But even if I’m wrong about that, that is, as I said, none of the FDA’s damn business. The FDA’s damn business is whether the booster shots are safe and effective or not.
Is this defined somewhere? I see the FDA and CDC doing this frequently, so I’ve assumed part of their medical mandate is indeed to consider questions such as global supply. It is an odd separation of powers, with ambiguous overlap, where different groups decide on donation of vaccines… even across different types of vaccine (eg the CDC seems to have donated HPV vaccines, indirectly, in the past, and now the White House seems to be managing COVID vaccine supply? And donation targets?). Inefficient designation of responsible party for these decisions, from what I know.
My understanding is that global public policy, and supply chains, and so on have nothing to do with the FDA's official powers.
However, the whole thing is a dumpster fire, and the FDA technically has a legislative mandate to control the legal right to buy "water hoses", which makes them the focal point during the dumpster fire.
In a deep sense, every person who dies because of a legally delayed treatment, or delayed testing, or very expensive manufacturing that putting life saving medicine out of their reach... is dead because of the FDA.
Since the FDA itself is not safe or effective eventually we will repeal the Kefauver-Harris amendment (which authorizes the FDAs current existence). By the time this happens, some people (the ones able to experience shame?) who worked at the FDA will be hiding the fact that they worked there because it will be a mark of shame.
But in the meantime...
...in the meantime the FDA is a bunch of doctors and biologists and statisticians who have the right to vote medicines "off the island". NOTE: they have almost no economists.
(In theory, the FDA has a positive role covering the asses of doctors who can't be bothered to read the primary literature themselves when pill pushers try to sell them on selling a new pill to random patients? If doctors actually were competent, we wouldn't need an FDA. But if you think doctors are competent, why have an FDA? (But then again: if doctors are incompetent, the FDA can't save you by itself. (None of it makes sense. No one smart can defend any of it that I've been able to find.)))
The FDA's formal right is to veto "drugs" and "medical devices" and "biologics" by default. They just ignore a request for authorization, and until they act, the thing is illegal.
Then, if someone trying to bring a medicine to market gets pushy, they can be rejected explicitly by saying that a positive burden of proof has not been met, wherein they report enough evidence, described with enough paperwork, in studies pre-registered with the FDA, etc, etc, etc.
The official question is whether the medicine is "Safe(TM)" and also "Effective(TM)" but these concepts are totally bullshit.
They can Goodheart these concepts to mean anything they want them to mean in practice. All medicine is unsafe at the wrong dose, for example. If the placebo effect is real, then in some sense all placebos are kind of effective... But they don't want to authorize placebos... That's the opposite of the kind of monopoly maintenance they want to do... And so on.
People (including the CDC, or the President, or Medicare, or anyone) can ask the FDA to put their finger on the scale for any reason, including bad reasons as well as potentially good reasons. Also: any of them can leak stuff to the press to badmouth the others. So the president, unless he's careful, is actually weaker than the FDA, because there ain't no way to vote any of them out...
Assuming friendly collusion among them all... Maybe they want to keep a drug out of Medicare coverage, because it might extend lives somewhat AND is definitely very expensive? It could be better for government budgets if the poor people (the ones on Medicare) just died quickly and cheaply. So then maybe the FDA could do something to help with this budget problem by denying that drug? It might sorta work... so long as no one worries too much about too many details?
Most medicine IS bullshit, and no one really cared for a long time. Robin Hanson was on about this for a long time in years gone by, but switched to other topics in the last ~5 years. No one cared.
Practically though: studies that randomly give people medical insurance (who otherwise had none) just find that they go to the doctor more, not that they have any better net health outcomes.
So since most medicine is overpriced bullshit anyway, the primary importance of it for the last 50 years has been who gets privileged access to the big fact juicy profits. The FDA controls the money spigot. So the FDA are the cockiest people in the room that everyone sucks up to. Everyone praises them because everyone wants money.
...
The deep deep problem is that it is fine for the FDA to regulate "the efficacy and safety of boob implants" and similar private medical bullshit...
...but good old fashioned public health (like "plagues and other communicable diseases") is NOT fake. Antibiotics are real. Vaccines are real. These things radically improved life expectancy in previous centuries! They are some of the only real medicine that exists. It is hard to extract the full value of the goodness from customers... how much is the patient's life worth? How much of that can be charged for?
If monopoly power applies here, the clearing price might be something "just barely less than all the patient's money to keep the patient from having to sell themselves into slavery" or some such? So the real medicine, in a system that extracts profits using scarcity pricing power, will bankrupt essentially all the patients :-(
So we have this system to facilitate and protect monopolies based on "soft private medical fraud" where all cause mortality might well GO UP after an Intent To Treat, and that just means you designed your study wrong, and should have measured some other "Efficacy" outcome so you could get in on the gravy train of profits in an acceptably legal and refined way...
...and this system being "fine" is predicated on the essential uselessness of medicine in general... and then along comes covid and finally we Actually Needed New And Real Medicine Very Fast... and we can't do it anymore? Not via normal processes :-(
...
Personally, I think Biden should go after the the FDA, so that no one else with more odious characteristics does first. Biden's best trait is "going off script towards decent common sense". If Trump goes after the FDA in his campaign in 2024, god help me I will vote for Trump. I will vote for anyone at the federal level who agrees with "FDA delenda est".
We can't eradicate covid because we don't have the tools. We need mass testing at scale in regionally isolated places that can be turned into "green zones" and then kept green by making every human who tries to go into a green zone go through a stop-and-test-and-incubate-and-test-again gate. Once two zones are both green, the gates between them can relax.
That's how SARS Version 1 was eradicated... but back then a simple temperature check was adequate because it was not infectious at low doses... it was only infectious at the high doses that occurred during the peak of the symptoms. So then after SARS Version 2 was built in a lab (with serial passage in humanized mice to optimize the ACE receptor attachment) it became infectious even before symptoms, and so it needs more complex testing :-(
(Biden should also go after Peter Daszak.)
But lots and lots and lots of of super cheap testing (with near zero "false negatives") is the key here to cleaning up the spilt milk I think...
