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PF-07302048 (BNT162 RNA-Based COVID-19 Vaccines)
Protocol C4591001

Table 7. Statistical Design Operating Characteristics: Probability of Success or
Failure for Interim Analyses

Vaccine Interim Analysis 1 Interim Analysis 2 Interim Analysis 3 Interim
Efficacy (Total Cases = 32) (Total Cases = 62) (Total Cases = 92) Analysis 4
(%) (Total Cases
= 120)
Probability Probability Probability Probability Probability Probability Probability of
of Success of Failure of Success of Failure of Success of Failure Success
(Cases in (Cases in (Cases in (Cases in (Cases in (Cases in (Cases
Vaccine Vaccine Vaccine Vaccine Vaccine Vaccine Vaccine
Group ≤6) Group ≥15) Group ≤15) Group ≥26) Group ≤25) Group ≥35) Group ≤35)
30 0.006 0.315 0.003 0.231 0.002 0.239 0.002
50 0.054 0.078 0.051 0.056 0.063 0.103 0.075
60 0.150 0.021 0.160 0.010 0.175 0.019 0.160
70 0.368 0.003 0.310 <0.001 0.195 0.001 0.085
80 0.722 <0.001 0.238 <0.001 0.037 <0.001 0.003

Table 8. Statistical Design Operating Characteristics: Probability of Success for
Final Analysis and Overall

Vaccine Efficacy (%) Final Analysis Overall Probability of Success
(Total Cases = 164)
Probability of Success (Cases in Vaccine
Group ≤53)
30 0.007 0.021
50 0.196 0.439
60 0.220 0.866
70 0.036 >0.999
80 <0.001 >0.999

If neither success nor futility has been declared after all IAs, the final analysis will be
performed and the first primary objective will have been met if there are 53 or fewer cases
observed in the vaccine group out of a total of 164 first confirmed cases from 7 days after
receipt of the second dose of investigational product onwards.

Only the first primary endpoint will be analyzed at IA. If the first primary objective is met,
the second primary objective will be evaluated at the final analysis. After the primary
objectives are met, the first 6 secondary VE endpoints (confirmed COVID-19 occurring from
14 days after the second dose in participants without evidence of infection and in all
participants, confirmed severe COVID-19 occurring from 7 days and from 14 days after the
second dose in participants without evidence of infection and in all participants) will be
evaluated sequentially in the stated order, by the same method used for the evaluation of
primary VE endpoints. Success thresholds for secondary VE endpoints will be appropriately
chosen to control overall Type I error at 2.5%. Further details will be provided in the SAP.
The remaining secondary VE endpoints will be evaluated descriptively to calculate the
observed VE with 95% CIs.

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