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Abbreviation Definition AE adverse event AESI adverse events of special interest BLA Biologics License Application BMI body mass index CDC US Centers for Disease Control CMC Chemistry, Manufacturing, and Control CoV Coronavirus 2019-nCoV 2019 novel Coronavirus COVID-19 Coronavirus Disease 2019 DART developmental and reproductive toxicity ELISpot enzyme-linked immunospot EUA Emergency Use Authorization FDA (US) Food and Drug Administration FIH first-in-human GMC geometric mean concentration GMFR geometric mean fold-rise GMT geometric mean titer HBV hepatitis B virus HCV hepatitis C virus HIV human immunodeficiency virus IFN γ interferon gamma IgG immunoglobulin G IL-2 interleukin 2 IL-4 interleukin 4 IM intramuscular(ly) IRR illness rate ratio LLN lower limit of normal LNP lipid nanoparticle MedDRA Medical Dictional for Regulatory Activities MERS Middle East respiratory syndrome modRNA nucleoside-modified RNA NAAT nucleic acid amplification test NHP nonhuman primate P2 S P2 mutant PBMC peripheral blood mononuclear cell PCR polymerase chain reaction PK药代动力学PT首选术语RBD受体结合结构域RNA RNA核糖酸RNA-LNP RNA RNA脂质纳米颗粒SAE SAE严重不良事件SARS严重急性呼吸综合症SARS-COV-2 SARS-COV-2 SARS COTORONAVIRUS-CORONAVIRUS-2；引起covid-19的病毒S尖峰糖蛋白SMQ标准化MEDDRA查询SOC系统器官类Th1 T辅助细胞类型1 TH2 T辅助细胞类型2美国美国USP美国Pharmacopeia
Pfizer-Biontech Covid-19疫苗VRBPAC简报
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