Has anybody else noticed the total fragmentation of the “IDW/alt middle” ecosystem over this? I can now get pilloried for advocating vaccine passports by the very same people who came to my aid last summer when I was criticizing wokeness. And some of the very same people who called me a conspiracy theorist last year when I wondered why we weren’t looking into the institute of virology, now agree with me about vaccines.
Food for thought for people that are saying that Matt and others should be patient with the FDA: check out the history with Act Up. Non-scientists can make valid rational contributions to science and to things like the FDA process, and open-minded scientists (which is most scientists in my experience) are glad to listen. People complaining is how a bureaucracy learns that the population wants something.
I think this is an important point, in principle. Insiders have the benefit of understanding the nuances of the system and why it operates the way it does, which may not be clear to outsiders. Often times, many outsider ideas have been fully considered and rejected for good reasons. But insiders can also be prone to institutional inertia and shackled by uninterrogated assumptions. Outsiders can bring valuable perspective that forces insiders to reassess how and why they do things.
All that said, I haven’t seen any real substantive engagement with the FDA process here. What are the steps before final approval? Why would it be prudent or not to accelerate them? A lot of the discussion here seems to be taking place in a vacuum. Despite proclaiming to understand the process, nothing in MY’s post actually discusses the process per se - what stage they are in, in terms of data collection and analysis, the purpose of those parts of the process, etc.
My thoughts are this. I do not know the whole FDA process. I don't have to know it to make comments. I see that over 3,600,000,000 (3.6 billion doses) have been given world wide. The data exists but apparently is not in the correct format. It's just like the question, "Can kids 11 years and 11 months old take a vaccine?" We are waiting for a phase 3 with less than 4,000 11-year olds in it when we could look at the results of 2 million 12-year olds in just the US (more worldwide). I don't know enough to say what changes should be made but I am quite convinced that changes should be made.
It's awesome that these vaccines were developed so quickly, but I have some misgivings about society only reopening because of high vaccination rates. There is a kind of unanswered question lingering now: if not for the vaccine, what would we have done? Would schools ever have reopened?
A year ago people were saying, what can we do to live with this thing? Which is an important conversation, because novel infectious diseases are not really all that uncommon.
Next time around it might take a decade to develop a vaccine. And we will not have answered pretty fundamental questions about the appropriate roles of government, private businesses, and individuals when this sort of thing happens.
On the WHO's VigiAccess database (https://www.vigiaccess.org) which describes itself as the "WHO Collaborating Center for International Drug Monitoring", if you search for "covid-19 vaccines" (https://www.vigiaccess.org), it says there have been over 1.4 million adverse reactions to the vaccines including 650k nervous system disorders, 50k blood/lymphatic disorders, 50k eye disorders, etc. If you rerun the search for "ibuprofen" and "Acetaminophen" you're find 150k adverse reactions presumably since 1992 (Ivermectin has only 5500 adverse reactions). So if you want to know why the vaccines are not being officially approved, go search https://www.vigiaccess.org and have a look at those 1.4 million adverse reactions to the vaccines.
One "market" idea I've been toying with is letting insurers charge an actuarial Covid premium to unvaccinated customers. This would at least shift some of the costs to persons choosing not to get vaccinated while keeping the government out of loop (other than rule making).
Matt left out the even BETTER news. A vaccinated person is MUCH let likely to transmit COVID 19 to another person, both because they are unlikely to become infected themselves AND, even if infected, their viral load is less.
And mandates are better justified (only justified?) by the reduced risk that the vaccinated person poses to others.
This take does nothing to engage with the fact that the FDA has approved drugs in the past (Vioxx, DES, etc.) then turned out to be public health disasters. If the process as-is cannot guarantee long term outcomes, the FDA is rightly reluctant to short-circuit it. To ask them to arbitrarily skip the process on the basis of "the scientific community's actual understanding and attitude" is just glib. What about the next cancer drug? Should that get special treatment too? What if the "scientific community" has a great "attitude" about it? Isn't cancer a crisis that should cause us to not be "fussy?" Those aren't rhetorical questions, either. Eventually the FDA would have to answer that question, for some drug, and maybe in federal court. This is an institution that is constantly under pressure from giant corporations and desperate patients, as the Biogen situation shows. They have to have rules and they have to follow them. If your rules don't hold up in a crisis, then they aren't rules at all. Damaging the institutional integrity of the FDA is not worth the specious rhetorical value of "full" authorization.
