2: The US is screwing it up.
3: The major drug companies might be able to save us, despite ourselves.
4: But the stupidity of The American People may yet snatch defeat from the jaws of victory.
This is one of a series of posts about vaccines for viral illness, and about a COVID-19 vaccine. See Post #741 for a quick run-through of flu vaccine effectiveness. My posts tend toward TL/DR, so in this post I’m only going to address Item 1: The Russians have it right.
To cut to the chase, this is basic game theory. Suppose you had a COVID-19 vaccine candidate that might be effective, but might be just a harmless placebo. That is, it has passed Phase I (safety) clinical trials. What’s the smartest thing you could do with it?
Before you answer: Please focus on the context of ongoing mortality, morbidity, and economic losses from the US COVID-19 pandemic. Plus the fact that the US has become an object of international scorn and pity due to worse-than-leaderless response to the pandemic. And don’t forget the cheapness. The cost per dose might be on order of $10, plus the cost of the nursing labor to administer the shot.
A: Sit on it for another half-year or more, until you were absolutely sure it worked? Or not. And if not, then go back to the drawing board.
B: Give it to people now, and tell them not to change their other precautions until six months from now, when you know whether or not it works.
The USA is has forcefully chosen Path A. Looks like the Russians are opting for B. All things considered, I’m fairly sure that B is a vastly smarter approach. No matter how you slice it.
It truly pains me to say this, but even the Communist Russians seem to be going about this more rationally than we are. But that’s what I truly believe. As a classically-trained capitalist economist. Who can do the simple math.
The Russians have it right.
You’ve probably read that the Russians have announced that they have a COVID-19 vaccine, and they are going ahead with administering it to people. Famously, Putin says that his own daughter has been vaccinated.
This has, of course, been met with much nay-saying, tsk-tsking, and general vaccine-shaming by the mainstream vaccine and public health community.
But I think the Russians have their heads screwed on straight, regarding this. And I’m briefly going to tell you why.
First, recall that drug development has three phases.
Phase I tests whether or not the drug or vaccine will kill you, or otherwise has severe side-effects. Phase I is done on a very small number of people, to keep the risks down in case it really is lethal. As a bonus, for vaccines, Phase I tells you whether or not people develop the appropriate antibodies when they are given the vaccine.
The Phase I trial results are why vaccine developers appear optimistic. For all the ones that are going forward, (most of) the test subjects developed the appropriate antibodies. (And that’s a tautology, because if the antibodies hadn’t appeared, they’d abandon that vaccine candidate as ineffective.)
Phase II tests whether or not the drug actually works. You randomize your volunteers into two groups, give one the drug/vaccine and the other a placebo, and see how well the drug/vaccine works.
Phase II is where the three vaccines relevant to the US are, right now. For the total crap-shoot vaccine that we’re paying for (Moderna, as I will discuss in the next post), they’re recruiting 30,000 individuals. You need that many — at least — to have sufficient “statistical power” to determine whether or not the vaccine works. Again, this is for a later post.
Phase III optimizes the dose/treatment regimen, before you go forward with production. E.g., do you need one shot or two, and how much of the drug/vaccine material should each shot contain. Maybe, you need a stronger version for the oldest old. And so on. Phase III fine-tunes it.
I’m guessing, all things considered, they’re going to skip Phase III for these vaccines. Because the need for any effective vaccine is so great.
Key question: What phases can you skip, and what phases should you skip, for development of a COVID-19 vaccine?
Our harrumphing vaccine and public-health establishment has come out with a clear and absolutely thought-free answer: None. Despite the ongoing deaths, despite the onset of the next great depression, these people, mired in their cautious drug-development mindset, cannot even conceive of doing this any other way. Plod through every traditional step, with all due un-haste, is their answer. I believe we had The US FDA commissioner add his harrumping to the chorus just a few days ago.
Source: Washington Post.
I particularly like the “no matter what” portion of that.
