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Comirnaty (tozinameran - Pfizer/BIONTECH) - versus control - for COVID-19 prophylaxis (excluding children) pdf   xlsx method abbreviations

Outcome Relative effect 95%CI LoD Trt. better when I2 k (RCT/OBS) Bayesian probability Overall ROB Publication bias Degree of certainty Endpoint importance Published MA

efficacy endpoints 00

6 months symptomatic COVID 0.09 [0.07, 0.11]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
confirmed Covid-19, from 1st dose 0.18 [0.13, 0.25]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
deaths 0.50 [0.09, 2.73]< 10%1 study (1/-)78.7 %NAnot evaluable crucial-
vaccine efficacy from randomization (ITT) 0.18 [0.13, 0.25]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
symptomatic Covid-19 0.05 [0.02, 0.10]< 10%1 study (1/-)100.0 %NAnot evaluable important-
6 months severe COVID-19 0.03 [0.00, 0.46]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
severe COVID-19 occurrence 0.25 [0.01, 5.62]< 10%1 study (1/-)80.6 %NAnot evaluable non important-
vaccine efficacy after dose 1 (and before dose 2) 0.48 [0.32, 0.71]< 10%1 study (1/-)100.0 %NAnot evaluable non important-

safety endpoints 00

related AE (TRAE) 4.91 [4.58, 5.26]< 10%1 study (1/-)0.0 %NAnot evaluable important-
related SAE (TRSAE) 8.00 [0.42, 151.43]< 10%1 study (1/-)8.5 %NAnot evaluable important-
serious adverse events 1.14 [0.88, 1.47]< 10%1 study (1/-)16.4 %NAnot evaluable important-
adverse events 2.62 [2.49, 2.76]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
life-threatening SAE 0.91 [0.51, 1.65]< 10%1 study (1/-)61.8 %NAnot evaluable non important-
severe adverse events 1.74 [1.41, 2.14]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

AE of interest endpoints 00

appendicitis 2.00 [0.60, 6.65]< 10%1 study (1/-)12.9 %NAnot evaluable non important-
Bell's palsy 7.99 [0.42, 151.24]< 10%1 study (1/-)8.5 %NAnot evaluable non important-
hypersensitivity, all terms 2.17 [0.82, 5.71]< 10%1 study (1/-)5.9 %NAnot evaluable non important-
immediate allergic reaction 1.00 [0.02, 50.42]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
lymphadenopathy, any 10.69 [4.63, 24.69]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
musculoskeletal and connective tissue disorders, any 3.65 [3.26, 4.09]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

reactogenicity (vaccines) endpoints 00

local adverse reaction, any, dose 1 24.90 [22.13, 28.03]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
local adverse reaction, any, dose 2 23.04 [20.30, 26.15]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
systemic adverse reaction, any, dose 1 1.63 [1.50, 1.78]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
systemic adverse reaction, any, dose 2 4.55 [4.13, 5.01]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

immunogenicity (vaccines) endpoints 00

LoD: level of statistical demonstration: Statistically conclusive: statistically significant with a strict control of overall risk of type 1 error (statistically demonstrated), does not take into account the risk of bias; suggested: nominally statistically significant but without a strict control of overall risk of type 1 error; inconclusive: not nominally statistically significant; safety concerns;
Bayesian probability: Bayesian posterior probability of treatment effect (computed with a noninformative prior); ROB: risk of bias; k: number of studies; published MA: number of published meta-analysis on the same topic; degree of certainty adapted from GRADE. Trt. better when: indicates when the relative treatment effect shows that the studied treatment is better than control.



 

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