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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
COVE Moderna/NIH phase 3 (study 301)
 
NCT04470427
RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (excluding children)some concern
15181/15170 conclusif
  • suggested 95 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias
  • suggested 93 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias
  • demonstrated 94 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias
  • demonstrated 98 % decrease in severe COVID-19 occurrence (PE) with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 14 % increase in adverse events with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 17.4-fold increase in arthralgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 41 % increase in hypersensitivity, all terms with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 2.5-fold increase in lymphadenopathy, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 26.6-fold increase in myalgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 42.3-fold increase in fever, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 32.7-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 14.0-fold increase in local adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 5.7-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias
  • statistically significant 8.5-fold increase in systemic adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias
Moderna study 201 100µg
 
NCT04405076
RCTSpikevax (Moderna mRNA-1273 COVID-19 vaccine)placeboCOVID-19 prophylaxis (excluding children)NA
189/186 no results
    No deaths or unsolicited AEs that led to discontinuation from study vaccine or the study occurred within 28 days. One SAE of community-acquired pneumonia occurred on day 33 at 50 µg mRNA-1273 in the older cohort, resolved on day 58 and led to study vaccine discontinuation.
    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
        Thompson OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)critical
        2961/989 suggested
        • suggested 90 % decrease in confirmed COVID (any severity) but with a very low degree of certainty due to critical risk of bias
        Agur unpublished OBSmRNA vaccineuncontrolled studyCOVID-19 prophylaxis (excluding children)NA
        -/- no results
          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
              Shemer OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
              -/- inconclusive
                Thompson -VISIOn Network (omicron) OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                -/- suggested
                • suggested 81 % decrease in hospitalization
                • suggested 52 % decrease in symptomatic Covid-19,confirmed COVID (any severity)
                Husby (Moderna) OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
                -/- safety concern
                • suggested 59 % decrease in death D28
                • statistically significant 2.9-fold increase in myocarditis
                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
                  Kirsebom (UKHSA) OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                  -/- suggested
                  • suggested 17 % decrease in symptomatic Covid-19
                  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 OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)critical
                      -/- suggested
                        Klein OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)critical
                        -/- suggested
                          Mayo Clinic (Puranik) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)serious
                          51738/25869 suggested
                          • suggested 75 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias
                          • suggested 42 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                          Mayo Clinic (Puranik) OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)serious
                          51738/25869 suggested
                          • suggested 81 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias
                          • suggested 76 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                          McMurry OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
                          -/- suggested
                            McMurry OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                            -/- suggested
                              Nanduri OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)serious
                              -/- suggested
                              • suggested 51 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                              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
                                Shibli OBSmRNA vaccinecontrolCOVID-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
                                  Tande unpublished OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                                  -/- no results
                                    Lauring OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                                    5728/5962 suggested
                                    • suggested 44 % decrease in death or ventilation
                                    • suggested 46 % decrease in death or ventilation
                                    • suggested 76 % decrease in death or ventilation
                                    • suggested 85 % decrease in hospitalization
                                    • suggested 85 % decrease in hospitalization
                                    • suggested 65 % decrease in hospitalization
                                    Southern California (Tseng) - delta OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
                                    -/- suggested
                                    • suggested 95 % decrease in confirmed COVID (any severity)
                                    Southern California (Tseng) - omicron OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
                                    -/- suggested
                                    • suggested 30 % decrease in confirmed COVID (any severity)
                                    Tenforde OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                                    -/- suggested
                                    • suggested 82 % decrease in confirmed COVID (any severity)
                                    Abu-Raddad OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                                    -/- no results
                                      Chung OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)NA
                                      53270/270763 suggested
                                      • suggested 94 % decrease in symptomatic Covid-19
                                      Chung OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)NA
                                      53270/270763 suggested
                                      • suggested 91 % decrease in symptomatic Covid-19
                                      Chung OBSmRNA vaccinecontrolCOVID-19 prophylaxis (excluding children)NA
                                      53270/270763 suggested
                                      • suggested 91 % decrease in symptomatic Covid-19
                                      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)
                                      Qatar (Tang) OBSSpikevax (Moderna mRNA-1273 COVID-19 vaccine)controlCOVID-19 prophylaxis (excluding children)serious
                                      -/- suggested
                                      • suggested 85 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                                      Qatar (Tang) OBSComirnaty (tozinameran - Pfizer/BIONTECH)controlCOVID-19 prophylaxis (excluding children)serious
                                      -/- suggested
                                      • suggested 53 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias
                                      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
                                      Aleman DESCmRNA vaccineuncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                                      -/- no results
                                        Benotmane DESCSpikevax (Moderna mRNA-1273 COVID-19 vaccine)uncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                                        -/- no results
                                          Boyarsky DESCmRNA vaccineuncontrolled studyCOVID-19 prophylaxis (excluding children)NA
                                          -/- no results
                                            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).