So can a mayor clean up the spilt milk for his own city? No. There is no mayor in the US could save his city this way... because there are no FDA approved tools that hit the necessary points in terms of testing price and testing scale.
And no company is likely to spend millions up front securing (from the FDA) a monopoly for testing systems with the right characteristics. The government itself is their only market, and is unlikely to buy, and if it bought eradication-focused test kits the company that paid for all the research that the FDA voted on at the end... would face an oligopsonistic buyer with non-trivial negotiating power.
The whole thing is insane, and baroque, and only could exist in a world where no one with actual power actually cared about any of it in a competent way :-(
It has all the flexibility and efficiency of communism, and all the charity and civic-mindedness of capitalism.
Mayors and governors should be able to simply hire a scientist and a doctor and build a public health system.
The FDA should not be able to veto this, but right now it can, and right now it is, de facto, actually vetoing stuff like this.
Hence: FDA delenda est. We must repeal the Kefauver-Harris amendment.
I think we will eventually beat covid. That is no reason to keep the FDA. The FDA is structurally broken and will kill more people the next time medical innovation could save lives. That's what the FDA's job actually amounts to: preventing life saving that lacks the confused pointless (monopoly-maintaining) sacred approval of the FDA.
If doctors actually were competent, we wouldn't need an FDA.
Seems wrong. Centralized approval means that we don't need millions of doctors reading the same literature and duplicating work to determine whether something is safe.
I'd say that even if doctors are not competent we still don't need an FDA that bans things, at most we need an FDA that evaluates strength of evidence for safety and efficacy and which competes with private firms doing the same.
I appreciate the response and I agree that it does "seem wrong" at first glance.
However, I think this appearnace is part of why the FDA is dangerous.
From what I can tell, the FDA is optimized to have a vaguely satisfying answer to every first order query that people raise "in general". The problems show up in the second and third order analysis, and then the messed up practical details that actually arise after people stop questioning and start following bad laws.
The FDA actually DO NOT make things particularly easier for competent doctors.
The signal provided by the FDA is too noisy and confused and tentative for doctors to actually use to actually do their job properly just by relying on that and nothing more.
Example: the FDA has not approved melatonin for sleep. Melatonin is simply a supplement, like concentrated lime juice or St John's Wort. I think lime juice is yummy and nutrious, I'm substantially more wary of St John's Wort, and melatonin is one of my "staples" that I keep in my medicine cabinet for "just in case". However, doctors treating the FDA as a source of "actual medical advice" miss all of this.
(The FDA's essential power is the power to veto coercively. They do this by default for everything new, and then sometimes they loop back around and remove things from the market for various reasons which might sometimes be "because someone who the formerly legal drug competed with wanted the legal drug to no longer be able to compete with them so they lobbied for removal". Once you're able to buy or not-buy anything (drug, food, healthy food, spice, or whatever) the FDA's input is done and over.)
The service you're thinking that the FDA provides is actually provided by multiple groups, and the best one I know of (for everyone in general) is the Cochrane Review folks.
Cochrane provides an actual useful service. They try to break things down to the point of actionability, and review their reviews as more research comes in, sometimes changing the practical upshot, which the FDA basically never does.
Returning to the example: For melatonin, Cochrane is in favor of it for jet lag but unconvinced for use in ICUs even after hearing the pitch in favor, and looking at studies.
Then separately there are often semi-large medical systems like Kaiser where they practice "evidence based medicine" where specifically their patients and their systems are subject to focused optimizing pressure of a similar sort. I've heard Kaiser doctors grouch about how they don't enjoy their job as much when it feels like they are just following corporate treatment policies and not actually "practicing medicine". Some doctors (who aren't burned out yet?) seem to like unusual patients where they don't have the EBM policies memorized, but maybe some doctors are happy to become "implementers of the policies of others" for the same handful of general practice problems, over and over and over.
But if you doubt doctor competence at anything but being a subservient lackey of wise bureacrats (which, maybe that's valid, because maybe some doctors ARE burned out and phoning it in) then getting treatment from a corporate system like Kaiser can make a lot of sense, precisely because "the kind of service you'd naively expect from the FDA" is actually being offered by that corporate system's best efforts towards generalized executive competence at science based medicine in an organizationally realistic way.
If there is a coherent positive argument for the FDA that round trips through the actual medical ecosystem... I've never heard it... and I've been looking for one since the FDA killed over half a million Americans just over 18 months ago.
The FDA has blood on their hands and I'm still can't figure out why this isn't common sense to the American voter, and also not even among particularly smart people!
Maybe I am missing something really obvious and big? The FDA has existed for longer than it has had legal support (it started out as a non-profit, basically, and then the government threw money and power at them during a crisis roughly a century ago) and so surely there are good and proper "Chesterton's Fence" style reasons to support them out of common sense non-hubristic conservatism?
And I do love common sense non-hubristic conservatism.
But at some point the weight of logic, evidence, and sanity has to pile up such that you fix the giant obvious death machine in your midst? Right? Eventually?
Also, the train of thought seems somewhat binary. If doctors are somewhat competent, but the doctors who worked at the FDA were unusually competent, then having an FDA would still make sense.
Lots of good points, as always. I particularly like this point for its combination of relevance and generality.
The trick is, there’s data about a lot of things, but if you slice what counts as relevant data finely enough, you can claim there’s no data whenever you’d prefer that there was no data. You want to worry about 16-17 year olds? Say that 18 year olds provide no data. If you wanted to, you could then say that people were the wrong gender, or the wrong race, or the wrong health status, or the wrong lifestyle, and keep doing that until your sample was small enough that there was ‘no data.’ Or you could realize that all data is data, and do something reasonable, but reasonable is not the watchword here.
Re: availability of over-the-counter rapid tests, a commenter on ACX who works at a pharmacy asked the following:
Question -- in Germany and other places with cheap rapid tests, is the pricetag doing all of the work of matching supply and demand? Or do they have it just as bad, with the actual price hidden in non-monetary forms? Are they merely "cheap", or actually plentiful?
So I looked into this topic a bit, and here was my response:
I'm from Germany but haven't bought any of the rapid tests myself, so I don't have any first-hand experience with the situation. From what I understand, you can use these tests to test yourself, but they aren't considered accurate enough to fulfill a condition of having to get a validated test for the bureaucracies.
