Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 10 of 14)

14.6 Immunogenicity of Pfizer-BioNTech COVID-19 Vaccine Administered as a First Booster Dose Following a Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Participants 18 Through 55 Years of Age

Effectiveness of a single and additional doses of Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA) was based on an assessment of NT50 against SARS-CoV-2 (USA_WA1/2020). In Study 2, analyses of NT50 1 month after the booster dose compared to 1 month after the primary series in individuals 18 through 55 years of age who had no serological or virological evidence of past SARS-CoV-2 infection up to 1 month after the booster vaccination demonstrated noninferiority for both GMR and difference in seroresponse rates. Seroresponse for a participant was defined as achieving a ≥4-fold rise in NT50 from baseline (before primary series). These analyses are summarized in Table 35 and Table 36.

Table 35: Geometric Mean 50% Neutralizing Titer (SARS-CoV-2 USA_WA1/2020) – Comparison of 1 Month After Booster Dose to 1 Month After Primary Series – Participants 18 Through 55 Years of Age Without Evidence of Infection up to 1 Month After Booster Dose * – Booster Dose Evaluable Immunogenicity Population
Assay n 1 Month After Booster Dose GMT § (95% CI § ) 1 Month After Primary Series GMT § (95% CI § ) 1 Month After Booster Dose/ 1 Month After Primary Series GMR (97.5% CI ) Met Noninferiority Objective # (Y/N)
Abbreviations: CI = confidence interval; GMR = geometric mean ratio; GMT = geometric mean titer; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no.Note: Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
*
Participants who had no serological or virological evidence (up to 1 month after receipt of a booster dose of Pfizer-BioNTech COVID-19 Vaccine) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected by NAAT [nasal swab]) and had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after the booster dose were included in the analysis.
All eligible participants who had received 2 doses of Pfizer-BioNTech COVID-19 Vaccine as initially randomized, with Dose 2 received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Pfizer-BioNTech COVID-19 Vaccine, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection within an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as determined by the clinician.
n = Number of participants with valid and determinate assay results at both sampling time points within specified window.
§
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.
GMRs and 2-sided 97.5% CIs were calculated by exponentiating the mean differences in the logarithms of the assay and the corresponding CIs (based on the Student t distribution).
#
Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the GMR is >0.67 and the point estimate of the GMR is ≥0.80.
Þ
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)Þ

212

2466.0(2202.6, 2760.8)

750.6(656.2, 858.6)

3.29(2.77, 3.90)

Y

Table 36: Seroresponse Rate for 50% Neutralizing Titer (SARS-CoV-2 USA_WA1/2020) – Comparison of 1 Month After Booster Dose to 1 Month After Primary Series – Participants 18 Through 55 Years of Age Without Evidence of Infection up to 1 Month After Booster Dose * – Booster Dose Evaluable Immunogenicity Population
Assay N 1 Month After Booster Dose n § % (95% CI ) 1 Month After Primary Series n § % (95% CI ) Difference (1 Month After Booster Dose — 1 Month After Primary Series) % # (97.5% CI Þ ) Met Noninferiority Objective ß (Y/N)
Abbreviations: CI = confidence interval; LLOQ = lower limit of quantitation; N-binding = SARS-CoV-2 nucleoprotein-binding; NAAT = nucleic acid amplification test; NT50 = 50% neutralizing titer; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; Y/N = yes/no.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 seroresponse.Note: Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
*
Participants who had no serological or virological evidence (up to 1 month after receipt of booster vaccination) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] negative and SARS-CoV-2 not detected by NAAT [nasal swab]) and had a negative NAAT (nasal swab) at any unscheduled visit up to 1 month after booster vaccination were included in the analysis.
All eligible participants who had received 2 doses of Pfizer-BioNTech COVID-19 Vaccine as initially randomized, with Dose 2 received within the predefined window (within 19 to 42 days after Dose 1), received a booster dose of Pfizer-BioNTech COVID-19 Vaccine, had at least 1 valid and determinate immunogenicity result after booster dose from a blood collection within an appropriate window (within 28 to 42 days after the booster dose), and had no other important protocol deviations as determined by the clinician.
N = number of participants with valid and determinate assay results for the specified assay at baseline, 1 month after Dose 2 and 1 month after the booster dose within specified window. These values are the denominators for the percentage calculations.
§
n = Number of participants with seroresponse for the given assay at the given dose/sampling time point.
Exact 2-sided CI based on the Clopper and Pearson method.
#
Difference in proportions, expressed as a percentage (1 month after booster dose – 1 month after Dose 2).
Þ
Adjusted Wald 2-sided CI for the difference in proportions, expressed as a percentage.
ß
Noninferiority is declared if the lower bound of the 2-sided 97.5% CI for the percentage difference is > -10%.
à
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)à

200

19999.5 (97.2, 100.0)

19698.0 (95.0, 99.5)

1.5(-0.7, 3.7)

Y

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