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Study Ref. Design studied treatmentcontrol treatmentpatientsstudy risk of biassample sizes Results

COVID-19 prophylaxis (excluding children) meta-analysis

BNT162b2 phase 3 (C4591001, Polack)
 
NCT04368728
RCTComirnaty (tozinameran - Pfizer/BIONTECH)placeboCOVID-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
Amit OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
7214/1895 suggested
    Dagan OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
    596618/596618 suggested
    • suggested 87 % decrease in hospitalization
    • suggested 94 % decrease in symptomatic Covid-19
    SIREN (HW england)
     
    ISRCTN11041050
    OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)serious
    -/- suggested
      Scotland cohort unpublished OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
      -/- suggested
        Shemer OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
        -/- inconclusive
          Husby (pfizer) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
          -/- inconclusive
            Patone OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 24 % increase in intracranial hemorrhage
            Shasha OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
            -/- safety concern
            • statistically significant 22 % increase in paresthesia
            Angel OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
            5517/757 suggested
            • suggested 97 % decrease in symptomatic Covid-19
            Barda OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-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) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
            -/- suggested
            • suggested 61 % decrease in confirmed COVID (any severity)
            Bjork OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
            -/- suggested
            • suggested 86 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity)
            Chodcik OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)serious
            503875/351897 inconclusive
              EPI-PHARE OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)critical
              -/- inconclusive
                Goldberg OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 94 % decrease in deaths
                • suggested 94 % decrease in hospitalization
                Haas OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 97 % decrease in deaths
                • suggested 97 % decrease in hospitalization
                • suggested 97 % decrease in symptomatic Covid-19
                Heymann OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 89 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity)
                Klein OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)critical
                -/- suggested
                  Nanduri OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-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 OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                  -/- inconclusive
                    Shibli OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                    -/- safety concern
                    • statistically significant 36 % increase in Bell's palsy
                    Tartof
                     
                    NCT04848584
                    OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-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 OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                    -/- suggested
                      Abu-Raddad OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                      -/- no results
                        England (Andrews) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                        581/130867 suggested
                        • suggested 49 % decrease in symptomatic Covid-19,confirmed COVID (any severity)
                        South Africa (Discovery Health, Collie) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                        -/- suggested
                        • suggested 70 % decrease in hospitalization
                        • suggested 50 % decrease in symptomatic Covid-19,confirmed COVID (any severity)
                        Tenforde OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-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 OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-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 DESCComirnaty (tozinameran - Pfizer/BIONTECH)uncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                        -/- no results
                          Rozen-Zvi DESCComirnaty (tozinameran - Pfizer/BIONTECH)uncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                          -/- no results
                            Yanay DESCComirnaty (tozinameran - Pfizer/BIONTECH)uncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                            -/- no results
                              Zadok DESCComirnaty (tozinameran - Pfizer/BIONTECH)uncontrolled studyCOVID-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).