Duclos P, Bentsi-Enchill A
Childhood Immunisation Division, Health and Welfare Canada, Ottawa, Ontario.
Drug Saf. 1993 Jun;8(6):404-13. doi: 10.2165/00002018-199308060-00002.
Despite a continuous search for safer and more immunogenic vaccines, adverse reactions still occur. Adverse reactions to vaccines are generally mild; severe events resulting in death or permanent damage are rare. In every instance, the benefits of preventing the disease far outweigh the risks of vaccination. In the early days of vaccine development, a number of accidents were associated with faulty production. Most recent problems encountered with the use of vaccines are due to programmatic errors. Because of the large number of doses administered it is probable that there will be some temporal and merely coincidental association between adverse events and vaccine administration. Immunisation has a direct protective effect for the individual and an indirect effect on herd immunity for the community. The major goal of postmarketing surveillance is the early detection of and appropriate response to adverse events in order to curtail a negative impact on immunisation programmes. Risk-benefit analyses for immunisation are faced with a number of potential difficulties; definition of the risks and benefits themselves, individual versus community risks and benefits, and the continuously evolving nature of risks with changes in disease epidemiology. Based on risk-benefit studies, for an individual just as for the community, it may not always be of interest to use the vaccine with the lowest complication rate. Good immunisation programmes should help to decrease the risk of adverse effects.
尽管一直在寻找更安全、免疫原性更强的疫苗，但不良反应仍会发生。疫苗不良反应一般较为轻微；导致死亡或永久性损伤的严重事件很少见。在每种情况下，预防疾病的益处都远大于接种疫苗的风险。在疫苗研发早期，一些事故与生产缺陷有关。最近疫苗使用中出现的问题多是由于规划性错误。由于接种剂量庞大，不良事件与疫苗接种之间可能会存在一些暂时的、仅仅是巧合的关联。免疫接种对个体有直接保护作用，对社区的群体免疫有间接作用。上市后监测的主要目标是尽早发现不良事件并做出适当反应，以减少对免疫规划的负面影响。免疫接种的风险效益分析面临一些潜在困难；风险和效益本身的定义、个体与社区的风险和效益，以及随着疾病流行病学变化风险不断演变的性质。基于风险效益研究，对于个体和社区来说，使用并发症发生率最低的疫苗可能并非总是最理想的。良好的免疫规划应有助于降低不良反应的风险。
