Covid 9/23: There Is a War

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

  1. There is a war to preserve or destroy our way of life.
  2. The FDA and CDC are on one side.
  3. They have made it even more clear than before which side that is.
  4. Despite their best efforts those who care will get booster shots. Technically the rule is six months after your second shot, and you have to be either over 65 or otherwise high risk either in terms of health conditions or your job.
  5. Despite their best efforts 5-11 year-olds will get shots in a month or so.

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:

  1. They aren’t doing that.
  2. That’s none of the FDA’s damn business.

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.

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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.

Pfizer/KPSC: Vaccine efficacy against any infection waning
Pfizer: GMT neutralizing titers after 1, 2, and 3 doses show significant rise after booster
Pfizer: GMT neutralizing titers Delta

I didn’t scrutinze each of the 53 pages, but it seems they wanted to draw 2 major conclusions:

  1. A Kaiser Permanente of Southern California study showed vaccine efficacy waning (Figure 1, p. 12, makes this point, but slide CC-13 of their presentation [6] makes the point better and is reproduced here: the right plot shows sustained efficacy versus hospitalization). I’m glad they honestly say that efficacy against hospitalization and death remained high (mostly > 90%). So that’s sort of wanting to have things both ways: yes, efficacy against any infection might decline (though they don’t seem to be aware of Simpson’s paradox!), but the efficacy we care about is still robust. Hmpf.
  2. A 3rd dose does indeed boost the geometric mean titer of antibodies, against both the wild-type and B.1.351 (Beta) variants (Figure 2, p. 19, makes this point, but slides CC-22 and CC-23 of their presentation make it more graphically, and include Delta). The rise after the 3rd dose is statistically significant, as shown by the confidence intervals. The 3rd dose is the rightmost 2 pairs of bars in each group. Note the vertical scale is a log scale, so these are really huge differences.

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

  1. Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?

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. 

  • Everybody thinks spacing the doses out further than the initial 3-4 weeks would have resulted in better immunity, but at the cost of slowing down vaccinations. So we chose faster vaccination in the face of a pandemic, but might want to reconsider that in the future.

I’m sure we’ll get to that ‘reconsider in the future’ real soon now.

And also this:

  • We know a boost will work; the question is whether that’s the best thing to do versus, say, vaccinating everybody else.

So, since that is none of your damn business, we’re done here, right?

Another “elephant in the room”, as Branswell put it, is the rare instances of myocarditis and pericarditis that sometimes happen in young men, and whether a 3rd dose will raise that frequency. Nobody knows, because the clinical trial here was too small to be powered to see such a rare event.

However, Israel has boosted 1.2 million people and seen exactly 1 case of this sort of heart inflammation. So that’s potentially a good omen if not exactly the RCT statistic we’d like to have in the best of all possible worlds. The acting chair of VRBPAC, Arnold Monto, cautioned that Israel is doing the oldest first, so their data under-represents males under 30 who are most at risk for myocarditis/pericarditis. So… the risk looks low, but really nobody knows.

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:

Another slightly cute detail: Pfizer’s presentation ran long, and when they attempted to review the Israeli data that had already been discussed, the chair cut them off. I admit that as a former pharma scientist, it’s a gleeful fantasy of mine to be able to tell a senior VP of a pharma company to sit down and shut up. (Perhaps I am a bad person. But it’s hard to resist the cravings for a teensy slice of schadenfreude pie.)

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.

At 3:30pm, the vote on the question above came out negative: 3 Yes, 16 No, 0 Abstain. Interestingly, that’s 19 votes out of the 18 committee members! There was one accidental vote, apparently by a speaker; their choice was unclear, but it could not have changed the outcome. (This will be a subject of gossip in the months to come: who barged in and voted without the right?)

Now they’re discussing changing the question, to see if they can endorse boosters for some subgroups of people, if not the entire population. Remember my prediction above, that this would be the sensible outcome? Maybe, just maybe

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:

My first reaction upon hearing that boosters were rejected was to ask the same thing: would these same “experts” say that, because the vaccines are still effective without boosters, vaccinated persons don’t need to wear masks and can resume normal life? Of course not. They use the criterion “prevents hospitalization” for evaluating boosters (2a) but switch back to “prevents infection” when the question is masks and other restrictions. What about those that are willing to accept the tiny risk of side effects to prevent infection so that they can get back to fully normal life? The Science (TM) tells us that one can’t transmit the virus if one is never infected to begin with.

Also, one of the No votes on boosters said that he feared approval would effectively turn boosters into a mandate and change the definition of fully vaccinated. So, it appears that the overzealousness to demand vaccine mandates has actually contributed to fewer people getting access to (booster) vaccines, thus paradoxically contributing to spread. A vivid illustration of the problem with, “That which is not mandatory should be prohibited.”

The biggest problem with public health professionals continues to be (1) elevation of their own normative value judgements — namely that NPIs are no big deal no matter how long they last — which have nothing to do with scientific expertise, (2) leading them to “shade” their interpretation of data to promote their preferred behavioral outcome rather than answering positive (non-normative) questions with positive scientific statements, (3) thus undermining the credibility of public health institutions (FDA, CDC) and leading to things like vaccine hesitancy.

And from Grumpy Economist:

What happened to the idea that the FDA’s job is to proclaim only whether a vaccine is safe and effective? Then if you want to take it, that’s up to you? (And we could argue about even that, i.e. whether “safe” is enough, whether FDA should have authority to make something unproven illegal, etc.) 

I want a booster. Pfizer wants to sell me a booster. The data say it’s safe and effective. Way more effective than masks. Period. 

They hypocrisy on masks vs. boosters is amazing.  

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:

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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…

“The initial recommendation that the CDC brought to the White House … was 10 feet. A political appointee in the White House said we can’t recommend 10 feet. Nobody can measure 10 feet. It’s inoperable. Society will shut down. So the compromise was around six feet,” Gottlieb said.

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.

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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:

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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.

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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.

  1. Frequency and tangibility of Covid-19. If a celebrity you know gets it, perhaps it will feel more real. If there’s more Covid-19, the benefits of vaccination go up.
  2. Severity and experience of Covid-19, that having Covid-19 sucks even if you don’t die, so again the benefits of vaccination go up. You don’t want this, so avoid it.

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.

“There is nothing special about them compared to any other preventive measure,” he said. “The great thing about the vaccine for COVID-19 is that it prevents the risk of serious illness. Fantastic. People get to make the choice about what they want to do with that information.”

But he said vaccination is not the only path to good health.

“It’s been treated almost like a religion and that’s just senseless,” Ladapo said. “We support measures to good health. That’s vaccination, losing weight, exercising more, eating more fruits and vegetables, everything.”

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?

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76 Responses to Covid 9/23: There Is a War

  1. lunashields says:

    I wonder how many of those 270k shots daily are those illegal booster shots by now. I am certainly hearing from a lot of people that they just got it.

  2. Michael Bacarella says:

    In an ideal world, wouldn’t we want to incorporate serology testing into “booster shot?” decision making, and thusly do away with all of the approximating worthiness garbage the FDA is trying to do here and replace it with this protocol instead?

