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).|
|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 *|
|COMIRNATYN †=1057Casesn1‡Surveillance Time § (n2¶)||PlaceboN †=1030Casesn1‡Surveillance Time § (n2¶)||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|
|COMIRNATYN †=1119Casesn1‡Surveillance Time § (n2¶)||PlaceboN †=1109Casesn1‡Surveillance Time § (n2¶)||Vaccine Efficacy %(95% CI #)|
|Adolescents12 through 15 years of age||00.362 (1098)||30Þ0.345 (1088)||100.0(87.5, 100.0)|
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).
|COMIRNATY||12 Through 15 Years/16 Through 25 Years|
|12 Through 15 Yearsn *=190||16 Through 25 Yearsn *=170|
|Assay||Time Point †||GMT ‡(95% CI ‡)||GMT ‡(95% CI ‡)||GMR §(95% CI §)||Met Noninferiority Objective ¶(Y/N)|
|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.|
|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|
COMIRNATY Suspension for Intramuscular Injection, multiple dose vials with gray caps and labels with gray borders are supplied in a carton containing 10 multiple dose vials (NDC 0069-2025-10) or 25 multiple dose vials (NDC 0069-2025-25).
One vial contains 6 doses of 0.3 mL.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial Storage Prior to Use
Cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders will arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F). Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
If cartons of COMIRNATY multiple dose vials with gray caps and labels with gray borders are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.
Vial Storage During Use
If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.
COMIRNATY multiple dose vials with gray caps and labels with gray borders may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the vial should be held between 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture.
DO NOT DILUTE PRIOR TO USE.
Transportation of Vials
If local redistribution is needed, vials may be transported at -90°C to -60°C (-130°F to -76°F), or at 2°C to 8°C (35°F to 46°F).
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