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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)
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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 bias suggested 82 % decrease in hospitalization with a moderate degree of certainty due to some concern in risk of bias Scotland cohort unpublished OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- suggested EPIPHARE (Janssen) OBS Janssen AD26 vaccine (JNJ-78436735) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 75 % increase in Myocardial infarction EPIPHARE (Vaxzevria) OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 29 % increase in Myocardial infarction statistically significant 41 % increase in pulmonary embolism Hippisley-Cox OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 10 % increase in venous thromboembolism Husby (janssen) OBS Janssen AD26 vaccine (JNJ-78436735) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Patone OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 1.3-fold increase in Guillain-Barré syndrome statistically significant 1.0-fold increase in Guillain-Barré syndrome Simpson (ChAdOx1) OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 98 % increase in immune thrombocytopenia Nabirova OBS Sputnik V (Gam-COVID-Vac) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 77 % decrease in new illness compatible with Covid-19 Bernal (PHE, 19th February 2021) OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- no results Burn (Vaxzevria) OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 1.0-fold increase in immune thrombocytopenia but with a very low degree of certainty due to critical risk of bias statistically significant 23 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias statistically significant 25 % increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias Edward (Vaxzevria) OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) critical -/- inconclusive Bernal unpublished OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 55 % decrease in deaths,deaths Pottegard OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 1.3-fold increase in intracranial hemorrhage but with a very low degree of certainty due to critical risk of bias statistically significant 79 % increase in pulmonary embolism but with a very low degree of certainty due to critical risk of bias statistically significant 2.0-fold increase in thrombocytopenia but with a very low degree of certainty due to critical risk of bias statistically significant 97 % increase in venous thromboembolism but with a very low degree of certainty due to critical risk of bias statistically significant 19.3-fold increase in cerebral venous sinus thrombosis (CVST) but with a very low degree of certainty due to critical 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);
Study risk of bias assessed for the study primary endpoint(s) or the main endpoints in case of no formally defined primary endpoint(s).