Study explorer (study characteristics and results) method abbreviations pdf   xlsx

display ongoing studies
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
Nguyen OBSComirnaty (tozinameran - Pfizer/BIONTECH)Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19)COVID-19 prophylaxis (excluding children)NA
-/- inconclusive
    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).