Worse, final FDA approval would mean the end of data testing and review. So we would never know if the vaccines really were safe. And never mind the liability issues the makers might face if FDA just gave up on normal authorization.
What the FDA is doing right now is the slow boring of hard boards. This post drives me crazy.
I'm sympathetic to this argument, but well over 300 million doses have already been administered in the United States. So, if "disastrous" problems with these vaccines are a worry, that horse has already left the barn (and EUA shouldn't have been granted in the first place).
The risks for the Pfizer vaccine compared to, say, Vioxx are in different universes. Vaccines are composed of fairly normal biological molecules, which engage with the cell in relatively predictable ways and are eventually degraded, often within hours but certainly days at most (for mRNA). Small-molecule drugs are designed to bind to a target protein and cause (or prevent) some conformational change, thereby impacting its function. The potential problems are at least two-fold: (1) the small molecule could also bind to one of the thousands of other proteins it encounters while in the body, causing an unanticipated effect and (2) repeated dosing in which even just the target protein's function is altered for such a long time may have other unintended effects.
On top of all that, the risks of Vioxx appear to have been known well before it was finally pulled from the market. From Wikipedia: "The Lancet published an editorial which condemned both Merck and the FDA for the continued availability of rofecoxib from 2000 until the recall [in 2004]." So it was, in fact, the slow-moving regulatory bureaucracy that failed to recognize and respond to growing signs of risk!
Short answer: the rules must exist for a reason, and it would be good to understand what the trade-offs are *for each case* rather than reflexively deferring to them.
It's not a rule if you determine case-by-case if you're going to follow it. That's the thing with rules: you do reflexively defer to them.
I can't comment intelligently on vaccines versus "small-molecule drugs" but I do know that mistakes during the polio vaccine rollout mistakenly gave a couple hundred thousand kids polio. It just seems to me that you're starting where you should end: that the vaccines should get final authorization because they're safe. They probably are, but to rush that just to get the at best arguable benefit of being able to say they are finally approved--it's not worth it.
The polio vaccine used inactivated or attenuated virus. The risks for that are a bit higher, as they can potentially revert to an infectious form. An mRNA wrapped up in an LNP will never become infectious no matter what.
> It's not a rule if you determine case-by-case if you're going to follow it. That's the thing with rules: you do reflexively defer to them.
Sure, sometimes we should defer because we don't have sufficient knowledge and/or experience to know the bounds that the rule effectively operates in. But those who made the rules should know this and be able to adjust when called for (as it all but certainly is now).
If there were a new cancer drug that showed broad promise against all cancers so that it could possibly reduce the 600,000 annual cancer deaths to 400,000, then absolutely they should be giving it the same sort of emergency special treatment. I don't believe there has been any advance against cancer that is anywhere near that significant in many decades, if ever.
This isn't really responsive. I'm not saying the vaccines should not get EUA treatment, nor am I saying your hypothetical cancer therapy shouldn't get EUA. I'm saying we wouldn't want to suspend the approval process entirely and just skip testing because things are looking good.
And anyway, any halfway decent lobbying campaign is going to be able to drum up the "broad promise" of a new therapy and the FDA will constantly be having to decide who gets special treatment, then the lawsuits from competing drug makers will come, then the approval process will get tied up in the courts so it takes even longer.
The military probably presumed that the FDA approval was weeks away when it said it was waiting for FDA approval. This FDA delay is outrageous.
Regarding youngsters, if I had a 10 or 11 year old, would I rather wait to see the Phase 3 with a few thousand of each of those ages in it? Or would I prefer to see the safety results on the 2 million 12 year olds who are already vaccinated? Data on 2 million 12 year olds is much more likely to show any safety concerns. It should be approved for the 10 and 11 year olds already and the data from their usage should be considered for the next tier of kids.
So the statistic I most want to see right now (and if you could find the people to give a decent estimate I'd consider it a major "service journalism" coup), is:
For various age / health condition buckets, given that a person is vaccinated, but they get a breakthrough infection from Delta or a similar aggressive variant, what is the chance they experience long-term health effects?
