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] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | crucial | - |
confirmed Covid-19, from 1st dose | 0.10 [0.03, 0.35] | | < 1 | | 93% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
death D28 | 0.41 [0.37, 0.46] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | crucial | - |
deaths | 0.50 [0.11, 2.28] | | < 1 | | 0% | 2 studies (2/-) | 81.4 % | some concern | not evaluable | moderate | crucial | - |
vaccine efficacy from randomization (ITT) | 0.11 [0.04, 0.29] | | < 1 | | 91% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
confirmed COVID (any severity) | 0.21 [0.13, 0.33] | | < 1 | | 98% | 12 studies (-/12) | 100.0 % | NA | low | | important | - |
death or ventilation | 0.56 [0.46, 0.68] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | important | - |
hospitalization | 0.11 [0.06, 0.20] | | < 1 | | 99% | 9 studies (-/9) | 100.0 % | low | not evaluable | high | important | - |
symptomatic Covid-19 | 0.05 [0.03, 0.09] | | < 1 | | 0% | 2 studies (2/-) | 100.0 % | some concern | not evaluable | moderate | important | - |
6 months severe COVID-19 | 0.03 [0.00, 0.46] | | < 1 | | 0% | 1 study (1/-) | 99.4 % | NA | not evaluable | | non important | - |
asymptomatic COVID case | 0.16 [0.08, 0.35] | | < 1 | | 91% | 4 studies (-/4) | 100.0 % | NA | not evaluable | | non important | - |
infection (PCR positive symptomatic or not) | 0.16 [0.10, 0.26] | | < 1 | | 98% | 11 studies (-/11) | 100.0 % | low | critical | high | non important | - |
severe COVID-19 occurrence | 0.06 [0.00, 0.84] | | < 1 | | 38% | 2 studies (2/-) | 98.1 % | some concern | not evaluable | moderate | non important | - |
transmission (symptomatic confirmed COVID19) | 0.53 [0.48, 0.58] | | < 1 | | 0% | 2 studies (-/2) | 100.0 % | serious | not evaluable | low | non important | - |
vaccine efficacy after dose 1 (and before dose 2) | 0.48 [0.32, 0.71] | | < 1 | | 0% | 1 study (1/-) | 100.0 % | NA | not evaluable | | non important | - |
safety endpoints 00 |
cerebrovascular thromboembolic events | 0.84 [0.55, 1.29] | | < 1 | | 0% | 1 study (-/1) | 78.8 % | NA | not evaluable | | important | - |
related AE (TRAE) | 4.91 [4.58, 5.26] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | important | - |
related SAE (TRSAE) | 8.00 [0.42, 151.43] | | < 1 | | 0% | 1 study (1/-) | 8.5 % | NA | not evaluable | | important | - |
serious adverse events | 1.10 [0.90, 1.33] | | < 1 | | 0% | 2 studies (2/-) | 17.7 % | some concern | not evaluable | moderate | important | - |
acute kidney injury | 0.44 [0.25, 0.78] | | < 1 | | 0% | 1 study (-/1) | 99.7 % | NA | not evaluable | | non important | - |
adverse events | 1.73 [0.77, 3.91] | | < 1 | | 100% | 2 studies (2/-) | 9.4 % | some concern | not evaluable | moderate | non important | - |
Anemia | 0.79 [0.67, 0.93] | | < 1 | | 0% | 1 study (-/1) | 99.8 % | NA | not evaluable | | non important | - |
arrhythmia | 0.89 [0.75, 1.06] | | < 1 | | 0% | 1 study (-/1) | 91.0 % | NA | not evaluable | | non important | - |
Arthritis or arthropathy | 0.95 [0.66, 1.36] | | < 1 | | 0% | 1 study (-/1) | 60.9 % | NA | not evaluable | | non important | - |
convulsions/seizures | 1.03 [0.85, 1.26] | | < 1 | | 0% | 2 studies (-/2) | 37.8 % | critical | not evaluable | very low | non important | - |
deep vein thrombosis | 0.87 [0.55, 1.39] | | < 1 | | 0% | 1 study (-/1) | 72.0 % | NA | not evaluable | | non important | - |
disseminated intravascular coagulation | 0.70 [0.39, 1.27] | | < 1 | | 0% | 1 study (-/1) | 88.0 % | NA | not evaluable | | non important | - |
Guillain-Barré syndrome | 0.83 [0.56, 1.22] | | < 1 | | 0% | 3 studies (-/3) | 83.2 % | NA | not evaluable | | non important | - |
Herpes simplex infection | 1.13 [0.94, 1.36] | | < 1 | | 0% | 1 study (-/1) | 10.0 % | NA | not evaluable | | non important | - |
herpes zoster infection | 1.25 [0.94, 1.66] | | < 1 | | 73% | 2 studies (-/2) | 6.3 % | moderate | not evaluable | moderate | non important | - |
immune thrombocytopenia | 2.60 [0.39, 17.24] | | < 1 | | 0% | 1 study (-/1) | 16.2 % | NA | not evaluable | | non important | - |
intracranial hemorrhage | 0.83 [0.33, 2.08] | | < 1 | | 83% | 2 studies (-/2) | 65.4 % | moderate | not evaluable | moderate | non important | - |