    1. Take vaccine
    2. Wait four weeks
    3. Take serology test to identify antibody response.
    4. If antibody response is below desired immunity threshold, goto step 1
    5. Otherwise, come back in a few months and begin at step 3

    This means people who are immunocompromised automatically get redosed a third, fourth and fifth time instead of being sitting ducks waiting for FDA to approve their next shot, and it also means people who are very immune can skip and forego the potential side-effects.

    • TheZvi says:

      That seems like way more complexity and extra steps and costs than we’d be able to implement at scale. If you have the cycles and want to make the right decision for yourself enough to bother, there’s something in that space that makes sense I guess, but in practice I don’t think one is going to bother.

      • Michael Bacarella says:

        Yeah it’s logistically more annoying than a broad simple public health recommendation.

        What I’m thinking about, and perhaps inferring too much from, is an anecdote from a cancer patient on Twitter where she posted that she had an antibody test after first and second shots and they each showed increases but her doctor said this conferred no effective immunity. Are there patients like this who have no path to getting a booster until the FDA finally allowed it in this meeting?

        Or are doctors technically allowed to authorize a third and fourth shot in that case (and as many more as it takes) if there’s no official recommendation allowing it? And will they risk doing so absent an official recommendation?

      • J says:

        My intuition is the same regarding using it as pubic health messaging, although in my own circles I already count seven people who used antibody tests to inform their strategies, all of whom have been reluctant to seek boosters absent official recommendations. So maybe people are willing to be data driven than we think, and would benefit from hearing it endorsed as an official strategy.

    • J says:

      Yes, this is what I came to say too. How strong of a signal is an igG/igM antibody test? I’m inclined to think it’s pretty strong, so I’ve been telling my elderly friend who recently tested negative to go get a booster. Another elderly friend had an extremely faint igG line, so I’m less sure what to conclude there. (I imagine line color has more to do with the size of the blood drop than it does with the actual titer)

  3. John Schilling says:

    “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…”

    I’m rather skeptical on this point. People aren’t doing all of these things because they have done a quantitative risk assessment and set their threshold at 97% vaccine effectiveness; they are doing these things because all of their friends and all of their thought leaders are saying “COVID is still very scary”. And to the extent that they are hanging that on anything quantitative, it is case and death counts that are dominated by e.g. wholly unvaccinated Floridians. Give everyone who wants the vaccine a booster shot, and there will still be lots of scary stories, and too many people will still believe that the only thing that is saving them from Florida’s fate is their faithful adherence to *all* of the standard rituals.

    It ends when enough Floridians, etc, have been vaccinated and/or infected that there aren’t any more new scary stories, and when enough time has spent that recycled old stories no longer scary. Boosters, while perhaps worthwhile in their own right, are unlikely to be more than a minor perturbation on this.

  4. J. Jocordy says:

    > 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.

    Could you link to this claim?

    • TheZvi says:

      It’s in Helen’s Tweetstorm, and it’s fundamental to their thinking process here on many slides and points.

      • Brett Bellmore says:

        Now, hold on. Why do we fight Covid at all? Why do we prefer vaccination to infection? They both grant immunity, and the infection might do it better.

        Because Covid has symptoms that are worse than the vaccine, of course, enough worse that it’s worth our while to do something about it.

        It logically follows that, as the average severity of the symptoms declines, we have less and less reason to prefer expensive shots over freely distributed infections, and probably at some point well short of equivalent symptoms, it’s just not worth our time anymore to be pushing vaccinations. I mean, how does the lost man hours of a mild case of Covid compare to the cost of the number of vaccinations necessary to prevent it?

        Now, I’ll admit there’s the ‘hair on fire’ problem of people freaking out, and demanding insane precautions, but that’s not a symptom of Covid, as such, is it? That’s a symptom of a sort of contagious hysteria, a moral panic.

        Maybe less effort to vaccinate people who don’t want it, and more effort to encourage people to chill out?

        That said, FDA delenda est! None of the above considerations excuse prohibiting people from getting the vaccine if they want it.

  5. JB says:

    “… 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”

    At several different points in today’s post, you seem to assume that anybody with a brain in their head will be able to figure out how to obtain a booster. Furthermore, you seem to imply that there’s a *single*, provably optimal hack for obtaining said booster (rather than the byzantine maze we were all confronted by this past spring, when trying to find available first doses).

    Maybe I don’t have a brain in my head, but it seems like “marking a box” could mean any of the following:

    1. “This is my first dose”
    [only works if provider isn’t checking vax database for your state, or if you cross state lines]

    2. “I’m immunocompromised”
    [may have to provide additional clinical details]

    3. “I have a comorbidity”
    [may have to provide additional clinical details]

    4. “I’m in a high-risk occupation”
    [will almost certainly be asked for additional details]

    5. “I found a pharmacy or grocery store that doesn’t give a sh*t”

    6. Other???

    Can you clarify which “box” you would recommend for people who are sick of being held hostage by the FDA and want to exercise some control over their own health? I all the usual caveats (you’re not providing medical advice, you’re not encouraging people to break the law, etc., etc.).

    Thanks!

    • TheZvi says:

      Yeah, all the usual caveats, but basically from what I heave heard…
      1. It is unlikely they will check the database.
      2. You are unlikely to have to provide clinical details, and in many places they have a policy of not asking, you just assert it, often without any details.
      3. You can probably find something you technically qualify under if you look at the list.
      4. I’ve seen reports of places that don’t give a **** and if you try enough times you’ll probably find one.

    • David W says:

      Keep in mind that all the incentives are for the vaccinators to believe you.

      For administering vaccine they get: paid, thanked, they hit their metrics and management’s goals and make the politicians happy, and they get the satisfaction of (statistically) saving a life or a hospital visit. Making the world a better place.

      For denying vaccine they get: a waste of time, an argument, and maybe the satisfaction of being an enforcer? No money, no gratitude. It’s not like there’s any pressure for using vaccines efficiently at this point, no one will give them a bonus for ordering less vaccine next week.

      That was even true back in March; everywhere I looked the comorbidity verification process was ‘checked a box’, they didn’t even verify the things that would have been easy like BMI. But now they’re also probably getting bored.

    • Lambet says:

      Are they vaccinating undocumented immigrants? If so, pretend to be one of them.

  6. sniffnoy says:

    Covid is seasonal.

    Do we really know this is true? It hasn’t even been around for 2 full years; the existing numbers seem like it could be pretty confounded by other events. Reminder that disease seasonality is still pretty mysterious on the whole. (OTOH, some of those confounders could be yearly occurrences that therefore aren’t really confounders at all but rather causes of seasonality in the first place. I just think we should be wary of this explanation due to how much seasonality varies between diseases.)

    • TheZvi says:

      I think we saw enough patterns that seemed related to weather, and which made sense under a seasonality model, especially if you include behavioral effects as ‘seasonal’ that this hypothesis seems almost certainly true to some extent, but I agree it’s complicated and the magnitude isn’t obvious. It would need to be large for there to be a winter surge, hence the uncertainty.

    • Matty Wacksen says:

      > It hasn’t even been around for 2 full years

      it’s not like covid (technically sars-cov2) is the only coronavirus out there, so it’s not like we don’t know anything beyond what we have learnt in the past years.

  7. Eye Beams are Cool says:

    Re: Auctions – Could not agree with you more. Would be competatively fair *and* make for great TV.