Because some of the anecdata is scary. I have an acquaintance who got infected _after_ being vaccinated, back around early April. She's ended up with heart and lung problems that leave her fatigued from just walking around for an hour or two, as well as migraines and brain fogs. She's basically not able to work or take care of her kids.
This has (as you might imagine) freaked me out a bit, and left me wondering whether maybe I _shouldn't_ be acting as blase as I had been. I went out to see Black Widow, and I've been going to the gym. If you told me that by acting this way, there is a 100% chance that at some point in the next year I'll get infected and have a really shitty week or two, and then be fine, I'd respond: cool, I'm down for that. The anti-lockdown arguments from last year make sense in that context. But if there's like a 2-3% chance that the shitty week is followed by a _lifetime_ of reduced heart, lung, and brain function? At that point I start to wonder if I should just steel myself for another six months of lockdown.
Going to start wearing a second N95 at home after reading this. i've gotten each vaccine (gotta catch em all, right?) but still. who knows what could happen?
Sure, part of the problem is simply time, but we should be at the point where we are just beginning to have a set of people from the earliest cohorts who got vaccinated (healthcare and other essential workers -- my friend who's in this category works in healthcare) who (a) got infected post-vax, and (b) either did or did not develop follow-up problems that lasted more than a month or two. Surely we have at least a few hundred examples by now of people in their 30s to 50s who got infected post-vax? It's just a question of whether we're capturing the data in a useful way.
The sample size obviously will rise over time -- and that will happen faster if Delta continues its rampant spread. :-/
I agree with you. I hope someone is trying to capture data like that too.
I shouldn't have made light of your comment.
What I had in mind when I read "long term" is something like shingles coming decades later yet due to childhood chicken pox. In that sense, I personally prefer to roll the dice on potential long term effects of vaccines, and not on actual covid.
Oh, I'm vaccinated -- I'm part of the Pfizer Pfam. I got the vaccine as soon as I was legally able to.
What I'm wrestling with is whether I should now resume basically all of my normal activities from the Before Times, or whether a breakthrough infection is still enough of a danger that I ought to be at least _somewhat_ more cautious than that. My spouse and I went to the goth club where we met to celebrate the anniversary of our first date, a couple weeks ago; now I'm not sure whether that was maybe a riskier thing to do than was sensible.
I got Moderna when they called. For me, for now, we're back to three quarter speed. My activities are mostly outdoors anyway (hiking, golf, skiing). I prefer dining outdoors. Seeing friends in smaller groups. Seeing family. The concert I'd love to go see again is Gogol Bordello, but I'm not mentally ready for a crowd like that yet. I could live like this for a couple of years, yet hoping that the data comes out sooner!
Also, specifically on the point of statistical power, if in fact breakthrough cases leading to symptoms lasting for month are as rare as I think they are, you'd expect that in a sample of hundreds to low thousands, you'd have a small enough number of those cases that it would be quite difficult to estimate the exact ratio, other than just saying "small".
But if the true ratio is closer to ten percent, then even hundreds of breakthroughs should be sufficient to start noticing it.
So I think on the question of "is this a big or small risk", we probably _do_ have enough cases out there to make a reasonably intelligent judgment -- _if_ we'd been following up on hundreds of thousands of people, in order to track down the hundreds or thousands of breakthroughs, and then following up on them to determine how bad the breakthroughs were.
I hadn't seen that, although I have been following Zeynep Tufekci for a while, I think originally because Ezra Klein recommended one of her takes from very early on in the pandemic.
And yeah, I appreciate the point she's making, and the point that Matt has made that the mRNA vaccines are _really really good_. It seems like the rate of breakthrough cases that are noticed at all is quite low, and then I _think_ that among those breakthrough cases, for people in my age cohort, the rate of serious consequences is also low. But precisely because the number of breakthrough cases is pretty low, it's hard to feel certain about the _second_ ratio. If that's less than 1%, fine... If it's 2%, 5%, 10%? That starts to sound a lot more concerning. The original target variant can break through on maybe 3-5% of people, Delta's somewhat higher, maybe 10%? And then if 10% of _those_ cases deal with chronic fatigue, or worse, for a year or more? That's... not great!
