Source: Washington Post.
It’s not like the Administration hasn’t been signalling this for days now. And, surprise, surprise, surprise, it’s scheduled for November 1. Isn’t there some other important event that occurs in early November? (Edit: I forgot to mention that November 1 is a Sunday, almost as if nobody even bothered to look at the calendar before they announced the date.)
My best guess is that they’re going to offer this “emergency” authorized vaccine to health care workers only. Nobody’s saying that, but that’s the only thing that makes good logical sense. And that’s what the Russians did (e.g., Post #777). The idea being that a) it’s known to be harmless, and b) even if it’s a dud (less than 50% effective, say, and so not meeting the standard that the FDA established) you can justify using it in a high-risk population if it reduces the odds of infection even a little bit.
And now some people will be offered the vaccine, and they have to come to some conclusion: Is this real, or is it just political theater?
Let me walk though my analysis of it.
Safety first
First, whatever it is, it’ll be safe. Safety is tested in Phase I trials, and all the vaccines have passed. Plus whatever they did and called Phase II, because they’re calling the current trials Phase III. So there are no common and dangerous side effects. By November 1, at least 15,000 people would have been given whatever vaccine it is. So if there are any uncommon side effects, those too will have been identified at that point.
In addition, given the mechanism of action of the vaccines that are currently being tested, there’s almost no way for them to be unsafe. There’s no virus in this vaccine, just a snipped of DNA or RNA encoding production of a single protein. All the ones that are well along are RNA or DNA-based vaccines. Anything using killed virus is still in the earliest phases (I think). So, to be clear, it’s not like in the olden days, when (e.g.) one child in 100,000 would get polio from the live-virus vaccine. It just can’t happen here.
All the people yakking about not taking this because it might turn out to be harmful are just clueless. Or they believe in one of those weird theories that all vaccines are harmful and/or they need to protect their precious bodily fluids.
This was developed quickly, but that doesn’t mean that they cut corners (up to now). I went over this in a much earlier post. Traditionally, vaccines made very little money, and were produced by archaic methods, such as incubating the virus in fertilized chicken eggs. (Which, by the way, is still how the season flu vaccine is made.) Now, by contrast, there’s a lot of money in a coronavirus vaccine, and state-of-the-art is light years beyond chicken eggs.
What I’m trying to say here is that if you’re just a regular citizen, and not part of the vaccine lunatic fringe, there’s no safety issue here for you. If there were, these would have been weeded out much earlier. And, assuming I’m right about the next point, no, you can’t accidentally get coronavirus from the vaccine, because the vaccine doesn’t contain any coronavirus. Just messenger RNA encoding one key surface protein of the coronavirus.
Might carry a lot of baggage
Second, I’d bet that we are talking about the Moderna vaccine. Even though the Administration won’t name it. But that’s not guaranteed. It would be far smarter, for example, to distribute (e.g.) a few million doses of the British (Jenner Institute/AstraZeneca) vaccine, because that’s farther along in the process. But I’m not sure this decision is being driven by what’s smart.
But my gut tells me that this will be the Moderna vaccine. If for no other reason than the fact that they are probably going to be unable to sell it, once it has competition. (See last point below). So if they are going to cash in, they’re going to have to cash in while they have a monopoly. And the way to do that is to have their friends in government assure that they have a monopoly on coronavirus vaccine in the US for as long as possible.
And so, unfortunately, if I’m right, this one comes with a lot of baggage. Doesn’t mean that it won’t work. But certainly shifts my subjective odds.
- The company making it has only been in business nine years.
- They’ve never successfully produced a vaccine.
- The method they are using (mRNA, described in earlier posts) has never been used to produce a successful human vaccine, by anyone, anywhere.
- They were on the edge of being “not financial viable” prior to COVID-19.
- They are already counting on the revenues from this vaccine to save the company.
- They were chosen in a classic act of crony capitalism, as the person put in charge of Operation Warp Speed left the board of Moderna just over a month before he chose (surprise) Moderna to produce America’s Vaccine.
- They’re imfringing on somebody else’s patent to produce this.
- They’ve gotten huge chunks of Federal money before, but illegally failed to disclose that on numerous occasions.
- Conveniently, they claim the vaccine can be stored at a temperature of -4F, while the manufacturer of a seemingly-identical (or at least similar) mRNA vaccine says that it requires -94F. You can get -4F in any standard freezer, you need hugely specialized equipment to achieve -94F.
- They are planning to sell it for maybe three times what competing vaccines will cost.
As an economist, my particular fear regarding the Moderna vaccine is the financial incentives for early release, if the vaccine turns out to be a dud.
