A descriptive efficacy analysis of Study 3 has been performed in 1,968 children 5 through 11 years of age without evidence of infection prior to 7 days after Dose 2. This analysis evaluated confirmed symptomatic COVID-19 cases accrued up to a data cutoff date of October 8, 2021.
Table 5 presents the specific demographic characteristics in participants who did not have evidence of prior infection with SARS-CoV-2 through 7 days after the second dose.
|Pfizer-BioNTech COVID-19 Vaccine * 10 mcg/Dose (N †=1305)n ‡ (%)||Placebo (N †=663) n ‡ (%)|
|Male||679 (52.0)||343 (51.7)|
|Female||626 (48.0)||320 (48.3)|
|Age at Vaccination|
|Mean (SD)||8.2 (1.93)||8.1 (1.98)|
|Min, max||(5, 11)||(5, 11)|
|White||1018 (78.0)||514 (77.5)|
|Black or African American||76 (5.8)||48 (7.2)|
|American Indian or Alaska Native||<1.0%||<1.0%|
|Asian||86 (6.6)||46 (6.9)|
|Native Hawaiian or other Pacific Islander||<1.0%||<1.0%|
|Other §||110 (8.4)||52 (7.8)|
|Hispanic or Latino||243 (18.6)||130 (19.6)|
|Not Hispanic or Latino||1059 (81.1)||533 (80.4)|
|Yes||262 (20.1)||133 (20.1)|
|No||1043 (79.9)||530 (79.9)|
The descriptive vaccine efficacy results in children 5 through 11 years of age without evidence of prior SARS-CoV-2 infection are presented in Table 6. None of the cases accrued met criteria for severe COVID-19 or multisystem inflammatory syndrome in children (MIS-C). No cases of COVID-19 were observed in either the vaccine group or the placebo group in participants with evidence of prior SARS-CoV-2 infection.
|First COVID-19 occurrence from 7 days after Dose 2 in children 5 through 11 years of age without evidence of prior SARS-CoV-2 infection *|
|Pfizer-BioNTech COVID-19 Vaccine †10 mcg/doseN ‡=1305Casesn1§Surveillance Time ¶ (n2#)||PlaceboN ‡=663Casesn1§Surveillance Time ¶ (n2#)||Vaccine Efficacy %(95% CI)|
|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).|
|Children 5 through 11 years of age||30.322 (1273)||160.159 (637)||90.7(67.7, 98.3)|
SARS-CoV-2 50% neutralizing antibody titers (NT50) 1 month after the primary series were compared between randomly selected subsets of Phase 2/3 participants 5 through 11 years of age from study C4591007 and the efficacy study C4591001 Phase 2/3 participants 16 through 25 years of age, using a microneutralization assay against the reference strain (USA_WA1/2020). The primary immunobridging analyses compared the geometric mean titers (using a geometric mean ratio [GMR]) and the seroresponse (defined as achieving at least 4-fold rise in SARS-CoV-2 NT50 from before Dose 1) rates in the evaluable immunogenicity population of participants without evidence of prior SARS-CoV-2 infection up to 1 month after Dose 2 in each group. The prespecified immunobridging criteria were met for both the GMR and the seroresponse difference (Table 7 and Table 8).
|Pfizer-BioNTech COVID-19 Vaccine||GMT Ratio (95%CI)(5 Through 11 Years of Age/ 16 Through 25 Years of Age)*, †|
|10 mcg/Dose ‡5 Through 11 Years of Agen §=264||30 mcg/Dose ¶16 Through 25 Years of Agen §=253|
|Assay||Time Point #||GMT Þ(95% CI Þ)||GMT Þ(95% CI Þ)|
|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 post-Dose 2 blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at pre-Dose 1 and 1 month after Dose 2, SARS-CoV-2 not detected by NAAT [nasal swab] at pre-Dose 1 and pre-Dose 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis.|
|SARS-CoV-2 neutralization assay — NT50 (titer)ß||1 month after Dose 2||1197.6(1106.1, 1296.6)||1146.5(1045.5, 1257.2)||1.04(0.93, 1.18)|
|Pfizer-BioNTech COVID-19 Vaccine||Difference in Seroresponse Rates %* (95% CI †)(5 Through 11 Years of Age minus 16 Through 25 Years of Age)‡|
|10 mcg/Dose §5 Through 11 Years of AgeN ¶=264||30 mcg/Dose #16 Through 25 Years of AgeN ¶=253|
|Assay||Time Point Þ||n ß (%)(95% CI à)||n ß (%)(95% CI à)|
|Abbreviations: LLOQ = lower limit of quantitation; NAAT = nucleic acid amplification test; N-binding = SARS-CoV-2 nucleoprotein–binding; NT50 = 50% neutralizing titer 50; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.Note: Seroresponse is defined as achieving a ≥4-fold rise from baseline (before Dose 1). If the baseline measurement is below the LLOQ, a postvaccination assay result ≥4 × LLOQ is considered a seroresponseNote: Participants who had no serological or virological evidence (up to 1 month post-Dose 2 blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative at Visit 1 and 1 month after Dose 2, SARS-CoV-2 not detected by NAAT [nasal swab] at Visits 1 and 2, and negative NAAT (nasal swab) at any unscheduled visit up to 1 month after Dose 2 blood collection) and had no medical history of COVID-19 were included in the analysis.|
|SARS-CoV-2 neutralization assay — NT50 (titer)è||1 month after Dose 2||262 (99.2)(97.3, 99.9)||251 (99.2)(97.2, 99.9)||0.0(-2.0, 2.2)|
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