So I hope somebody is trying to piece together the data.
This goes back to something I was saying a year ago -- that we ought to be allocating potentially _billions_ of dollars on training an army of public health workers to follow up on the first waves of vaccine recipients, because the stakes of understanding some of these second-order questions about the longer-term outcome are so high, in terms of both saving lives if things turn out worse than we expected, and maintaining confidence / accelerating vaccine deployment in order to quash the virus and restore a "normal" economy. But, well, we didn't do that... :-/
Also, regarding Delta and kids, I'm aware of a family in my network (friend of a friend) where their young unvaccinated kid has been hospitalized for the past week. Again, anecdata, but... ¯\_(ツ)_/¯
First, whenever this comes up, a lot of people bring up an argument that I think is actually the best argument against the position, and I’ve never seen you actually respond to it, so I hope you do. And that is: if people are skeptical about the vaccine, and you tell them “yeah, the FDA has a normal process for the full authorization of vaccines, but in this case they decided to skip it to get it fully approved faster,” then that seems likely to increase hesitancy rather than decrease it. I don’t have evidence to support this, but the theory sounds super plausible to me, and I have yet to hear a good argument why it isn’t. I would love to though!
Second, and maybe this is a nitpick, but you write:
“Now if I went around tweeting all day “don’t take the vaccines unless you’re highly vulnerable, they’re experimental treatments the FDA hasn’t approved because they say they don’t have enough safety data yet” people would (rightly) get very mad at me. Spreading that message would (rightly) be considered an anti-social and chaotic thing to be doing. But the message is true”
Well…no it’s not true. If you cut out the “don’t take the vaccines” part, then it would be true. But you’re taking a 50% true and 50% false statement and claiming the whole thing is true in a strange way.
"don’t take the vaccines unless you’re highly vulnerable" isn't a statement that is true or false - it is an imperative without a truth value whose appropriateness depends on your value system. The second half is a statement that is true, and that gives a reason that makes the imperative somewhat more appropriate for some value systems (though doesn't sufficiently support it for many).
Another huge step forward would be to allow a single dose of a vaccine to qualify you for practical immunity. People who want two doses can still get them, but if all we can talk you into (or incentivize you into) is one dose, we should take it, not refuse it. This wouldn't need to be a legal annoucement, it could just be bully pulpit stuff from the White House, since vaccine mandates aren't really happening anyway.
That vaccination advertisement in the tweet from Mayor Bowser is terrible if you think paying people is a good lever to increase vaccination. You have to read the fine print to even know there's a payment!
Those stimulus checks should have been tied to cash. Send out $1,000 to every person that's been vaccinated, or gets vaccinated. Watch those rates shoot through the roof
It's not the FDA that's wrong on the EUA, it's the army, schools, etc. It's perfectly right for the FDA to say that the data on a vaccine is good enough for an emergency. The problem is that institutions like the army don't have a designation that says - in an emergency, we can require use of EUA vaccines. What confuses the issues is that the Pfizer and Moderna vaccines are so good. Imagine we only had the J&J or AstraZeneca vaccines. There is significant benefit - clears the 50% efficacy hurdle fairly easily, but some clear side effects, the fact that they're trickling out might mean that there's more to come, there's some risk involved. You wouldn't want to give full approval without a bit more data. However, even with if the vaccine isn't great, we'd want the army and schools and such to be able to require the vaccine, because in an emergency we want to essentially force people to do more for the social good.
Ideally I think the process would look like - FDA provides EUA, CDC defines the start and end of an emergency, during an emergency, all institutions nationally treat EUA as full authorization.
Yes - but that's a problem with the institutions/mandates and the law. None of these are able to distinguish normal times from an emergency. The answer isn't to change the FDA but to fix the institutions.
Has anybody else noticed the total fragmentation of the “IDW/alt middle” ecosystem over this? I can now get pilloried for advocating vaccine passports by the very same people who came to my aid last summer when I was criticizing wokeness. And some of the very same people who called me a conspiracy theorist last year when I wondered why we weren’t looking into the institute of virology, now agree with me about vaccines.
