| 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 | - |
| death D28 | 0.41 [0.37, 0.46] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | crucial | - |
| deaths | 0.54 [0.30, 0.95] | | < 1 | | 0% | 9 studies (11/-) | 98.3 % | some concern | not evaluable | moderate | crucial | - |
| deaths (time to event analysis only) | 0.12 [0.06, 0.24] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | crucial | - |
| hospitalization or death | 0.39 [0.33, 0.46] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | 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 | - |
| clinical deterioration | 0.44 [0.37, 0.52] | | < 1 | | 0% | 1 study (-/1) | 100.0 % | NA | not evaluable | | important | - |
| 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 | - |
| death or ventilation | 0.43 [0.13, 1.50] | | < 1 | | 79% | 2 studies (-/2) | 90.6 % | low | not evaluable | high | important | - |
| hospitalization | 0.25 [0.07, 0.85] | | < 1 | | 0% | 5 studies (8/-) | 98.7 % | some concern | not evaluable | moderate | important | - |
| new illness compatible with Covid-19 | 0.08 [0.01, 0.77] | | < 1 | | 0% | 1 study (4/-) | 98.5 % | NA | not evaluable | | important | - |
| symptomatic Covid-19 | 0.33 [0.20, 0.53] | | < 1 | | 92% | 12 studies (19/-) | 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 | 0.54 [0.19, 1.54] | | < 1 | | 86% | 2 studies (2/-) | 87.4 % | some concern | not evaluable | moderate | non important | - |
| ICU admission | 1.00 [0.02, 52.45] | | < 1 | | 0% | 1 study (1/-) | 50.0 % | NA | not evaluable | | non important | - |
| infection (PCR positive symptomatic or not) | 0.71 [0.53, 0.93] | | < 1 | | 61% | 10 studies (12/-) | 99.3 % | some concern | low | moderate | non important | - |
| severe COVID-19 occurrence | 0.22 [0.11, 0.41] | | < 1 | | 0% | 6 studies (9/-) | 100.0 % | some concern | not evaluable | moderate | non important | - |
| transmission (hospitalization for COVID19) | 0.77 [0.53, 1.11] | | < 1 | | 0% | 1 study (-/1) | 92.0 % | NA | not evaluable | | non important | - |
| transmission (symptomatic confirmed COVID19) | 0.58 [0.47, 0.72] | | < 1 | | 82% | 3 studies (-/3) | 100.0 % | serious | not evaluable | low | non important | - |
| vaccine efficacy after dose 1 (and before dose 2) | 0.35 [0.18, 0.68] | | < 1 | | 75% | 2 studies (2/-) | 99.9 % | some concern | not evaluable | moderate | 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 | 1.18 [0.87, 1.61] | | < 1 | | 64% | 7 studies (8/-) | 14.4 % | 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 | 2.23 [1.38, 3.60] | | < 1 | | 99% | 9 studies (14/-) | 0.1 % | 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 | - |
| ATE (Myocardial infarction or ischemic stroke) | 0.50 [0.12, 2.00] | | < 1 | | 0% | 1 study (4/-) | 83.6 % | NA | not evaluable | | non important | - |
| ATE with thrombocytopenia | 1.57 [0.65, 3.79] | | < 1 | | 0% | 1 study (-/1) | 15.8 % | 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 | 3.00 [0.61, 14.86] | | < 1 | | 0% | 1 study (1/-) | 9.0 % | 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 | 1.00 [0.06, 15.98] | | < 1 | | 0% | 1 study (2/-) | 50.0 % | 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 | 1.55 [0.93, 2.59] | | < 1 | | 63% | 4 studies (-/4) | 4.7 % | serious | not evaluable | low | non important | - |
| intracranial hemorrhage | 0.27 [0.05, 1.33] | | < 1 | | 0% | 5 studies (5/-) | 94.6 % | low | not evaluable | high | non important | - |
| ischemic stroke | 0.67 [0.11, 3.99] | | < 1 | | 0% | 1 study (7/-) | 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 (8/-) | 50.0 % | NA | not evaluable | | non important | - |
| myocarditis | 2.11 [1.19, 3.74] | | < 1 | | 76% | 5 studies (-/5) | 0.6 % | 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 | 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 (8/-) | 10.9 % | NA | not evaluable | | non important | - |
| serious adverse events (SAE), any | 0.88 [0.72, 1.08] | | < 1 | | 0% | 5 studies (5/-) | 88.8 % | 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 | - |
| splanchnic vein thrombosis (SVT) | 1.38 [0.72, 2.65] | | < 1 | | 0% | 1 study (-/1) | 16.7 % | NA | not evaluable | | non important | - |
| stroke (non-specific, hemorrhagic, and ischemic) | 0.99 [0.88, 1.10] | | < 1 | | 12% | 2 studies (-/2) | 59.1 % | critical | not evaluable | very low | non important | - |
| stroke with thrombocytopenia | 2.21 [0.99, 4.92] | | < 1 | | 0% | 1 study (-/1) | 2.6 % | NA | not evaluable | | non important | - |
| thrombocytopenia | 1.24 [1.00, 1.54] | | < 1 | | 88% | 4 studies (-/4) | 2.7 % | critical | not evaluable | very low | 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 | 2.75 [0.88, 8.64] | | < 1 | | 0% | 1 study (2/-) | 4.2 % | NA | not evaluable | | non important | - |
| VTE with thrombocytopenia | 0.91 [0.64, 1.28] | | < 1 | | 0% | 2 studies (-/2) | 71.2 % | critical | not evaluable | very low | 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 | 1.76 [0.65, 4.75] | | < 1 | | 0% | 4 studies (5/-) | 13.3 % | 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 | 1.47 [0.11, 19.07] | | < 1 | | 0% | 2 studies (2/-) | 38.6 % | some concern | not evaluable | moderate | 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 | - |
| multiple sclerosis | 1.95 [0.07, 58.15] | | < 1 | | 0% | 1 study (1/-) | 35.2 % | 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 | 1.95 [0.18, 21.52] | | < 1 | | 0% | 1 study (1/-) | 29.4 % | NA | not evaluable | | non important | - |
| Potential Immune Gastrointestinal disorders | 0.33 [0.03, 3.13] | | < 1 | | 0% | 1 study (2/-) | 83.3 % | NA | not evaluable | | non important | - |
| Potential Immune Musculoskeletal disorders | 0.98 [0.06, 15.60] | | < 1 | | 0% | 1 study (1/-) | 50.7 % | NA | not evaluable | | non important | - |
| Potential Immune Neuroinflammatory disorders | 1.22 [0.33, 4.54] | | < 1 | | 0% | 1 study (1/-) | 38.4 % | NA | not evaluable | | non important | - |
| Potential Immune Skin disorders | 0.73 [0.16, 3.27] | | < 1 | | 0% | 1 study (1/-) | 65.8 % | NA | not evaluable | | non important | - |
| Potential Immune Vasculitides | 0.49 [0.02, 14.54] | | < 1 | | 0% | 1 study (1/-) | 65.9 % | NA | not evaluable | | non important | - |
| Thromboembolic events | 0.49 [0.15, 1.62] | | < 1 | | 0% | 1 study (1/-) | 87.9 % | 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 | - |
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 | - |
