UPDATE: Thanks to a commenter for finding the study protocol for the Pfizer study. That helps a lot.
1. If you assume that everyone is identical, and if you want to try to eradicate the virus by giving everyone the vaccine, then you don’t need to show that it is 90 percent effective. My guess is that 20 percent effectiveness will do the trick. The problem you face is a PR problem. Most people hear the word “vaccine” and think “super-power that keeps me from getting sick.” But to be honest you would have to say “You might still get sick, but if everyone takes the vaccine and also exercises some degree of precaution, the virus will die out and eventually you won’t have to worry about it.”
2. But if your goal with the virus is to target high-risk populations or people whose working conditions might expose them to high viral loads and make them safe, then you want the super-power story to be true. I would want to see that high viral load does not degrade the effectiveness of the vaccine, and I would want to see that being in a high-risk category does not degrade the effectiveness of the vaccine.
3. The most I can find out about the Pfizer study is from this press release.
The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.
There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.
There are a number of comparisons you could make between the placebo group and the treatment group.
–number of people who tested positive for the virus
–number of people who tested positive and showed symptoms (this appears to be what they used)
–number of “severe cases” (this was reported in the press release)
–number of hospitalizations (is this the same as “severe cases”?)
–number of deaths
Suppose that nobody in either group died from the virus. A headline that says “Vaccine prevents zero deaths” would not be very inspiring, would it?
When a study can look at many possible outcome measures and chooses to report only those that favor the drug, this is known as p-hacking. I don’t know that Pfizer was p-hacking, but I don’t know that they weren’t.
UPDATE: the protocol specified the outcome measures in advance, so no p-hacking.
The context here is one in which people who spread the virus differ greatly in their ability to spread it (at least, that seems like a good guess), and people who come in contact with the virus differ greatly in the extent to which they get sick. In that context, a ratio of 162/22000 compared to 8/22000 is promising but not definitive. I would be much more impressed if it were 1620/22000 and 80/22000. With the smaller numbers, I can think of a dozen ways to get those results without the vaccine actually being effective.
UPDATE: Now that I have seen the protocol, I can go back to the first two points. For the purpose of trying to eradicate the virus with universal vaccination, you don’t need much efficacy. But I think you want to be really, really, confident that there is some efficacy, because otherwise you will have blown it with the public if your vaccine campaign does not eradicate the virus. If I were the public official in charge of making the decision, I would want to see a larger number of cases in the sample before I would make this kind of a bet.
For the purpose of protecting vulnerable populations, you need to conduct a different protocol, in my opinion. Again, you want to know how the vaccine does as viral load goes up and as vulnerability of the individual goes up. I think that would argue for a different study protocol altogether.