vaccines - versus Comirnaty (tozinameran - Pfizer/BIONTECH) - 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

deaths 0.10 [0.07, 0.15]< 10%2 studies (-/2)100.0 %seriousnot evaluable lowcrucial-
hospitalization or death 0.23 [0.12, 0.44]< 10%1 study (-/1)100.0 %NAnot evaluable crucial-
confirmed COVID (any severity) 0.18 [0.11, 0.28]< 199%8 studies (1/7)100.0 %NAnot evaluable important-
hospitalization 0.21 [0.01, 3.05]< 199%4 studies (-/4)87.2 %NAnot evaluable important-
symptomatic Covid-19 0.21 [0.03, 1.45]< 189%2 studies (-/2)94.2 %NAnot evaluable important-
severe COVID-19 (FDA definition) 0.25 [0.01, 5.50]< 10%1 study (1/-)80.8 %NAnot evaluable non important-
severe COVID-19 occurrence 0.06 [0.05, 0.08]< 10%4 studies (1/3)100.0 %NAnot evaluable non important-

safety endpoints 00

adverse events 1.14 [0.78, 1.66]< 10%1 study (1/-)24.7 %NAnot evaluable non important-
arrhythmia 1.99 [0.07, 59.22]< 10%1 study (1/-)34.8 %NAnot evaluable non important-
hypertension 0.50 [0.02, 14.80]< 10%1 study (1/-)65.5 %NAnot evaluable non important-
intracranial hemorrhage 1.01 [0.02, 51.28]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
ischemic stroke 1.01 [0.02, 51.28]< 10%1 study (1/-)49.7 %NAnot evaluable non important-
Myocardial infarction 0.89 [0.24, 3.25]< 10%3 studies (3/-)57.0 %lownot evaluable highnon important-
pulmonary embolism 0.32 [0.03, 3.48]< 10%2 studies (2/-)82.3 %lownot evaluable highnon important-
serious adverse events (SAE), any 1.53 [0.25, 9.36]< 10%1 study (1/-)32.3 %NAnot evaluable non important-
stroke (non-specific, hemorrhagic, and ischemic) 0.99 [0.06, 15.88]< 10%1 study (1/-)50.2 %NAnot evaluable non important-
venous thromboembolism 2.03 [0.07, 61.21]< 10%1 study (1/-)34.4 %NAnot evaluable non important-

AE of interest endpoints 00

cerebral venous sinus thrombosis (CVST) 0.50 [0.02, 14.80]< 10%1 study (1/-)65.5 %NAnot evaluable important-
appendicitis 3.97 [0.18, 88.14]< 10%1 study (1/-)19.4 %NAnot evaluable non important-

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.