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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
60 studies excluded by filtering options (1 RCT / 59 OBS)

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).

 

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