    Re: Food waste – You only get to 30 to 40% wasted if you use a definition of waste that is as far from common usage as the Very Official definiton of sex trafficing is away from the common usage. It includes things like an orchard composting fruit that was rotting on the tree. At risk of hunger means not hungry. Being sex trafficked means running your own onlyfans. Wasting food means throwing away food that was never fit for consumption. Becasue modern society is addicted to shitty metrics.

    • TheZvi says:

      Thanks for the note on food waste. After running a household with kids where time is a much bigger limiting factor than most costs of food and having to put in weekly grocery orders, I was ready to believe the 30%-40% number on a very straightforward basis. I do think people in America throw out quite a bit of food in ways they could prevent.

    • John Bennett says:

      This isn’t correct. In 2010 the USDA found 31% of the food supply is wasted “at the retail and consumer levels.” They specifically clarify that this is all post-harvest, so excludes the things you raise. I fully expect this number has gone up in the last ten years, hence the 30-40% estimates for food waste now.

      https://www.ers.usda.gov/data-products/food-availability-per-capita-data-system/food-loss/

  8. sniffnoy says:

    I’m wondering what counts as a “comorbidity”. I got a vaccine here in NY early by having a “comorbidity” by their standards. I’m guessing I can probably get a third one in two weeks by applying that same standard again?

    • TheZvi says:

      My basic plan is to walk in, say I have a qualifying condition and use the fact that I got vaccinated in March (by having a technically qualifying condition) as my evidence of that.

      • Szezine says:

        Field report from getting my booster shot:

        I made an appointment on CVS.com and said I have a weakened immune system. I provided my name and date of birth, but no other information – I left my insurance info and drivers’ license number blank.

        When I got the shot, they just asked for my name and birthday, then gave it to me – no other questions.

        I highly recommend those planning to get the third shot take a similar route (making appointment in advance online) – since it seems to let you avoid answering any questions in person.

  9. Respectfully, I was in the process of planning my trip to a vaccination clinic until I happened upon the detail that the FDA had only approved the boosters for people at least 6 months out. This is useful information, and I think your post would be improved by explicitly mentioning it. As it is, the only reference to six months is from the FDA Q and A, which given your opinion of them I glossed over and without context would have chalked up as arbitrary or some other tomfoolery anyway. You say you yourself are getting one in seven days, at the six months mark, but on the read through I had interpreted that as “I’ve waited long enough, I’m not waiting longer since clearly There is a War.” Because as far as I knew before 10 minutes ago, the government’s plan was still to wait 8 months.

  10. J says:

    Thanks to your ongoing efforts, my 40+ year old sibling finally got vaccinated about three weeks before getting infected by her kids. She still had it pretty bad, so I think it’s likely you saved her a trip to the hospital or worse.

    She was on the brink of getting vaccinated weeks earlier, but “That Guy” had cast enough doubt that a family member talked her out of it. So I’m glad you specifically mentioned him back then. Thanks to our civilization’s shiny new censorship machine it was maddeningly difficult to actually find good counter arguments to his claims, since we’re all supposed to just pretend bad claims don’t exist. So mostly I had to just point to the favorable evidence rather than being able to give a point by point rebuttal.

    My sister is also a needle phobe who specifically mentioned being stressed out about the mandatory photos of people getting stabbed that apparently have to accompany anything even vaguely vaccine related. So I’m sure thousands at minimum will die due to our disinterest in finishing a nasal spray vaccine or otherwise accommodating the anxious.

    And her family is fox news conservative, so all the tribal hate made it especially hard for her to take their claims seriously. She stayed up all night making her decision, and had 250 browser tabs open by the end. So people do try, and do pay attention.

    Thanks for all your efforts.

    • Matty Wacksen says:

      >Thanks to our civilization’s shiny new censorship machine it was maddeningly difficult to actually find good counter arguments to his claims, since we’re all supposed to just pretend bad claims don’t exist

      I had the same experience. I wanted to know whether the “vector vaccines alter your DNA” claims had any truth to them, given that “dna altering virus” is definitely something that exists. As far as I can tell, this is (probably) false, but it was really hard to find any evidence beyond “prof. dr. X says this is a conspiracy theory, now get your vaccine they are safe and effective ™”. It was really frustrating; I’m not surprised that many people feel like they are being tricked.

      • Viral vector COVID vaccines definitely do not alter your DNA.

        The virus used is an adenovirus (Ad26 in J&J, Ad26 and Ad5 in the Russian Sputnik, and a chimpanzee virus ChAdOx1 in AstraZeneca/Oxford). Adenoviruses are something you’re exposed to all the time. (Ok, not the chimp one. That was a bit of cleverness to use a vector virus to which you weren’t already resistant, unless you were a zookeeper who exchanged nasal fluids with chimps. I don’t want to think about that in too much detail!)

        Armed with the virus names, now you can look them up and see for yourself.

        Each of them is replication-incompetent, i.e., they infect 1 cell, 1 time, and they’re done. They cause that 1 cell to display some spike protein, which your immune system then sees, and starts generating immunity.

        The mRNA vaccines don’t alter your DNA either: first because they’re mRNA not DNA, and second because the mRNA is localized to a small bit of muscle tissue in your arm. It never escapes that tissue because (a) it doesn’t reproduce and (b) it gets cleared out by your body’s defenses in 24-48hr anyway.

        You can get much more detailed explanations by googling things like “AstraZeneca vaccine mechanism of action” and picking reliable sources.

      • Matty Wacksen says:

        Replying to @Weekend Editor:

        Yes, this is more or less what I found (eventually) also, though quite a few of the sources used weasel words like “these viruses have not been observed to replicate multiple times” or “there is no evidence to suggest they can replicate like this” etc.

        >You can get much more detailed explanations by googling things like “AstraZeneca vaccine mechanism of action” and picking reliable sources.

        This was surprisingly hard! I was hoping to find something like “here is the case for why viral vaccines could alter your dna, but this is why this is not the case for these specific viral vaccines”, but it seems like everyone was trying really hard to avoid any kind of association between “viral vaccines” and “change your dna”. Not that “virus changes your dna” is particularly unusual; I do wish that people had made the strongest case possible for it in this case and then debunked *that*.

  11. atgabara says:

    As far as I can tell, London Breed is not actually behind the mask mandate, so it’s weird to call her behavior hypocritical:
    “Looks like the mask order was issued under the authority of the San Francisco County Health Officer, an appointee of the SF Board of Supervisors, whom California law gives the authority to issue pandemic-related public health orders.” (https://twitter.com/RyanRadia/status/1440063023771648001)

    I would think it’s clear from her explanation of her behavior that she was not behind the mask mandate. I don’t know if she has any power to change it.

  12. krixus says:

    > In seven days, it will be six months since my second shot, and I will get my third.

    Any recommendations for mix and match, or would you just stick with Pfizer?

  13. Garrett says:

    War you say?

    Here’s another good one you could’ve used:

  14. Basil Marte says:

    “Everybody thinks spacing the doses out further than the initial 3-4 weeks would have resulted in better immunity, but at the cost of slowing down vaccinations. So we chose faster vaccination in the face of a pandemic, but might want to reconsider that in the future.”
    Did I miss the point where grue and bleen flipped? The US did *not* choose faster vaccination by not doing a First Doses First policy during the period when doses were scarce, even if we ignore such acts of incompetence (indistinguishable from malice) as reserving pairs of doses and keeping the second in a fridge, or stockpiling AZ doses and not doing anything with them due to lack of even emergency approval.

