Nobody appears to have any evidence that the vaccine is either dangerous or ineffective. What people are complaining about is a lack of evidence in the other direction, both because the Russians have not been publishing information on their research and because it is being brought out prior to the usual stage three testing. My conclusion, assuming as seems likely that Putin has or could hire competent people to develop a vaccine, is that it will probably work and probably not have serious side effects.
My basis for that is what I have read about the other vaccine projects. It seems clear that everyone else is being very careful, unwilling to bring out a vaccine until they are virtually certain of both effectiveness and safety. A vaccine that has passed the stage two testing is probably safe and probably effective, but probably is not sufficient.
Insisting that you have to be certain a drug is safe is good rhetoric but bad science, since safety is not an option. To see whyy, consider the case of Diethylstilbestrol (DES), a fertility drug that turned out to produce medical complications in the daughters of some of the women who had taken it. The complications took a minimum of ten to twelve years to appear and the most serious, a form of cancer, appeared, according to varying estimates, in between one in 250 and one in 10,000 of the daughters. In order to be sure a drug did not have such an effect it would be necessary to give it to something upwards of a hundred thousand pregnant women then wait fifteen years or so and do extensive analysis of the medical problems of their children. Applying that standard to protecting against every long-term risk one could think of would make the production of new medical drugs very nearly impossible.
The current global death rate from Covid is about six thousand a day, so each month by which the introduction of a virus is delayed costs about 180,000 lives. That, plus other costs associated with the pandemic, should be set against the risks of introducing a vaccine earlier, when we can be less certain of its safety and efficacy. I do not know enough about the risks of vaccines that have passed the stage one and stage two tests, how serious and how likely they are, to judge whether the caution exhibited by everyone except the Russians would or would not pass a cost/benefit test, and I doubt that current policies are based on any such calculation. But, given how cautious everyone else is being, I doubt that the risk of serious side effects is as much as 25%. If I am correct, the odds are that Putin's decision will turn out to be correct ex post, whether or not it was correct ex ante.
9 comments:
Of course.
Unfortunately, regulators are far more interested in covering their candy asses than in prevention of needless death and disease.
That's the whole idea behind the "precautionary principle" - that it's better for other people to suffer the slings and arrows of outrageous fortune, than to take responsibility for imperfect attempts to take arms against them.
We have a serious disconnect between the interests of the public and the interests of regulators.
> I do not know enough about the risks of vaccines that have passed the stage one and stage two tests, how serious and how likely they are, to judge whether the caution exhibited by everyone except the Russians would or would not pass a cost/benefit test, and I doubt that current policies are based on any such calculation.
And this is why ignoring economists is usually the best course of action.
Armchair bullshit with no investment, but "it stands to reason, doesn't it?" And I've never seen you mark your nonsense to market after your barroom speculation.
Though I mostly agree -- stage-2 success should provide quite a bit of faith -- I think you are too cavalier about quantifying the benefits of a partially effective vaccine. In particular, it will lead to behavioral changes and these could be highly influential. This is the sort of complete analysis I would typically expect to see here.
"A vaccine that has passed the stage two testing is probably safe and probably effective"
I think your bar for "probability" might be low?
From Wikipedia:
As of 2010, about 50% of drug candidates either fail during the Phase III trial or are rejected by the national regulatory agency. For vaccines, the probability of success ranges from 7% for non-industry-sponsored candidates to 40% for industry-sponsored candidates.
Tom Hudson,
That is not correct.
You have left out a paragraph break between your two sentences. The second paragraph is not about completing phase 3, but 1+2+3. According to the source, the success rate at phase 3 (PoS3A) is 40% for non-industry and 80% for industry. (Probably we should restrict to diseases that humans naturally fight off and not long-shots like HIV. But if we restrict to respiratory diseases, the numbers don't change, still 40/80.)
Is Russia actually doing anything differently than anyone else?
How many people are they giving the vaccine?
I doubt that they are distributing it more than 10x as fast as vaccines that are distributed via phase 3 trials. The Russian company said that it could produce a million doses a year, which is probably not enough to do much. That's 100k/month. Is Russia actually distributing that many? I thought that the trials were aiming for more than 10k/month, but I haven't been able to verify they've achieved that speed.
...
Phase 2 doesn't really attempt to measure efficacy. For vaccines, you can measure whether people are producing antibodies, which is something, but really not enough.
Since you have to vaccinate a lot of people to save a single person from covid, a small chance of side effects is a big deal. You want a very low level of side effects before you vaccinate the world. You might accept a higher rate of side effects (or ignorance) in vaccinating health care workers, especially nursing home workers. But you want to be very sure that the vaccine doesn't cause covid.
This sounds like both a question of institutional incentives, and one of biology. While it's pretty clear that many drug regulators have institutional incentives that slow drug development, there's also the prestige incentive of being the first to approve a vaccine: It's plausible that the Russian government is over-eager. In terms of the biology, the failure rate is quite high, so in the absence of unusual evidence in support of this vaccine, I'd have to guess that it either has unfortunate side effects or fails to provide sufficient immunity. (That is, why should it be any different that most vaccine candidates?) The standard testing regime is to ramp up testing for a reason: If you test with 10 subjects, you'll tend to find problems that affect 1 in 10, then test with 100, then 1000, and so on, so as to avoid large scale problems. In pharma, that's fairly well approximated with phase I, phase II, and phase III trials, with some adjustments because you need to know safety first, and the question of effectiveness can wait for phase III. In this case, the phase III trials haven't been run yet, and the data hasn't been shared -- so which is the more plausible story: Overeager announcement, or excessive caution everywhere else?
Applying that standard to protecting against every long-term risk one could think of would make the production of new medical drugs very nearly impossible.
Correct. That's why the endpoints of a Phase 1 clinical trial are near-term safety (obviously) and estimating the dose-response curve. So assessing safety is an option and not bad science.
A vaccine that has passed the stage two testing is probably safe and probably effective, but probably is not sufficient
"Probably?" You're comfortable describing an outcome (P2->P3) achieved only 58% of the time as probable?
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