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 (3/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
deaths | 0.54 [0.27, 1.10] | | < 1 | | 0% | 7 studies (7/-) | 95.5 % | some concern | not evaluable | moderate | crucial | - |
vaccine efficacy from randomization (ITT) | 0.11 [0.04, 0.29] | | < 1 | | 91% | 2 studies (3/-) | 100.0 % | some concern | not evaluable | moderate | crucial | - |
confirmed COVID (any severity) | 0.10 [0.05, 0.17] | | < 1 | | 0% | 1 study (2/-) | 100.0 % | NA | not evaluable | | important | - |
conversion to SARS-CoV- 2–positive status via NP swab | 2.27 [1.09, 4.76] | | < 1 | | 0% | 1 study (1/-) | 1.5 % | NA | not evaluable | | important | - |
hospitalization | 0.23 [0.06, 0.92] | | < 1 | | 9% | 4 studies (6/-) | 98.1 % | some concern | not evaluable | moderate | important | - |
symptomatic Covid-19 | 0.33 [0.18, 0.59] | | < 1 | | 92% | 11 studies (18/-) | 100.0 % | some concern | low | 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 | 0.96 [0.49, 1.90] | | < 1 | | 0% | 1 study (1/-) | 54.4 % | NA | not evaluable | | non important | - |
infection (PCR positive symptomatic or not) | 0.73 [0.53, 1.01] | | < 1 | | 45% | 8 studies (10/-) | 97.2 % | some concern | not evaluable | moderate | non important | - |
severe COVID-19 occurrence | 0.21 [0.11, 0.40] | | < 1 | | 0% | 5 studies (8/-) | 100.0 % | some concern | not evaluable | moderate | 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 |
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 | 1.40 [0.91, 2.14] | | < 1 | | 68% | 5 studies (5/-) | 6.3 % | some concern | not evaluable | moderate | important | - |
adverse events | 1.68 [1.10, 2.56] | | < 1 | | 99% | 8 studies (12/-) | 0.8 % | some concern | not evaluable | moderate | non important | - |
ATE (Myocardial infarction or ischemic stroke) | 0.50 [0.12, 2.00] | | < 1 | | 0% | 1 study (3/-) | 83.6 % | NA | not evaluable | | non important | - |
deep vein thrombosis | 3.00 [0.61, 14.86] | | < 1 | | 0% | 1 study (1/-) | 9.0 % | NA | not evaluable | | non important | - |
Guillain-Barré syndrome | 1.00 [0.06, 15.98] | | < 1 | | 0% | 1 study (2/-) | 50.0 % | NA | not evaluable | | non important | - |
intracranial hemorrhage | 0.28 [0.04, 1.81] | | < 1 | | 0% | 4 studies (4/-) | 90.9 % | low | not evaluable | high | non important | - |
ischemic stroke | 0.67 [0.11, 3.99] | | < 1 | | 0% | 1 study (6/-) | 67.1 % | NA | not evaluable | | 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 | 1.00 [0.02, 50.39] | | < 1 | | 0% | 1 study (7/-) | 50.0 % | NA | not evaluable | | non important | - |
pericarditis | 2.00 [0.07, 59.60] | | < 1 | | 0% | 1 study (1/-) | 34.7 % | NA | not evaluable | | non important | - |
pulmonary embolism | 4.00 [0.45, 35.79] | | < 1 | | 0% | 1 study (7/-) | 10.9 % | NA | not evaluable | | non important | - |
serious adverse events (SAE), any | 0.98 [0.71, 1.34] | | < 1 | | 0% | 4 studies (4/-) | 56.0 % | NA | not evaluable | | non important | - |
severe adverse events | 1.74 [1.41, 2.14] | | < 1 | | 0% | 1 study (1/-) | 0.0 % | NA | not evaluable | | non important | - |
venous thromboembolism | 2.75 [0.88, 8.64] | | < 1 | | 0% | 1 study (1/-) | 4.2 % | NA | not evaluable | | non important | - |
AE of interest endpoints 00 |
cerebral venous sinus thrombosis (CVST) | 2.00 [0.07, 59.60] | | < 1 | | 0% | 1 study (1/-) | 34.7 % | NA | not evaluable | | important | - |
appendicitis | 1.33 [0.62, 2.84] | | < 1 | | 0% | 3 studies (3/-) | 23.5 % | 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 | 2.54 [0.72, 9.02] | | < 1 | | 0% | 3 studies (4/-) | 7.5 % | 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 | - |
Potential Immune Gastrointestinal disorders | 0.50 [0.02, 14.81] | | < 1 | | 0% | 1 study (1/-) | 65.5 % | 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 (2/-) | 0.0 % | NA | not evaluable | | non important | - |
systemic adverse reaction, any, dose 2 | 5.53 [3.79, 8.06] | | < 1 | | 98% | 2 studies (3/-) | 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 | - |