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IgG titer serologic response (seroconversion) T cell response fever, grade 3-4 local adverse reaction, any, dose 1 local adverse reaction, any, dose 2 local adverse reaction, grade 3-4, dose 2 severe muscle pain, dose 1 severe muscle pain, dose 2 systemic adverse reaction, any, dose 1 systemic adverse reaction, any, dose 2 systemic adverse reaction, grade 3-4, dose 2 appendicitis arthralgia, grade 3-4 Bell's palsy cerebral venous sinus thrombosis (CVST) hypersensitivity, all terms immediate allergic reaction lymphadenopathy, any lymphadenopathy, grade 3-4 musculoskeletal and connective tissue disorders, any myalgia, grade 3-4 myelitis acute kidney injury adverse events Anemia arrhythmia Arthritis or arthropathy cerebrovascular thromboembolic events convulsions/seizures deep vein thrombosis disseminated intravascular coagulation Guillain-Barré syndrome Herpes simplex infection herpes zoster infection immune thrombocytopenia intracranial hemorrhage ischemic stroke life-threatening SAE Myocardial infarction myocarditis neutropenia paresthesia pericarditis pulmonary embolism related AE (TRAE) related SAE (TRSAE) serious adverse events severe adverse events thrombocytopenia Transverse myelitis uveitis venous thromboembolism VTE with thrombocytopenia 6 months severe COVID-19 6 months symptomatic COVID asymptomatic COVID case confirmed COVID (any severity) confirmed Covid-19, from 1st dose death D28 death or ventilation 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) vaccine efficacy from randomization (ITT)
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COVID-19 prophylaxis (excluding children) meta-analysis BNT162b2 phase 3 (C4591001, Polack) NCT04368728 RCT Comirnaty (tozinameran - Pfizer/BIONTECH) placebo COVID-19 prophylaxis (excluding children) some concern 21720/21728 conclusif suggested 91 % decrease in 6 months symptomatic COVID with a moderate degree of certainty due to some concern in risk of bias suggested 82 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias suggested 82 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias demonstrated 95 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 3.9-fold increase in related AE (TRAE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 1.6-fold increase in adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 74 % increase in severe adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 9.7-fold increase in lymphadenopathy, any with a moderate degree of certainty due to some concern in risk of bias statistically significant 2.7-fold increase in musculoskeletal and connective tissue disorders, any with a moderate degree of certainty due to some concern in risk of bias statistically significant 23.9-fold increase in local adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias statistically significant 22.0-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias statistically significant 63 % increase in systemic adverse reaction, any, dose 1 with a moderate degree of certainty due to some concern in risk of bias statistically significant 3.6-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias COVE Moderna/NIH phase 3 (study 301) NCT04470427 RCT Spikevax (Moderna mRNA-1273 COVID-19 vaccine) placebo COVID-19 prophylaxis (excluding children) some concern 15181/15170 conclusif suggested 95 % decrease in confirmed Covid-19, from 1st dose with a moderate degree of certainty due to some concern in risk of bias suggested 93 % decrease in vaccine efficacy from randomization (ITT) with a moderate degree of certainty due to some concern in risk of bias demonstrated 94 % decrease in symptomatic Covid-19 (PE) with a moderate degree of certainty due to some concern in risk of bias demonstrated 98 % decrease in severe COVID-19 occurrence (PE) with a moderate degree of certainty due to some concern in risk of bias statistically significant 14 % increase in adverse events with a moderate degree of certainty due to some concern in risk of bias statistically significant 17.4-fold increase in arthralgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias statistically significant 41 % increase in hypersensitivity, all terms with a moderate degree of certainty due to some concern in risk of bias statistically significant 2.5-fold increase in lymphadenopathy, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias statistically significant 26.6-fold increase in myalgia, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias statistically significant 42.3-fold increase in fever, grade 3-4 with a moderate degree of certainty due to some concern in risk of bias statistically significant 32.7-fold increase in local adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias statistically significant 14.0-fold increase in local adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias statistically significant 5.7-fold increase in systemic adverse reaction, any, dose 2 with a moderate degree of certainty due to some concern in risk of bias statistically significant 8.5-fold increase in systemic adverse reaction, grade 3-4, dose 2 with a moderate degree of certainty due to some concern in risk of bias Moderna study 201 100µg NCT04405076 RCT Spikevax (Moderna mRNA-1273 COVID-19 vaccine) placebo COVID-19 prophylaxis (excluding children) NA 189/186 no results No deaths or unsolicited AEs that led to discontinuation from study vaccine or the study occurred within 28 days. One SAE of community-acquired pneumonia occurred on day 33 at 50 µg mRNA-1273 in the older cohort, resolved on day 58 and led to study vaccine discontinuation. Nguyen OBS Comirnaty (tozinameran - Pfizer/BIONTECH) Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) COVID-19 prophylaxis (excluding children) NA -/- inconclusive Amit OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 7214/1895 suggested Dagan OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 596618/596618 suggested suggested 87 % decrease in hospitalization suggested 94 % decrease in symptomatic Covid-19 SIREN (HW england) ISRCTN11041050 OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious -/- suggested Thompson OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) critical 2961/989 suggested suggested 90 % decrease in confirmed COVID (any severity) but with a very low degree of certainty due to critical risk of bias Agur unpublished OBS mRNA vaccine uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Scotland cohort unpublished OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested Shemer OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Shemer OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Thompson -VISIOn Network (omicron) OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 81 % decrease in hospitalization suggested 52 % decrease in symptomatic Covid-19,confirmed COVID (any severity) Husby (Moderna) OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) NA -/- safety concern suggested 59 % decrease in death D28 