Just label the vials "Hydroxychloroquine. This product has not been proven to prevent Covid. Any representation to the contrary IS A CRIMINAL OFFENSE."
The best argument against the AZ vaccine now is that while the FDA was delaying it, the SA variant came about and the AZ vaccine is pretty ineffective against that. I would have approved it a couple of months ago but now, I don't know. Note that this is not the same as saying that a fast approval would have been an error. It's not hard to imagine that within 24 months, there will be variants that get around all of the current vaccines. Squashing this pandemic may take a few rounds of vaccines and vaccine updates.
As a quibble, an Emergency Use Authorization is NOT an FDA Approval. (A friend who got first vaccine recently said the nurse spent what seemed like five minutes with a Miranda-type warning emphasizing that the FDA had NOT approved the vaccine.)
It seems it should be easier for the FDA to deliver an emergency non-approval in what is clearly an emergency situation.
Sentences like "But I don’t think that Denmark, which is using the AZ product on non-seniors while reserving the mRNA vaccines for seniors, is run by masturbating libertarians." are why I subscribe. Thank you!
This is maybe nitpicking, but it looks like the David Leonhardt vaccine efficacy comparison isn't apples to apples. I think the comparison he's making is:
Out of 75,000 who got a vaccine in the trials a couple months ago, zero have died of covid during those couple months.
Out of 75,000 random Americans in February 2020, about 150 have died of covid during the past year.
Some of that difference is the vaccine, some is looking at a shorter time period. The more relevant comparison is: out of 75,000 random non-vaccinated Americans at the time of the vaccine trials, __ have died of covid since then. I don't know what that number is; probably more like 50 than 150.
You have a small error in this piece. So far COVID has killed about 148 Americans per 100,000, based on the NYT page you cited. You had an example of 75,000 people and said that it killed about 150, but that should be about 111.
Although your number might be an underestimate if we only account for people above 18. If we assume that 486,000 above 18 have died of COVID then the death rate of people 18+ per 100K is 232. And for your example of 75K it is 175.
Anyone else feel like "follow the science" has become a meaningless platitude? It's beginning to sound like ... "we played hard", "give the other team credit", "moving on to the next game", etc. Like ... IDK. Doesn't seem plausible that we're the only country with science on our side.
I agree. In fact, when I see two people having a legitimate disagreement, appealing to different factual observations, it is almost always the one with the weaker set of facts that says "follow the science".
America is so process-oriented, and well-meaning bureaucrats and their supporters have invested so much to get them approved that it's nearly impossible to go back. regardless.
To those with any knowledge of social media/influencer marketing: what's the current landscape for social media campaigns in favor of vaccinations? I'm not a regular user, but I would figure a good way to get hesitant populations to get vaccines is to see friends/neighbors/favorite creators doing it. Can anyone shed light on whether any of this is happening and, if not, how it could?
According to a NYT article from December, AstraZeneca never reported their adverse event that halted trials to the FDA and officials learned about it from news reports. That plus their confusing results undermined confidence. To those pointing to the UK/European approval - those bodies do not evaluate the raw data, just the summary data provided by the pharmaceutical company. Hopefully it's not a mistake to do so. But both the adverse event and the lower efficacy are biologically plausible due to the vector that AZ is using.
I am curious if those that want AZ approved immediately also want Sputnik V and Sinopharm approved - both of those are in widespread use worldwide and have higher reported efficacy rates.
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
No. I think the Republican party had something to contribute in this area in the past. It's not like Democratic city governments have always covered themselves in glory on effectiveness. And this had something to do with high growth areas in the west being traditionally Republican in the post-war era. But the trend of the Republican party becoming useless started about 30 years ago and was mostly complete about 10 years ago. Trump is kind of the icing on that cake.
It has to do with part of the original post, near the end:
"'Costly regulations are hurting the country' is the classic conservative and libertarian policy critique. But when I scrolled the front pages of Cato, Heritage, and AEI last week, none of them were highlighting content calling for approval of the AstraZeneca vaccine. Congressional Republicans are criticizing the Biden administration for all kinds of stuff, but they’re not calling on the FDA to approve the AstraZeneca vaccine."
