is, by all stretches, not even close. For most people, it’s a mild flu. For a (vanishingly small percentage) a more serious condition that, when coupled with other poorly managed health conditions– a potential death sentence.

  5. The only people undermining it are the democrats and their bootlickers on CNN and at reason koch industrial corp.

  6. LOL! Another ORANGEMANBAD article?

    They could come out with a placebo vaccine tomorrow, start attributing COVID deaths only for death from pneumonia with COVID present and attribute the remaining death rate to the natural failure rate of vaccines. Science! would quickly confirm the miracle and we could all be done with the COVID theater.

    Of course, that will never happen, because the point is to keep everyone frightened and dependent on the government for salvation. Bailey seems fine with that.

    1. Another ORANGEMANBAD article?

      Orange Man bad?!? He BAD, all right! He SOOO BAD, He be GOOD! He be GREAT! He Make America Great Again!

      We KNOW He can Make America Great Again, because, as a bad-ass businessman, He Made Himself and His Family Great Again! He Pussy Grabber in Chief!

      See The Atlantic article by using the below search-string in quotes:
      “The Many Scandals of Donald Trump: A Cheat Sheet” or this one…

      https://reason.com/2019/09/02/republicans-choose-trumpism-over-property-rights-and-the-rule-of-law/

      He pussy-grab His creditors in 7 bankruptcies, His illegal sub-human workers ripped off of pay on His building projects, and His “students” in His fake Get-Rich-like-Me realty schools, and so on. So, He has a GREAT record of ripping others off! So SURELY He can rip off other nations, other ethnic groups, etc., in trade wars and border wars, for the benefit of ALL of us!!!

      All Hail to THE Pussy Grabber in Chief!!!

      Most of all, HAIL the Chief, for having revoked karma! What comes around, will no longer go around!!! The Donald has figured out that all of the un-Americans are SOOO stupid, that we can pussy-grab them all day, every day, and they will NEVER think of pussy-grabbing us right back!

      Orange Man Bad-Ass Pussy-Grabber all right!

      We CAN grab all the pussy, all the time, and NONE will be smart enough to EVER grab our pussies right back!

      These voters simply cannot or will not recognize the central illusion of politics… You can pussy-grab all of the people some of the time, and you can pussy-grab some of the people all of the time, but you cannot pussy-grab all of the people all of the time! Sooner or later, karma catches up, and the others will pussy-grab you right back!

      1. >>We CAN grab all the pussy, all the time

        you may have misinterpreted the basis for the pussy-grabbing assertion.

        1. Pussy-grabbing is often facilitated by raw political power, and FEAR in those ruled! As an example, I give you… Caligula!

          https://historycollection.com/12-historically-important-perverts/6/

          “As to deviancy, among the sundry depravities attributed to Caligula, sex with his sisters was just a start – as contemporaries put it: “He lived in habitual incest with all his sisters, and at a large banquet he placed each of them in turn below him, while his wife reclined above“. At dinner parties, he was in the habit of ordering the wives of guests to accompany him to his bedroom, and after having sex with them, would return to the party and rate their performance, berating the cuckolded husbands if their wives had been lacking.”

          Caligula for ya… The depths to which we will sink, if given absolute political power. Caligula, I hope, will NOT further inspire our Pussy Grabber in Chief!

          1. right but Caligula would feed you to the lions for prude-ing up the party … the 21st century implication is it is offered in exchange for being next-to/part-of the power … women’s lib and all

            1. Yeah man, I hate to ‘fess, but I have a few hints about what you are saying… Don’t tell anyone, but I am a geezer! In my day, we ate trilobites for breakfast, and rode dinosaurs!

              I also tried to chase the hippie babes… Tried to lie to them, but I never could get it quite right! Never abused them in quite the right way… I (vaguely a little bit, or at least fantasized about it) tried to do the “Charles Manson” mind-control abuser-thing with them, but never could get it quite right! Then, much later in life, I read that abuse-seeking babes never had good relationships with their fathers… They seek to re-create their bad-dad thing, somehow!

