Vaccine Information: Pfizer-BioNTech Covid-19 Vaccine (Page 6 of 9)

18.2 Efficacy of Primary Series 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 11.

Table 11: 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#) Placebo N =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 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 12).

Table 12: 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 *
12 Through 15 Yearsn =190 16 Through 25 Years n =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)
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 (Group 1 [12 through 15 years of age] – Group 2 [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.
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 a Third Primary Series Dose in Individuals with Certain Kinds of Immunocompromise

From an independent report (Kamar N, Abravanel F, Marion O, et al. Three doses of an mRNA Covid-19 vaccine in solid-organ transplant recipients. N Engl J Med) , a single arm study has been conducted in 101 individuals who had undergone various solid organ transplant procedures (heart, kidney, liver, lung, pancreas) 97±8 months previously. A third dose of the Pfizer-BioNTech COVID-19 vaccine was administered to 99 of these individuals approximately 2 months after they had received a second dose. Among the 59 patients who had been seronegative before the third dose, 26 (44%) were seropositive at 4 weeks after the third dose. All 40 patients who had been seropositive before the third dose were still seropositive 4 weeks later. The prevalence of anti-SARS-CoV-2 antibodies was 68% (67 of 99 patients) 4 weeks after the third dose.

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