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Spikevax (Moderna mRNA-1273 COVID-19 vaccine) - 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

confirmed Covid-19, from 1st dose 0.05 [0.03, 0.09]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
death D28 0.41 [0.37, 0.46]< 10%1 study (-/1)100.0 %NAnot evaluable crucial-
deaths 0.50 [0.02, 14.84]< 10%1 study (1/-)65.4 %NAnot evaluable crucial-
vaccine efficacy from randomization (ITT) 0.07 [0.04, 0.11]< 10%1 study (1/-)100.0 %NAnot evaluable crucial-
confirmed COVID (any severity) 0.08 [0.01, 0.71]< 199%3 studies (-/3)98.8 %lownot evaluable highimportant-
hospitalization 0.19 [0.04, 0.81]< 10%1 study (-/1)98.8 %NAnot evaluable important-
symptomatic Covid-19 0.14 [0.06, 0.30]< 195%7 studies (1/6)100.0 %moderateserious moderateimportant-
severe COVID-19 occurrence 0.06 [0.04, 0.08]< 10%5 studies (1/4)100.0 %seriousnot evaluable lownon important-

safety endpoints 00

serious adverse events 1.04 [0.78, 1.40]< 10%1 study (1/-)38.6 %NAnot evaluable important-
adverse events 1.14 [1.08, 1.20]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
convulsions/seizures 1.04 [0.84, 1.29]< 10%1 study (-/1)36.0 %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 0.70 [0.22, 2.27]< 10%1 study (-/1)72.4 %NAnot evaluable non important-
immune thrombocytopenia 1.12 [0.64, 1.95]< 10%1 study (-/1)34.4 %NAnot evaluable non important-
ischemic stroke 0.97 [0.87, 1.08]< 10%1 study (-/1)71.0 %NAnot evaluable non important-
Myocardial infarction 1.02 [0.89, 1.17]< 10%1 study (-/1)39.2 %NAnot evaluable non important-
myocarditis 2.12 [0.65, 6.89]< 192%2 studies (-/2)10.5 %moderatenot evaluable moderatenon important-
pericarditis 1.18 [0.78, 1.78]< 10%1 study (-/1)21.4 %NAnot evaluable non important-
pulmonary embolism 1.01 [0.86, 1.19]< 10%1 study (-/1)45.2 %NAnot evaluable non important-
Transverse myelitis 1.45 [0.07, 31.68]< 10%1 study (-/1)40.8 %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) 1.27 [0.31, 5.21]< 10%2 studies (-/2)36.8 %seriousnot evaluable lowimportant-
appendicitis 0.82 [0.73, 0.92]< 10%2 studies (1/1)99.9 %criticalnot evaluable very lownon important-
arthralgia, grade 3-4 18.37 [13.54, 24.91]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Bell's palsy 0.98 [0.73, 1.32]< 118%4 studies (1/3)55.8 %seriousnot evaluable lownon important-
hypersensitivity, all terms 1.41 [1.15, 1.72]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
lymphadenopathy, grade 3-4 1.00 [0.06, 15.97]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
musculoskeletal and connective tissue disorders, any 1.00 [0.06, 15.97]< 10%1 study (1/-)50.0 %NAnot evaluable non important-
myalgia, grade 3-4 27.64 [20.93, 36.50]< 10%1 study (1/-)0.0 %NAnot evaluable non important-

reactogenicity (vaccines) endpoints 00

fever, grade 3-4 43.29 [17.83, 105.10]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
local adverse reaction, any, dose 2 33.74 [31.59, 36.03]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
local adverse reaction, grade 3-4, dose 2 15.04 [11.83, 19.12]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
systemic adverse reaction, any, dose 2 6.69 [6.35, 7.05]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
systemic adverse reaction, grade 3-4, dose 2 9.50 [8.38, 10.77]< 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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