COVID-19 and the Emerging Regulatory Guidance for Ongoing Clinical Trials in the European UnionCOVID-19 및 유럽 연합에서 진행 중인 임상 시험에 대한 새로운 규제 지침Article Published on 2021-06-012022-09-11 Journal: Clinical Pharmacology and Therapeutics [Category] MERS, SARS, 신약개발, 임상, [키워드] activity affected change Clinic visits clinical clinical trial coding competent coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 case data integrity defined documentation management EMA European European Medicines Agency evaluate evaluated Guidance Health information Informed consent initial investigational medicinal product management measure National NCA pandemic provided ranged Regulatory searched self-monitoring significantly Sponsor starting point telemedicine visits Trial union website [DOI] 10.1002/cpt.2225 PMC 바로가기 [Article Type] Article
Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2Review Published on 2021-05-032022-10-28 Journal: Vaccines [Category] COVID-19, [키워드] acute respiratory syndrome assessment biosafety candidate Candidates Characteristics clinical development coronavirus coronavirus disease COVID-19 COVID-19 vaccine drug effective Efficacy effort EMA environmental risk assessment European European Medicines Agency feature highlight include Nucleic acid-based vaccines organism over pandemic platform Protein-based vaccines recombinant recombinant viral vector vaccines Regulatory risk Safe SARS-CoV-2 union vaccination Vaccine vaccine candidate vector Viral vector vaccine viral vectors virus [DOI] 10.3390/vaccines9050453 PMC 바로가기 [Article Type] Review
Efficacy of synthetic glucocorticoids in COVID-19 endothelites코로나19 내피세포에서 합성 글루코코르티코이드의 효능Review Published on 2021-05-012022-09-11 Journal: Naunyn-Schmiedeberg's Archives of Pharmacology [Category] 임상, [키워드] acute respiratory syndrome airway anti-inflammatory effect caused characterized Combination contribute COVID-19 COVID-19 infection COVID-19 patients COVID-19 vaccine Cytokine storm Desametasone described develop Dexamethasone disease disorders effective EMA endothelial Endothelial dysfunction European Medicines Agency Evidence functional gcs global pandemic glucocorticoid Glucocorticoids hospitalized patient increased risk Inflammatory inflammatory state Injury lesions neurological New coronavirus new coronavirus SARS-CoV-2 organ pandemic patients with COVID-19 randomized trial renal responsible Safe SARS-CoV-2 Severe acute respiratory syndrome severe complications severe COVID-19 shown Stage Therapeutic benefit therapeutic efficacy therapeutic utility tissue Vascular venous with COVID-19 [DOI] 10.1007/s00210-021-02049-7 PMC 바로가기 [Article Type] Review
COVID-19 vaccine decisions: considering the choices and opportunitiesCOVID-19 백신 결정: 선택과 기회 고려Editorial Published on 2021-05-012022-09-12 Journal: Microbes and infection [Category] 진단, [키워드] antibodies asked benefit Brazil China clinical trial coronavirus disease COVID-19 COVID-19 vaccine drug EMA Emergency use authorization Europe European Medicines Agency FDA feature FIVE food India Medicine MHRA North America operation produced receive receiving released Russia speed table United Kingdom Vaccine Vaccine distribution Vaccines Virus-neutralizing antibodies. [DOI] 10.1016/j.micinf.2021.104811 PMC 바로가기 [Article Type] Editorial
Lead Discovery of SARS-CoV-2 Main Protease Inhibitors through Covalent Docking-Based Virtual Screening공유 도킹 기반 가상 스크리닝을 통한 SARS-CoV-2 주요 프로테아제 억제제의 선도적 발견Article Published on 2021-04-262022-09-11 Journal: Journal of Chemical Information and Modeling [Category] SARS, 치료제, [키워드] acting acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 approval candidate characterized chymotrypsin Clinical data coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 patients cure cysteine cysteine protease database docking drug Economy effective drug effective drugs effort EMA enzyme European Medicines Agency FDA food Health house identify in silico inhibitor Ligand M pro Michael pandemic peptide predict predictive power risk SARS-CoV-2 Screening severe acute respiratory syndrome Coronavirus target protein the SARS-CoV-2 treat Vaccine Virtual screening [DOI] 10.1021/acs.jcim.1c00184 PMC 바로가기 [Article Type] Article
