Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Page 5 of 8)

18.2 Efficacy of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Adolescents 12 Through 15 Years of Age

A descriptive efficacy analysis of Study 2 has been performed in approximately 2,200 adolescents 12 through 15 years of age evaluating confirmed COVID-19 cases accrued up to a data cutoff date of March 13, 2021.

The efficacy information in adolescents 12 through 15 years of age is presented in Table 7.

Table 7: Vaccine Efficacy – First COVID-19 Occurrence From 7 Days After Dose 2: Without Evidence of Infection and With or Without Evidence of Infection Prior to 7 Days After Dose 2 – Blinded Placebo-Controlled Follow-up Period, Adolescents 12 Through 15 Years of Age Evaluable Efficacy (7 Days) Population
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 (30 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.
Þ
Confidence interval (CI) for vaccine efficacy is derived based on the Clopper and Pearson method adjusted for surveillance time.
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 *
Pfizer-BioNTech COVID-19 Vaccine N =1005Casesn1§Surveillance Time (n2#) PlaceboN =978Casesn1§Surveillance Time (n2#) Vaccine Efficacy %(95% CI Þ)
Adolescents 12 through 15 years of age 00.154 (1001) 160.147 (972) 100.0(75.3, 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
Pfizer-BioNTech COVID-19 Vaccine N =1119Casesn1§Surveillance Time (n2#) Placebo N =1110Casesn1§Surveillance Time (n2#) Vaccine Efficacy %(95% CI Þ)
Adolescents 12 through 15 years of age 00.170 (1109) 180.163 (1094) 100.0(78.1, 100.0)

18.3 Immunogenicity of Primary Series of Pfizer-BioNTech COVID-19 Vaccine in Adolescents 12 Through 15 Years of Age

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 8).

Table 8: Summary of Geometric Mean Ratio for 50% Neutralizing Titer – Comparison of Adolescents 12 Through 15 Years of Age to Participants 16 Through 25 Years of Age (Immunogenicity Subset) –Participants Without Evidence of Infection up to 1 Month After Dose 2 – Dose 2 Evaluable Immunogenicity Population
Pfizer-BioNTech COVID-19 Vaccine *
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.
*
Pfizer-BioNTech COVID-19 Vaccine (30 mcg modRNA).
n = Number of participants with valid and determinate assay results for the specified assay at the given dose/sampling time point.
Protocol-specified timing for blood sample collection.
§
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 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (12 through 15 years of age minus 16 through 25 years of age) and the corresponding CI (based on the Student t distribution).
#
Noninferiority is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 0.67.
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.
12 Through 15 Yearsn =190 16 Through 25 Yearsn =170 12 Through 15 Years/ 16 Through 25 Years
Assay Time Point GMT §(95% CI §) GMT §(95% CI §) GMR (95% CI ) Met Noninferiority Objective #(Y/N)
SARS-CoV-2 neutralization assay — NT50 (titer)Þ 1 month after Dose 2 1239.5(1095.5, 1402.5) 705.1(621.4, 800.2) 1.76(1.47, 2.10) Y

18.4 Immunogenicity of the Bivalent Vaccine (Original and Omicron BA.1) Administered as a Second Booster Dose

In an analysis of a subset from Study 4, a total of 610 adults greater than 55 years of age who had previously received a 2-dose primary series and 1 booster dose with Pfizer-BioNTech COVID-19 Vaccine received 1 of the following as a second booster dose: Pfizer-BioNTech COVID-19 Vaccine or bivalent vaccine (Original and Omicron BA.1). GMRs and seroresponse rates were evaluated at 1 month after vaccination with the bivalent vaccine (Original and Omicron BA.1). The bivalent vaccine (Original and Omicron BA.1) booster dose was administered 4.7 to 11.5 months (median 6.3 months) after the first booster dose. The Pfizer-BioNTech COVID-19 Vaccine booster dose was administered 5.3 to 13.1 months (median 6.3 months) after the first booster dose.

The primary objective of the study was to assess superiority with respect to level of 50% neutralizing titer (NT50) and noninferiority with respect to seroresponse rate of the anti-Omicron BA.1 immune response induced by a dose of the bivalent vaccine (Original and Omicron BA.1) relative to the response elicited by a dose of Pfizer-BioNTech COVID-19 Vaccine given as a second booster dose in participants greater than 55 years of age.

A secondary objective of the study was to assess noninferiority with respect to level of NT50 to the Original SARS-COV-2 strain induced by a dose of the bivalent vaccine (Original and Omicron BA.1) relative to the response elicited by a dose of Pfizer-BioNTech COVID-19 Vaccine given as a second booster dose. A comparison of seroresponse rates to the Original strain was descriptive.

Superiority of the anti-Omicron BA.1 NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2-sided 95% CI for GMR was >1. Noninferiority of the anti-Original NT50 for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met, as the lower bound of the 2-sided 95% CI for GMR was >0.67 and the point estimate of the GMR was ≥0.8 (Table 9).

Non-inferiority of the seroresponse rate to the Omicron BA.1 variant for the bivalent vaccine (Original and Omicron BA.1) relative to Pfizer-BioNTech COVID-19 Vaccine was met as the lower limit of the 2-sided 95% CI for the difference in percentages of participants with seroresponse is >-5% (Table 10). A descriptive summary of seroresponse to the Original strain is also included in Table 10.

