Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 8 of 14)

14.4 Immunogenicity of 2-Dose Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Participants 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 28 and Table 29).

Table 28: 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
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 (5 through 11 years of age minus 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.

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 Age n § =264

30 mcg/Dose 16 Through 25 Years of Age n § =253

Assay

Time Point #

GMT Þ (95% CI Þ )

GMT Þ (95% CI Þ )

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 29: Difference in 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
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 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.
*
Difference in proportions, expressed as a percentage (5 through 11 years of age minus 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% provided that the immunobridging criteria based on GMR were met.
§
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.

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 Age N =264

30 mcg/Dose # 16 Through 25 Years of Age N =253

Assay

Time Point Þ

n ß (%)(95% CI à )

n ß (%) (95% CI à )

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)

VxLabels.com provides trustworthy package insert and label information about marketed drugs and vaccines as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VxLabels.com. Every individual vaccine label and package insert entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

https://vxlabels.com/lib/vaccines/vax/pfizer-biontech-covid-19-vaccine-bivalent/page/8/

Clinical Trials

Vx Labels

Vaccine Sections

Vaccine Information by RSS

About

As the leading independent provider of trustworthy vaccine information, our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VxLabels.com provides the full vaccine subset of the FDA's repository. Vaccine information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2023. All Rights Reserved.