statistically significant 2.9-fold increase in myocarditis Husby (pfizer) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Patone OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 24 % increase in intracranial hemorrhage Shasha OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 22 % increase in paresthesia Kirsebom (UKHSA) OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 17 % decrease in symptomatic Covid-19 Angel OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 5517/757 suggested suggested 97 % decrease in symptomatic Covid-19 Barda OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 43 % increase in herpes zoster infection but with a very low degree of certainty due to critical risk of bias statistically significant 2.2-fold increase in myocarditis but with a very low degree of certainty due to critical risk of bias statistically significant 40 % increase in appendicitis but with a very low degree of certainty due to critical risk of bias statistically significant 1.4-fold increase in lymphadenopathy, any but with a very low degree of certainty due to critical risk of bias Bernal (PHE, 19th February 2021) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 61 % decrease in confirmed COVID (any severity) Bjork OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 86 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity) Chodcik OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious 503875/351897 inconclusive EPI-PHARE OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- inconclusive Goldberg OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 94 % decrease in deaths suggested 94 % decrease in hospitalization Haas OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 97 % decrease in deaths suggested 97 % decrease in hospitalization suggested 97 % decrease in symptomatic Covid-19 Heymann OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 89 % decrease in infection (PCR positive symptomatic or not),confirmed COVID (any severity) Klein OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) critical -/- suggested Klein OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- suggested Mayo Clinic (Puranik) OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) serious 51738/25869 suggested suggested 81 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias suggested 76 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias Mayo Clinic (Puranik) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious 51738/25869 suggested suggested 75 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias suggested 42 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias McMurry OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) NA -/- suggested McMurry OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested Nanduri OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) serious -/- suggested suggested 51 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias Nanduri OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious -/- suggested suggested 52 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias Pawlowski OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- inconclusive Shibli OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 36 % increase in Bell's palsy Shibli OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- safety concern statistically significant 36 % increase in Bell's palsy Tartof NCT04848584 OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (children), COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 73 % decrease in confirmed COVID (any severity) suggested 91 % decrease in confirmed COVID (any severity) suggested 90 % decrease in hospitalization Weekes OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested Tande unpublished OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- no results Lauring OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA 5728/5962 suggested suggested 44 % decrease in death or ventilation suggested 46 % decrease in death or ventilation suggested 76 % decrease in death or ventilation suggested 85 % decrease in hospitalization suggested 85 % decrease in hospitalization suggested 65 % decrease in hospitalization Southern California (Tseng) - delta OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 95 % decrease in confirmed COVID (any severity) Southern California (Tseng) - omicron OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 30 % decrease in confirmed COVID (any severity) Tenforde OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 82 % decrease in confirmed COVID (any severity) Abu-Raddad OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- no results Chung OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) NA 53270/270763 suggested suggested 94 % decrease in symptomatic Covid-19 Chung OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 53270/270763 suggested suggested 91 % decrease in symptomatic Covid-19 Chung OBS mRNA vaccine control COVID-19 prophylaxis (excluding children) NA 53270/270763 suggested suggested 91 % decrease in symptomatic Covid-19 England (Andrews) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA 581/130867 suggested suggested 49 % decrease in symptomatic Covid-19,confirmed COVID (any severity) Qatar (Tang) OBS Spikevax (Moderna mRNA-1273 COVID-19 vaccine) control COVID-19 prophylaxis (excluding children) serious -/- suggested suggested 85 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias Qatar (Tang) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious -/- suggested suggested 53 % decrease in symptomatic Covid-19 but with a low degree of certainty due to high risk of bias South Africa (Discovery Health, Collie) OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) NA -/- suggested suggested 70 % decrease in hospitalization suggested 50 % decrease in symptomatic Covid-19,confirmed COVID (any severity) Tenforde OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) serious 1194/1895 suggested suggested 84 % decrease in hospitalization,severe COVID-19 occurrence but with a low degree of certainty due to high risk of bias Wan OBS Comirnaty (tozinameran - Pfizer/BIONTECH) control COVID-19 prophylaxis (excluding children) critical -/- safety concern statistically significant 1.4-fold increase in Bell's palsy but with a very low degree of certainty due to critical risk of bias Aleman DESC mRNA vaccine uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Benotmane DESC Spikevax (Moderna mRNA-1273 COVID-19 vaccine) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Boyarsky DESC mRNA vaccine uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Palich DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Rozen-Zvi DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Yanay DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results Zadok DESC Comirnaty (tozinameran - Pfizer/BIONTECH) uncontrolled study COVID-19 prophylaxis (excluding children) NA -/- no results
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).