    • Different agencies chose different ways: Pfizer & Moderna (I think!) chose 3-4 weeks so as to get more people vaccinated quickly; the FDA & CDC chose not to do First Doses First.

      These decisions tugged in opposite directions.

      Getting multiple independent agencies to converge on a consistent solution to a coordination problem is hard under the best of circumstances, and these were not the best of circumstances.

      (And thanks for the grue/bleen thing. Haven’t seen that one in a while. I like it.)

      • Basil Marte says:

        That’s not quite what I meant. For the most part, every Western country’s agency had the same vaccines: AZ, Pfizer, Moderna, Johnson (and some approved various Russian and/or Chinese vaccines as well), and for the first several months of 2021, there were more people willing to get vaccinated than there were doses. In some countries (the examples I think I know are the UK and Hungary) the agencies said, sod the 3-4 weeks the manufacturers chose, we’re delaying the second doses until everyone who wanted to get a first shot received it. This is what “faster vaccination” physics::means in the context of vaccine doses being the bottleneck. Additionally, it symbolic::means “worse protection” to the extent that people are morons, compare the 2-4 months they spend with one dose to the “full protection” of two and complain about its inferiority, because they don’t intuitively understand the situation (probably either they don’t get that U(1)>0.5*U(0)+0.5*U(2) or they don’t get that there’s a shortage of doses). As far as I can tell, at the time nobody knew (or cared) that in the long term, first-doses-first would happen to give physics::better immunity. Anyway, the US agencies (along with several others) chose not to do first-doses-first.

  15. steeven says:

    Regarding PhDs getting vaccinated, I wonder if this is one of those times where further data shows that, actually, PhDs are avoiding vaccines. There isn’t much to do about that fact, it just seems like whether or not PhDs get vaccinated is inconsequential since there are so few of them

  16. Catweazle says:

    > There is a war to preserve or destroy our way of life.

    In May, we were just about ready to fully return to normal. The Great Unmasking was underway. In June, there was “One Last Scare”. Yet today, a stone’s throw from October, we are still stuck with masking, social distancing, any many other NPIs that seem a tad excessive for the vaccinated. Let’s not even talk about kids. In many respects we seem to be going backwards.

    I find it baffling that no-one is talking about an end game or off-ramp. Do people really assume that Covid will merrily disappear once all the deplorables have been vaxxed? Or is everybody just happy to wear masks essentially forever? Has this fabled herd immunity been observed in the real world, or is it purely hypothetical?

    Compare & contrast to Denmark, Holland, etc, My Dutch cousins tell me that masking and social distancing are now a thing of the past. Only thing left is a corona pass providing access to pubs, discos, museums etc. It’s called corona pass, not vaccine passport, because natural immunity or a negative test also gets you one. Important to avoid polarization in society, and all that.

    This may not last if hospitals get overwhelmed, but at least they have the will to get back to the old normal, and are sticking to the plan.

    Where did it all go so horribly wrong for us? Genuine question. Could it really be the low vaccination rate? That doesn’t seem to make sense – the highest vaxxed cities have the stickiest and strictest mask mandates.

    • Dave says:

      Surely the answer to your questions has a lot to do with 2,000+ casualties per day.

      Why hasn’t that happened elsewhere? I don’t really understand the reason. Perhaps the key statistic is what percentage of Americans over 70 still aren’t vaccinated. Our World in Data lists the vaccination rate for over-70 in Denmark as 99% and change. OWID doesn’t include US data on this, but Mayo Clinic says only 90% of Americans over 75 are vaccinated. That’s a big gap in the demographic where most of the dying tends to happen.

      • Dave says:

        Would be very curious to see the breakdown by age *and party.* I’m not one to blame Trump (or anything to do with politics) for vaccine hesitancy as a whole. But it wouldn’t surprise me if the 10% of 75+-year-olds who aren’t vaccinated turned out to be almost 100% MAGA.

      • Catweazle says:

        If we ever want to get back to the old normal, we’ll need immunity against severe covid. Either through vaccination or infection. The unvaccinated have made their choice, and regrettably they will do this the hard way, and a certain percentage will end up as a casualty statistic. Just like a (much smaller) percentage of the vaccinated, but that’s beside the point.

        What I don’t understand is, why do we all need to mask/social distance to slow this process down? Surely the quicker this is over with the better, as long as hospitals don’t get overwhelmed of course. Think of this as a controlled burn.

        If you’re in a blue state with a high vaxx rate and plenty of hospital capacity left, why not relax the NPIs so cases climb until say 80% of hospital capacity?

      • Dave says:

        I don’t necessarily disagree, but re hospital capacity 2 things: (1) There was a paper linked to on Marginal Revolution a year ago that found hospital crowding starts to increase the death rate of admitted people even far short of 80% full, (2) monoclonal antibodies are extremely effective and now fairly widely available, but they might start to run out well before we get to 80% full, which would also drive up the death rate.

    • Tom W says:

      American political polarization has got to the point where some people will forgo vaccination to avoid looking like Democrats, while others will religiously vaccinate and then act like the shot provides zero protection to avoid looking like Republicans.

  17. (Sorry; this comment turned longer than I’d hoped it would be!)

    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.

    Glad to hear it was useful.

    It seems we each begin from rather different priors about the FDA.

    Your FDA priors seem pretty negative, but at least they show your passion for making things better, which speaks well of you.

    My FDA priors, if I may meekly and briefly defend them at most one time and never bother you about them again, are based on spending a generation working on things that (eventually) might go before the FDA. I’ve seen the FDA make the right decision most of the time, and have some understanding from my (former) colleagues in clinical & regulatory of why things are the way they are. Not perfect, of course, and hair-tearingly frustrating sometimes. (That said, I have a few stories that would curl your hair. It’s just that the boring correct thing happens most of the time.)

    That’s distinct from the question of waning immunity over time, which I mostly consider to probably be a statistical artifact.

    At least in one Israeli dataset, it seems to have been a wicked huge instance of Simpson’s paradox. First surfaced by Jeffrey Morris at COVID-19 Data Science. If I were still teaching, this example would be the best thing to show to students on how you can get yourself wrapped around the axle if you don’t carefully check your data for confounders!

    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.

    I did a piece on the rate of vaccine waste in the US. The result more or less was that (a) we’re generously giving away a lot of vaccine already, (b) our ‘waste’ rate is about 3.4%, and (c) that’s remarkably and statistically significantly better than we’ve done in past vaccination campaigns. We’re really doing ok on that score, which is why I plan to get a booster and not worry it might be ‘taking it away’ from somebody else.

    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.

    Two small corrections: (a) it boosts antibody levels, which are just a small part of immunity (memory B-cells are what’s really interesting, but there’s no good assay for that), and (b) this is one month after dose three (not dose two).

    The Israeli data (further down the post) was even shorter-term, showing reduced confirmed infections starting 2 weeks after dose 3, cutting off at 1 month. So yeah, short-term stuff, but when you’re in a hurry all data are short-term.

    * We know a boost will work; the question is whether that’s the best thing to do versus, say, vaccinating everybody else.

    So, since that is none of your damn business, we’re done here, right?

