Vaccine Information: Comirnaty (Page 4 of 5)
14.2 Efficacy in Adolescents 12 Through 15 Years of Age
A descriptive efficacy analysis of Study 2 has been performed in 2,260 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of September 2, 2021.
The vaccine efficacy information in adolescents 12 through 15 years of age is presented in Table 9.
Note: Confirmed cases were determined by Reverse Transcription-Polymerase Chain Reaction (RT-PCR) and at least 1 symptom consistent with COVID-19 (symptoms included: fever; new or increased cough; new or increased shortness of breath; chills; new or increased muscle pain; new loss of taste or smell; sore throat; diarrhea; vomiting). | |||
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First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age without evidence of prior SARS-CoV-2 infection * | |||
Vaccine Efficacy % (95% CI # ) | |||
Adolescents12 through 15 years of age | 00.343 (1043) | 280.322 (1019) | 100.0(86.8, 100.0) |
First COVID-19 occurrence from 7 days after Dose 2 in adolescents 12 through 15 years of age with or without evidence of prior SARS-CoV-2 infection | |||
Vaccine Efficacy % (95% CI # ) | |||
Adolescents12 through 15 years of age | 00.362 (1098) | 30Þ0.345 (1088) | 100.0(87.5, 100.0) |
14.3 Immunogenicity in Adolescents 12 Through 15 Years of Age
In Study 2, an analysis of SARS-CoV-2 50% neutralizing titers (NT50) 1 month after Dose 2 in a randomly selected subset of participants demonstrated non-inferior immune responses (within 1.5-fold) comparing adolescents 12 through 15 years of age to participants 16 through 25 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after Dose 2 (Table 10).
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; NAAT = nucleic-acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2. | ||||||
Note: Participants who had no serological or virological evidence (up to 1 month after receipt of the last dose) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2), and had negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 were included in the analysis. | ||||||
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COMIRNATY | ||||||
12 Through 15 Years n * =190 | 16 Through 25 Years n * =170 | 12 Through 15 Years/ 16 Through 25 Years | ||||
Assay | Time Point † | Met Noninferiority Objective ¶ (Y/N) | ||||
SARS-CoV-2 neutralization assay — NT50 (titer)# | 1 month after Dose 2 | 1253.6(1117.7, 1406.1) | 708.1(625.9, 801.1) | 1.77(1.50, 2.09) | Y |
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