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mRNA 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

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 0.10 [0.03, 0.35]< 193%2 studies (2/-)100.0 %some concernnot evaluable moderatecrucial-
deaths 0.50 [0.11, 2.28]< 10%2 studies (2/-)81.4 %some concernnot evaluable moderatecrucial-
vaccine efficacy from randomization (ITT) 0.11 [0.04, 0.29]< 191%2 studies (2/-)100.0 %some concernnot evaluable moderatecrucial-
symptomatic Covid-19 0.05 [0.03, 0.09]< 10%2 studies (2/-)100.0 %some concernnot evaluable moderateimportant-
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 0.06 [0.00, 0.84]< 138%2 studies (2/-)98.1 %some concernnot evaluable moderatenon 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 1.10 [0.90, 1.33]< 10%2 studies (2/-)17.7 %some concernnot evaluable moderateimportant-
adverse events 1.73 [0.77, 3.91]< 1100%2 studies (2/-)9.4 %some concernnot evaluable moderatenon 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 1.42 [0.52, 3.86]< 10%2 studies (2/-)24.5 %some concernnot evaluable moderatenon important-
arthralgia, grade 3-4 18.37 [13.54, 24.91]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
Bell's palsy 4.32 [0.72, 25.96]< 10%2 studies (2/-)5.6 %some concernnot evaluable moderatenon important-
hypersensitivity, all terms 1.43 [1.18, 1.74]< 10%2 studies (2/-)0.0 %some concernnot evaluable moderatenon 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-
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 3.64 [3.25, 4.08]< 10%2 studies (2/-)0.0 %some concernnot evaluable moderatenon 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 1 24.90 [22.13, 28.03]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
local adverse reaction, any, dose 2 27.99 [19.26, 40.68]< 196%2 studies (2/-)0.0 %some concernnot evaluable moderatenon 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 1 1.63 [1.50, 1.78]< 10%1 study (1/-)0.0 %NAnot evaluable non important-
systemic adverse reaction, any, dose 2 5.53 [3.79, 8.06]< 198%2 studies (2/-)0.0 %some concernnot evaluable moderatenon 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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