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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 pulmonary embolism serious adverse events serious adverse events (SAE), any splanchnic vein thrombosis (SVT) stroke (non-specific, hemorrhagic, and ischemic) stroke with thrombocytopenia thrombocytopenia venous thromboembolism VTE with thrombocytopenia asymptomatic COVID case deaths hospitalization infection (PCR positive symptomatic or not) 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 Com-COV2 ISRCTN 27841311 RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) vaccines 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% Com-COV ISRCTN69254139 RCT Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) Comirnaty (tozinameran - Pfizer/BIONTECH) COVID-19 prophylaxis (excluding children) NA -/- inconclusive 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) 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 Scotland cohort unpublished OBS Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) control COVID-19 prophylaxis (excluding children) NA -/- suggested 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 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 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).