McMahon A W, Iskander J K, Haber P, Braun M M, Ball R
Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, Food and Drug Administration, USA.
Vaccine. 2008 Jan 17;26(3):427-9. doi: 10.1016/j.vaccine.2007.10.071. Epub 2007 Nov 29.
Thimerosal as a preservative (in all but trace amounts) was removed from vaccines used in infants starting in the late 1990s, though the preservative-including inactivated influenza vaccine is still available for use in individuals >or=6 months of age. We compared the proportion of injection site reactions, rash, and infections reported to the Vaccine Adverse Event Reporting System (VAERS) after preservative-free (PFV), preservative-including (PIV), and preservative unknown (PUV) vaccines in reports from 7/1/2004 to 1/4/2006. There were 145, 175, and 216 reports after vaccination with PFV, PIV, and PUV, respectively. The most frequently reported coding terms (fever, rash, and urticaria) were seen in similar proportions in the PFV, PIV, and PUV groups. No difference was detected in the proportion of injection site reactions (ISR), rash, or infections in the PIV, PFV, and PUV reports. Keeping in mind the inherent limitations of VAERS, including underreporting and potential reporting biases, we conclude that there were no substantial differences in the proportion of rash, ISR, and infection reports in the PIV, PFV and PUV reports in infants.
从20世纪90年代末开始，用于婴儿的疫苗中不再添加硫柳汞作为防腐剂（除痕量外），不过含防腐剂的灭活流感疫苗仍可用于6个月及以上的人群。我们比较了2004年7月1日至2006年1月4日期间，无防腐剂疫苗（PFV）、含防腐剂疫苗（PIV）和防腐剂情况未知疫苗（PUV）接种后向疫苗不良事件报告系统（VAERS）报告的注射部位反应、皮疹和感染的比例。接种PFV、PIV和PUV疫苗后分别有145份、175份和216份报告。在PFV、PIV和PUV组中，最常报告的编码术语（发热、皮疹和荨麻疹）出现的比例相似。在PIV、PFV和PUV报告中，注射部位反应（ISR）、皮疹或感染的比例未检测到差异。考虑到VAERS的固有局限性，包括报告不足和潜在的报告偏差，我们得出结论，婴儿中PIV、PFV和PUV报告的皮疹、ISR和感染报告比例没有实质性差异。