These validated tests (PCR and antigen tests) are currently being subsidized so citizens can get them for free, but this will end at some point in October (FAQ by the German government).
This random German article from June, which I haven't fact-checked, claims that the supermarket self tests used to be sold at 5€ (vs. bought by them at >=3€), but demand at that price eventually ran out (e.g. because these tests aren't considered validated, or because other tests are subsidized, or because the stores overestimated demand and bought too much, or something), so now stores like Aldi and Lidl are selling them at a loss at 0.8€ to get rid of them.
Ultimately this scenario sounds consistent with the philosophy of "let people try to profit from disaster, and supply and demand will equilibrate at an acceptable price; forbid people from trying to profit from disaster, and that won't happen", but that sufficiently fits my preconceptions that I'd want to find more reporting before truly updating on that.
In any case, whether at 0.8€, 3€, or 5€, all those prices are a far cry from the prices in the U.S..
I'm from Germany but haven't bought any of the rapid tests myself, so I don't have any first-hand experience with the situation. From what I understand, you can use these tests to test yourself, but they aren't considered accurate enough to fulfill a condition of having to get a validated test for the bureaucracies.
I spent some time in Germany recently, and this is (or at least "was", when I was there) wrong. The tests themselves are considered accurate enough, but the bureacracies usually don't trust you to do it (or do it correctly). In some German states you can do a test at the restaurant to be let in. You can buy a test, take it to a pharmacy, and let the pharmacy do it and then validate it. In some German states it is ok for some jobs to test yourself regularly. Back then I think employers also had to provide take-home tests for free (or if not required, strongly encouraged).
Thanks, I appreciate the clarification. I'd indeed misunderstood that part of the rules - I figured since there's such a thing as a "gold standard" test, rapid tests wouldn't be considered "good enough" by the bureaucracies (even if they sound good enough for individuals who understand type 1 and 2 errors), but it makes sense if their main worries are instead that one might lie about the test result, or not perform the test correctly, or something.
And e.g. this page (in German) says that the Covid self tests are indeed identical to antigen tests except that they have to be administered by oneself and are hence only available / useful for private citizens.
(Side note: Somehow your quote from my comment ends on "As far as I know, the "antigen tests" are the same as the "rapid tests".", but that sentence isn't by me. Presumably it was meant to be part of your own comment?)
Anyone have any thoughts about someone already vaccinated with Pfizer getting a Pfizer booster or instead obtaining an additional shot of Moderna or J&J instead (or maybe in addition to?)? Thoughts about effectiveness, morality, risk, etc are appreciated. If it makes any difference to your thinking, I'm at elevated risk because of health issues.
I kind of feel like the mixing approach would be more effective, but to be honest I've not really had the time to keep up with much of anything except work for the past couple of months.
I have no moral concerns about consuming limited doses for boosters when many haven't even had their first shot yet, especially if you have health issues. This is not zero-sum. More doses can be manufactured. Supply is not the main issue anymore. There are other problems stopping people from getting first doses that are mostly beyond your control. I do have some moral concerns about lying to get a treatment that is not authorized, but it may be the lesser of evils given your situation.
I have heard concerns about developing immunity to the adenovirus vector itself, eventually making boosters ineffective as well as limiting the use of said vector for future vaccines and gene therapy. There's also a risk that one has been exposed to the natural virus already, making the initial dose less effective. If J&J is your only option, that shouldn't stop you, but it's not. The Pfizer and Moderna shots don't have this issue since they're delivered via lipid nanoparticles instead.
There's no obvious functional difference between the Pfizer and Moderna versions. They work on the same principles: mRNA (coding for the spike protein) in a lipid vehicle. They were tested with differing dosing and schedules, have slightly different formulations, and different branding.
Moderna's dose size is probably a little too high so it causes more severe side effects. But given the higher contagiousness of the now-prevalent Delta variant, a stronger reaction is probably a sign of better protection.
There is no plausible scientific reason (that I've heard of) not to boost with one of these two, regardless of what you started with (especially J&J, since it's weaker), but the FDA is only authorizing regimens that have been tested to their satisfaction, and considering the expense of clinical trials, the pharmaceutical companies might not get around to testing mixed regimens with their competitors for a while, if at all.
I'm less certain about the rest of this comment.
The timing of the booster matters. Getting it a day after your second dose probably won't do much. But if it's six months after, it should have a stronger effect. But you might get infected in those six months. I don't know what to recommend here.
I think that risks from the disease far outweigh the risks from the vaccine, even factoring in a 100% chance of getting a booster and only a 5% chance of getting the disease. Long COVID seems to happen sometimes even for mild infections, but perhaps unusual health conditions could change the calculation. Risks from the vaccine seem really overblown, and I don't think a booster changes that.
Thank you for this.
It turns out that I've been reflexively clenching my teeth when I mask, which resulted in a fractured tooth.
I've been doing disaster relief work for Hurricane Ida, I'm 46, fat and male.
I got my 3rd Pfizer dose on August 16.
Sure looks to me like it was something that happened in October.
Disease spread is exponential. Perhaps there is an ongoing set of infections that formed the baseline number around Sept. 1, and then schools acted as a partially-separate subpopulation in which spread started slowly before gaining steam in October.
This hypothesis is inspired by Hawaii data, as Hawaii has a clear flu season even though the weather is similar all year long. One explanation in Hawaii would have to do with schools; another would be that tourists from colder climates are artificially generating a flu season when they visit Hawaii. Edit: on second thought, assuming "week 0" corresponds to Jan 1 in that data, I think it fits the tourist hypothesis better. Also, it's fair to say that there may be months in Hawaii when people systematically stay indoors, facilitating spread of flu. But that would include school.
Thanks for the analysis. I read the whole thing, and there’s one thing i was hoping for answers on that i didn’t see:
What’s the current data suggest for the interplay between natural immunity and vaccination? Should someone wait until their antibody numbers are down to a certain level before being vaccinated, similar to spacing out vaccine doses by 6 months?
Also, another element of the “war” seems to be the lack of any recognition of natural immunity: mainstream discussions never ever mention it when talking about “the unvaccinated,” large swathes of with are likely people who didn’t bother because they’ve had the disease.
