Pediatrics. 1997 Feb;99(2):282-8. doi: 10.1542/peds.99.2.282.
In 1991 and 1992, the US Food and Drug Administration approved two acellular pertussis vaccines combined with diphtheria and tetanus toxoids for use as the fourth and fifth doses after the initial three-dose primary series with the standard whole-cell pertussis vaccine administered at 2, 4, and 6 months of age. Recently completed trials of acellular pertussis vaccines conducted in Europe have documented the efficacy of these vaccines when administered as a primary series in infancy. Based on these studies, two acellular pertussis vaccines, Tripedia (Connaught Laboratories, Swiftwater, PA) and ACEL-IMUNE (Wyeth-Lederle Laboratories, Pearl River, NY), were licensed by the Food and Drug Administration for the initial three-dose series. Additional acellular pertussis vaccines are likely to be licensed for use in infants in the future. The recommendations in this statement supplement previous American Academy of Pediatrics guidelines for the use of acellular pertussis vaccines.
1991年和1992年，美国食品药品监督管理局批准了两种无细胞百日咳疫苗，它们与白喉和破伤风类毒素联合使用，作为在2、4和6月龄接种标准全细胞百日咳疫苗进行初始三剂基础免疫系列后的第四剂和第五剂。欧洲最近完成的无细胞百日咳疫苗试验证明了这些疫苗在婴儿期作为基础免疫系列接种时的有效性。基于这些研究，两种无细胞百日咳疫苗，即Tripedia（康诺特实验室，宾夕法尼亚州斯威夫特沃特）和ACEL-IMUNE（惠氏-礼来实验室，纽约州珍珠河），获得了美国食品药品监督管理局批准用于初始三剂系列。未来可能会有更多的无细胞百日咳疫苗获得许可用于婴儿。本声明中的建议补充了美国儿科学会先前关于使用无细胞百日咳疫苗的指南。