    Not quite: the FDA is supposed to consider safety, efficacy, and degree of medical need. This would fall under the third item (admittedly, the lowest priority). If there’s low medical need, then they’ll have higher standards for safety & efficacy. If there’s high medical need (say, untreatable cancers), then they’ll pull back a bit on safety (but not efficacy).

    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.

    Probably I don’t understand what you’re trying to say here.

    I meant that we do not have data on myocarditis/pericarditis for the third shot, in the group at risk (men under 30). We do have data for the first and second shot, and you’re right that the risk with the vaccine is orders of magnitude better than getting COVID-19. The third shot will probably look like the second shot as far as heart inflammations go, but that’s an extrapolation. They’re being careful about extrapolation, probably too careful.

    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.

    I agree that this is messed up, pritnear crazy. That’s why I ranted so hard about Simpson’s paradox in the Israeli data, even going so far as to recalculate the vaccine efficacies and their confidence intervals in the different age cohorts to demonstrate it. And that’s pretty much what Jonathan Sterne’s excellent slides at the VRBPAC were about. So at some technical level they know a lot of the ‘waning’ is artifactual, but they communicate it poorly.

    When you turn that around and consider a booster shot? Suddenly the ‘risk’ is that maybe immunity isn’t waning.

    I believe here they were weighing “medical need”, mostly. They don’t want to start another vaccination campaign without need. (There is some concern with myocarditis, but that can be avoided by telling men under 30 to do something else. And pointing out that the myocarditis cases resolve successfully with treatment.) I agree with you that they’re being overly risk-averse here.

    Last time, the move from 18 years old to 16 years old got 4 no votes.

    Given how much trouble they got into last time on 16-18 year olds with poorly powered data, I just do not get why they did it again. And… if you dig in a bit, you can see that there were no 16-18 year olds in the booster trial! So they’re asking for an EUA including a population they tested poorly last time and this time did not test at all. That’s… special.

    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.

    I did some arithmetic about this. There are about 53 million Americans over 65. There are about 17-20 million healthcare workers. Possibly 100 million have complicating conditions. There’s some overlap there, but probably not huge? So that adds up to 53 + 20 + 100 = 173 million. Given a US population of 330 million, that’s 52%.

    So… why not just boost everybody, and especially encourage the old, immunocompromised, and healthcare workers to take it? I dunno. Woulda been simpler, no?

    The effectiveness is still very good, but to me the difference between 90% (or 85%!) and 98% is a really big deal.

    I believe she’s looking at the error bars on the efficacies, which indicate the difference was not statistically significant between the pre-Delta and Delta patients.

    We somehow need to keep saying this over and over, but a reminder:

    Yeah. The miscarriage/infertility thing makes me tear my hair out. I wrote a piece on COVID-19 vaccines and fertility because people kept asking me about it, and I just wanted to be able to hand them something. Turns out the conspiracy theory is because some idiot doesn’t know how to run BLASTP, and thought a 4 amino acid sequence was significant.

    The Chris Rock Probably Cannot Smell What Anyone Is Cooking, Because He Has Covid-19

    Wow. I agree that people can and will interpret this differently. I’m a decent scientist, but a terrible science communicator. Talking to the public about this is like walking in a minefield.

    Just to wrap up the news with a conclusion, today’s ACIP meeting decided booster shots in 4 groups:

    1. Age > 65yr or LTCF residents? Passed: 15-0.

    2. Age 50-64yr with underlying conditions? Passed: 13-2.

    3. Age 18-49yr with underlying conditions? Passed: 9-6.

    4. Age 18-64yr in occupational/institutional high risk setting? Failed: 6-9.

    • TheZvi says:

      Thanks for this, very constructive throughout especially where we disagree. It’s an interesting part of this that we agree the Israeli data is hopelessly confounded, the difference is that I think there’s plenty of other evidence that can substitute in the job. You can imagine what I think of the CDC’s votes, and their ‘worries about complexity’ right before disagreeing with the FDA which totally won’t confuse people way more. The quotes like ‘why not just give everyone a booster then?’ make me react in exactly the way you’d think. You ask it with the obviously correct implication that yes we should do that, the CDC guy asked it as in ‘the horror the horror.’ People might get medicine! Can’t have that. Also, as others have noted, I don’t understand what happens now in practice, in terms of the FDA and CDC disagreeing.

      The asking for 16 year olds thing, I would argue strongly that they’re right from a Bayesian or theoretical perspective (e.g. if you want to place a bet on whether there’s a reason a 16yo shouldn’t get a booster but an 18yo should that involves some sort of break point, I’d happily take your action) but it was obviously deeply stupid strategically and I share your frustration there. But an FDA that was on our side would, I would think, basically say “oh that was stupid can we please just vote on 18 instead of 16 given everyone’s in a huff about this?” even if they think 18 is magic.

      The medical need thing is clarifying to exactly how they’re justifying that things they think should overrule our entire lives suddenly shouldn’t matter because the need isn’t sufficiently ‘medical’ for them, and that’s the place I simply can’t even. Need is need, and the booster would pass a ‘medical need’ test in my book purely for its mental health benefits alone even if you don’t count the ‘nonmedical’ obvious huge benefits.

      Also, since when is reducing infectiousness in a pandemic not a rather large medical need?

      If I had to guess, the big crux over the FDA is that you take the system and its logic as givens, and see the FDA making good decisions given they’ve already decided what counts as acceptable data and what people need to do before it’s considered sufficient and what kind of burden of evidence is necessary to allow things, etc. And you’re not looking at (or focusing on) all the extra drugs that never got tested or approved at all because it was too expensive or impossible to do that, as a result, or all the delays, etc, the ‘invisible graveyard’ effect. Whereas I’m saying, there’s your problem right there.

      I’m also furious about the FDA treating “should we let people do X?” be answered by asking “should we start an X campaign to do X everywhere we can?” which sounds a lot like they’re taking the role of the executive and very much abusing their authority to make political decisions, and telling people they can’t have medicine because if they allowed it others might do things the FDA doesn’t approve of with that, so YOU can’t protect yourself.

      And Covid has driven home time and again how much this sabotage costs us, with the delays in testing and vaccination and treatments and all that, but if anything they’re being unusually reasonable about the whole thing, and the default situation is way worse.

      I can (weakly) buy that the FDA is doing a very good job of “being the FDA” and within their philosophical framework that letting people have medicine or choose whether to have it is their least favorite thing and should only be done when someone spends a billion dollars and there are absolutely no problems and all the evidence is in the official correct forms etc. That, once you accept that premise, they do a good job of analyzing the data they do have the way a jury is tasked to analyzes exactly the information they’re allowed to see, and that they then apply their principles reasonably (although in no way that reflects cost-benefit analysis for patients, but that’s outside their framework).

      In that context, I’m curious what you think happened with Aduhelm, since that seems to be the FDA making the kind of error you think it rarely makes.

      I’d also ask, the FDA either (and it’s not clear to me which one they did) (A) accepted the Israeli data as strong evidence of things that we both agree it shouldn’t be used for because of the Simpson’s Paradox issues and other statistical concerns OR they (B) didn’t do that but used evidence they weren’t officially considering to conclude things that are indeed true for epistemically good reasons, but violated the principle that they don’t do that, which makes it weird they didn’t do that in other places, so I’m curious how this went. If they accepted the Israeli data then that raises the question of whether they actually are good at examining such data – similarly, the CDC made some very boneheaded errors over the last few months.

