display ongoing studies
summary
treatment
patients
method
baseline characteristics
risk of bias
references
serologic response (seroconversion) T cell response local adverse reaction, any, dose 1 local adverse reaction, any, dose 2 severe muscle pain, dose 1 severe muscle pain, dose 2 systemic adverse reaction, any, dose 1 systemic adverse reaction, any, dose 2 appendicitis Bell's palsy cerebral venous sinus thrombosis (CVST) hypersensitivity, all terms immediate allergic reaction lymphadenopathy, any musculoskeletal and connective tissue disorders, any myelitis acute kidney injury adverse events Anemia arrhythmia Arthritis or arthropathy cerebrovascular thromboembolic events convulsions/seizures deep vein thrombosis disseminated intravascular coagulation Guillain-Barré syndrome Herpes simplex infection herpes zoster infection immune thrombocytopenia intracranial hemorrhage ischemic stroke life-threatening SAE Myocardial infarction myocarditis neutropenia paresthesia pericarditis pulmonary embolism related AE (TRAE) related SAE (TRSAE) serious adverse events severe adverse events thrombocytopenia Transverse myelitis uveitis venous thromboembolism VTE with thrombocytopenia 6 months severe COVID-19 6 months symptomatic COVID asymptomatic COVID case confirmed COVID (any severity) confirmed Covid-19, from 1st dose deaths hospitalization infection (PCR positive symptomatic or not) severe COVID-19 occurrence symptomatic Covid-19 transmission (symptomatic confirmed COVID19) vaccine efficacy after dose 1 (and before dose 2) vaccine efficacy from randomization (ITT)
overview
numeric
bar chart
forest plot
medians
figures
uncontrolled
O6
Study
Ref.
Design
studied treatment control treatment patients study risk of bias sample sizes
Results
COVID-19 prophylaxis (excluding children) meta-analysis BNT162b2 phase 3 (C4591001, Polack) NCT04368728 RCT Comirnaty (tozinameran - Pfizer/BIONTECH) placebo COVID-19 prophylaxis (excluding children) some concern 21720/21728 conclusif suggested 91 % decrease in 6 months symptomatic COVID with a moderate degree of certainty due to some concern in risk of bias suggested 82 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias suggested 82 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias demonstrated 95 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 3.9-fold increase in related AE (TRAE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 1.6-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 74 % increase in severe adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 9.7-fold increase in lymphadenopathy, any with a moderate degree of certainty due to some concern in risk of bias statistically significant 2.7-fold increase in musculoskeletal and connective tissue disorders, any with a moderate degree of certainty due to some concern in risk of bias statistically significant 23.9-fold increase in local adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias statistically significant 22.0-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias statistically significant 63 % increase in systemic adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias statistically significant 3.6-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias Nguyen OBS Comirnaty (tozinameran - Pfizer/BIONTECH) Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) COVID-19 prophylaxis (excluding children) NA -/- inconclusive Amit OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 7214/1895 suggested Dagan OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 596618/596618 suggested suggested 87 % decrease in hospitalization suggested 94 % decrease in symptomatic Covid-19 SIREN (HW england) ISRCTN11041050 OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious -/- suggested Scotland cohort unpublished OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested Shemer OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Husby (pfizer) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Patone OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 24 % increase in intracranial hemorrhage Shasha OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 22 % increase in paresthesia Angel OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 5517/757 suggested suggested 97 % decrease in symptomatic Covid-19 Barda OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 43 % increase in herpes zoster infection but with a very low degree of certainty due to critical risk of bias statistically significant 2.2-fold increase in myocarditis but with a very low degree of certainty due to critical risk of bias statistically significant 40 % increase in appendicitis but with a very low degree of certainty due to critical risk of bias statistically significant 1.4-fold increase in lymphadenopathy, any but with a very low degree of certainty due to critical risk of bias Bernal (PHE, 19th February 2021) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 61 % decrease in confirmed COVID (any severity) Bjork OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 86 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity) Chodcik OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious 503875/351897 inconclusive EPI-PHARE OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- inconclusive Goldberg OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 94 % decrease in deaths suggested 94 % decrease in hospitalization Haas OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 97 % decrease in deaths suggested 97 % decrease in hospitalization suggested 97 % decrease in symptomatic Covid-19 Heymann OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 89 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity) Klein OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- suggested Nanduri OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious -/- suggested suggested 52 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias Pawlowski OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Shibli OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 36 % increase in Bell's palsy Tartof NCT04848584 OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (children), COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 73 % decrease in confirmed COVID (any severity) suggested 91 % decrease in confirmed COVID (any severity) suggested 90 % decrease in hospitalization Weekes OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested Abu-Raddad OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- no results England (Andrews) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 581/130867 suggested suggested 49 % decrease in symptomatic Covid-19,confirmed COVID (any severity) South Africa (Discovery Health, Collie) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 70 % decrease in hospitalization suggested 50 % decrease in symptomatic Covid-19,confirmed COVID (any severity) Tenforde OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious 1194/1895 suggested suggested 84 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias Wan OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 1.4-fold increase in Bell's palsy but with a very low degree of certainty due to critical risk of bias Palich DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Rozen-Zvi DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Yanay DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Zadok DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results
PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).