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Should the FDA give final approval to COVID-19 vaccines immediately?

I've been involved this evening in a truly dispiriting discussion of whether the FDA should immediately grant full approval of COVID-19 vaccines. The motivation for this is that many people say they're hesitant to get the vaccine while it's still under "emergency" approval, and we might get some of them to reconsider if only the FDA would grant full approval.

The most dispiriting part of all this is that so many of the critics simply declare that the FDA is unbelievably stupid and there's no reason for not just declaring full approval since we've given the vaccines to millions of people worldwide and it seems to be fine. This despite the fact that not a single one of them seems to have the slightest idea of what the approval process is and why it's in place.

I'm not going to pretend to any special expertise either, but I can at least point out a few things:

  • Despite what the Twitterati seem to believe, the folks at the FDA are not idiots. They might be wrong, but they aren't idiots and they're well aware of the benefits of granting full approval.
  • There is a documented process for granting full approval. Pfizer and others submitted the data for that approval in May and asked for expedited review. This was granted, of course, which means review will take about six months instead of two years.
  • Like it or not, approval is based on actual scientific studies (RCTs), not just the observation that lots of people have already gotten the vaccine and seem to be OK. This is the only reliable way to do things, and that doesn't change just because we'd really, really like it to.
  • The FDA, of course, could change the approval process midstream and simply issue a full approval. However, skeptics would rightfully assume that this means the approval is political, not based on science. It would pretty much destroy the FDA's credibility.

It's true that the FDA approval process takes a long time. That's why we also have an emergency use approval process that allows drugs to be prescribed in an emergency if they look promising but haven't gotten through the full approval process yet. This makes perfect sense, and it's what we've done.

In addition to all this, I doubt that full approval will make very much real-world difference when it eventually comes. Is it possible that more states would be willing to mandate vaccination if the vaccines had full approval? Maybe, but there's not much evidence for it. And can you imagine the backlash if a state did mandate vaccination based on an obviously rushed and political approval process? It would be a debacle.

55 thoughts on “Should the FDA give final approval to COVID-19 vaccines immediately?

    1. cld

      But then my question is, at that point they may be recommending a booster shot, so does that have to be approved in the same way?

      If so how will that look, --the vaccine is approved, but it's not good enough, you need the booster, which isn't approved?

  1. Dana Decker

    Maybe the FDA should have had *already in place* two (or more) schedules based on how severe the disease is and how many will be affected.

    Take your time with Thalidomide. (They did, fortunately). The urgency and scope of that drug was low.

    Do it faster (with admittedly looser standards) for vaccines intended for global pandemics.

    A single approach is fine in the abstract - there is an aesthetic appeal - but sometimes it postpones necessary relief for hundreds of millions.

    1. lawnorder

      The FDA does, in fact, have a "faster (with admittedly looser standards)" process already in place. It's called "emergency use authorization".

  2. kenalovell

    Claiming not to be vaccinated because the vaccine is "experimental" is largely a convenient excuse seized on by people who don't want it for other reasons. Once it's been finally approved, they'll think of something else.

    1. kevin273

      I agree. My bet is they'll argue that, since the approval process was expedited, the vaccine still hasn't been thoroughly tested. The same people who were like, "Operation Warp Speed FTW!" when Trump was president are now decrying emergency authorization, we know they'll apply the same hyperskeptisism to vaccine approval that they applied to Obama's birth certificate.

    2. Jasper_in_Boston

      There are no doubt people who cite this excuse (and I believe you're correct most will find a different excuse). But I think the bigger issue in the US is the perception among institutions (employers, schools, healthcare providers, cinemas, hotels, restaurants etc) that they're on questionable legal ground if they try to mandate vaccination prior to final approval. IOW the big problem in America -- in addition to politicized vaccine hesitancy itself -- is lack of coercion. People aren't facing inconvenience if they remain unvaccinated. And that's bad.

      1. Dee Znutz

        This is exactly right.

        The US military is one such organization that is waiting for full approval to mandate it across all members. It will be this way for businesses and schools and many other areas as well.

  3. Punditbot

    Hat tip to Dana Decker who got to it first. But people anxious to rush FDA approvals should remember Thalidomide.

  4. Special Newb

    Nate Silver has been marinating in stupid pandemic statements for months and months.

    The big thing about FDA approval is military but especially businesses. Hospitals are one thing, but businesses in general want the legal cover that approval would give. I do agree that rushing the approval would fail because the rushing would be seen suspiciously.

