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Keith Peden PhD VRBPAC会议2024年10月10日...
Established in 1988 Andrew Lewis was appointed Laboratory Chief in 1997 Keith Peden was appointed Laboratory Chief in 2011 LDNAV was last reviewed in 2018 While the Lab was set up to review and study DNA viruses as vaccines or vaccine-vectored vaccines, its role has evolved to encompass other viruses and cell-substrate safety issues as priorities change and emergencies arise
疫苗和相关生物产品咨询委员会2020年12月17日会议简报文件 - 赞助商附录
AE adverse event AESI adverse event of special interest AIDS acquired immunodeficiency syndrome ARDS acute respiratory distress syndrome CBRN chemical, biological, radiological, or nuclear CDC Centers for Disease Control and Prevention EUA Emergency Use Authorization FDA Food and Drug Administration hACE2 human angiotensin converting enzyme 2 HHS Health and Human Services HIV human immunodeficiency virus IM intramuscular LNP脂质纳米粒子中东呼吸综合征mRNA Messenger RNA NAAT NAAT核酸扩增基于测试RT-PCR逆转录 - 转录 - 聚合酶链链反应SAE严重不良事件SARS-COV-SARS-COV-2严重急性急性呼吸道呼吸道综合征2 VE疫苗效应VRBPAC效应VRBPAC效果
Pfizer-Biontech Covid-19疫苗VRBPAC简报
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