What mpowell is saying is that in the past, the Republican Party and its associated think tanks would have been pushing for faster approval of the vaccine because it fits extremely well with their criticism of over-regulation by the federal government. But now, the GOP is more concerned with who can say what on Twitter than with a productive contribution to policy/politics like advocacy for reduced regulation in a situation where there's a pretty good argument for it.
>"It also implicitly assumes that disease and illness are endemic aspects of the human condition and that delaying the arrival of new medication by a month or four is a small price to pay for establishing broad confidence that when doctors prescribe you something, it will work."<
Many treatments the FDA investigates, such as new ones for advanced cancer, involve patients at high risk of dying. These treatments *may*, if approved, save their lives for some period of time. It's clear that during the FDA approval process many patients will die who would otherwise survive had their timing been better for treatments later approved.
If AZ is given just to young people, very few of whom die from COVID, we'll save some lives (and we could probably open schools sooner), but given that we're just talking a few months until we have very large supplies of the other three vaccines available, the benefits of immediate approval of AZ are not as great as we may think.
What I'm saying is that the difference between the AZ approval of those for "endemic" (and often very very deadly) diseases is not as great as this post suggests.
Isn't there an unknown up-side: the vaccines may have some useful reduction in spread that isn't well-tested by the clinical trials? If so, the up-side wouldn't be a ton of lives saved, but ending uncontrolled community spread sooner would be valuable.
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
I think you're right. Vaccine hesitancy will replace vaccine access as the biggest problem surprisingly quickly. The percentage of the country that is eager enough to wait in lines for a new vaccine might be a lot smaller than policy makers are prepared for. And once they are covered all these scheduling problems will evaporate overnight.
I'm concerned about vaccine hesitancy as well. In Israel, despite its incredible success in rolling out vaccinations (and the national pride about that), they're finding it harder and harder to get people to come in to get their shots. There are reports that they're running at half capacity simply because enough people aren't showing up.
"Channel 12 also reports that the Health Ministry is considering a campaign of just calling the holdouts and annoying them into getting vaccinated, which Peled Raz says would be fine by her. “If it makes them uncomfortable, that’s also okay; it’s a more gentle form of encouragement.”
Very well written and thoughtful. You are exactly right about why we have normal drug approval processes and how they are designed to strike a balance between (1) getting innovative, medically helpful products to market and (2) preventing over ambitious drug companies from pushing or fudging or short circuiting. But here it is not helpful to think of it as preserving the status quo against the risk of potential harm to consumers, because the status quo—no vaccine—is itself more harmful than the most flubbed drug rollout in the history of the FDA by factors and factors.
Likewise, to my knowledge (which is admittedly not focused on this area), there has never been as much attention on a particular drug as each of these vaccines, there has never been so much data publicly released or discussed, and there has never been such a concerted, worldwide effort to evaluate, approve, and deploy these vaccines. And there has probably not been so much government-as-partner involvement in the development of these products (I could be wrong about this?).
This degree of transparency, government involvement from
Day 1, and the ability to crowdsource the decisions of other reputable bodies should optimize and substantially shorten the timeline for decision making.
Moreover, it’s not like these companies would be fleecing just consumers if it were snake oil—they’d be fleecing the government and we’d all suffer tremendously (at least in terms of opportunity costs). The upside to the companies for flubbing this is nonexistent.
Finally, I don’t tend to put as much faith in other governments’ regulatory bodies or the WHO compared to our own, but even so I think there should be some sort of common sense reciprocity that kicks in to abbreviate the decision making process. If it’s good enough for a billion other people, you would think it’s good enough for us.
Can AZ actually deliver a meaningful number of doses quickly enough to make a difference? I thought Europeans were buying it all?
Just label the vials "Hydroxychloroquine. This product has not been proven to prevent Covid. Any representation to the contrary IS A CRIMINAL OFFENSE."
The best argument against the AZ vaccine now is that while the FDA was delaying it, the SA variant came about and the AZ vaccine is pretty ineffective against that. I would have approved it a couple of months ago but now, I don't know. Note that this is not the same as saying that a fast approval would have been an error. It's not hard to imagine that within 24 months, there will be variants that get around all of the current vaccines. Squashing this pandemic may take a few rounds of vaccines and vaccine updates.
basically this article:
https://www.theatlantic.com/ideas/archive/2021/02/end-pandemic-sight-how-we-win/618016/
authorize AZ
maximize first doses
simplify the tiers and get everyone into the process now
First, I agree - get shots in arms.