Impact of Ribosome Activity on SARS-CoV-2 LNP – Based mRNA VaccinesMolecular Biosciences Published on 2021-04-202022-10-31 Journal: Frontiers in Molecular Biosciences [Category] COVID-19, [키워드] activity Affect affected alteration approved authorisation catastrophic China COVID-19 distribution drug Efficacy EMA emergency situation European Medicines Agency expand FDA food functional General population Genetic immune response Impact in vivo Interaction LNP mechanism Messenger RNA modifications mRNA national health authority pandemic respiratory ribosome SARS-CoV-2 stages target cell Topic understanding Vaccine Vaccines variety viral infection WHO World Health Organization Wuhan [DOI] 10.3389/fmolb.2021.654866 PMC 바로가기 [Article Type] Molecular Biosciences
Analysis of Thrombotic Adverse Reactions of COVID-19 AstraZeneca Vaccine Reported to EudraVigilance DatabaseArticle Published on 2021-04-162022-10-28 Journal: Vaccines [Category] COVID-19, [키워드] Adverse Adverse drug reaction adverse event adverse events Adverse reaction Adverse reactions Analysis assessment AstraZeneca benefit Blood Characteristics Committee Comorbidities Conducting COVID-19 database death effective EMA European country European Medicines Agency event fatality group identify pandemic pharmacovigilance reaction Research retrospective Safe specificity submitted the vaccine thrombosis thrombotic vaccination Vaccine Vaccines World Health Organization’ [DOI] 10.3390/vaccines9040393 PMC 바로가기 [Article Type] Article
Thrombocytopenia and Intracranial Venous Sinus Thrombosis after “COVID-19 Vaccine AstraZeneca” ExposureArticle Published on 2021-04-092022-10-30 Journal: Journal of Clinical Medicine [Category] COVID-19, [키워드] “COVID-19 antibodies anticoagulation antiplatelet approved AstraZeneca AZD1222 ChAdOx1 nCoV-19 clinical manifestation coagulation disorder concerning Corona Coronavirus infection Course COVID-19 COVID-19 vaccine COVID-19 vaccine AstraZeneca cranial death diagnosed diagnostic died elevated EMA European Medicines Agency evaluated event exposure expression first vaccination headache Headaches immunological Intervention Intracerebral hemorrhage Intracranial Laboratory management Manifestations Mild MRI normalized observation occipital Oxford Patient Platelet platelet factor 4 antibodies Prevent raised resulting rheolysis Seizure Sinus somnolence Spike protein the vaccine thrombocytopenia thrombosis thrombotic event Treatment university vaccination Vaccine venous Venous sinus thrombosis venous thromboembolic while women [DOI] 10.3390/jcm10081599 PMC 바로가기 [Article Type] Article
A Rare Case of Cerebral Venous Thrombosis and Disseminated Intravascular Coagulation Temporally Associated to the COVID-19 Vaccine AdministrationCase Report Published on 2021-04-082022-10-30 Journal: Journal of Personalized Medicine [Category] COVID-19, [키워드] abdomen added Administered administration adopted adrenal hemorrhage AIFA AstraZeneca Atypical benefit bleeding Blood blood clot blood platelet Brain cerebral Cerebral venous thrombosis coagulation factor Computed tomography confirmed COVID-19 case country COVID-19 COVID-19 infection COVID-19 vaccine death deaths died Disseminated intravascular coagulation distal EMA European country European Medicines Agency genetic alteration hemorrhage Hospitalization intensive care intravascular coagulation Italian Italy left upper lobe lobes magnetic resonance imaging measure Medicine MRI Nasopharyngeal swab Patient persistence reported right middle lobe risk Side effects the vaccine the WHO Thorax Thromboembolic event thrombosis Vaccine vaccine dose Venous thrombosis vessel was performed WHO with COVID-19 [DOI] 10.3390/jpm11040285 PMC 바로가기 [Article Type] Case Report
First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use AuthorizationFocused Review Published on 2021-03-052022-11-01 Journal: Discoveries [Category] COVID-19, [키워드] authorization Commission Contact contagiousness coronavirus COVID-19 COVID-19 associated symptom Critical EMA Emergency Emergency use authorization Europe European Medicines Agency. globe Government incidence increase in individuals Infection limitations Moderna mRNA vaccine mRNA-based vaccines pandemic Pneumonia reported resource responsible restrict Spread Stage the disease the vaccine Treatment triggered US FDA US Food and Drug Administration USA Vaccine Vaccine development virus Wuhan [DOI] 10.15190/d.2021.1 PMC 바로가기 [Article Type] Focused Review