Calculate vaccine efficacy confidence Interval using the exact method

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I'm trying to calculate confidence intervals for vaccine efficacy studies.

All the studies I am looking at claim that they use the Exact method and cite this free PDF: Statistical Methods in Cancer Research Volume II: The Design and Analysis of Cohort Studies It is my understanding that the exact method is also sometimes called the Clopper Pearson method.

The data I have is: Person-years of vaccinated, Person-years of unvaccinated, Number of cases among vaccinated, Number of cases among unvaccinated,

Efficacy is easy to calculate: 1 - ( (Number of cases among vaccinated/Person-years of vaccinated) / (Number of cases among unvaccinated/Person-years of unvaccinated) ) * 100

But calculating the confidence interval is harder.

At first I thought that this website gave the code I needed:

testall <- binom.test(8, 8+162)
(theta <- testall$conf.int)
(VE <- (1-2*theta)/(1-theta))

In this example, 8 is the number of cases in the vaccinated group and 162 is the number of cases in the unvaccinated group. But I have had a few problems with this.

(1) there are some studies where the size of the two cohorts (vaccinated vs. not vaccinated) are different. I don't think that this code works for those cohorts. (2) I want to be able to adjust the type of confidence interval. For example, one study used "one-sided α risk of 2·5%" where as another study used "a two-sided α level of 5%". I'm not clear if this effects the numbers.

Either way, when I tried to run the numbers, it didn't work.

Here is an example of a data sets I am trying to validate:

  • Number of cases among vaccinated: 176
  • Number of cases among unvaccinated: 221
  • Person-years of vaccinated: 11,793
  • Person-years of unvaccinated: 5,809

Efficacy: 60.8 95%

Two sided 95% CI: 52.0–68.0

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