The incentive for the major drug companies is clear: If it’s a dud, they cannot afford to release it under any circumstances. If you are Johnson and Johnson, or AstraZeneca, or any of the top-drawer drug companies, you would not release it, due to the adverse effect this would have on their valuable commercial reputation. You could not afford to release it, and be known for a generation as the company that gave America a dud vaccine. So if (e.g.) Johnson and Johnson agreed to release the vaccine early, I’d feel pretty comfortable that the vaccine was effective.
The incentive for Moderna is not clear: If it’s a dud, plausibly they cannot afford NOT to release it on an emergency basis. It’s going to be selling for three times what the competitors’ vaccines will sell for. If it’s a dud, once that is known, and there is competition, they aren’t going to be able to sell it. And yet, they are already counting on the vaccine revenue stream to more-or-less save the company. And they don’t have a commercial reputation to harm, because they’ve never produced a vaccine. And so, strictly as a profit-and-loss calculation, if their vaccine is a dud, the best thing they can do may be to have it be released, exclusively, on an emergency basis. Basically, dump it now. If Moderna agrees to release this early, I can’t even guess whether that signals that the vaccine is excellent, or that its a dud. I think they have an incentive to be first-in-market under any circumstances.
Meeting the FDA 50% effectiveness criterion in time is barely plausible.
It’s barely (emphasis barely) plausible that an effective vaccine will have been shown to exceed the FDA 50% effectiveness threshold by the time this is approved. But only barely.
Conveniently, I did the math just yesterday, in Post #798. I’ll repeat the chart here and discuss some of the nuances. The basic idea is obvious: The better the vaccine is, the less data you need to gather in order the know that with some certainty. The more borderline-effective, the more you have to gather before you can have some assurance that it exceeds the FDA’s 50% effectiveness criterion.
The proposed sample size (30,000 people) and timeframe (half a year or so) were really set up so that a borderline vaccine could pass. (In effect, they dovetail with the FDA’s 50% effectiveness criterion). A vaccine that is far better than borderline will be known to meet the FDA’s criterion within just a month or two of testing.
The only real nuance here is that you have to add six weeks to all of these figures to account for the vaccine protocol for the Moderna vaccine.. It takes two shots, four weeks apart, and then an additional two weeks to build up antibodies. So the actual vaccine “trial” doesn’t start until six weeks after they’ve given a person their first shot.
A second nuance is that they’ve had some people in this trial for a while now. They started recruiting on July 27. They enrolled about 1000 people the first week. The expectation at the time is that they’d have the full 30,000 in two months. I think they recently passed the 15,000 mark.
So you can probably use 15,000 as a reasonable benchmark, as of about two weeks ago. But you have to “start the clock” six weeks after that, because that’s how long it takes to get one person fully vaccinated and immune.
And so, in terms of the chart below, best guess, they’ll have an average of maybe one month of data, on maybe 15,000 participants. If they were smart, they would have improved their statistical efficiency somewhat by making the placebo group somewhat smaller than the vaccine group. But putting that aside, if the vaccine is 85% effective or better, they’ll just barely have enough time (enough person-days of exposure) to be able to say that they exceed the FDA criterion. (That is, that the “95% confidence interval” excludes a value of 50% effective).
I now wonder if this is why the president of Moderna was cited, just a couple of weeks ago, saying that he “wouldn’t be surprised” if the vaccine were 90% effective. That was an odd thing to say. You don’t, for example, see the president of Johnson and Johnson speculating that their vaccine will be spectacularly effective. But, basically, Moderna needs that to happen for this whole sequence of events to be legit.
That would be a heck of a thing, wouldn’t it? If this in fact turned out to be 90% effective. Quite the stroke of luck, if a technique that has been tried many times, but has never before resulted in a successful human vaccine, somehow manages to knock it out of the park, just when we really need it. The very first time it ever works, and it produces something akin to a miracle. And be easy to distribute using ordinary off-the-shelf freezers, to boot.
The boy who cried “wolf”
To me, this highlights one of the many problems with having a President who’s a habitual liar and who routinely abuses the power of the office. This might be a really beneficial thing. Or it might be a sham. But, unfortunately, given the people holding the levers of power right now, you’re going to have to take a guess as to which it is. Due in large part to that extensive record of lies. You’d be borderline crazy to take the President’s word for it.
I’ve already stated my criterion. If they distribute the vaccine in a reasonable, equitable, and politics-blind manner, I’ll interpret that to mean that it’s not much good. Because if the vaccine is effective, I just can’t see this administration giving up such a great opportunity to reward allies and punish enemies.
