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. 2021 May 27:NEJMoa2107456. doi: 10.1056/NEJMoa2107456

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.