      In terms of whether the FDA mostly makes right decisions, let’s say that we’re in the world where they make consistent decisions that properly examine the data they consider at the time and the rules they operate under. Does that make their decisions right? Does that mean that it should be this difficult and expensive to allow people access to medicines? That we wouldn’t be better off in an alternative regime? That the FDA’s net effect on a given potential drug, starting from when someone discovers it (and potentially starting when someone is deciding whether to look for new drugs at all) is mostly making the right decisions and getting the right results? In general, not regarding Covid. I’m curious which bullets are being bitten.

      The thing where the measurements were ‘inside margin of error’ therefore there weren’t big differences, isn’t that not how any of that works? A lack of significance there merely means that the data was underpowered, and the patterns involved seemed very clear and the effect sizes quite large – and her statement definitely gives a very misleading impression. I’d like us to be smarter than frequentism on such matters. Is this view less naive than it sounds when you described it?

      In terms of this:
      I meant that we do not have data on myocarditis/pericarditis for the third shot, in the group at risk (men under 30). We do have data for the first and second shot, and you’re right that the risk with the vaccine is orders of magnitude better than getting COVID-19. The third shot will probably look like the second shot as far as heart inflammations go, but that’s an extrapolation. They’re being careful about extrapolation, probably too careful.

      I feel like this is 90% an isolated demand for rigor and 9.9% an isolated demand for safety (which should probably be a thing/post too now that I type that) and maybe 0.1% anything else? I get the technical argument that we ‘don’t have data’ but here’s some things I expect you to agree we do know.

      1. The risk here, for shots one and two, is orders of magnitude below the risk level where, if the third shot was as risky on this as shot two, we would want to avoid giving young men booster shots (except perhaps in cases where they had a pre-existing condition that moved the needle by orders of magnitude).
      2. Our prior on the third dose makes it unlikely that side effects would be much worse than dose two, before we gather any data on it.
      3. We have given the third dose to lot of people, and their side effects from shot three are comparable or somewhat less bad than shot two (although none of them involve young men under 30) and involve zero cases of the thing we’re worried about (although it’s so rare in the populations it was given to you wouldn’t expect any).
      4. Our prior that other side effects don’t get any worse, but this particular one is going to go up by orders of magnitude, should be very, very low, and if it did happen we’d notice a lot of confusion about why.
      5. Technically we also have no data about a lot of other things that *could* go wrong, but almost certainly won’t.
      6. People are if anything way overly paranoid about this already and could make the choice to forgo the third shot if they want to.

      At which point, I don’t buy that this is a situation in which I have useful uncertainty about the situation. Yeah, it’s ‘extrapolation’ but I take that about as seriously as a philosopher telling me I can’t do induction. Or to put it another way, eventually we will find out whether this is a problem. How likely is it we’ll find one? What would a prediction market say? At what odds would you be willing to make a bet that there’s an issue here? Would you take 10 to 1? 100 to 1? 1000 to 1? Of course, I don’t think we actually disagree here much, and your prior isn’t that different from mine that in physical terms the concern is bogus.

      Anyway, getting late, but thanks again for all your work and for engaging seriously.

      • The quotes like ‘why not just give everyone a booster then?’ make me react in exactly the way you’d think. You ask it with the obviously correct implication that yes we should do that, the CDC guy asked it as in ‘the horror the horror.’

        Probably they’re worrying about medical need, again. If you vaccinate a lot of people who don’t need it, the anti-vax activists will use that to undermine the effort. Maddeningly enough.

        Also, the people on these committees are not just researchers but also clinicians with lots of experience. They’ve seen things go very, very badly from recklessly applied medical treatments. So they’re more cautious than you and me. Whether they’re too cautious is a question I’m not competent to answer, so I try not to have an opinion on it. ([Scott’s Razor](https://astralcodexten.substack.com/p/open-thread-164): “a level of complexity where I no longer feel comfortable having an opinion on it”.)

        The asking for 16 year olds thing, I would argue strongly that they’re right from a Bayesian or theoretical perspective (e.g. if you want to place a bet on whether there’s a reason a 16yo shouldn’t get a booster but an 18yo should that involves some sort of break point, I’d happily take your action) but it was obviously deeply stupid strategically and I share your frustration there.

        I’m not the betting sort. (Another difference between us, which at least I find pretty entertaining.)

        The 16-18 year old thing probably comes from having to draw a line somewhere for pediatrics. Children are not just small adults, they’re really quite different. The geezer dose of flu vaccine that I got would whallop a young kid so hard it would be dangerous. Doses have to be scaled by more than just body mass, but by immune system stage of development, bone mass, circulatory system area (hence doses quoted in peculiar units like mg/m^2), and so on.

        Hence, the invention of pediatrics. We have to draw a line somewhere, and it happened to be 18. So the exact line is a historical accident, but the need to have docs who specialize in kids is a biological fact. Sure, there’s a continuum, but we drew the line at 18 and that’s the world we live in and for which docs train.

        I dunno how to do better here, either. (I seem to be saying that a lot lately.)

        The medical need thing is clarifying to exactly how they’re justifying that things they think should overrule our entire lives…

        It is true that they tend to take a narrow view of the issue before them. That can be either good or bad.

        And you’re not looking at (or focusing on) all the extra drugs that never got tested or approved at all because it was too expensive or impossible to do that, as a result, or all the delays, etc, the ‘invisible graveyard’ effect. Whereas I’m saying, there’s your problem right there.

        *laughing happily* Oh, trust me: I’ve worked on many of those molecules in the not-so-invisible graveyard! So I know exactly what it’s like to fail that way, and paid a lot of attention to it. Some things failed at the FDA level, many more failed when management chickened out and wouldn’t even go to the FDA, and still more failed when we had a good research program but the clinical people wouldn’t believe it enough to start a trial.

        So I’m painfully aware of that, to the point of having scars. I worked on stuff that got all the way through maybe twice in my whole career. The failure rate of pipeline molecules is enormous, and a constant source of worry. At one employer, we even paid big bonuses to anybody who could make a project fail earlier, to save the time, trouble, and expense of going further.

        … should only be done when someone spends a billion dollars and there are absolutely no problems and all the evidence is in the official correct forms etc.

        (Emphasis added.)

        A sad fact, tangential to your argument: if you look at the resources that go into drug research, development, & regulatory submission and divide by the number of approved drugs, the answer is very much not pretty. It takes 10 years, a billion dollars, and a couple hundred PhD’s, MD’s and lawyers on average to get a new drug all the way through. This trend has gotten steadily worse since the 1950s, despite much regulatory reform and enormous scientific and technological progress. There was a scary paper in Nature Reviews Drug Discovery showing this a couple years ago. It’s even higher now.

        In that context, I’m curious what you think happened with Aduhelm, since that seems to be the FDA making the kind of error you think it rarely makes.

        I hope it’s no surprise to you that I think they screwed up there? I mean, it does happen…

        Aducanamab does what it says on the box: it reduces or even eliminates beta amyloid plaques. Unfortunately, so do other drug candidates that don’t move the needle on symptoms. Aducanumab had one trial stopped “for futility” and another that showed maybe a small effect if you jiggered the statistics.

        So the FDA approved it, apparently hoping to find an efficacy in a larger population post-approval. They gave Biogen several years to do this, and most of us predict Biogen will take every single day of that time to collect revenue.