    I disagree that seeing effects on 150 million people doesn't tell us anything reliably. We discovered the heart inflammation which is so rare that no studies might ever have caught it.

    Also as I understand it approval is 2022 6 months from now.

    In the end I don't think it will matter that much. Even Fox might not matter much, acceptance gap is largely unchanged since vaccines came out.

    For those who are not conspiracy anti-vax who put it off likeca dentist appointment or eye doctor check up, they are assessing their risk: good odds to be something you get over if you are young and healthy. Cases crashed big time meaning there was just less coronavirus out there so less risk of catching it.

    The single thing that will best convince people who CAN be convinced is what's going on now: a new surge with hospitals full and people dying left and right. And indeed, vaccinations are going up this week.

    1. peterlorre

      The question in my mind is really more about why Pfizer or others haven't been able to provide compelling evidence on a more rapid timeline given vaccine use and its apparent efficacy. There is something perverse about screaming at the FDA for not changing their policy to approve a therapy that hasn't been shown effective, rather than flaming Pfizer for not taking advantage of the clear efficacy of the drug and just designing a faster trial.

      The FDA is well aware of what is happening to people who get the shot, and how important adoption of these vaccines is. I'm sure that they would be willing to work with a company to allay their fears that an expedited trial would cause them to lose lose full approval for some random bureaucratic reason.

      1. ScentOfViolets

        Because trials don't work like that, and we know bupkis about the human body, let alone human biochemistry.

        1. peterlorre

          This is utter bullshit. We know a huge amount about the human body, clinical trials, and we specifically have extensively studied how vaccines work and their interaction with the immune system. We know how to look for safety signals. We also know how to calculate confidence intervals and how to estimate power.

          Pfizer has an extremely sophisticated clinical sciences arm that could implement a fast track study if they were confident the FDA would let them do it.

          1. ScentOfViolets

            Can we cure cancer? Replace damaged brain tissue with fresh new stuff? Regrow arms and legs? No you say?

            Can we even cure baldness, or for that matter, turn white hair back to its original color? No?

            Yeah, you're an idiot, all right.

  5. bebopman

    As mr. drum suggests, one of the fda’s most important assets is its credibility. Emergency authorization is one thing, but if it gave in here, it would lose that all important credibility, not just on covid but in the future , which is just what the skeptics want.

  6. Justin

    Maybe the FDA hasn’t done this yet.

    https://www.fda.gov/files/drugs/published/FDA%E2%80%99s-Pre-Approval-Inspection-(PAI)-Program-and-How-to-prepare-for-a-successful-outcome.pdf

    There is a lot more to approval than just safety, purity, and efficacy. They evaluate the facility, the production process, and the quality system. Recall when that company emergent biosolutions had a contamination issue due to a series of problems. This is the other part of FDA approval.

  7. D_Ohrk_E1

    Of course there's a process that things have to go through, but let's put it this way: If you have an emergency need but the bureaucracy tells you to get in line, how would you feel about that bureaucracy?

    The basic project management triangle: Cost - Quality - Time.

    If you need to slash time but want to maintain quality, you throw money at it. Redirect people to the process to speed up the approval, etc.

    When Congress produced the Defense Production Act, this was their way of resolving problems through the application of the project management triangle. Throw money at the problem to speed up production without compromising quality.

    Does the FDA need a presidential order?

    Whereas SARS-CoV-2 remains an existential threat to humankind; that we have been administering effective vaccines for over half a year under EUA provided by the FDA; that we have a process of review by the FDA to grant ordinary approval of those vaccines; that the vaccine manufacturers have submitted paperwork seeking ordinary approval; that quality of its review shall not be compromised by the necessity of speed,

    therefore, this order authorizes and directs the FDA to redirect personnel and monies dedicated to other reviews and programs, towards the goal of accelerating the FDA's review of COVID-19 vaccines for ordinary approval within the next 30 days.

    Do it.

    1. Joseph Harbin

      @D_Ohrk_E1

      Exactly.

      The argument here is that the government shouldn't rush things and be open to charges of rushing things for political purposes.* Instead it should follow the established process and be open to charges of being heartless bureaucrats. Nonsense.

      We're not talking about a baldness cure. We're talking about a vaccine to stop the spread of a virus that has already killed 600 thousand in the US and 4 million worldwide. The vaccine is only "experimental" in that it's "new," but the risk/reward of these vaccines after 300+ million doses is hardly a secret.

      If defies common sense that the government can't do anything to speed the process. The benefits may be hard to quantify (even after the fact), but any roadblocks to boosting vax rates should be overcome whenever possible.