Table 9: Study 4 — Geometric Mean Ratios – Participants Without Evidence of Infection Up to 1 Month After the Second Booster Dose – Immunogenicity Subset – Participants Greater Than 55 Years of Age – Evaluable Immunogenicity Population
Assay Vaccine Group(as randomized) Sampling Time Point * N GMT(95% CI ) GMR(95% CI §)
Abbreviations: 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.Note: Immunogenicity subset = a random sample of 230 participants in each vaccine group.Note: Participants who had no serological or virological evidence (prior to the 1-month post–study vaccination blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] result negative at the study vaccination and the 1-month post–study vaccination visits, negative NAAT [nasal swab] result at the study vaccination visit, and any unscheduled visit prior to the 1-month post–study vaccination blood sample collection) and had no medical history of COVID-19 were included in the analysis.
*
Protocol-specified timing for blood sample collection.
n = number of participants with valid and determinate assay results for the specified assay at the given sampling time point.
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 95% CIs were calculated by exponentiating the mean difference of the logarithms of the titers (vaccine group in the corresponding row — Pfizer-BioNTech COVID-19 Vaccine) and the corresponding CI (based on the Student t distribution). Superiority for anti-Omicron BA.1 immune response is declared if the lower bound of the 2-sided 95% CI for the GMR is greater than 1 after satisfying multiplicity adjustment. Noninferiority for anti-Original strain is declared if the lower limit of the 2-sided 95% CI for the GMR is greater than 0.67 (1.5-fold criterion) and the point estimate of the GMR is ≥0.8, after satisfying multiplicity adjustment.
SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in January 2020] and Omicron B.1.1.529 subvariant BA.1).
SARS-CoV-2 neutralization assay — Omicron BA.1 — NT50 (titer) Pfizer-BioNTech COVID-19 Vaccine 1 month 163 455.8(365.9, 567.6)
Bivalent Vaccine (Original and Omicron BA.1) 1 month 178 711.0(588.3, 859.2) 1.56(1.17, 2.08)
SARS-CoV-2 neutralization assay — Original strain — NT50 (titer) Pfizer-BioNTech COVID-19 Vaccine 1 month 182 5998.1(5223.6, 6887.4)
Bivalent Vaccine (Original and Omicron BA.1) 1 month 186 5933.2(5188.2, 6785.2) 0.99(0.82, 1.20)
Table 10: Study 4 — Number (%) of Participants Achieving Seroresponse – Participants Without Evidence of Infection Up to 1 Month After the Second Booster Dose – Immunogenicity Subset – Participants Greater Than 55 Years of Age – Evaluable Immunogenicity Population
Assay Vaccine Group(as randomized) Sampling Time Point * N n (%)(95% CI §) Difference %(95% CI #)
Abbreviations: 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.Note: Immunogenicity subset = a random sample of 230 participants in each vaccine group.Note: Seroresponse is defined as achieving ≥ 4-fold rise from baseline (before the second booster dose). If the baseline measurement is below the LLOQ, the postvaccination measure of ≥ 4 × LLOQ is considered a seroresponse.Note: Participants who had no serological or virological evidence (prior to the 1-month post–study vaccination blood sample collection) of past SARS-CoV-2 infection (i.e., N-binding antibody [serum] result negative at the study vaccination and the 1-month post–study vaccination visits, negative NAAT [nasal swab] result at the study vaccination visit, and any unscheduled visit prior to the 1-month post–study vaccination blood sample collection) and had no medical history of COVID-19 were included in the analysis.
*
Protocol-specified timing for blood sample collection.
N = Number of participants with valid and determinate assay results for the specified assay at both the pre-vaccination time point and the given sampling time point. This value is the denominator for the percentage calculation.
n = Number of participants with seroresponse at 1 month after vaccination for the given assay.
§
Exact 2-sided CI based on the Clopper and Pearson method.
Difference in proportions, expressed as a percentage (vaccine group in the corresponding row — Pfizer-BioNTech COVID-19 Vaccine.
#
2-sided CI based on the Miettinen and Nurminen method for the difference in proportions, expressed as a percentage. Noninferiority for anti-Omicron BA.1 seroresponse is declared if the lower bound of the 2-sided 95% CI for the difference is greater than -5% after satisfying multiplicity adjustment.
Þ
SARS-CoV-2 NT50 were determined using a validated 384-well assay platform (original strain [USA-WA1/2020, isolated in January 2020] and Omicron B.1.1.529 subvariant BA.1).
SARS-CoV-2 neutralization assay — Omicron BA.1 — NT50 (titer)Þ Pfizer-BioNTech COVID-19 Vaccine 1 month 149 85 (57.0)(48.7, 65.1)
Bivalent Vaccine (Original and Omicron BA.1) 1 month 169 121 (71.6)(64.2, 78.3) 14.6(4.0, 24.9)
SARS-CoV-2 neutralization assay — Original strain — NT50 (titer)Þ Pfizer-BioNTech COVID-19 Vaccine 1 month 179 88 (49.2)(41.6, 56.7)
Bivalent Vaccine (Original and Omicron BA.1) 1 month 186 93 (50.0)(42.6, 57.4)

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