Food for thought for people that are saying that Matt and others should be patient with the FDA: check out the history with Act Up. Non-scientists can make valid rational contributions to science and to things like the FDA process, and open-minded scientists (which is most scientists in my experience) are glad to listen. People complaining is how a bureaucracy learns that the population wants something.
I think this is an important point, in principle. Insiders have the benefit of understanding the nuances of the system and why it operates the way it does, which may not be clear to outsiders. Often times, many outsider ideas have been fully considered and rejected for good reasons. But insiders can also be prone to institutional inertia and shackled by uninterrogated assumptions. Outsiders can bring valuable perspective that forces insiders to reassess how and why they do things.
All that said, I haven’t seen any real substantive engagement with the FDA process here. What are the steps before final approval? Why would it be prudent or not to accelerate them? A lot of the discussion here seems to be taking place in a vacuum. Despite proclaiming to understand the process, nothing in MY’s post actually discusses the process per se - what stage they are in, in terms of data collection and analysis, the purpose of those parts of the process, etc.
My thoughts are this. I do not know the whole FDA process. I don't have to know it to make comments. I see that over 3,600,000,000 (3.6 billion doses) have been given world wide. The data exists but apparently is not in the correct format. It's just like the question, "Can kids 11 years and 11 months old take a vaccine?" We are waiting for a phase 3 with less than 4,000 11-year olds in it when we could look at the results of 2 million 12-year olds in just the US (more worldwide). I don't know enough to say what changes should be made but I am quite convinced that changes should be made.
It's awesome that these vaccines were developed so quickly, but I have some misgivings about society only reopening because of high vaccination rates. There is a kind of unanswered question lingering now: if not for the vaccine, what would we have done? Would schools ever have reopened?
A year ago people were saying, what can we do to live with this thing? Which is an important conversation, because novel infectious diseases are not really all that uncommon.
Next time around it might take a decade to develop a vaccine. And we will not have answered pretty fundamental questions about the appropriate roles of government, private businesses, and individuals when this sort of thing happens.
On the WHO's VigiAccess database (https://www.vigiaccess.org) which describes itself as the "WHO Collaborating Center for International Drug Monitoring", if you search for "covid-19 vaccines" (https://www.vigiaccess.org), it says there have been over 1.4 million adverse reactions to the vaccines including 650k nervous system disorders, 50k blood/lymphatic disorders, 50k eye disorders, etc. If you rerun the search for "ibuprofen" and "Acetaminophen" you're find 150k adverse reactions presumably since 1992 (Ivermectin has only 5500 adverse reactions). So if you want to know why the vaccines are not being officially approved, go search https://www.vigiaccess.org and have a look at those 1.4 million adverse reactions to the vaccines.
One "market" idea I've been toying with is letting insurers charge an actuarial Covid premium to unvaccinated customers. This would at least shift some of the costs to persons choosing not to get vaccinated while keeping the government out of loop (other than rule making).
Nailed it as I see it. I have seen no reporting on WHY the vaccines are solely EUA. What's the hold up?
Question: can President Biden simply order the FDA to approve the vaccine?
Matt left out the even BETTER news. A vaccinated person is MUCH let likely to transmit COVID 19 to another person, both because they are unlikely to become infected themselves AND, even if infected, their viral load is less.
And mandates are better justified (only justified?) by the reduced risk that the vaccinated person poses to others.
This take does nothing to engage with the fact that the FDA has approved drugs in the past (Vioxx, DES, etc.) then turned out to be public health disasters. If the process as-is cannot guarantee long term outcomes, the FDA is rightly reluctant to short-circuit it. To ask them to arbitrarily skip the process on the basis of "the scientific community's actual understanding and attitude" is just glib. What about the next cancer drug? Should that get special treatment too? What if the "scientific community" has a great "attitude" about it? Isn't cancer a crisis that should cause us to not be "fussy?" Those aren't rhetorical questions, either. Eventually the FDA would have to answer that question, for some drug, and maybe in federal court. This is an institution that is constantly under pressure from giant corporations and desperate patients, as the Biogen situation shows. They have to have rules and they have to follow them. If your rules don't hold up in a crisis, then they aren't rules at all. Damaging the institutional integrity of the FDA is not worth the specious rhetorical value of "full" authorization.
