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Comirnaty (tozinameran - Pfizer/BIONTECH) in COVID-19 prophylaxis (excluding children) - Summary of results

OutcomeTE95% CInkI2ROBPub. bias 6 months symptomatic COVIDdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.09 [0.07; 0.11] 0.09[0.07; 0.11]BNT162b2 phase 3 (C4591001, Polack), 202010%46,077NAnot evaluable confirmed Covid-19, from 1st dosedetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.18 [0.13; 0.25] 0.18[0.13; 0.25]BNT162b2 phase 3 (C4591001, Polack), 202010%42,572NAnot evaluable deathsdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.50 [0.09; 2.73] 0.50[0.09; 2.73]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable vaccine efficacy from randomization (ITT)detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.18 [0.13; 0.25] 0.18[0.13; 0.25]BNT162b2 phase 3 (C4591001, Polack), 202010%42,572NAnot evaluable confirmed COVID (any severity)detailed resultsC4591031- first boost, 2021 (REV) 18.52 [7.91; 43.34] 18.52[7.91; 43.34]C4591031- first boost, 2021 (REV)10%10,125NAnot evaluable symptomatic Covid-19detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.05 [0.02; 0.10] 0.05[0.02; 0.10]BNT162b2 phase 3 (C4591001, Polack), 202010%36,523NAnot evaluable 6 months severe COVID-19detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.03 [0.00; 0.46] 0.03[0.00; 0.46]BNT162b2 phase 3 (C4591001, Polack), 202010%NAnot evaluable severe COVID-19 (FDA definition)detailed resultsC4591031- first boost, 2021 (REV) 4.03 [0.18; 89.41] 4.03[0.18; 89.41]C4591031- first boost, 2021 (REV)10%10,125NAnot evaluable severe COVID-19 occurrencedetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.25 [0.01; 5.62] C4591031- first boost, 2021 (REV) 4.03 [0.18; 89.41] 1.01[0.07; 15.37]BNT162b2 phase 3 (C4591001, Polack), 2020, C4591031- first boost, 2021 (REV)235%52,698lownot evaluable vaccine efficacy after dose 1 (and before dose 2)detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.48 [0.32; 0.71] 0.48[0.32; 0.71]BNT162b2 phase 3 (C4591001, Polack), 202010%43,355NAnot evaluable related AE (TRAE)detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 4.91 [4.58; 5.26] 4.91[4.58; 5.26]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable related SAE (TRSAE)detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 8.00 [0.42; 151.43] 8.00[0.42; 151.43]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable serious adverse eventsdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 1.14 [0.88; 1.47] 1.14[0.88; 1.47]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable adverse eventsdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 2.62 [2.49; 2.76] 2.62[2.49; 2.76]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable arrhythmiadetailed resultsC4591031- first boost, 2021 (REV) 0.50 [0.02; 15.01] 0.50[0.02; 15.01]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable hypertensiondetailed resultsC4591031- first boost, 2021 (REV) 2.01 [0.07; 60.05] 2.01[0.07; 60.05]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable life-threatening SAEdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 0.91 [0.51; 1.65] 0.91[0.51; 1.65]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable Myocardial infarction detailed resultsC4591031- first boost, 2021 (REV) 1.34 [0.30; 6.00] 1.34[0.30; 6.00]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable pulmonary embolismdetailed resultsC4591031- first boost, 2021 (REV) 6.04 [0.30; 120.71] 6.04[0.30; 120.71]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable severe adverse eventsdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 1.74 [1.41; 2.14] 1.74[1.41; 2.14]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable stroke (non-specific, hemorrhagic, and ischemic)detailed resultsC4591031- first boost, 2021 (REV) 1.01 [0.06; 16.10] 1.01[0.06; 16.10]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable cerebral venous sinus thrombosis (CVST)detailed resultsC4591031- first boost, 2021 (REV) 2.01 [0.07; 60.05] 2.01[0.07; 60.05]C4591031- first boost, 2021 (REV)10%10,075NAnot evaluable appendicitisdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 2.00 [0.60; 6.65] C4591031- first boost, 2021 (REV) 0.25 [0.01; 5.58] 1.18[0.20; 6.93]BNT162b2 phase 3 (C4591001, Polack), 2020, C4591031- first boost, 2021 (REV)233%53,523moderatenot evaluable Bell's palsydetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 7.99 [0.42; 151.24] 7.99[0.42; 151.24]BNT162b2 phase 3 (C4591001, Polack), 202010%37,586NAnot evaluable hypersensitivity, all termsdetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 2.17 [0.82; 5.71] 2.17[0.82; 5.71]BNT162b2 phase 3 (C4591001, Polack), 202010%43,252NAnot evaluable immediate allergic reactiondetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 1.00 [0.02; 50.42] 1.00[0.02; 50.42]BNT162b2 phase 3 (C4591001, Polack), 202010%43,448NAnot evaluable lymphadenopathy, anydetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 10.69 [4.63; 24.69] 10.69[4.63; 24.69]BNT162b2 phase 3 (C4591001, Polack), 202010%37,586NAnot evaluable musculoskeletal and connective tissue disorders, anydetailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 3.65 [3.26; 4.09] 3.65[3.26; 4.09]BNT162b2 phase 3 (C4591001, Polack), 202010%37,586NAnot evaluable local adverse reaction, any, dose 1detailed resultsOut of scaleBNT162b2 phase 3 (C4591001, Polack), 2020 24.90 [22.13; 28.03] 24.90[22.13; 28.03]BNT162b2 phase 3 (C4591001, Polack), 202010%8,183NAnot evaluable local adverse reaction, any, dose 2detailed resultsOut of scaleBNT162b2 phase 3 (C4591001, Polack), 2020 23.04 [20.30; 26.15] 23.04[20.30; 26.15]BNT162b2 phase 3 (C4591001, Polack), 202010%7,507NAnot evaluable systemic adverse reaction, any, dose 1detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 1.63 [1.50; 1.78] 1.63[1.50; 1.78]BNT162b2 phase 3 (C4591001, Polack), 202010%8,183NAnot evaluable systemic adverse reaction, any, dose 2detailed resultsBNT162b2 phase 3 (C4591001, Polack), 2020 4.55 [4.13; 5.01] 4.55[4.13; 5.01]BNT162b2 phase 3 (C4591001, Polack), 202010%7,507NAnot evaluable0.020.01.0relative treatment effectwww.metaEvidence.org2024-05-15 07:11 +02:00

TE: relative treatment effect (measured by a risk ratio, an odds ratio or an hazard ratio depending on what is reported in the papers); k: number of studies; n: total number of patients; ROB: risk of bias (ROB 2.0); Pub. bias: publication bias; OBS: observational studies; RCT: randomized clinical trials
studied treatment is better when TE > 1; studied treatment is better when TE < 1;

pathologies: 89 - treatments: 758 - roots T: 290

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