              Enough psychobabbling for now… Suffice it to say, I have had a “happy ending” now for some decades! Hippy babes? The hippies can have them!

              1. Don’t tell anyone, but I am a geezer!

                We all know that you’re a worthless decrepit obsolete old piece of shit, Hihn.

                1. Who told you?!?!

                  Dammit, I told Dillinger NOT to tell ANYONE!

        2. “you may have misinterpreted the basis for the pussy-grabbing assertion.”

          You misspelled “lie about”; he’s been corrected and continues to lie about it.

  7. At this point the epidemic is pretty much over and the virus is just another endemic coronavirus. So the urgency for the vaccine is (or should be in a sane world) over.
    I think all pharmaceuticals should be easier to bring to market, but I’m not going to take a vaccine for a relatively low risk virus that hasn’t been thoroughly tested and shown to be safe and effective.

    1. This has been the biggest redpill for me. I used to naively think the FDA should be shuttered now I’m beginning to think that they should be criminally charged and publicly tried(ala nuremburg) for the thousands of excess deaths they are directly responsible for throughout history. I used to think the “Ronald Reagan admin are murderers” aids epidemic take was hyperbole now it’s pretty clearly a fact in my mind. requiring Double blind studies for generics in the face of a pandemic is so laughably retarded it would be eye rolled away by Ayn Rand.

    2. Check out death-camp McHitler over here.

  8. Moderna and Pfizer mRNA vaccines are already in Phase 3 efficacy clinical trials.

    Might want to adjust that to just Pfizer, Ron:

    Moderna vaccine trials slowed by insufficient minority participants: report

    Good thing you got FDA out of the way, racist.

    1. And I should say, the citing of the Tuskegee Experiments as some sort of justification or rationalization as to why black people shouldn’t be able to enjoy a COVID vaccine developed on the backs of white test subjects is just *fingerkiss* perfection.

    2. I thought we were supposed to be equal?

      1. Again, the mention of the Tuskegee Experiments in support of expanding government testing of drug treatments on minorities is nothing short of marvellous.

        1. Next I suppose we’ll be told it’s also a reason to break for nationalized healthcare.

          Because why the fuck not?

    3. Moderna COVID-19 vaccine trials have been slowed after contractors did not recruit enough minority participants to determine how the product will affect different demographics, Reuters reported Tuesday.

      So much for social constructs…

  9. Even when Trumps right he must be wrong.

  10. One bright side of the whole COVID debacle? Nobody has died of vaping since February. Safety achieved!

    1. Even while, amusingly, one of the theorized drawbacks to vaping (compared to doing nothing at all) is an increased risk of…wait for it…respiratory illnesses.

      I’ve been waiting for that shoe to drop, but it hasn’t made it into any of my news feeds yet. Weird, right?

    2. Yes, it is rather amazing how MORTAL THREATS (vaping) go away when REAL a threat appears on the horizon!

      Speaking of which, I would sincerely like to re-direct the attentions of one and all, towards the DEADLY THREATS posed by blowing upon cheap plastic flutes, WITHOUT the blessings of a Government-Almighty-licensed physician!!!

      To find precise details on what NOT to do, to avoid the flute police, please see http://www.churchofsqrls.com/DONT_DO_THIS/ … This has been a pubic service, courtesy of the Church of SQRLS!

      1. Go eat shit Hihn.

        1. Wow, what clever wit! Did your mommy help you write that?

    3. And climate change stopped. ( except in California)

  11. We have one shot at getting this vaccine right. The anti-vax moment is small but loud, and they will jump on any missteps. Messing up the covid vaccine would sow distrust on all the other vaccines. The covid vaccine must be done carefully, not cut corners, and be safe and effective upon approval. If there is a problem then it would be very difficult for the public to trust the corrected vaccine.

    1. I think people of ordinary intelligence listen to anti-vaxxers about as much as they’ll listen to anti-Monsanto activists, which is to say barely if at all. 30 seconds is all your normal antivax person needs to clearly convey to you that they are a complete idiot.

