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Table 1: Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 – 
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset) – Safety Population ............................................ 2  
                       
090177e19939f70a\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0235489
                                 
Summary of Differences Between CSR Reactogenicity Data and Updated Reactogenicity Data for Study C4591001 –  
Subjects 12 Through 15 and 16 Through 25 Years of Age (Reactogenicity Subset)  – Safety Population  
                Vaccine Group (as Administered)  
 BNT162b2 (30 μg)  Placebo  
 12-15 Years  16-25 Years  12-15 Years  16-25 Years  
Number of total reactogenicity records  173851  81933  173007  84472  
Number (%) records affecteda 80 (0.05)  118 (0.14)  31 (0.02)  27 (0.03)  
Number of subjects  1131  536 1129  561 
Number (%) subjects with any records affected  14 (1.24)  23 (4.29)  11 (0.97)  10 (1.78)  
Maximum difference (updated data -CSR data) across any local reaction term of the percentage of 
subjects with a local reaction within 7 days of first vaccinationb  0.18 0.03 0.35 0.36 
Maximum difference (updated data -CSR data) across any local reaction term of the percentage of 
subjects with a local reaction within 7 days of second vaccinationb  0.09 0.19 0.08 0.20 
Maximum difference (updated data -CSR data) across any systemic event term of the percentage 
of subjects with a systemic event within 7 days of  first vaccinationb  0.09 0.17 0.09 0.00 
Maximum difference (updated data -CSR data) across any systemic event term of the percentage 
of subjects with a systemic event within 7 days of second vaccinationb  0.30 0.78 0.15 0.20 
Maximum difference (updated data -CSR data) across any local reaction term of the duration in 
mean days following first vaccinationb  0.00 0.01 -0.01 0.09 
Maximum difference (updated data -CSR data) across any local reaction term of the duration in 
mean days following  second vaccinationb  0.01 0.05 0.01 0.00 
Maximum difference (updated data -CSR data) across any systemic event term of the duration in 
mean days following first vaccinationb  0.01 0.03 0.02 0.00 
Maximum difference (updated data -CSR data) across any systemic event term of the duration in 
mean days following second vaccinationb  0.01 0.08 -0.01 -0.13 
Difference (updated data -CSR data) of number of subjects with a duration of a ny local reaction 
>7 days following either vaccination  0 0 0 0 
Difference (updated data -CSR data) of number of subjects with a duration of a ny systemic event 
>7 days following either vaccination  0 1 0 0 
Abbreviations: CRF  = case report form; CSR = clinical study report  
Note: CSR data is data reported in the CSR that was entered into the electronic diary by the subject and symptom resolved page by the investigator. Updated data 
is the CSR data and the reactogenicity data entered in the AE log CRF page by the investigator.  
a. An affected record is any record that changed during the reactogenicity update.  
b. Maximum difference is displayed as a percentage and is for reactogenicity data.  
 
 
090177e19939f70a\Final\Final On: 31-Jan-2022 15:29 (GMT)
FDA-CBER-2022-5812-0235490