      1. Joseph Harbin

        Oh...

        * The "rushing things for political purposes" worry is really a "rushing things to save lives -- perhaps tens of thousands of lives" worry. Why the fuck do people (Dems) always worry about bad-faith accusations from political opponents who always make bad-faith accusations no matter what you do. Ignore them.

      2. aldoushickman

        I'm sorry--what exactly is being held up here? Full FDA approval won't magically generate more doses (we have a surplus anyway), and it won't actually get more people to get vaccinated particularly quicker (do you really think significant numbers of holdouts are doing so because they are sticklers for FDA bureaucratic processes?).

        1. Joseph Harbin

          Full approval opens the door to vaccine mandates for schools, businesses, military, etc., that can be enforced with less justification for lawsuits and other delays.

          1. Clyde Schechter

            Yes, I agree that this is the real point here. While there is no law saying that you can't impose such a mandate while the drug is under EUA but not final approval, many institutions seem to fear they will be sued.

            So I think the solution is not to have the FDA change its procedures but rather we need a special statute providing a "safe harbor" for businesses, the military, and other institutions shielding them from liability for mandating covid-19 vaccination among their employees/students/faculty/whatever, and directing the courts to uphold such mandates in actions seeking to enjoin them.

            Of course, the prospects of getting any law through Congress (other than tax cuts for billionaires and corporations) seem dismal. But state legislatures can enact these statutes--and in many states this kind of thing would pass.

          2. Joseph Harbin

            @Clyde Schechter

            Except the states that need a mandate most are the states least likely to pass that kind of law. And since a law is unlikely to make it through Congress, let the agencies of the executive branch do the work that needs to be done.

    2. colbatguano

      If you need to slash time but want to maintain quality, you throw money at it. Redirect people to the process to speed up the approval, etc.

      This seems like the best answer. The 6 months isn't some mandated time limit, but basically how long it takes given currently allocated resources. Add more resources and cut the time down.

  8. rick_jones

    What’s in a name? Perhaps rather that an Emergency Use Authorization (EUA) what we need is an Exigent Use Authorization (EUA)…

  9. Atticus

    I think if the vaccine is fully approved that will convince an extremely small percentage of the current anti-vaxxers to get inoculated. They'll just find another excuse or be persuaded by some other meme.

    And I totally agree with Kevin. The last thing we want to do is toss out the tight standards and control we have. We have the emergency approval procedure in place, which we have used to inoculate about half the country and saved hundreds of thousands of lives.

  10. tdbach

    I may be misinformed here, despite not watching a minute of Fox News, but with the new school year fast approaching, as well as other government-managed enterprises (e.g., the military), I believe the only way they can mandate vaccination is if it has full FDA approval, like all the other mandated vaccinations. That would seem to me a pretty compelling reason to expedite the approval process.

  11. skeptonomist

    Of course the testing and approval should be sped up. The existing procedure was not really designed for a pandemic and did not take account of the way mRNA vaccines can be almost instantly designed. We know now that the mRNA vaccines were ready to go almost as soon as the DNA sequence was available - why ignore this knowledge? The death toll from delaying distribution is far greater than anything that would come from premature approval. How the approval process is revised is something that has to be studied carefully when it comes to procedures for the long term. However, there is no reason that emergency approval could not be granted immediately. So what if it is said to be "political" - the extreme Republican line is already that vaccines are a political plot. Actually this is a long-standing idea among various groups, not invented by Republicans. It is the kind of idea that does not need any real justification.

    The gain from getting started earlier should outweigh propaganda disadvantages. It is important to get the production and distribution apparatus going as soon as possible. If you set up and run things based on propaganda rather than the best scientific knowledge, that is the process which is "political".

    1. skeptonomist

      Kevin strictly addresses the question of whether full approval should be granted immediately, which is not a question of great importance, People who cite this for not getting vaccinated are just giving and excuse. But Kevin seems to think that the existing procedure is something that must be followed, regardless of new knowledge.

  12. Ken Rhodes

    In Dave Leonhardt's column in this morning's NY Times he makes this point:

    >>The difference between emergency authorization and full approval matters. Right now, the military, schools and other organizations cannot easily require vaccinations. The “lack of FDA licensure leave schools, colleges, businesses in a legal quandary,” Dr. Jerome Adams, a former surgeon general, recently wrote. Adams argued that lives were at stake and that the issue should be receiving more media coverage than it has.>>

    This seems to somewhat contradict Kevin's closing point:
    >>I doubt that full approval will make very much real-world difference when it eventually comes. Is it possible that more states would be willing to mandate vaccination if the vaccines had full approval? Maybe, but there's not much evidence for it.>>

    States? What about employers? What about schools? What about hospitals? It surely seems possible to me that a lot more hesitant folks would have to go ahead and get their shots if they could be required to.