Worse, final FDA approval would mean the end of data testing and review. So we would never know if the vaccines really were safe. And never mind the liability issues the makers might face if FDA just gave up on normal authorization.
What the FDA is doing right now is the slow boring of hard boards. This post drives me crazy.
I'm sympathetic to this argument, but well over 300 million doses have already been administered in the United States. So, if "disastrous" problems with these vaccines are a worry, that horse has already left the barn (and EUA shouldn't have been granted in the first place).
The risks for the Pfizer vaccine compared to, say, Vioxx are in different universes. Vaccines are composed of fairly normal biological molecules, which engage with the cell in relatively predictable ways and are eventually degraded, often within hours but certainly days at most (for mRNA). Small-molecule drugs are designed to bind to a target protein and cause (or prevent) some conformational change, thereby impacting its function. The potential problems are at least two-fold: (1) the small molecule could also bind to one of the thousands of other proteins it encounters while in the body, causing an unanticipated effect and (2) repeated dosing in which even just the target protein's function is altered for such a long time may have other unintended effects.
On top of all that, the risks of Vioxx appear to have been known well before it was finally pulled from the market. From Wikipedia: "The Lancet published an editorial which condemned both Merck and the FDA for the continued availability of rofecoxib from 2000 until the recall [in 2004]." So it was, in fact, the slow-moving regulatory bureaucracy that failed to recognize and respond to growing signs of risk!
Short answer: the rules must exist for a reason, and it would be good to understand what the trade-offs are *for each case* rather than reflexively deferring to them.
It's not a rule if you determine case-by-case if you're going to follow it. That's the thing with rules: you do reflexively defer to them.
I can't comment intelligently on vaccines versus "small-molecule drugs" but I do know that mistakes during the polio vaccine rollout mistakenly gave a couple hundred thousand kids polio. It just seems to me that you're starting where you should end: that the vaccines should get final authorization because they're safe. They probably are, but to rush that just to get the at best arguable benefit of being able to say they are finally approved--it's not worth it.
The polio vaccine used inactivated or attenuated virus. The risks for that are a bit higher, as they can potentially revert to an infectious form. An mRNA wrapped up in an LNP will never become infectious no matter what.
> It's not a rule if you determine case-by-case if you're going to follow it. That's the thing with rules: you do reflexively defer to them.
Sure, sometimes we should defer because we don't have sufficient knowledge and/or experience to know the bounds that the rule effectively operates in. But those who made the rules should know this and be able to adjust when called for (as it all but certainly is now).
If there were a new cancer drug that showed broad promise against all cancers so that it could possibly reduce the 600,000 annual cancer deaths to 400,000, then absolutely they should be giving it the same sort of emergency special treatment. I don't believe there has been any advance against cancer that is anywhere near that significant in many decades, if ever.
This isn't really responsive. I'm not saying the vaccines should not get EUA treatment, nor am I saying your hypothetical cancer therapy shouldn't get EUA. I'm saying we wouldn't want to suspend the approval process entirely and just skip testing because things are looking good.
And anyway, any halfway decent lobbying campaign is going to be able to drum up the "broad promise" of a new therapy and the FDA will constantly be having to decide who gets special treatment, then the lawsuits from competing drug makers will come, then the approval process will get tied up in the courts so it takes even longer.
The military probably presumed that the FDA approval was weeks away when it said it was waiting for FDA approval. This FDA delay is outrageous.
Regarding youngsters, if I had a 10 or 11 year old, would I rather wait to see the Phase 3 with a few thousand of each of those ages in it? Or would I prefer to see the safety results on the 2 million 12 year olds who are already vaccinated? Data on 2 million 12 year olds is much more likely to show any safety concerns. It should be approved for the 10 and 11 year olds already and the data from their usage should be considered for the next tier of kids.
So the statistic I most want to see right now (and if you could find the people to give a decent estimate I'd consider it a major "service journalism" coup), is:
For various age / health condition buckets, given that a person is vaccinated, but they get a breakthrough infection from Delta or a similar aggressive variant, what is the chance they experience long-term health effects?
Because some of the anecdata is scary. I have an acquaintance who got infected _after_ being vaccinated, back around early April. She's ended up with heart and lung problems that leave her fatigued from just walking around for an hour or two, as well as migraines and brain fogs. She's basically not able to work or take care of her kids.