    2. If it takes 10-15 years to get a vaccine right, then I guess we will just have to do without jobs, funerals, church services, sporting events, and life itself. I wonder how many years into such a “emergency quarantine” it would take before the peasants turned out and turned out every politician advocating for extreme caution? But I think we all know that the pandemic will be found to die as soon as the votes are counted after Nov. 3rd. Whomever wins will become the “economic savior” of the country.

      1. The scientists are only asking for a few months of follow up after participants receive the test vaccine.

          1. The ones running the trials and the ones evaluating the results.

    3. We have one shot at getting this vaccine right.

      Um, what?

      1. Right? People acting like this is some sort of existential crisis when over 99% of the world population is in no danger.

        1. An approved vaccine given to all the children would allow us to re-open the schools and get the parents back two work. Danger or no danger the schools are still closed and we need to open them.

          1. An approved vaccine given to all the children would allow us to re-open the schools and get the parents back two work.

            No, it wouldn’t. Simply opening the schools would allow us to re-open the schools. There is no federal, state, or local law prescribing that schools must remain closed until a useless vaccine is developed to protect children with, for all practical purposes, no vulnerability at all to this virus. Fuck you, fuck your bootlicking authoritarian shit.

    4. “If there is a problem then it would be very difficult for the public to trust the corrected vaccine.”

      I wish that the public was more forgiving, but I am afraid that Molly-G is correct on this one. We are ALL perfect in our own eyes, and extremely unforgiving of those of us who are less perfect than we are! Human, meet hypocrisy! So has it always been, and so is it likely to always be!

      1. Eat shit you demented old obsolete piece of shit.

        1. Wow, what literary talent and rapier wit! Let’s see if I can match or exceed it, with some OTHER brilliantly smart comments that I have created just now!

          Fuck off, spaz!
          You eat shit, you said so yourself!
          You’re a racist Hitler-lover!
          Take your meds!
          That’s so retarded!
          You’re a Marxist!
          Your feet stink and you don’t love Trump!
          Your source is leftist, so it must be false!
          Trump rules and leftists drool!
          You are SOOO icky-poo!
          But Goo-Goo-Gah-Gah!

          Wow, I am now 11 times as smart and original as you are!

    5. The anti-vax moment is small but loud, and they will jump on any missteps.

      “Wouldn’t you know it, this vaccine we rushed to market in less than 6 months because congress passed a law relieving us of any liability for damage caused by vaccines has a higher rate of fatal complications than the virus it is supposed to treat, SO OF COURSE THESE ANTIVAX LUNATICS ARE GOING TO MAKE HAY OUT OF THIS!”

      Perhaps if the government would stop behaving in the precise manner that the conspiracy theorists describe, the power of their argument might diminish.

    6. “We have one shot at getting this vaccine right…”

      Bull…….
      shit.

  12. Is there anything Trump can’t do wrong?

    1. His spray tan game is pretty solid.

  13. words words words words Orange Man Bad words words words

  14. Because Democrats aren’t politicizing the coronavirus pandemic at all.

  15. Ronald, you’re always so equivocal about Trump. He’s right over here, but he blows it over there.

    This is a national disaster and disgrace, and you know it. You’d be hard pressed to find many worse national responses anywhere in the world to this pandemic.

    Did you see William Foege, epidemiologist and prior head of CDC- one of this country’s true heroes fighting disease, sent a letter to current CDC head Robert Redfield? He begged Redfield to finally muster the courage to do the right thing and stand up to the perpetrator of this disaster, Trump. He called what is happening a slaughter. He said:

    “You could upfront, acknowledge the tragedy of responding poorly, apologize for what has happened and your role in acquiescing. Don’t shy away from the fact this has been an unacceptable toll on our country. It is a slaughter and not just a political dispute. .. This will go down as a colossal failure of the public health system of this country. The biggest challenge in a century and we let the country down. The public health texts of the future will use this as a lesson on how not to handle an infectious disease pandemic.”

