Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 5 of 7)

18.2 Efficacy of Primary Series in Children 5 Through 11 Years of Age

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.

Table 5: Demographics Characteristics – Participants Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 – 5 Through 11 Years of Age – Evaluable Efficacy Population
Pfizer-BioNTech COVID-19 Vaccine * 10 mcg/Dose (N =1305)n (%) Placebo (N =663) n (%)
*
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
N = number of participants in the specified group from the evaluable efficacy population with no evidence of SARS CoV-2 infection prior to 7 days after Dose 2. This value is the denominator for the percentage calculations. Evaluable efficacy population included all eligible randomized participants who received all vaccination(s) as randomized within the predefined window, had no other important protocol deviations as determined by the clinician.
n = Number of participants with the specified characteristic.
§
Includes multiracial and not reported.
Number of participants who have 1 or more comorbidities that increase the risk of severe COVID-19 disease: defined as participants who had at least 1 of the prespecified comorbidities based on MMWR 69(32);1081–1088 and/or obesity (BMI ≥ 95th percentile).
Sex
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)
Median 8.0 8.0
Min, max (5, 11) (5, 11)
Race
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)
Ethnicity
Hispanic or Latino 243 (18.6) 130 (19.6)
Not Hispanic or Latino 1059 (81.1) 533 (80.4)
Not reported <1.0% <1.0%
Comorbidities
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.

Table 6: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection Prior to 7 Days After Dose 2 – Phase 2/3 –Children 5 Through 11 Years of Age Evaluable Efficacy Population
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).
*
Participants who had no evidence 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 prior to 7 days after Dose 2 were included in the analysis.
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
N = Number of participants in the specified group.
§
n1 = Number of participants meeting the endpoint definition.
Total surveillance time in 1000 person-years for the given endpoint across all participants within each group at risk for the endpoint. Time period for COVID-19 case accrual is from 7 days after Dose 2 to the end of the surveillance period.
#
n2 = Number of participants at risk for the endpoint.
Children 5 through 11 years of age 30.322 (1273) 160.159 (637) 90.7(67.7, 98.3)

18.3 Immunogenicity of Primary Series in Children 5 Through 11 Years of Age

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).

Table 7: SARS-CoV-2 GMTs (NT50) at 1 Month After Primary Series – Immunobridging Subset — Participants 5 Through 11 Years of Age (Study 3) and Participants 16 Through 25 Years of Age (Study 2) – Without Evidence of SARS-CoV-2 Infection up to 1 Month After Dose 2 – Evaluable Immunogenicity Population
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.
*
GMT ratio and 2-sided 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (Group 1 [5 through 11 years of age] — Group 2 [16 through 25 years of age]) and the corresponding CI (based on the Student t distribution).
Immunobridging is declared if the lower bound of the 2-sided 95% CI for the GMT ratio is greater than 0.67 and the point estimate of the GMR is ≥0.8.
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
§
n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time point.
Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
#
Protocol-specified timing for blood sample collection.
Þ
GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the titers and the corresponding CIs (based on the Student t distribution). Assay results below the LLOQ were set to 0.5 × LLOQ.
ß
SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
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)
Table 8: Percentages of Participants with Seroresponse at 1 Month After Primary Series – Immunobridging Subset –Participants 5 Through 11 Years of Age (Study 3) and Participants 16 Through 25 Years of Age (Study 2) Without Evidence of Infection up to 1 Month After Dose 2 – Evaluable Immunogenicity Population
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.
*
Difference in proportions, expressed as a percentage (Group 1 [5 through 11 years of age] – Group 2 [16 through 25 years of age]).
2-Sided CI, based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage.
Immunobridging is declared if the lower bound of the 2-sided 95% CI for the difference in proportions is greater than -10.0%.
§
Pfizer-BioNTech COVID-19 Vaccine (10 mcg modRNA).
N = number of participants with valid and determinate assay results both before vaccination and at 1 month after Dose 2. These values are the denominators for the percentage calculations.
#
Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
Þ
Protocol-specified timing for blood sample collection.
ß
n = Number of participants with seroresponse for the given assay at the given dose/sampling time point.
à
Exact 2-sided CI based on the Clopper and Pearson method.
è
SARS-CoV-2 NT50 were determined using the SARS-CoV-2 mNeonGreen Virus Microneutralization Assay. The assay uses a fluorescent reporter virus derived from the USA_WA1/2020 strain and virus neutralization is read on Vero cell monolayers. The sample NT50 is defined as the reciprocal serum dilution at which 50% of the virus is neutralized.
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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