This has (as you might imagine) freaked me out a bit, and left me wondering whether maybe I _shouldn't_ be acting as blase as I had been. I went out to see Black Widow, and I've been going to the gym. If you told me that by acting this way, there is a 100% chance that at some point in the next year I'll get infected and have a really shitty week or two, and then be fine, I'd respond: cool, I'm down for that. The anti-lockdown arguments from last year make sense in that context. But if there's like a 2-3% chance that the shitty week is followed by a _lifetime_ of reduced heart, lung, and brain function? At that point I start to wonder if I should just steel myself for another six months of lockdown.
Going to start wearing a second N95 at home after reading this. i've gotten each vaccine (gotta catch em all, right?) but still. who knows what could happen?
You want to see the stats on "long term" health effects "right now"? Kinda hard to get that data right now. :-)
Sure, part of the problem is simply time, but we should be at the point where we are just beginning to have a set of people from the earliest cohorts who got vaccinated (healthcare and other essential workers -- my friend who's in this category works in healthcare) who (a) got infected post-vax, and (b) either did or did not develop follow-up problems that lasted more than a month or two. Surely we have at least a few hundred examples by now of people in their 30s to 50s who got infected post-vax? It's just a question of whether we're capturing the data in a useful way.
The sample size obviously will rise over time -- and that will happen faster if Delta continues its rampant spread. :-/
I agree with you. I hope someone is trying to capture data like that too.
I shouldn't have made light of your comment.
What I had in mind when I read "long term" is something like shingles coming decades later yet due to childhood chicken pox. In that sense, I personally prefer to roll the dice on potential long term effects of vaccines, and not on actual covid.
Oh, I'm vaccinated -- I'm part of the Pfizer Pfam. I got the vaccine as soon as I was legally able to.
What I'm wrestling with is whether I should now resume basically all of my normal activities from the Before Times, or whether a breakthrough infection is still enough of a danger that I ought to be at least _somewhat_ more cautious than that. My spouse and I went to the goth club where we met to celebrate the anniversary of our first date, a couple weeks ago; now I'm not sure whether that was maybe a riskier thing to do than was sensible.
I got Moderna when they called. For me, for now, we're back to three quarter speed. My activities are mostly outdoors anyway (hiking, golf, skiing). I prefer dining outdoors. Seeing friends in smaller groups. Seeing family. The concert I'd love to go see again is Gogol Bordello, but I'm not mentally ready for a crowd like that yet. I could live like this for a couple of years, yet hoping that the data comes out sooner!
This doesn't really answer your question but you may still find it interesting if you haven't seen it yet: https://www.theinsight.org/p/vaccine-efficacy-statistical-power
Also, specifically on the point of statistical power, if in fact breakthrough cases leading to symptoms lasting for month are as rare as I think they are, you'd expect that in a sample of hundreds to low thousands, you'd have a small enough number of those cases that it would be quite difficult to estimate the exact ratio, other than just saying "small".
But if the true ratio is closer to ten percent, then even hundreds of breakthroughs should be sufficient to start noticing it.
So I think on the question of "is this a big or small risk", we probably _do_ have enough cases out there to make a reasonably intelligent judgment -- _if_ we'd been following up on hundreds of thousands of people, in order to track down the hundreds or thousands of breakthroughs, and then following up on them to determine how bad the breakthroughs were.
I hadn't seen that, although I have been following Zeynep Tufekci for a while, I think originally because Ezra Klein recommended one of her takes from very early on in the pandemic.
And yeah, I appreciate the point she's making, and the point that Matt has made that the mRNA vaccines are _really really good_. It seems like the rate of breakthrough cases that are noticed at all is quite low, and then I _think_ that among those breakthrough cases, for people in my age cohort, the rate of serious consequences is also low. But precisely because the number of breakthrough cases is pretty low, it's hard to feel certain about the _second_ ratio. If that's less than 1%, fine... If it's 2%, 5%, 10%? That starts to sound a lot more concerning. The original target variant can break through on maybe 3-5% of people, Delta's somewhat higher, maybe 10%? And then if 10% of _those_ cases deal with chronic fatigue, or worse, for a year or more? That's... not great!
So I hope somebody is trying to piece together the data.
