125742 S51 M5 5351 c4591001 followup table

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Follow -up Time After Dose 2 – Phase 2/3 Subjects ≥16 Years of Age and With or Without Evidence of Infection Prior to 7 
Days After Dose 2 – Evaluable Efficacy (7 Days) Populatio n 
  Vaccine Group (as Randomized)  
   
  BNT162b2 (30 μg)  
(Na=21047)  
nb (%) Placebo  
(Na=21210)  
nb (%) Total  
(Na=42257)  
nb (%) 
   
Subjects (%) with length of follow -up of:        
Original blinded placebo -controlled follow -up period        
    <2 Months  840 (4.0)  910 (4.3)  1750 (4.1)  
    ≥2 Months to <4 months  7411 (35.2)  7851 (37.0)  15262 (36.1)  
    ≥4 Months to <6 months  11031 (52.4)  11158 (52.6)  22189 (52.5)  
    ≥6 Months  1765 (8.4)  1291 (6.1)  3056 (7.2)   
Note: Human immunodeficiency virus (HIV) -positive subjects are not included in this summary.  
a.     N = number of subjects in the specified group, or the total sample. This value is the denominator for the  percentage calculations.  
b.     n = Number of subjects with the specified characteristic.  
PFIZER CONFIDENTIAL SDTM Creation: 25MAR2021 (23:24) Source Data: adsl Table Generation: 13AUG2021 (16:37)  
(Cutoff Date: 13MAR2021, Snapshot Date: 25MAR2021) Outp ut File: ./nda2_unblinded/C4591001_BLA_RR/adsl_fu_d2_p3_nohiv_ge16_eval   
 
090177e197d03bcb\Final\Final On: 16-Aug-2021 00:11 (GMT)
FDA-CBER-2021-5683-0651806