As a quibble, an Emergency Use Authorization is NOT an FDA Approval. (A friend who got first vaccine recently said the nurse spent what seemed like five minutes with a Miranda-type warning emphasizing that the FDA had NOT approved the vaccine.)
It seems it should be easier for the FDA to deliver an emergency non-approval in what is clearly an emergency situation.
Sentences like "But I don’t think that Denmark, which is using the AZ product on non-seniors while reserving the mRNA vaccines for seniors, is run by masturbating libertarians." are why I subscribe. Thank you!
This is maybe nitpicking, but it looks like the David Leonhardt vaccine efficacy comparison isn't apples to apples. I think the comparison he's making is:
Out of 75,000 who got a vaccine in the trials a couple months ago, zero have died of covid during those couple months.
Out of 75,000 random Americans in February 2020, about 150 have died of covid during the past year.
Some of that difference is the vaccine, some is looking at a shorter time period. The more relevant comparison is: out of 75,000 random non-vaccinated Americans at the time of the vaccine trials, __ have died of covid since then. I don't know what that number is; probably more like 50 than 150.
You have a small error in this piece. So far COVID has killed about 148 Americans per 100,000, based on the NYT page you cited. You had an example of 75,000 people and said that it killed about 150, but that should be about 111.
Although your number might be an underestimate if we only account for people above 18. If we assume that 486,000 above 18 have died of COVID then the death rate of people 18+ per 100K is 232. And for your example of 75K it is 175.
Anyone else feel like "follow the science" has become a meaningless platitude? It's beginning to sound like ... "we played hard", "give the other team credit", "moving on to the next game", etc. Like ... IDK. Doesn't seem plausible that we're the only country with science on our side.
I agree. In fact, when I see two people having a legitimate disagreement, appealing to different factual observations, it is almost always the one with the weaker set of facts that says "follow the science".
America is so process-oriented, and well-meaning bureaucrats and their supporters have invested so much to get them approved that it's nearly impossible to go back. regardless.
To those with any knowledge of social media/influencer marketing: what's the current landscape for social media campaigns in favor of vaccinations? I'm not a regular user, but I would figure a good way to get hesitant populations to get vaccines is to see friends/neighbors/favorite creators doing it. Can anyone shed light on whether any of this is happening and, if not, how it could?
According to a NYT article from December, AstraZeneca never reported their adverse event that halted trials to the FDA and officials learned about it from news reports. That plus their confusing results undermined confidence. To those pointing to the UK/European approval - those bodies do not evaluate the raw data, just the summary data provided by the pharmaceutical company. Hopefully it's not a mistake to do so. But both the adverse event and the lower efficacy are biologically plausible due to the vector that AZ is using.
I am curious if those that want AZ approved immediately also want Sputnik V and Sinopharm approved - both of those are in widespread use worldwide and have higher reported efficacy rates.
It's too bad that Republicans and libertarians have become so obsessed with their various culture war hang-ups that any useful good government ideas they may have contributed are squarely in the past at this point.
No. I think the Republican party had something to contribute in this area in the past. It's not like Democratic city governments have always covered themselves in glory on effectiveness. And this had something to do with high growth areas in the west being traditionally Republican in the post-war era. But the trend of the Republican party becoming useless started about 30 years ago and was mostly complete about 10 years ago. Trump is kind of the icing on that cake.
It has to do with part of the original post, near the end:
"'Costly regulations are hurting the country' is the classic conservative and libertarian policy critique. But when I scrolled the front pages of Cato, Heritage, and AEI last week, none of them were highlighting content calling for approval of the AstraZeneca vaccine. Congressional Republicans are criticizing the Biden administration for all kinds of stuff, but they’re not calling on the FDA to approve the AstraZeneca vaccine."
What mpowell is saying is that in the past, the Republican Party and its associated think tanks would have been pushing for faster approval of the vaccine because it fits extremely well with their criticism of over-regulation by the federal government. But now, the GOP is more concerned with who can say what on Twitter than with a productive contribution to policy/politics like advocacy for reduced regulation in a situation where there's a pretty good argument for it.