        Also, Derek Lowe, a med-chem blogger whom I seriously admire and trust, pointed out some news about some underhanded meetings between a Biogen exec and an FDA official in the Office of Neuroscience. That’s not supposed to happen, and is supposed to be reported when it does.

        Here’s [Derek reacting to the initial approval](https://www.science.org/content/blog-post/aducanumab-approval), and I agree with him that efficacy was not demonstrated.

        The result is several people resigned in protest, and there’s an internal investigation in progress. It was really that bad.

        … the FDA either… (A) accepted the Israeli data as strong evidence of things that we both agree it shouldn’t be used for because of the Simpson’s Paradox issues and other statistical concerns OR they (B) didn’t do that but used evidence they weren’t officially considering to conclude things that are indeed true for epistemically good reasons, but violated the principle that they don’t do that…

        I really don’t know.

        I do remember that in Helen Branswell’s live-blogging, she said the Sterne presentation on misleading artifacts confounding VE was delivered in such a soft voice she thought people might not pay attention. In theory that shouldn’t matter, but in practice it does. (“In theory, theory and practice are the same, but in practice they’re different.”)

        In terms of whether the FDA mostly makes right decisions, let’s say that we’re in the world where they make consistent decisions that properly examine the data they consider at the time and the rules they operate under. Does that make their decisions right?

        One can consider counterfactual worlds in which the FDA and CDC are replaced by something else. Again, I don’t think I’m competent to have much of an opinion about that. It’s a heavy lift, though.

        The thing where the measurements were ‘inside margin of error’ therefore there weren’t big differences, isn’t that not how any of that works?

        That’s pretty much how it works. (Whether Bayesian or frequentist, either way.)

        Statistical significance tells you whether what you’re seeing in the data is real: would it likely reproduce if you did the experiment again?

        Strength of effect tells you, given that you believe the effect is real, is it big enough to make a difference when you use it?

        And it’s in that order. I’ve seen plenty of datasets that have large effect sizes about which people were excited, but low significance… and they didn’t reproduce when the experiment was tried again. Tons of such examples.

        A third stage after significance and strength, is of course [Goodhart’s law](https://en.wikipedia.org/wiki/Goodhart%27s_law), which probably kills all manner of projects that we don’t hear about. Something that works in cell culture fails in animal studies because the rest of the body compensates, for example.

        I feel like this is 90% an isolated demand for rigor and 9.9% an isolated demand for safety (which should probably be a thing/post too now that I type that) and maybe 0.1% anything else?

        I’m tempted to reply that it’s not isolated, because they do this all the time. But while amusing, that runs the risk of sounding too saracastic; so I beg your pardon for letting that joke slip past my filters.

        I simply meant that we really don’t know the side-effects a third shot in the population of younger males who are at risk for myocarditis. (The Israelis vaccinated eldest first, and didn’t sample young males well. So their low rate might not mean much. In the US, we haven’t given many third shots yet, especially to men under 30 where the worrisome spot is.) The myocarditis risk was nonzero enough with the 2nd shot to cause some worry, and we were very fortunate that nobody “paused” the mRNA vaccines like they did to J&J. (Dodged a bullet there!)

        It’s probable that it’s a bit worse than the 2nd shot here (that’s my prior: stronger innate immune reactions with each subsequent shot, culminating in ugly [antibody-dependent enhancement](https://en.wikipedia.org/wiki/Antibody-dependent_enhancement)). Absent measurements, we all worry about that.

        We could, of course, hold off on boosting young men until we can run a quick trial where they’d be supervised for cardiac risks and kept safe for a couple weeks. I’m slightly sad that that’s probably not gonna happen.

        Yeah, it’s ‘extrapolation’ but I take that about as seriously as a philosopher telling me I can’t do induction.

        Side note: this was hilarious!

  18. H.P. says:

    The CDC advisors have made their own recommendations that are different in many respects than the FDA decision. Most of the reasons mentioned, of course, have little to do with science or the specific question at hand. They are concerned with complexity but not apparently worried about coming to a different conclusion than the FDA. Speaking of confusion, the articles I’ve read have left me completely in the dark as to the legal effect of the CDC advisors’ decision.
    https://www.cnn.com/2021/09/23/health/pfizer-acip-booster-recommendation/index.html

  19. stlisi says:

    This is a minor point, but schools in the South start in early August.

  20. It’s actually the Centers for Disease Control, plural.

    Except… today I learned it’s *actually* actually the Centers for Disease Control and Prevention, and that all of these names (and more) have been correct at different times in its history! See the infobox on https://en.wikipedia.org/wiki/Centers_for_Disease_Control_and_Prevention for the history.

  21. Emb says:

    I suspect you’ve already seen it, but I hope it makes it to next week’s update:

    The kids are alright

  22. q says:

    Assuming I’m interpreting your Simpson’s paradox parenthetical correctly: the Kaiser study does not suffer from Simpson’s paradox issues. They write “Adjusted VE” in that slide — and in the paper they do describe that they adjust for a number of confounders (including age) in their model, which avoids Simpson’s paradox (at least for those confounders).

    I do not think differential undocumented infection is big enough to explain waning in the various studies, as e.g. in Israel I think immunity appeared to lower for earlier than later vaccinators even when there were few cases in between their vaccination times.

    The level of skepticism seems fair, but I do not really understand where the conviction that waning is not happening comes from (reports from hospitals, or even state governments, about how absurdly full of only unvaccinated their hospital is seem unreliable; no reliable national count of breakthroughs [or even breakthrough hospitalizations really — the CDC number isn’t consistent with state reports] even exists). I have not closely looked at and don’t know how to interpret the PHE UK data, but it did not seem like clearly contradictory to Israel.

    If the issue is inconsistency with trials, the trials showed very strong protection from just 1 dose of mRNA, but now everyone seems to agree that 1 dose gives you rather weak protection (from https://www.nejm.org/doi/full/10.1056/nejmoa2108891). I am curious how that consensus was reached.

  23. Matty Wacksen says:

    >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

    Given that I know someone who was in hospital after being vaccinated who does not fit this profile, I am no longer sure this is true (I am being intentionally vague to preserve some anonymity).

    >Do boosters clearly work? Yes.

    The question isn’t whether they “work”, it’s whether or not they pass a cost-benefit test. And both “cost” and “benefit” are poorly defined here. Your usual “let’s consider the marginal cost of a single infection” doesn’t work when considering a population-wide recommendation/mandate. I mean “vaccines are safe and effective” has been a nice meme, but I think I’m being entirely uncontroversial in saying that (a) serious side effects beyond pain at the injection side have been more common than expected initially and (b) seem to get worse at dose 2 compared to dose 1, extrapolate if you wish.

    >There. Is. A. War.

    I believe there are multiple “wars”, there’s one on drugs and one on terror; I guess we can add whatever this new war is to the list. Personally, I’m in favour of dropping the violent analogy but I guess a state of permanent emergency is neccessary to justify coercive measures.

  24. AnonCo says:

    >There is a war.

    So when do we update from: “Vaccine Mandates will not be a slippery slope of authoritarianism, vaccines mandates will be a freedom-preserving substitute for other more draconian measures”

    If not the FDA and CDC, who exactly will be coming along and allowing us to get rid of theses other worse but pointless measures?