Would love to see some analysis at the awesomely detailed level you’ve provided concerning natural immunity and antibody testing.
My heuristic for this at this point (without going into the evidence I'm using): Natural infection counts as something like +2 vaccine doses. So if you're infected but not vaccinated it's as good or somewhat better than 2-dose mRNA, and if you're vaccinated plus infected you're effectively immune.
The issue, as I've mentioned, is that a lot of people are wrong about whether they've been infected, in both directions, or would claim it if it was helpful, so it's hard to use it as a criteria officially. On a personal level, yeah, big game.
My employer is being flexible and has agreed to accept proof of past exposure and anti body response. I’m writing up a page or so to explain the protective nature of nature immunity, and I’m asking around places like here to try to get my facts straight.
Requiring anti body testing as an alternative to vaccine passport at least helps restore a little liberty without sacrificing safety.
Antibody testing is not the only method. There is a much more expensive T-cell testing, that can also confirm prior infection. None of the tests are approved by FDA for the purpose of determining natural immunity.
They are emergency authorized for verifying prior infection, though. As far as I can tell, they constitute medical proof of natural immunity in some capacity, but the test itself can't tell you to what extent that natural immunity is protective.
However, the studies I looked at on natural immunity show it seems to be about 80% effective at preventing infection, median 7 months after infection (https://pubmed.ncbi.nlm.nih.gov/33844963/), so that + an anti-body test to confirm I really had it seems sufficient.
Can you write something up about AstraZeneca's prophylactic monoclonal antibody shots that they're working on?
I too am baffled by the "cancelation" of natural immunity. The main issue (besides Zvi's points) with whether to allow for natural immunity as an alternative (documented infection and recovery) is that we don't want to create perverse incentives to have "covid parties" (yeah, that's a thing). But that ought to be surmountable by having a cutoff - you need to have recovered prior to a certain date (in the US, maybe middle of August?), and in order to get a vax passport out of it, you need to get an antibody test at your own expense. In other words, it should be more a matter of figuring out the game theory than biology, which seems to point towards natural immunity pretty much working. I do think that allowing for immunity through natural infection would help to keep the peace.
Thanks for all the Covid posts Zvi! I just wanted to point out that things aren't so bad at Stanford (from my point of view). They're following the state recommendations for masks indoors and they're having everyone self-test once a week; all teaching is in person.
I suspect that it is hard for the administration to be any more lenient than that, both from a liability perspective and because of pressure from students and staff. As with all rules, it remains to be seen if they're actually followed/enforced.
Two reasons you could recommend boosters for vulnerable only:
It does seem that, temporarily supply shortages aside, you should advocate universal 'vaccination' (say w/ moderna) iff you also advocate ongoing doses until a real vaccine is available.
Good catch. Looks like the overrule is on the narrow frontline issue and she's going to align with the FDA.
Would have been great if she'd gone for the correct answer, but at least now we know where we're at.
I mean, it kinda makes sense for Walensky to be able to overrule ACIP if you think of the latter as quasi-legislative. Then Walensky would get to overrule anything short of a 2/3 majority.
In a sane world, we'd let anybody who wants to get a booster go and schedule one after six months, subject to the following proviso: if someone else comes along who hasn't gotten their 1st or 2nd shot yet, and there aren't any Moderna or J&J doses available OR if they got their 2nd dose before you did, then your appointment would get automatically rescheduled with, say, 48 hours notice. I mean, really, how hard can it be to write a computer program to do this? Why do we even need to get in the weeds, when we're already nicely sorted into a single parameter queue?
The vaccination rate is at 700 thousand a day. It was a million a day. Perhaps, until we get to a million a day again, including boosters, this postponing is not necessary.
Yeah, as long as people who got their last doses a longer time ago to bump people, we can just keep the shots rolling. It really shouldn't be this hard.
The FDA, having observed and accepted conclusive evidence that booster shots are highly effective, has rejected allowing people to get those booster shots unless they are over the age of 65, are immunocompromised or high risk, or are willing to lie on a form. The CDC will probably concur.
I think we all know what this means. It means war!
Don’t get me wrong. The FDA has been hard at work for decades ensuring people die or twist their lives into knots from a lack of access to medicine. Refusing to acknowledge that there is a war doesn’t change the fact that there is a war.
What changed this week was that the FDA gave us an unusually clear proof that there is a war, which side of that war they are on, and how far they are willing to go.
The good news is that, because of the exceptions, anyone who wants a booster can still get a booster, so on reflection this is a win-win. We know exactly what is going on, and it didn’t cost us all that much.
The CDC is now meeting to consider who should have the ability to get booster shots, not withstanding the FDA already having made that same decision. And they are being explicit that the point of vaccination, according to the CDC, they are now claiming, is to prevent hospitalization and death and NOT to prevent infection.
Let me say that again. The CDC explicitly claims that it does not think it is an important goal of a medical intervention to prevent Covid-19 infections that don’t result in hospitalization. Or, by implication, to prevent you from spreading the disease to others.
Tell that to all the people who see a mild infection somewhere vaguely around them, and quarantine for two weeks or shut down their office, and freak out. Tell that to all the people at the CDC mandating such behaviors. Tell that to all the people saying vaccinations are a social responsibility, or requiring it to engage in ordinary life activities. Tell that to everyone, at the CDC and elsewhere, warning us about ‘Long Covid,’ or suffers from it. Tell that to everyone who simply gets Covid-19 and has a really bad time for a week. Tell that to everyone around you deciding whether they can live their lives.
There. Is. A. War.
(As a weird aside, did you know their name is short for “Center For Disease Control”?)
Executive Summary
Let’s run the numbers.
The Numbers
Predictions
Prediction from last week: 900k cases (-5%) and 13,000 deaths (-1%).
Results: 815k cases (-14%) and 13,822 deaths (+7%).
Prediction for next week: 750k cases (-7%) and 13,800 deaths (unchanged).