ischemic stroke | 0.98 [0.89, 1.07] | | < 1 | | 0% | 2 studies (-/2) | 70.1 % | critical | not evaluable | very low | non important | - |
life-threatening SAE | 0.91 [0.51, 1.65] | | < 1 | | 0% | 1 study (1/-) | 61.8 % | NA | not evaluable | | non important | - |
Myocardial infarction | 1.04 [0.93, 1.16] | | < 1 | | 0% | 3 studies (-/3) | 24.9 % | critical | not evaluable | very low | non important | - |
myocarditis | 1.98 [1.09, 3.60] | | < 1 | | 80% | 4 studies (-/4) | 1.3 % | moderate | not evaluable | moderate | non important | - |
neutropenia | 0.87 [0.46, 1.65] | | < 1 | | 0% | 1 study (-/1) | 66.5 % | NA | not evaluable | | non important | - |
paresthesia | 1.18 [1.09, 1.28] | | < 1 | | 20% | 2 studies (-/2) | 0.0 % | moderate | not evaluable | moderate | non important | - |
pericarditis | 1.21 [0.86, 1.70] | | < 1 | | 0% | 2 studies (-/2) | 13.9 % | critical | not evaluable | very low | non important | - |
pulmonary embolism | 1.03 [0.86, 1.24] | | < 1 | | 29% | 3 studies (-/3) | 36.6 % | critical | not evaluable | very low | non important | - |
severe adverse events | 1.74 [1.41, 2.14] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
thrombocytopenia | 0.94 [0.66, 1.33] | | < 1 | | 0% | 1 study (-/1) | 63.5 % | NA | not evaluable | | non important | - |
Transverse myelitis | 1.45 [0.07, 31.68] | | < 1 | | 0% | 1 study (-/1) | 40.8 % | NA | not evaluable | | non important | - |
uveitis | 1.27 [0.64, 2.52] | | < 1 | | 0% | 1 study (-/1) | 24.7 % | NA | not evaluable | | non important | - |
venous thromboembolism | 1.16 [1.00, 1.34] | | < 1 | | 0% | 1 study (-/1) | 2.3 % | NA | not evaluable | | non important | - |
VTE with thrombocytopenia | 0.86 [0.58, 1.27] | | < 1 | | 0% | 1 study (-/1) | 77.5 % | NA | not evaluable | | non important | - |
AE of interest endpoints 00 |
cerebral venous sinus thrombosis (CVST) | 1.37 [0.47, 3.95] | | < 1 | | 0% | 3 studies (-/3) | 28.2 % | moderate | not evaluable | moderate | important | - |
appendicitis | 1.42 [0.52, 3.86] | | < 1 | | 0% | 2 studies (2/-) | 24.5 % | some concern | not evaluable | moderate | non important | - |
arthralgia, grade 3-4 | 18.37 [13.54, 24.91] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
Bell's palsy | 4.32 [0.72, 25.96] | | < 1 | | 0% | 2 studies (2/-) | 5.6 % | some concern | not evaluable | moderate | non important | - |
hypersensitivity, all terms | 1.43 [1.18, 1.74] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
immediate allergic reaction | 1.00 [0.02, 50.42] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
lymphadenopathy, any | 10.69 [4.63, 24.69] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
lymphadenopathy, grade 3-4 | 1.00 [0.06, 15.97] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
musculoskeletal and connective tissue disorders, any | 3.64 [3.25, 4.08] | | < 1 | | 0% | 2 studies (2/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
myalgia, grade 3-4 | 27.64 [20.93, 36.50] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
myelitis | 1.05 [0.77, 1.43] | | < 1 | | 14% | 2 studies (-/2) | 37.5 % | NA | not evaluable | | non important | - |
reactogenicity (vaccines) endpoints 00 |
fever, grade 3-4 | 43.29 [17.83, 105.10] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
local adverse reaction, any, dose 1 | 24.90 [22.13, 28.03] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
local adverse reaction, any, dose 2 | 27.99 [19.26, 40.68] | | < 1 | | 96% | 2 studies (2/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
local adverse reaction, grade 3-4, dose 2 | 15.04 [11.83, 19.12] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
systemic adverse reaction, any, dose 1 | 1.63 [1.50, 1.78] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
systemic adverse reaction, any, dose 2 | 5.53 [3.79, 8.06] | | < 1 | | 98% | 2 studies (2/-) | 0.0 % | some concern | not evaluable | moderate | non important | - |
systemic adverse reaction, grade 3-4, dose 2 | 9.50 [8.38, 10.77] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
immunogenicity (vaccines) endpoints 00 |
serologic response (seroconversion) | 0.09 [0.00, 5.02] | | > 1 | | 70% | 2 studies (-/2) | 12.4 % | NA | not evaluable | | non important | - |