    Any day now….

    The beatings will continue until morale improves.

    (Sorry, I’m going to keep beating this drum – I don’t expect you to respond :)

  25. Asdf says:

    If vaccination could end NPIs, we would see a correlation between vaccination and ending NPIs.

    Instead we see the opposite. The places with the worst NPIs have the highest vax rates.

    The one possible exception is children, but unvaccinated children are safer then most vaccinated adults, so getting them the vaccine won’t change their risk profile.

    Ending NPIs means ending COVID hysteria. COVID hysteria OBVIOUSLY is not driven by actual risk levels, so this idea that boosters or anything else will change the mood is silly.

    Some people say that restrictions lifted over the summer, but not really. Not for people in school. Not for most service workers. Not for anyone on public transit. Not for many people in a government building. Not for many people working for large companies. Not for anyone in a blue area for all but the briefest of moments.

    Stop bargaining with these psychopaths.

    I ask only one question at this point. Who is telling me what to do? The unvaccinated are not telling me what to do. The vaxxed are. The unvaxxed have and endgame….leaving other people alone. The vaxxed, at least the ones obsessed with whether others are vaccinated, have no endgame.

    And no the hospitals near me are not and have never come close to reaching icu capacity throughout the pandemic, and even if they did I’ve been to the hospital and they could always clear up space by dumping some drug addicts or gangbangers on the street.

    I got my shot and I want to be left alone. I don’t want to be compelled to forever boosters and forever NPIs. Don’t give those people and inch.

    • natesmithny says:

      Britain. High vax rate, consequently low NPI rate. Had a high case rate but far lower per capital deaths than the US.

      Btw I’m not telling anything about what you should do. Do you. I’m not judging.

  26. Orion says:

    I notice that I am confused about why the FDA needs to approve a booster shot for Comirnaty. Comirnaty is an FDA-approved drug now, right? With a brand-name and everything. Doesn’t that mean doctors can already prescribe it “off-label” for nonstandard uses and dosages?

    • Docs who prescribe off-label (mostly) face increased exposure to malpractice suits if anything goes wrong. So if you want a lot of docs to do something, it has to be accepted practice.

      It’s one of those irritating things where you have to work the system and know its quirks to make things happen, rather than just expecting people to Do The Right Thing. It’s not ideal, but it’s where we are.

  27. natesmithny says:

    I got a booster by pretending it was my first dose. If people want boosters, they should lie.

    This is the first time I’ve disagreed with the zvi, but I think for certain cohorts the risk of a third dose (tiny) needs to be matched against the risk from covid (also tiny, for certain vaccinated age groups). The fact that the CDC wants to tread lightly around that is fine with me.

    I think people should be allowed to get boosters, but not mandated. Bear in mind, many employers and schools have said if the CDC recommends boosters, they’ll Mandate them, regardless of age or prior covid infection.

  28. Anopn says:

    Let’s assume there is a war and the FDA must be destroyed. How would you destroy the FDA?

    If this was a game and your win condition was to actually destroy the FDA, what strategy would you employ to maximize your chances of winning the game?

  29. Got my booster this morning! Modest side-effects so far, just a bit tired.

  30. J says:

    Seeing some family get reinfected recently after about a year despite also being vaxxed in the interim. Have we talked recently about what the course of treatment should be for people who test positive? I get the feeling that most docs will just ignore you by default unless you need hospitalization.

    • TheZvi says:

      That’s basically right. If the case is mild docs will mostly tell you to isolate until it goes away, and none of what follows is medical advice, etc. My understanding at this point is you should megadose Vitamin D at that point (cause its a free action) and take zinc (also free), and depending on how you’re feeling consider fluvoxamine (although that’s NOT a free action, it has side effects), and otherwise take it easy and treat symptoms only unless things get worse, and that’s good enough for the vast majority of cases especially for vaccinated/reinfected people.

      • Brett Bellmore says:

        Honestly, you should probably already be taking the Vitamin D and Zinc. Taking it once you’re symptomatic is kind of like going out to buy a fire extinguisher after your house catches fire.

        I credit the fact that I had a mild case despite being 62 and overweight, with a history of lung problems, to having started the D and Zinc at least a month prior.

      • TheZvi says:

        Confirming that I agree with Brett that people should likely be taking D and Zinc anyway, but I do think it also matters a non-trivial amount in the endgame.

  31. J&J Buendia says:

    A close relative of mine got the J&J vaccine back in March. I almost advised them to wait it out and get a different shot, but when they asked for advice I gave them the mainstream opinion at the time which was to get whatever shot they were first offered. With how things have played out, I highly regret having given that advice.

    They are in a category that would now be officially approved for a booster if they’d gotten the Pfizer to start with. They are now considering two options:

    (1) get a Pfizer shot anyway.

    (2) get a second J&J shot.

    Neither option is 100% approved, but likely both would be easy to do in practice. The advantage I see to the J&J option is that a second J&J shot is likely to be approved eventually as a booster for those who got J&J to begin with. So if they go with option 2, they will be on an “officially approved” path as long as no one looks closely at the dates. I don’t have any intrinsic respect for “official approval” in this case, but it could have some instrumental value in talking to doctors in the future or something, I don’t know.

    Does anyone here have a reason to think that (1) or (2) would be clearly better for either medical reality reasons, or bureaucratic reality reasons?

    • TheZvi says:

      My prior is that the mRNA shot is better because mix-and-match is better but that both would work fine. I doubt the ‘official approval’ question will matter but there’s some chance it will matter, I guess. I’d get the Pfizer shot (and if the official approval shot comes back I’d just go get a 3rd shot at that point to fix it) but that’s not medical advice etc.

  32. J says:

    I did some research yesterday on behalf of older friends who took J&J. Pharmacies are indeed toeing the official line and saying there aren’t any second doses on offer for such souls.

    It looks pretty easy to schedule a “first” or “second” dose on big pharmacy websites like CVS. I’m not sure if the pharmacists re-ask the questions in person; if not, then getting the dose looks like mainly a matter of selecting the right boxes on the website. If so, then people might get asked in person if they’ve ever had a covid vax before, and would have to decide how to answer. They might also get asked for their vax card, which they might not want to have on them. I don’t like fibbing, so while this looks like the most straightforward approach, I’m hesitant to recommend it.

    I hear things about walk-in vaccination events; not sure if those are no-questions-asked or not.

    Anybody have any experience with those first two options?

    I also tried the most-clearly-approved approach of looking for a doctor that would prescribe a Pfizer dose. The receptionist at the clinic seemed confused that I would even ask and said that no, the doctor doesn’t prescribe covid vaccines. (headdesk.jpg). Maddeningly, the government keeps saying menacing things about doctors using the permission they were just granted by that same government. But there must be doctors out there willing to do the sane thing, possibly even without the patient presenting in person. (This also seems like a handy way for them to get paid for some really easy televisits). So I’m still looking for such a person. (I was a little surprised not to turn up a bunch on google, but that is already known not to be an unbiased reflection of the internet).

    • Walk in clinics truly are “no questions asked,” at least from my experience. If you come in and say you’re unvaccinated, they’ll set you right up. If you don’t volunteer your insurance they’ll probably only ask for ID. And they only even ask that for making a record of your current appointment, they aren’t going to cross reference it with any other data.

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