It turns out the death jump was mostly real, while the small bump in cases mostly wasn’t. It’s odd that the errors here were in different directions, since that means it’s unlikely both were primarily caused by holiday issues. I interpret this as a new normal of steadily declining cases (but not at this week’s pace, because I think some of that was catching up to trend), which I expect to continue for a few months, after which Winter Is Coming and we may have an issue. Deaths should start dropping soon as well but there’s no reason to think the peak will be sharp.
I heard on the radio that the CDC is speculating there may not be a winter surge this time due to background immunity levels, and I agree that it could go either way, and I’m not sure which is more likely so I must have this close to 50%.
Deaths
Cases peaked three weeks ago, so we should see this start to decline soon.
Cases
Cases still increased this week in the Northeast, but only a small amount and I expect that to reverse soon. Clearly this wave is now headed in the right direction.
Vaccinations
This represents only 272k first doses per day, which isn’t much, although every little bit helps especially once we’re already this far along. What’s clear is that on top of FDA approval not doing much directly, the new mandates and pressures also aren’t getting the job done, all they’re doing (at most) is preventing a faster decline.
Then again, it turns out vaccinations aren’t that important, if we were to listen to what the FDA and CDC have to say when thinking about booster shots, so by their accounting it should all be fine.
Vaccine Effectiveness
Vaccines work for 5-11 year-olds, with a reduced dose of 10 micrograms. Everyone is so excited they hope to get this approved by the FDA in a month, maybe six weeks if it slips a bit. There’s nothing that’s going to happen to kids during that month due to everyone freaking out about them not being vaccinated, so it’s fine. Zero cases in the trial of any serious safety concern, which makes sense given there were only a few thousand kids, so I don’t really know what anyone was expecting or learned there. Here’s hoping this is accurate, combined with the booster shots anyone who cares enough will find a way to get:
I’d post a Padme theme about partial doses in adults, but I grow tired.
Two doses of J&J are 94% effective against symptomatic infection. So this whole time we’ve literally been stopping after one shot of J&J but doing two shots of mRNA, and that was the entire difference the whole time.
How old are these studies? They’re old enough that they’re explaining the 94% vs. 79% difference by pointing to the American arm not involving Delta cases, as the data came from June and July. Which is confusing to me, because the majority of the cases in June and July in America were Delta, and 94% represents fully robust protection, so if Delta knocked this down to 79% then there wouldn’t be room for much Delta at all. This is a rather large difference to explain, so I looked at the paper via the stat article on this. Looks like the period measured started on the day of vaccination, whenever that was, so the bulk of cases included periods stretching back months, and in America there weren’t that many cases in June and July versus earlier in the year, so the whole thing does mostly makes sense except for the part where we’re only hearing about this now. Oh well.
This was the most convincing piece of evidence I’ve seen so far, by a wide margin, that vaccine immunity is indeed substantially lower against Delta. The differences here are large, it’s in a properly done study with every incentive to find the opposite, and I don’t think it matters that it’ the J&J vaccine here rather than mRNA. I’m much more confident the drop-off here is real, and that for mRNA we’re looking at levels in the low 80s without a third shot.
That’s distinct from the question of waning immunity over time, which I mostly consider to probably be a statistical artifact.
But no matter in either case, because luckily, those booster shots are on their way as soon as the FDA approves them, and our lives won’t be thrown into chaos once more as everyone freaks out about all this.
Oh. Wait.
FDA Recommends Technically Banning Most Booster Shots
When there is a war, it is the good and honorable thing to declare war. Then all involved can respond accordingly. Before I get to the details of what happened, I want to thank the FDA for properly following the formalities. The FDA is remarkably good, once it can be bothered to examine the evidence, and to the extent that it considers such evidence to be ‘admissible’ in its court via being in the proper form and done with the proper permissions, at presenting that evidence fairly and drawing the correct logical conclusions.
Which is great. I really do appreciate it. I’d much rather they honestly analyze the evidence and make their decision anyway, rather than manipulating or misinterpreting the evidence to justify their decisions.
Anyway, last week a commentator took on the time and mental health burdens of observing the FDA meeting so the rest of us didn’t have to, and created this excellent summary of what happened. I want to stop and say: Thank you.
It’s quite long, but it’s pretty great, so if you want further detail, please look there. I’ll hit the parts I consider most relevant.
Before we look at what happened, since the linked post mentions it up front, it’s worth tackling the question of the booster shots given here taking shots away from people in other countries. I have two responses to that, which are essentially:
It’s a policy question, not a regulatory one. It’s none of their damn business the same way that this is most definitely none of their damn business, but is such people’s favorite thing, scaring people and especially kids, while avoiding their least favorite thing, letting people have medicine.
My model strongly says that if boosters aren’t allowed at this time, we’re not going to take the booster shots we would have given and ship them overseas. We’re instead going to let them sit around until the expire, on the hopes that we’ll find a way to get boosters approved, or that enough people realize they can mark a box on a form and get a booster anyway. Prove me wrong, kids.
But even if I’m wrong about that, that is, as I said, none of the FDA’s damn business. The FDA’s damn business is whether the booster shots are safe and effective or not.
All right, enough on that question, on with the show. There was a bunch of data presented. Here’s the first thing he notes.
I didn’t scrutinze each of the 53 pages, but it seems they wanted to draw 2 major conclusions:
So… yeah, it works. But the evidence of need is slightly sketchy.
The FDA slide deck makes substantially the same points. [7] There’s some slightly subtle foofraw about noninferiority criteria according to the 97.5% lower confidence limit of the difference of… something or other. But the details here are unlikely to be of broad interest: the game is to make sure the 3rd dose doesn’t harm immunity, and after that it helps.
Is it that easy? Do boosters clearly work? Yes.
Ignore for the moment the question of waning immunity, and focus on the second point. This boosts your immune response level by an order of magnitude, which is known to have a very large effect in your vulnerability to Covid. That’s not comparing to immunity that’s faded over time, it’s comparing to one month after dose two. So it’s clearly much better immunity than two shots alone. It works.
Then there’s a bunch of arguments over whether immunity is fading, and I’m confused as to why we should care.
Let’s say that the two-shot regime was still considered a full 96% effective versus infection and 99.5% versus death. And let’s be conservative and say that the third shot boosted that to 98% and 99.8%. In what way would that not be effective? How are we not moving on to discussing safety?