    Really, you all at Reason should muster some journalism courage about this disgrace.

    https://www.usatoday.com/story/news/investigations/2020/10/06/expert-cdcs-redfield-should-expose-trump-covid-failures-leave-post/5899724002/

    1. LMFAO. You’re so fucking mentally ill.

    2. Hey, jackass! How about the answers to how you’re going to fix climate change to make those nasty wildfires go away?
      Did you forget the answers? Or maybe you’re just full of shit.

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  17. Sweden was demonized by left wing media and Democrats for not shutting down businesses from March to June (when Sweden had a very high mortality rate).

    But Sweden’s daily death rate is now 0.1 per million people (i.e. 1 death per day), and has been below 0.25 per million since mid August.

    In sharp contrast, the US death rate has remained above 2.2 per million since mid July, while the US cumulative death rate surpassed Sweden’s a month ago, and has surpassed 4 other countries since then.
    https://ourworldindata.org/coronavirus-data-explorer?zoomToSelection=true&time=2020-03-01..latest&country=USA~SWE&region=World&deathsMetric=true&interval=smoothed&perCapita=true&smoothing=7&pickerMetric=gdp_per_capita&pickerSort=desc

    1. Shhh, JackandAce is trying to spin a narrative here.

    2. We aren’t in a national lockdown now. We’ve never been in a national lockdown. I live in NY. It was a disaster here when the virus took hold and we were open. Post-lockdown we’ve done great. Schools open, restaurants open.

      You can’t eliminate the first 4 months of a country’s response because you don’t like the data. Sweden had in essence then the same policies, which by the way weren’t wide open.

      For the pandemic, Sweden’s death rate per 100k population is 57. The US 64. Both in the same category. Only 10 countries are worse than America, 14 worse than Sweden. Every other country fared better. Neither is a model for praise.

      Given the difference in population characteristics, it’s curious you choose to include another one, New Zealand. They had a national lockdown. Death rate per 100k is .51.

      https://coronavirus.jhu.edu/data/mortality

      I might add, keep an eye on Stockholm. Things are getting worse in the city that holds one quarter of the country’s population.

    3. Some other things to keep in mind about Sweden, they did limit crowd size, and they in fact shut down bars and restaurants that didn’t follow guidelines. We never had a country-wide lockdown, and they’ve never been completely open.

      Also, as far as deaths…Sweden has universal health care, we don’t. Maybe you’re suggesting that’s the way to go. You may be right.

      1. Hey, jackass! How about the answers to how you’re going to fix climate change to make those nasty wildfires go away?
        Did you forget the answers? Or maybe you’re just full of shit.

  18. Judging by all the commercials by lawyers I see on TV, FDA approval doesn’t do much. To a large extent I believe it is because, other than DOD, government agencies don’t change their methods. Even when they computerize record keeping they don’t take advantage of technology. For example, back when BPA was a crisis, a group of scientists got together and came up with a system of evaluating endocrine changing substances. Depending on the use, the series of tests ranged from $5,000 to over a million bucks. The FDA should have a super computer that can run a series tests to see if drugs/vaccines present any hazards to people. Then demand testing based on that analysis. If a company did it, the FDA would still insist on the old methodology of testing maintaining the same timeline for approval.

    Perhaps a partnership between the FDA and Pharma to develop such a system would speed drug/vaccine development and reduce costs.

  19. If the FDA used their current procedures in the 50s, we wouldn’t have had the polio vaccine until the 70s. The FDA tries to only allow “safe” medicines, where “safe” is defined as zero side effects to anyone. What they don’t balance is the effects of not taking the medicine. I remember the FDA sitting on a muscular dystrophy drug because of some side effects of the drug. Meanwhile, kids were dying because their muscular dystrophy was getting progressively worse. Yes, their process is that stupid.

    https://komonews.com/news/local/time-running-short-mom-lobbies-fda-for-drug-to-save-sons-life

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