Jefferson Tom, Rudin Melanie
Health Reviews Ltd, Rome, Italy.
Expert Opin Drug Saf. 2002 Jul;1(2):195-8. doi: 10.1517/14740338.1.2.195.
The first international meeting to focus exclusively on vaccine safety, brought together vaccine surveillance specialists, trialists, pharmaceutical companies, regulators, researchers and academics to examine and discuss methodological problems in the assessment of the safety of human vaccines. The 1st International Symposium on the Evaluation of Safety of Human Vaccines took place in Rome, Italy on 22 - 23 May 2002. The Istituto Superiore di Sanitá (ISS), Rome, Italy, sponsored the symposium. The symposium was opened by D Greco (Head of Epidemiology and Biostatistics, ISS and a well-known vaccine trialist) who spoke of the need for the gathering and sharing of information regarding adverse effects of vaccines, as single studies "are not enough" and "have their limitations". Vaccines have come along way since their first use, however, as there is public concern over real or perceived adverse events, collaboration is of great importance as uncertainty about the effectiveness and safety may affect coverage of immunisation programmes.
首届专门聚焦疫苗安全性的国际会议汇聚了疫苗监测专家、试验人员、制药公司、监管机构、研究人员和学者,共同审视和讨论人类疫苗安全性评估中的方法学问题。首届人类疫苗安全性评估国际研讨会于2002年5月22日至23日在意大利罗马举行。意大利罗马的高等卫生研究院(ISS)主办了此次研讨会。研讨会由D·格雷科(ISS流行病学与生物统计学负责人、著名疫苗试验人员)致开幕辞,他谈到收集和分享疫苗不良反应信息的必要性,因为单个研究“不够充分”且“存在局限性”。自首次使用以来,疫苗已经取得了长足的发展,然而,由于公众对实际发生或察觉到的不良事件存在担忧,鉴于有效性和安全性方面的不确定性可能影响免疫规划的覆盖率,合作至关重要。