    1. Ken Rhodes

      Following up on that column by Leonhardt...
      >>The situation also feeds uncertainty and skepticism among some Americans who have not yet gotten a shot. Those skeptics ... are effectively taking the FDA at its word. The FDA leaders’ official position is that “they don’t have enough safety data yet.” The strangest part of all this is that the FDA’s official position does not reflect its leaders’ actual views: They agree with the CDC and other scientists that Americans should be getting vaccinated as soon as possible.>>

      >>Why, then, hasn’t the F.D.A. taken the final step of formal approval? It is following a version of its traditional, cautious process for vaccine approval. ... But I think the FDA’s leaders have failed to understand how most Americans really think about the vaccines. It is different from the way that scientists and epidemiologists do. It’s less technical and based more on an accumulation of the publicly known facts. FDA officials are acting as if most Americans are experts in the nuances of their approval process and will be shocked if the agency expedites it. In reality, many Americans know almost nothing about that process. But some are understandably confused by the mixed messages that the FDA is sending.>>

      ...and to that I add:
      What adjustment is made in the approval process to make a tradeoff between the time delay to approval and the number of trial cases in the emergency-use period? Shouldn't there be some calculation that can accommodate forty million trials over X months vs. the typical small sample sizes for new medications over Y months?

  13. Austin

    Agree with almost everyone on here: there are very few vaccine skeptics who are skeptical solely because the vaccine is "emergency approved" and not "fully approved." The rest of the unvaccinated will simply change their justification to something else if/when the FDA fully approves the vaccine.

    I'm OK with just letting the vaccine go through the normal process for "full approval." One reason for that methodical process is because drugs sometimes have unintended side effects that take years to emerge in data. Just because 150+ million people have taken it (including myself) and are doing fine in the first ~6 months doesn't mean that 1-5 years from now we won't find out that these vaccines cause a higher incidence of X disease or problem. It's less likely for that future tragedy to occur if the FDA takes its time now to review the vaccines' interactions with all processes in the body.

    1. Joseph Harbin

      It's less likely for that future tragedy to occur if the FDA takes its time now to review the vaccines' interactions with all processes in the body.

      Better to risk tragedy today for the chance to avoid tragedy years down the road?

      ...drugs sometimes have unintended side effects that take years to emerge in data.

      Expediting the process now is saving months, not years. There's never a guarantee some side effect, maybe deadly, won't emerge years after approval. We'll deal with it then if that happens. If you think that's reckless, you may be surprised to learn of many things "approved" for our food, air, and water.

  14. TriassicSands

    "Despite what the Twitterati seem to believe, the folks at the FDA are not idiots. They might be wrong, but they aren't idiots... -- KD

    While I think the FDA should follow the expedited procedure for COVID-19 vaccines, their recent approval of the new Alzheimer's drug, Aduhelm (aducanumab), would seem to argue that they may well be idiots.

    "Evidence, we don't need no stinking evidence."

    I doubt if expedited full approval will have much effect on convincing stupid people to get vaccinated. They'll just switch from "it's experimental," to " the process was bogus."

    YOCAFIST! (You Can't Fix Stupid!)

  15. gesvol

    Is there anything that prevents municipalities, companies, schools, military, etc. from going ahead and implementing a policy of something like "Right now our policy is that vaccines are voluntary. However if and when the vaccines are fully approved by the FDA, it will be mandatory to get the vaccine."

    Just did a Google search and while there is a scattering of such announcements, doesn't seem like it's exactly widespread. Seems like something like that might a) encourage some to just go ahead and get the vaccine to get it over with and b) provide another instrument to pressure the FDA for as fast as approval as possible. Because it seems like right now FDA approval leading to widespread mandates is more theoretical than something that is known.

    That said, I also don't know enough about what is involved in FDA full approvals to know how much of the constraints is due to resources and how much is due just time needed to get it done. (According to the above, it's already being fast-tracked for full approval, which takes 25% of the normal time. Can the process be sped up any further? I have no way of knowing, except there obviously has to be some sort of time constraint. All the resources and money in the world couldn't shorten the approval process to 24 hours as an absurd example. If you remove money and resources as a constraint, what is the fastest time to approval without skipping any of the boxes that it has been determined need to be checked? I have no way of knowing myself.)

