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 0.17 [0.13, 0.22]< 10%2 studies (1/1)100.0 %lownot evaluable highcrucial-
deaths 0.09 [0.05, 0.19]< 194%4 studies (1/3)100.0 %NAnot evaluable crucial-
vaccine efficacy from randomization (ITT) 0.18 [0.13, 0.25]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
confirmed COVID (any severity) 0.21 [0.10, 0.42]< 199%7 studies (-/7)100.0 %NAnot evaluable important-
hospitalization 0.11 [0.05, 0.20]< 199%7 studies (-/7)100.0 %lownot evaluable highimportant-
symptomatic Covid-19 0.14 [0.07, 0.27]< 199%16 studies (1/15)100.0 %lowlow highimportant-
6 months severe COVID-19 0.03 [0.00, 0.46]< 10%1 study (1/-)99.4 %NAnot evaluable non important-
asymptomatic COVID case 0.16 [0.08, 0.35]< 191%4 studies (-/4)100.0 %NAnot evaluable non important-
infection (PCR positive symptomatic or not) 0.16 [0.10, 0.26]< 198%11 studies (-/11)100.0 %lowcritical highnon important-
severe COVID-19 occurrence 0.09 [0.05, 0.17]< 197%9 studies (1/8)100.0 %moderatenot evaluable moderatenon important-
transmission (symptomatic confirmed COVID19) 0.53 [0.48, 0.58]< 10%2 studies (-/2)100.0 %seriousnot evaluable lownon important-
vaccine efficacy after dose 1 (and before dose 2) 0.29 [0.19, 0.46]< 175%6 studies (1/5)100.0 %lownot evaluable highnon important-

safety endpoints 00

cerebrovascular thromboembolic events 0.84 [0.55, 1.29]< 10%1 study (-/1)78.8 %NAnot evaluable important-
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-
acute kidney injury 0.44 [0.25, 0.78]< 10%1 study (-/1)99.7 %NAnot evaluable non important-
adverse events 2.62 [2.49, 2.76]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Anemia 0.79 [0.67, 0.93]< 10%1 study (-/1)99.8 %NAnot evaluable non important-
arrhythmia 0.89 [0.75, 1.06]< 10%1 study (-/1)91.0 %NAnot evaluable non important-
Arthritis or arthropathy 0.95 [0.66, 1.36]< 10%1 study (-/1)60.9 %NAnot evaluable non important-
convulsions/seizures 1.03 [0.85, 1.26]< 10%2 studies (-/2)37.8 %criticalnot evaluable very lownon important-
deep vein thrombosis 0.87 [0.55, 1.39]< 10%1 study (-/1)72.0 %NAnot evaluable non important-
disseminated intravascular coagulation 0.70 [0.39, 1.27]< 10%1 study (-/1)88.0 %NAnot evaluable non important-
Guillain-Barré syndrome 0.83 [0.56, 1.22]< 10%3 studies (-/3)83.2 %NAnot evaluable non important-
Herpes simplex infection 1.13 [0.94, 1.36]< 10%1 study (-/1)10.0 %NAnot evaluable non important-
herpes zoster infection 1.25 [0.94, 1.66]< 173%2 studies (-/2)6.3 %moderatenot evaluable moderatenon important-
immune thrombocytopenia 1.12 [0.64, 1.95]< 10%1 study (-/1)34.4 %NAnot evaluable non important-
intracranial hemorrhage 0.83 [0.33, 2.08]< 183%2 studies (-/2)65.4 %moderatenot evaluable moderatenon important-
ischemic stroke 0.98 [0.89, 1.07]< 10%2 studies (-/2)70.1 %criticalnot evaluable very lownon important-
life-threatening SAE 0.91 [0.51, 1.65]< 10%1 study (1/-)61.8 %NAnot evaluable non important-
Myocardial infarction 1.04 [0.93, 1.16]< 10%3 studies (-/3)24.9 %criticalnot evaluable very lownon important-
myocarditis 1.40 [0.96, 2.04]< 136%3 studies (-/3)3.9 %moderatenot evaluable moderatenon important-
neutropenia 0.87 [0.46, 1.65]< 10%1 study (-/1)66.5 %NAnot evaluable non important-
paresthesia 1.18 [1.09, 1.28]< 120%2 studies (-/2)0.0 %moderatenot evaluable moderatenon important-
pericarditis 1.21 [0.86, 1.70]< 10%2 studies (-/2)13.9 %criticalnot evaluable very lownon important-
pulmonary embolism 1.03 [0.86, 1.24]< 129%3 studies (-/3)36.6 %criticalnot evaluable very lownon important-
severe adverse events 1.74 [1.41, 2.14]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
thrombocytopenia 0.94 [0.66, 1.33]< 10%1 study (-/1)63.5 %NAnot evaluable non important-
Transverse myelitis 1.45 [0.07, 31.68]< 10%1 study (-/1)40.8 %NAnot evaluable non important-
uveitis 1.27 [0.64, 2.52]< 10%1 study (-/1)24.7 %NAnot evaluable non important-
venous thromboembolism 1.16 [1.00, 1.34]< 10%1 study (-/1)2.3 %NAnot evaluable non important-
VTE with thrombocytopenia 0.86 [0.58, 1.27]< 10%1 study (-/1)77.5 %NAnot evaluable non important-

AE of interest endpoints 00

cerebral venous sinus thrombosis (CVST) 1.30 [0.45, 3.73]< 10%3 studies (-/3)31.5 %moderatenot evaluable moderateimportant-
appendicitis 1.14 [0.69, 1.86]< 181%3 studies (1/2)30.8 %criticalnot evaluable very lownon important-
Bell's palsy 1.05 [0.88, 1.26]< 164%10 studies (1/9)28.9 %lowlow highnon 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 4.80 [1.13, 20.41]< 191%2 studies (1/1)1.7 %seriousnot evaluable lownon important-
musculoskeletal and connective tissue disorders, any 3.65 [3.26, 4.09]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
myelitis 1.05 [0.77, 1.43]< 114%2 studies (-/2)37.5 %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

serologic response (seroconversion) 0.09 [0.00, 5.02]> 170%2 studies (-/2)12.4 %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.