If your answer is ‘96% is good enough’ then please, I beg you, take a look around. Look at what the people who are vaccinated are still doing in the name of prevention. Look at the things they’re being told they have to do, and the worry and stress they go through each day. We can cut all that in half here, with one shot, far less than half as obnoxious as all that other stuff, and also stop the general spread that much more. These are the same people who talk endlessly about how awful it is to not save every life you can, no matter the cost. How is this even a question?
These people are telling us to suspend our way of life indefinitely to get extra protection, while simultaneously telling us that we don’t need additional protection from a booster because what we have is good enough.
So what’s the question? This is the question:
Question to the Committee
Please vote Yes or No.
Somehow the difference between 16 and 18 years old is a really big deal to these people. As he notes, there were 4 “No” votes on the original vaccine over this, people who were willing to stop the vaccine over this question.
The justification of this is that ‘there were no 16-17 year olds in the testing group’ as if 18 were a magical number that made everyone below that threshold a different physical magisterium rather than us having a social convention about being 18.
Here’s an interesting bullet point from the introductory remarks.
I’m sure we’ll get to that ‘reconsider in the future’ real soon now.
And also this:
So, since that is none of your damn business, we’re done here, right?
That really, really, really gives us enough information, along with the 1% of the United States that has had a booster, by comparing it to the rate of such cases in a similar group from the first two shots, realizing that compared to Covid these risks were always absurdly small, and moving on with our lives.
I did love this:
So the conclusion was that they ‘failed to resolve’ the question of waning immunity, because it turns out that the FDA is smart enough to find the problems with the Israeli data.
But as I was worried about last week, they didn’t consider at all the data that the rest of us are actually using as the basis of deciding whether or not there is waning immunity, which is the data coming in all around from everywhere else.
Thus, we have a situation in which the public health experts, when deciding precautions, act as if immunity is waning a lot. And when talking to the public they say immunity is waning a lot. Except when they’re trying to tell someone to get vaccinated, in which case they mumble for a while. And of course, in that context, the answer of maybe it’s waning and maybe it’s not means it is waning, because you have to average out the possible worlds when deciding what to do, and guard against the ‘risk’ that waning is happening.
When you turn that around and consider a booster shot? Suddenly the ‘risk’ is that maybe immunity isn’t waning. That would be terrible. There’s a ‘risk’ that we might have given people life saving medicine when there weren’t enough lives being saved, so we have to withhold the medicine until we’re damn sure that isn’t the case. Instead, people should be constantly stressed out, wear masks everywhere, socially distance and otherwise cripple their lives indefinitely, for the same reasons that weren’t good enough evidence when it counted.
The concern with myocarditis/pericarditis really isn’t any less stupid, and even if you decide it isn’t stupid, it is confined to young males, so if we wanted to be stupid in a reasonable way we could let such people make a choice without taking it away from everyone else, or even approve for, say, men over 35 and women over 18, or whatever made everyone stop freaking out over nothing.
If you considered a pandemic that caused the symptoms and side effects of Covid-19 prevention we’d damn well have approved at least the third shot, and likely the fourth shot to be safe.
So we start with the first vote, which did not go well.
It wasn’t unanimous, which is a good sign. That’s still a lot of no votes, but I suspect they are weakly held. Last time, the move from 18 years old to 16 years old got 4 no votes. It stands to reason that at least 4 votes would probably flip here if we’d moved from 16 to 18. If we assume we had an accidental no vote (because probability and because the committee would likely notice the extra yes vote if it happened here) we go from 15-3 to 11-7, maybe better, so it would make sense to take a minute and check? And then check, say, Over 25? Or a split of men over 35 and women over 18, or something? Or ask people what they’d support?
What they did next instead was to check a very limited case, those over 65 or who are immunocompromised, or at high risk for exposures or comorbid conditions:
And yes, we’ve been through this before, and yes almost everyone has a plausible ‘comorbid condition’ or ‘high exposure’ if you think about it long enough, so one doesn’t even have to lie. And yes, that would take care of the bulk of the real ‘risk in the room’ if everyone treated this as a personal puzzle to solve. Except for those who got Moderna or Johnson & Johnson as their first shot, of course, but screw them, at least for now. They seem to have ‘not gotten a decision’ which means they could get a decision later, at least.
There was no third vote. There was no attempt, once it was established that everyone supported some boosters, to find out how many boosters a majority did support, and go with that.
The President of the United States arranged for life saving medicine to be available to Americans who want it, and announced a program to get it to them. The FDA advisory committee agreed it was safe and effective life saving medicine (at minimum in everyone but young males) and decided that it would exclude those without an Officially Valid Excuse from getting access to that medicine indefinitely. They made it clear that part of this was resentment of the President arranging for life saving medicine without getting their approval first, part of this was their general principle of not preventing people from getting medicine being their least favorite thing in the world, and part of it was because in some hypothetical other world those vaccines had a fixed supply and now that fixed supply would go to the third world instead of sitting idle waiting for their approval, and if that turns out to be true I’m going to be glad I don’t own a hat I’d then have to eat.
I’m going to quote The Grumpy Economist and Marginal Revolution in full here, who summarize the situation well. From MR:
And from Grumpy Economist:
Indeed. Mandatory masks, banned boosters. There is a war.
Then the FDA decided to string us all along for five days, giving hope that perhaps they were going to disregard the recommendations, because what else would be taking so long?
Something was causing an unusual delay, which was getting so bad that the CDC was about to have to potentially postpone their meeting until the FDA makes up its mind. The suspense was killing us.
Then, last night, the FDA went with the recommendations. You’ll need to find an Official Excuse to get your booster shot, or convince someone to give you one without one.
It’s up to you if you want a booster. If you do want one, whether or not you are officially supposed to be on the list, go get one.
In seven days, it will be six months since my second shot, and I will get my third.
The CDC Tries To Respond
For the CDC meeting I’m going with a Twitter thread from Helen Branswell, who I’ve found to be a reliable source. Lots of interesting stuff.
The CDC has to decide what to recommend in light of the FDA’s decision, so they scheduled a meeting for yesterday and today, and, as noted above, whoops.
