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美国国立变态反应与传染病研究所(NIAID)所长Fauci宣布,几家公司研制的百日咳无细胞菌苗(APV)体现了“百日咳免疫接种中新的最高标准”。这些产品无疑将在数月内顺利地获得美国食品与药物管理局的销售许可证。 25000多名儿童参加了NIAID在瑞典和意大利(非强制性实施百日咳菌苗接种的国家)进行的两项试验。试验目的是比较美国Chiron公司、SmithKline Beecham(SB)公司及Connaught药厂生产的APV和Connaught生产的百日咳全菌体菌苗的作用,后者是目前美国DTP配方的一部分。新菌苗按相同的配方制成白喉-破伤风类毒素-百日咳无细胞菌苗(DTaP)后进行试验。
Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID), announced that acellular pertussis vaccine (APV) developed by several companies represents the “new highest standard in pertussis immunization.” These products will undoubtedly get the sales license from the U.S. Food and Drug Administration within a few months. More than 25,000 children participated in two trials conducted by NIAID in Sweden and Italy (countries that do not enforce pertussis vaccination). The purpose of the trial was to compare the effects of APV and Connaught’s whole-body pertussis vaccine produced by Chiron, SmithKline Beecham (SB) and Connaught Pharmaceuticals, part of the current U.S. DTP formulation. The new vaccine was formulated in the same formulation as diphtheria-tetanus toxoid-pertussis acellular bacterin (DTaP) and tested.