This goes back to something I was saying a year ago -- that we ought to be allocating potentially _billions_ of dollars on training an army of public health workers to follow up on the first waves of vaccine recipients, because the stakes of understanding some of these second-order questions about the longer-term outcome are so high, in terms of both saving lives if things turn out worse than we expected, and maintaining confidence / accelerating vaccine deployment in order to quash the virus and restore a "normal" economy. But, well, we didn't do that... :-/
Well, I should say _worked_ in healthcare, because she doesn't work at all now, and has no idea how long it will be before she can again. :-(
Also, regarding Delta and kids, I'm aware of a family in my network (friend of a friend) where their young unvaccinated kid has been hospitalized for the past week. Again, anecdata, but... ¯\_(ツ)_/¯
Two things.
First, whenever this comes up, a lot of people bring up an argument that I think is actually the best argument against the position, and I’ve never seen you actually respond to it, so I hope you do. And that is: if people are skeptical about the vaccine, and you tell them “yeah, the FDA has a normal process for the full authorization of vaccines, but in this case they decided to skip it to get it fully approved faster,” then that seems likely to increase hesitancy rather than decrease it. I don’t have evidence to support this, but the theory sounds super plausible to me, and I have yet to hear a good argument why it isn’t. I would love to though!
Second, and maybe this is a nitpick, but you write:
“Now if I went around tweeting all day “don’t take the vaccines unless you’re highly vulnerable, they’re experimental treatments the FDA hasn’t approved because they say they don’t have enough safety data yet” people would (rightly) get very mad at me. Spreading that message would (rightly) be considered an anti-social and chaotic thing to be doing. But the message is true”
Well…no it’s not true. If you cut out the “don’t take the vaccines” part, then it would be true. But you’re taking a 50% true and 50% false statement and claiming the whole thing is true in a strange way.
"don’t take the vaccines unless you’re highly vulnerable" isn't a statement that is true or false - it is an imperative without a truth value whose appropriateness depends on your value system. The second half is a statement that is true, and that gives a reason that makes the imperative somewhat more appropriate for some value systems (though doesn't sufficiently support it for many).
Another huge step forward would be to allow a single dose of a vaccine to qualify you for practical immunity. People who want two doses can still get them, but if all we can talk you into (or incentivize you into) is one dose, we should take it, not refuse it. This wouldn't need to be a legal annoucement, it could just be bully pulpit stuff from the White House, since vaccine mandates aren't really happening anyway.
I'm not sure that's a great idea given how much less effective a single dose appears to be against the delta variant.
Good point. It appears that Moderna (and J&J) are effective against delta after one shot, but Pfizer is not https://www.healthline.com/health-news/heres-how-well-covid-19-vaccines-work-against-the-delta-variant
That vaccination advertisement in the tweet from Mayor Bowser is terrible if you think paying people is a good lever to increase vaccination. You have to read the fine print to even know there's a payment!
Those stimulus checks should have been tied to cash. Send out $1,000 to every person that's been vaccinated, or gets vaccinated. Watch those rates shoot through the roof
It's not the FDA that's wrong on the EUA, it's the army, schools, etc. It's perfectly right for the FDA to say that the data on a vaccine is good enough for an emergency. The problem is that institutions like the army don't have a designation that says - in an emergency, we can require use of EUA vaccines. What confuses the issues is that the Pfizer and Moderna vaccines are so good. Imagine we only had the J&J or AstraZeneca vaccines. There is significant benefit - clears the 50% efficacy hurdle fairly easily, but some clear side effects, the fact that they're trickling out might mean that there's more to come, there's some risk involved. You wouldn't want to give full approval without a bit more data. However, even with if the vaccine isn't great, we'd want the army and schools and such to be able to require the vaccine, because in an emergency we want to essentially force people to do more for the social good.
Ideally I think the process would look like - FDA provides EUA, CDC defines the start and end of an emergency, during an emergency, all institutions nationally treat EUA as full authorization.
The problem is that institutions are concerned about lawsuits regarding mandates if they don’t have full FDA approval for the vaccine.
Yes - but that's a problem with the institutions/mandates and the law. None of these are able to distinguish normal times from an emergency. The answer isn't to change the FDA but to fix the institutions.