Some good news made more explicit, which fits my priors:
Mixing and matching vaccines continues to be obviously a good idea, and the regulatory bodies are going to keep not allowing it due to ‘lack of data’ despite no theory of why there would be a problem, and the companies involved will continue not to study it because it’s not worth it to them to do that. Which in practice means that even for those who would otherwise qualify, we’re going to continue banning even second shots for those who got J&J for at least a while longer, and third shots for Moderna, although in practice this is something people can work around.
The trick is, there’s data about a lot of things, but if you slice what counts as relevant data finely enough, you can claim there’s no data whenever you’d prefer that there was no data. You want to worry about 16-17 year olds? Say that 18 year olds provide no data. If you wanted to, you could then say that people were the wrong gender, or the wrong race, or the wrong health status, or the wrong lifestyle, and keep doing that until your sample was small enough that there was ‘no data.’ Or you could realize that all data is data, and do something reasonable, but reasonable is not the watchword here.
Meanwhile, there’s a non-zero chance that we’ll get the even-more-perverse response that, well, it’s not like this is urgent or anything, let’s wait until all three booster shots are ready before we allow anyone to get one.
Given what we know, it’s sufficiently clear that longer dose intervals are vastly better. The original intervals were chosen to get the studies done faster and get shots into arms faster, and were guesses. In the UK it is a scandal that the officials aren’t ‘doing enough’ to inform people to avoid the horrible mistake of not spacing out their doses longer, and there’s widespread speculation that the differences are big enough to explain differences between countries. So how’s it going on that?
This graphic seems right and pretty great, a lot of people remain confused about this:
I always find it interesting when I disagree with my source’s interpretation of the information they’re sharing, such as this slide:
The effectiveness is still very good, but to me the difference between 90% (or 85%!) and 98% is a really big deal. That’s a factor of five or more, on top of already being higher risk to begin with. In practical terms I do see this as ‘a lot lower.’
The other thing this slide is doing is claiming that there’s no substantial reduction in vaccine efficiency against hospitalization under Delta.
Given they have this slide, I’d be skeptical we’re going to get a good ruling:
If they’re grouping people like this, it shows how they’re thinking. People are living their lives with one set of concerns. NPIs are being considered and mandated at great stress and expense with another related but different set of concerns. Then the booster is being considered with a much narrower set of concerns that treats the previous concerns, and the actions taken in response to them, as illegitimate things to worry about, and places the burden of proof entirely on those claiming there’s an issue, despite the same people treating the issues as huge in other contexts, once again.
Yes, we don’t have data on one specific super rare and not important side effect, so it’s possible that the third dose will suddenly do ten times as much of that as the second one, in the sense that a lot of things are possible and many things do come to pass, but if the other side effects are at slightly lower rates I can’t think of any reason to think it’s plausible. Would happily accept wagers on that (unless someone has actual data).
We somehow need to keep saying this over and over, but a reminder:
Vaccine Mandates
At least one of the FDA “no” votes on boosters justified their decision by saying that approving the booster would amount to a de facto mandate, because once it was no longer forbidden it would of course be compulsory. They did have a point, and it was driven home rather quickly when the next day Pfizer announced that they’d proven their vaccine safe and effective in 5-11 year olds, because partisans have a principle that no time should ever be wasted in such situations:
This seems to be the consensus, that the moment the vaccine is permitted in children it should also be compulsory. No middle ground, no period of ‘we think this is a good idea but it’s up to you.’ Zero to sixty in 3.5, hand over the keys, shut up and let us drive.
Of course, it’s not your fault that the other half of the calculation is doing dumb things, like imposing mandates in minute one or withholding the shot that’s a ticket to a normal life without all the extra daily trauma for months on end for no good reason. If anything, you’ll need to move even more in the other direction, since things have already gone too far. So, whoops, and the cycle continues.
There is a war. You may not be the baddies, but let’s say you’re probably not the purely goodies either.
NPIs Including Mask and Testing Mandates
You know that whole thing about six feet apart? Well…
So he’s wrong, we do know where it comes from, it’s an arbitrary number picked in the hopes people would listen to it. Which is reasonable in context, but important to know.
What else is there to say at this point? Here’s what things are like in San Francisco.
Unless you are, you know, the mayor.
Link is a six minute interview with her, with gems like this.
Oh, so it’s fine, then. I agree, actually, there are more important things in life, but then why the hell is there a mask mandate?
Is it because you are famous and powerful, and therefore your experiences are better and you have power and thus the rules shouldn’t apply to you?
I do thank her for explicitly endorsing this argument. History in the making.
The alternative explanation is that the rules were never intended to be obeyed, and there was always the expectation that no one follows rules so rules are fake. So she’s not a hypocrite, you see, because she thinks the rules are fake for everyone which makes it okay? Kelsey sums up one issue with that.
The mask is off in more ways than one. Let’s respond accordingly.
In Los Angeles, by contrast, they justified their full red carpet by pointing to alternative procedures to keep things safe, and I’m going to disagree with my source and say that this all looks reasonable to me.
Meanwhile, in Texas: A business owner expelled some customers for wearing masks. I am willing to bite this bullet. The people in question are being dumbasses and assholes, and the solution to ‘I’m tired of the government bossing us around’ is not to start bossing other people around for the hell of it, but hey. Their call. You can set whatever dress code you want, and customers are free to go elsewhere.
Think of the Children
There was an article in the New York Times about how schools and children are causing the Covid-19 surge and are at terrible risk. I won’t link to it, but this appears to be what it claimed, and how that checks out. First, a completely unsubstantiated assumption about schools, because it fits the scare tactics desired:
So here’s the thing, in addition to the whole kids-don’t-get-severe-Covid thing. Covid is seasonal.
So when do schools reopen? The beginning of September? Here’s Covid cases, nationwide, last year by week in that period:
Sure looks to me like it was something that happened in October. What about this year? We peaked the week of September 1?
If your hypothesis is schools are causing Covid-19 to surge, it should strike you as rather odd that Covid-19 cases peaked right before school starts two years in a row, despite schools causing increased testing.
