summary
treatment
patients
method
baseline characteristics
risk of bias
references
systemic adverse reaction, any, dose 1 systemic adverse reaction, any, dose 2 appendicitis Bell's palsy cerebral venous sinus thrombosis (CVST) immediate allergic reaction multiple sclerosis myelitis Potential Immune Gastrointestinal disorders Potential Immune Musculoskeletal disorders Potential Immune Neuroinflammatory disorders Potential Immune Skin disorders Potential Immune Vasculitides Thromboembolic events adverse events ATE (Myocardial infarction or ischemic stroke) ATE with thrombocytopenia deep vein thrombosis disseminated intravascular coagulation Guillain-Barré syndrome immune thrombocytopenia intracranial hemorrhage ischemic stroke Myocardial infarction myocarditis pericarditis pulmonary embolism serious adverse events serious adverse events (SAE), any severe adverse events splanchnic vein thrombosis (SVT) stroke (non-specific, hemorrhagic, and ischemic) stroke with thrombocytopenia thrombocytopenia venous thromboembolism VTE with thrombocytopenia asymptomatic COVID case confirmed COVID (any severity) confirmed Covid-19, from 1st dose deaths hospitalization infection (PCR positive symptomatic or not) new illness compatible with Covid-19 severe COVID-19 occurrence symptomatic Covid-19 transmission (symptomatic confirmed COVID19) vaccine efficacy after dose 1 (and before dose 2)
overview
numeric
bar chart
forest plot
medians
figures
uncontrolled
O6
Study
Ref.
Design
studied treatment control treatment patients study risk of bias sample sizes
Results
COVID-19 prophylaxis (excluding children) meta-analysis Asano NCT04568031 RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) placebo COVID-19 prophylaxis (excluding children) NA -/- inconclusive AstraZeneca phase 3 US (D8110C00001) NCT04516746 RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) placebo COVID-19 prophylaxis (excluding children) NA 21583/10796 safety concern suggested 76 % decrease in symptomatic Covid-19 statistically significant 62 % increase in adverse events statistically significant vaccine efficacy of 78.9% in preventing symptomatic COVID-19 and 100% efficacy in preventing severe or critical disease and hospitalization. In participants 65 years and older, who comprised 20% of the trial population, vaccine efficacy against symptomatic COVID-19 was 79.9% Fengcai NCT04566770 RCT CanSino (Convidecia) placebo COVID-19 prophylaxis (excluding children) NA 320/110 safety concern statistically significant 19.2-fold increase in systemic adverse reaction, any, dose 1 statistically significant 3.4-fold increase in systemic adverse reaction, any, dose 2 Kulkarni CTRI/2020/08/027170 RCT Covishield (Oxford/AZ formulation) placebo COVID-19 prophylaxis (excluding children) NA 1200/300 inconclusive There were no thromboembolic-associated or autoimmune-related SAEs Sadoff NCT04436276 RCT Janssen AD26 vaccine (JNJ-78436735) placebo COVID-19 prophylaxis (excluding children) NA -/- inconclusive Interim Results of a Phase 1–2a Trial : cohort 1 (healthy adults 18-55y) and 3 (>65y). Data that are reported here were collected after the administration of the second dose (either vaccine or placebo) in cohort 1a and after the first dose in cohort 3 AstraZeneca Oxford pooled analysis (COV003, COV001, COV002, COV005)_safety RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA 12282/11962 inconclusive pooled data of four trials are registered at ISRCTN89951424 (COV003) and ClinicalTrials.gov, NCT04324606 (COV001), NCT04400838 (COV002), andNCT04444674 (COV005) CanSino phase 2 (Zhu) NCT04341389 RCT CanSino (Convidecia) placebo COVID-19 prophylaxis (excluding children) NA 382/126 inconclusive No serious adverse events were documented within 28 days ChAdOx1 phase 3 (AstraZeneca) NCT04400838 RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) some concern 5807/5829 conclusif demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias RESIST (Sputnik V Gamaleya Research Institute Russia) NCT04530396 RCT Sputnik V (Gam-COVID-Vac) placebo COVID-19 prophylaxis (excluding children) high 16501/5476 suggested suggested 73 % decrease in confirmed Covid-19, from 1st dose but with a low degree of certainty due to high risk of bias suggested 92 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias ENSEMBLE (COV3001) unpublished NCT04505722 RCT Janssen AD26 vaccine (JNJ-78436735) placebo COVID-19 prophylaxis (excluding children) some concern 21895/21888 conclusif suggested 81 % decrease in deaths with a moderate degree of certainty due to some concern in risk of bias demonstrated 67 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of biassuggested 82 % decrease in hospitalization with a moderate degree of certainty due to some concern in risk of bias
PE: primary endpoint; (a): to be demonstrated a result must be statistically significant on a primary endpoint (with multiplicity adjustment if necessary);