Not even if shortcutting would save lives? That’s what I argued, with numbers to back it up, of course, with respect to skipping Phase I testing, in Post #601. And some experts agree, as documented in Post #658).
And the logic there ain’t rocket science: If 1000/day are dying from this, taking two months for Phase I testing amounts to adding 60,000 to the death toll. Compared to skipping Phase I and having the vaccine two months sooner. If you only need to test 30,000 for Phase II, you literally couldn’t kill enough of your volunteers (in Phase II, if the vaccine proves 100% fatal) to make up for the souls lost from the two month delay from a careful Phase I.
In all fairness, possibly the bureaucrats making these decisions assumed that the pandemic would be well under control in the US by the time the vaccine became available. So they might have figured that the loss-of-life from delay was minimal. Right now, I’d say that assumption was wrong, and that if decisions were made on the basis of that assumption, those decisions need to be revisited in an updated cost-benefit framework that includes significant additional deaths due to delayed delivery times for the vaccines.
Not even if more people were going to die as a result of poverty from the oncoming Great Depression? Because, let’s face it, poor people die younger, uninsured people die younger, and it sure looks like, as a country, we’re going to get massive increases in the poor and uninsured the longer this goes on.
Nope, no matter what. Not even if God him/her self manifested and ordered it so? To me, that’s a sure sign of Emerson’s hobgoblin of little minds. We have a bureaucrat, in time of great crisis, making path-breaking decision in favor of every last rule that the bureaucracy normally enforces. No matter what. Wow, now that’s forceful leadership. /s By manfully stating his intent not to deviate an inch from the standard protocols, he has aggressively what, exactly? I’d say, covered his butt against mainstream criticism. Only those on the fringe, such as economists like me, are going to point out how fundamentally stupid this approach is, given the current circumstances.
Maybe the FDA commissioner is enforcing this “business as usual” vaccine development as a way to build public confidence. So, in effect, he’s talking to the anti-vaccination sympathizers. Trying to make sure that people have no excuse not to get the vaccine. In which case, I think he’s wasting his breath. But I’ll address that when I get to the post on Point 4 above, the stupidity of The American People.
OK, what about the Russians? What are they up to? Here’s what I think is going on.
I think they have a vaccine candidate that has passed Phase I trials, and shows some activity in generating the appropriate antibodies. I think that because, at this point, virtually everybody has one like that. And I’m pretty sure theirs is safe, because Putin made such a big deal about giving it to his own daughter. That’s a stunt to underline safety, not effectiveness.
I’m pretty sure they don’t know whether or not it works. That’s just math. Assuming they are using volunteers to test it, instead of (e.g.) giving it to prisoners and then deliberately exposing them to COVID-19. Soviet-style. Barring that, they’re in the same boat as everybody else — it’s going to take a huge amount of time to accumulate enough infections in your placebo group to be able to tell whether or not the vaccine works.
But they’re doing the rational thing, and using it now. And if they are totally rational, they are telling people not to trust it until the data show up (in six months).
If it turns out to be just a harmless placebo, and people obey the instructions to continue all current COVID-19 precautions, then there’s no damage done. They’ve wasted $10/person on a placebo. But if the vaccine is even modestly effective, then they’ve gotten an important head-start on getting the spread of infection under control. Half-a-year or more before we, in the Capitalist USA, firmly obeying our government bureaucracy, will have managed that feat.
It’s just classic game theory. Heads I win (effective vaccine), tails I don’t lose (mere placebo). We’re just just not smart enough, or maybe bold enough, to act on that.
People who claim that the Russians are being stupid about this have it dead wrong. We’re the ones who are being stupid. We’re following every bureaucracy-mandated rule for vaccine development. Said rules have been developed to maximize safety, in normal times. Said rules being a foolish consistency, under current conditions.
We are slavishly following the dictates of our faceless government bureaucracy, while the Russians have the good sense and the independence of thought to take this gamble.
Truly, The World Turned Upside-Down.