This is one of many data points that suggest that if anything schools prevent transmission, from a thread addressing various issues here:
I’ve seen lots and lots of claims that various peaks and valleys corresponded to when schools opened or closed and blamed the schools. I’m actually asking here, does anyone care to explain why the obvious test goes the other way?
Anyway, there was something else more concrete.
So it seems that the number got inflated by an order of magnitude or so (at least a factor of about six), via taking the number of kids hospitalized ‘with either confirmed Covid-19 or suspected Covid-19′ and taking that as the number of kids hospitalized ‘FOR Covid-19.’ No matter what some people might think, an extra zero matters.
Also the article claims that kids are more likely to spread Covid than the elderly, and generally as likely to spread it as adults, with sources that should not have survived scrutiny. I flat out disbelieve any such claims, they don’t make any sense.
I don’t know if they eventually printed a correction somewhere. Which is the point.
Lest you think this is everyone picking on an unimportant article, a link to it was where I first learned that Pfizer had found their vaccine to be safe and effective in 5-11 year-olds, before I saw any of these issues brought up. Whoops.
So really, how’s it going?
This is the future (some people) want. A mask, being forced onto the face of a crying two-year old, forever (1 minute video). Yes, you can say there are ‘better ways’ to do this, but this is frequently what actually happens, until their spirits die enough to yield.
When they grow up, if they’re lucky, they get to go to Stanford.
It’s not a few isolated places. Colleges are going completely crazy with their restrictions. Maybe we can hope that this will sufficiently ruin college that people stop going. Yet I fear that this is what the students actually want, that they have gone mad with various forms of righteousness and the love of telling others what to think and do, and this is merely the latest symptom of that.
Meanwhile, one of the children in my son’s preschool has already tested positive for Covid-19. Luckily, preschool is mostly a myth that does not actually exist and he was going to not have class on Tuesday or Wednesday anyway, so it only cost one day of school. As an illustration of what I think of the testing regime in place, I did make some attempt to get him an at-home rapid Covid test when I found out he had actually gone to school with another positive child, cause the cost seemed so low, but when both Duane Reed and CVS said they and everyone else were sold out due to all the demand for weekly tests, I shrugged and went home rather than considering devoting actual effort to the task.
This seems to be a general problem, for example:
The Chris Rock Probably Cannot Smell What Anyone Is Cooking, Because He Has Covid-19
I wish him well, one of the funniest people in the world, taking time out while he’s sick to help others. There’s a twist, here’s the friendly version of the problem.
Chris Rock got J&J. For some reason, a lot of people did not think ‘I did X and then Y happened to me, Y is bad so do X’ was a particularly compelling argument, whether or not they support doing X. Those who already opposed X saw it as a Catch-22 absurdist theater, and quite reasonably asked what wouldn’t be used as a reason to get the vaccine?
This calls for theory of mind. Depending on your priors and what you already know, this could be evidence vaccination is a good idea, or it could be evidence against that, because it’s providing several distinct potential updates.
We learned two things. First, Chris Rock got Covid-19. Second, based on his experiences, he is reporting that you do not want this.
Chris likely had one of two updates in mind.
Those are real effects, both plausibly changing behavior and doing so for mostly good reasons. The issue is that there are several other potential updates.
3. Effectiveness of vaccination. Chris Rock still got Covid-19 anyway, and it still sucked, so what’s the point?
4. Effectiveness of J&J in particular. One shot of J&J is less effective, so make sure you get a second shot of some kind.
5. Arrogance of elites and non-relevance and non-trustworthiness of their arguments. Chris Rock was vaccinated, got Covid and then used that as evidence for vaccination, while failing to mention he’d been vaccinated. And That’s Terrible.
Which of these dominate, and thus which direction you update, and whether Chris’s statement was a good idea, thus varies from person to person, based on what they know and believe already.
In particular, this relates to Agnus Callard’s concept of the verdict. To reach a verdict on a question is to consider the matter decided and hold your belief strongly, ignoring future potential evidence to the contrary unless it is sufficiently and unexpectedly strong. In the pure Bayesian sense this should either be a continuous effect (you update but your prior was extreme so it doesn’t much matter) or not an effect at all, but in practice humans need to think like this often because we don’t have enough compute not to.
The pro-vaccine camp has reached the verdict that vaccines work, because there’s overwhelming evidence that they work, but also because there’s a social consensus that there’s overwhelming evidence that they work. It’s unthinkable that they might not. Thus, when they see a statement like Chris’s many won’t even notice that it’s a bit of evidence against vaccine effectiveness, at least for J&J, because who cares? Verdict is in.
Whereas if the verdict isn’t in, and you have real doubts, that becomes quite salient. Similar things go on here for the other variables that one might change in response to this information.
In Other News
Kelsey Piper speaks truth about the whole Ivermectin debacle, although none of it should come as news.
An Atlantic article claims that an increasing percentage of those hospitalized for Covid-19 have mild symptoms, rendering the hospitalization numbers misleading. From the beginning I’ve been skeptical of using hospitalization numbers as anything but a measure of the status of hospitals, exactly because the decisions made in hospitals aren’t consistent over time and that makes it hard to interpret the numbers, although things like the second derivative can still be useful.
Looks like the data on PhDs not getting vaccinated wasn’t real. If I’d been making substantial updates off this data, I’d question much harder the procedure that caused me not to catch this error. As it is, I still do think I should have been more suspicious than I was, and will update accordingly. It’s tough to know when to spend time on such questions, as I don’t have enough funding/time to dig deep into every data source.
A reminder that almost everyone, almost everywhere, whether they know or admit it or not, is usually either talking nonsense or talking price.
I mean… yes? And lots of people are mandating a bunch of other preventative measures that are vastly less effective and more expensive and ‘risky’ than the booster shots.
And by the way, we’re also not allowing most people to get those booster shots.
A very interesting thought, in a great thread discussing supply chain issues:
Slack can take many forms. Wasting a lot of food on a regular basis isn’t great, but it ensures the slack remains in the system, since in a pinch we could respond to a shortage by wasting less. The principle can be extended.
Not Covid
Someone finally gets it, and proposes auctions replace the coin toss in cricket. What I’d most like to see is an auction for the football in overtime in the NFL. Where are you willing to start in order to get the ball?