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 9.
|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).|
|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#)||PlaceboN ‡=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)|
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 10).
|Pfizer-BioNTech COVID-19 Vaccine *|
|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)|
|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.|
|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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