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AE adverse event AECI adverse events of clinical interest AESI adverse events of special interest aEUA emergency use authorization amendment BLA biologics license application BNT162b2 name of the investigational product prior to authorization or approval BPCA Best Pharmaceuticals for Children Act CFR Code of Federal Regulations CDC Centers for Disease Control and Prevention CI confidence interval CMC chemistry, manufacturing, and controls CMV巨细胞病毒comirnaty的任何表述，批准的产品，comirnaty，不论应变成分或价值成本的成本分数编码符号，对不良反应术语covid-19 Coronavirus疾病2019 cr完全反应CSR临床研究报告covid-19 Cornavirus疾病的临床研究报告和ecmmo ecmmo ecmborector ecmbro ecmbro ecmbro ecmborection ecmborection ecmbrow ecmborection ecmbrow ecmbro ecmbro incorection ecmbrow ecmbrow ELISA enzyme-linked immunosorbent assay EUA emergency use authorization ES executive summary FDA Food and Drug Administration FDAAA Food and Drug Administration Amendments Act of 2007 FFRNT fluorescent focus reduction neutralization test GMFR geometric mean fold rise GMR geometric mean ratio GMT geometric mean titer GRMP good review management principles ICH International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use) IM intramuscular IS injection site ISE integrated summary of efficacy ITT intent-to-treat LB lower bound LL lower limit LLOQ lower limit of quantification LNP lipid nanoparticles MI myocardial infarction MIS-A multisystem inflammatory syndrome in adults MIS-C multisystem inflammatory syndrome in children mITT all-available immunogenicity population NAAT核酸扩增测试NDA新药应用NME新分子实体
2023年9月11日临床评论备忘录 - comirnaty
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