Geier Mark R, Geier David A, Zahalsky Arthur C
The Genetic Centers of America, 14 Redgate Ct, Silver Spring, MD 20905, USA.
Expert Opin Drug Saf. 2003 Mar;2(2):113-22. doi: 10.1517/14740338.2.2.113.
Hepatitis B is one of the most important infectious causes of acute and chronic liver disease both in the US and worldwide. In order to combat the life-threatening effects of hepatitis B infection, recombinant hepatitis B vaccines have been developed. The medical and scientific communities have generally accepted that recombinant hepatitis B vaccine - a highly purified, genetically engineered, single antigen vaccine - is a safe vaccine. Information is presented showing that hepatitis B vaccine contains yeast, aluminium, thimerosal and hepatitis B surface antigen epitopes, which may result in hepatitis B vaccine being associated with autoimmune diseases among susceptible adult vaccine recipients. There is little doubt that the benefits of this vaccine overall far outweigh its risks. Physicians and patients should evaluate the risks and benefits of hepatitis B vaccination and, together, make an informed consent decision as to whether to undergo vaccination. Individuals who experience an adverse reaction to hepatitis B vaccination should report it to the Vaccine Adverse Event Reporting System database and be advised that they may be eligible for compensation from the no-fault National Vaccine Injury Compensation Program, administered by the US Court of Claims. The authors strongly urge that additional research be conducted into the molecular basis of adverse events following hepatitis B vaccine administration, so that further recommendations may be made on how to improve their safety profiles.
在美国和全球范围内，乙型肝炎是急性和慢性肝病最重要的感染性病因之一。为了对抗乙型肝炎感染危及生命的影响，已研发出重组乙型肝炎疫苗。医学和科学界普遍认为，重组乙型肝炎疫苗——一种高度纯化、基因工程改造的单抗原疫苗——是一种安全的疫苗。现有信息表明，乙型肝炎疫苗含有酵母、铝、硫柳汞和乙型肝炎表面抗原表位，这可能导致易感成年疫苗接种者中乙型肝炎疫苗与自身免疫性疾病有关联。毫无疑问，这种疫苗的总体益处远远超过其风险。医生和患者应评估乙型肝炎疫苗接种的风险和益处，并共同就是否接种疫苗做出明智的同意决定。对乙型肝炎疫苗接种出现不良反应的个体应向疫苗不良反应报告系统数据库报告，并被告知他们可能有资格从由美国索赔法院管理的无过错国家疫苗伤害赔偿计划中获得赔偿。作者强烈敦促对乙型肝炎疫苗接种后不良事件的分子基础进行更多研究，以便就如何改善其安全性概况提出进一步建议。
