Table 3. Vaccine Efficacy against Covid-19 in Participants 12 to 15 Years of Age.*.
Efficacy End Point† | BNT162b2 | Placebo | % Vaccine Efficacy (95% CI)‡ | ||
---|---|---|---|---|---|
No. of Participants with Event/Total No.§ | Surveillance Time (No. at Risk)¶ | No. of Participants with Event/Total No.§ | Surveillance Time (No. at Risk)¶ | ||
Covid-19 occurrence at least 7 days after dose 2 in participants without evidence of previous infection | 0/1005 | 0.154 (1001) | 16/978 | 0.147 (972) | 100 (75.3–100) |
Covid-19 occurrence at least 7 days after dose 2 in participants with or without evidence of previous infection | 0/1119 | 0.170 (1109) | 18/1110 | 0.163 (1094) | 100 (78.1–100) |
Results are for the efficacy population that could be evaluated, which included all eligible 12-to-15-year-old participants who received two doses of BNT162b2 or placebo as randomly assigned, with dose 2 received within the prespecified window, and had no major protocol deviations.
Participants without evidence of previous infection were those who had no serologic or virologic evidence of past SARS-CoV-2 infection before 7 days after dose 2 (i.e., N-binding antibody testing [serum] negative at vaccination visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at vaccination visits 1 and 2) and had negative NAAT results (nasal swab) at any unscheduled visit before 7 days after dose 2.
The 95% confidence interval for vaccine efficacy was derived on the basis of the Clopper–Pearson method with adjustment for surveillance time.
The number of participants with a first occurrence of Covid-19 at 7 or more days after dose 2 and the total number of participants with data are shown.
Total surveillance time in 1000 person-years for the given end point across all participants within each group of participants who were at risk for the end point is shown. The period for Covid-19 case accrual was from 7 days after dose 2 to the end of the surveillance period.