Exactly.
>"It also implicitly assumes that disease and illness are endemic aspects of the human condition and that delaying the arrival of new medication by a month or four is a small price to pay for establishing broad confidence that when doctors prescribe you something, it will work."<
Many treatments the FDA investigates, such as new ones for advanced cancer, involve patients at high risk of dying. These treatments *may*, if approved, save their lives for some period of time. It's clear that during the FDA approval process many patients will die who would otherwise survive had their timing been better for treatments later approved.
If AZ is given just to young people, very few of whom die from COVID, we'll save some lives (and we could probably open schools sooner), but given that we're just talking a few months until we have very large supplies of the other three vaccines available, the benefits of immediate approval of AZ are not as great as we may think.
What I'm saying is that the difference between the AZ approval of those for "endemic" (and often very very deadly) diseases is not as great as this post suggests.
Isn't there an unknown up-side: the vaccines may have some useful reduction in spread that isn't well-tested by the clinical trials? If so, the up-side wouldn't be a ton of lives saved, but ending uncontrolled community spread sooner would be valuable.
At the end of December, the US was averaging 250,000 vaccination shots per day. Currently we're at just under 1.9 million shots per day. In a few weeks, especially if J&J is approved, I would hardly be surprised if we're at 3 million per day. Back in December Biden aggressively called for a goal of 1 million per day, then had to scurry around to increase the bar to 1.5 million per day, obviously well below where we're at.
I'm not saying we shouldn't treat this as a great emergency and not consider all possible resources. I'm just saying we're currently well ahead of where anyone thought we'd be with likely more progress to come. It's possible that the situation will be resolved positively under current processes.
I think you're right. Vaccine hesitancy will replace vaccine access as the biggest problem surprisingly quickly. The percentage of the country that is eager enough to wait in lines for a new vaccine might be a lot smaller than policy makers are prepared for. And once they are covered all these scheduling problems will evaporate overnight.
I'm concerned about vaccine hesitancy as well. In Israel, despite its incredible success in rolling out vaccinations (and the national pride about that), they're finding it harder and harder to get people to come in to get their shots. There are reports that they're running at half capacity simply because enough people aren't showing up.
https://www.timesofisrael.com/israels-vaccination-stagnation-why-weve-caught-it-how-to-cure-it/
Just saw this as well:
"Channel 12 also reports that the Health Ministry is considering a campaign of just calling the holdouts and annoying them into getting vaccinated, which Peled Raz says would be fine by her. “If it makes them uncomfortable, that’s also okay; it’s a more gentle form of encouragement.”
https://www.timesofisrael.com/the-pass-is-always-greener-what-the-press-is-saying-about-needling-the-shot-shy/
Very well written and thoughtful. You are exactly right about why we have normal drug approval processes and how they are designed to strike a balance between (1) getting innovative, medically helpful products to market and (2) preventing over ambitious drug companies from pushing or fudging or short circuiting. But here it is not helpful to think of it as preserving the status quo against the risk of potential harm to consumers, because the status quo—no vaccine—is itself more harmful than the most flubbed drug rollout in the history of the FDA by factors and factors.
Likewise, to my knowledge (which is admittedly not focused on this area), there has never been as much attention on a particular drug as each of these vaccines, there has never been so much data publicly released or discussed, and there has never been such a concerted, worldwide effort to evaluate, approve, and deploy these vaccines. And there has probably not been so much government-as-partner involvement in the development of these products (I could be wrong about this?).
This degree of transparency, government involvement from
Day 1, and the ability to crowdsource the decisions of other reputable bodies should optimize and substantially shorten the timeline for decision making.
Moreover, it’s not like these companies would be fleecing just consumers if it were snake oil—they’d be fleecing the government and we’d all suffer tremendously (at least in terms of opportunity costs). The upside to the companies for flubbing this is nonexistent.
Finally, I don’t tend to put as much faith in other governments’ regulatory bodies or the WHO compared to our own, but even so I think there should be some sort of common sense reciprocity that kicks in to abbreviate the decision making process. If it’s good enough for a billion other people, you would think it’s good enough for us.