    1. Clyde Schechter

      "If you remove money and resources as a constraint, what is the fastest time to approval without skipping any of the boxes that it has been determined need to be checked? I have no way of knowing myself."

      Excellent question. I don't know either.

      But I do know that even when they were considering the EUA, they didn't pull out all the stops to do it. For example, they still took weekends off while the vaccine was already ready for distribution and the data required were already in their hands. While the total delay from this probably only amounted to about a week, this was at a time when about 3,000 Americans (that's one 9/11) were dying every day.

      The situation now is less dire, and their delays will be less consequential, but the fact that they didn't even work overtime when things were really critical is not at all encouraging and makes me wonder whether the organization has the right culture and work climate for the task. I don't know anybody at the FDA, but certainly in every scientific environment I have worked in, in circumstances like that everybody would have been working as fast and as long as they could to get it done. And they wouldn't have asked for overtime pay to do that. Scientists will, and routinely do, work close to 24/7 for considerably less urgent reasons than that.

  16. rational thought

    I am 100% with kevin here.

    Seems like the argument some are making here is

    Based on the SCIENCE and what I think , even though we do not have enough data yet to support full approoval, the risk/reward ratio is such that it is still the best decision to get vaccinated.

    But others, for all sorts of various reasons, have come to a different conclusion and have decided that the risks of the vaccine outweigh the risks of getting covid.

    They do not agree with me so they must be wrong and their position should just be given no respect.

    Therefore, since their position is worthless and invalid, it is morally acceptable to lie to them and trick them into making the " right" decision ( i.e. my decision) for their own good.

    And just giving the vaccine full approval, even though it does not meet the criteria to do so, will then trick some into getting the vaccine as now they will assume ( incorrectly) that it has met the criteria.

    Well, first it is not going to work. Largely because in order to trick anyone that way, you have to have the credibility so they believe you. And the "experts " like fauci have wasted the credibility they did have on stupid lies and misleading statements on things like masks, level of herd immunity, when we will likely get the vaccine, etc. So they have no credibility left with a large part of the public.

    A huge part of the problem in getting people to get vaccinated is that most people do not understand these issues, and would normally rely on the govt experts to explain the facts. But once they figure out you lie and mislead on things like masking, they will now have no reason to believe you and will look for other experts on social media. Who might really be full of crap.

    If there might actually be some issue where the decision is so crucial and the facts so clear to the informed but confusing to the uninformed, so lying to get them to " do the right thing" is something you have to do, you only get that ability to lie and have people believe it once or twice in a generation. Credibility is invaluable. Do not waste it.

    Second, the fda has not been dragged into the mud like who and the cdc have by misleading statements and lies. They may still have more credibility with the public. And you want to waste that now with something that will not work?

    Third, this is not how a democratic republic is supposed to work. It is just not the morally right thing to do.

  17. ScentOfViolets

    Yeah, I'm sure that any number of us here have more expertise than those lazy good-fer-nothins at the FDA. And we've spent more time analyzing case-by-case studies to boot, amirite? That's snark for those of you who don't get it, BTW.

    Bottom line: These people have expertise and experience that we don't, and they were given the authority they have for good reason. Second-guessing them is exactly like second-guessing the physician you've had for years when they say a biopsy is indicated. It really is just that simple.

    Addendum: I recognize a few of the people making disparaging comments of the FDA as being some of the people who are most prickly when their own expertise is called into question. Those folks at the FDA undoubtedly put in just as much time and sweat mastering their professions as (I'll grant for the sake of argument) you did with yours. Assuming anything less is being childish.

  18. pjcamp1905

    In fact, it would look very much like the approval of the useless and expensive Alzheimer's drug from a few weeks ago. That whole deal did the FDA a world of good.

  19. dmcantor

    With 30+ years in Pharmaceutical R&D, I do have some familiarity with FDA processes. The agency is famously risk averse, and this can lead to many people dying unnecessarily. The reason we have an Emergency Use option is the extreme activism by HIV advocates, where folks were dying while the FDA dithered.

    Now, they have reason to be risk averse. FDA got raked over the coals for the Vioxx debacle, even though they had absolutely no blame in it whatsoever.

    Science means using the data you have at hand. Ignoring the outcomes of hundreds of millions of vaccinations is in no way, shape, or form scientific.

    Yeah, it goes against standard practice. The standard practice should have been changed decades ago.

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