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首页> 外文期刊>Anticancer Research: International Journal of Cancer Research and Treatment >Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents.
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Oral polio vaccine and human cancer: a reassessment of SV40 as a contaminant based upon legal documents.

机译：口服脊髓灰质炎疫苗和人类癌症：根据法律文件对SV40作为污染物进行了重新评估。

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To date, the scientific literature and research examining SV40 and cancer-related diseases has been based upon an assumption that SV40 was not present in any poliovirus vaccine administered in the United States and was removed from the killed polio vaccine by 1963. The basis for this presumption has been that the regulations for live oral polio vaccine required that SV40 be removed from the seeds and monovalent pools ultimately produced in the manufacturing process. The Division of Biologic Standards permitted an additional two tissue culture passages--from three to five--in order to allow manufacturers the ability to remove this contaminant from the oral poliovirus vaccines then awaiting licensure. The confirmation of the removal by one drug manufacturer, Lederle, has been made public at an international symposium in January 1997, where its representatives stated that all of Lederle's seeds had been tested and screened to assure that it was free from SV40 virus. However, in litigation involving the Lederle oral polio vaccine, the manufacturer's internal documents failed to reveal such removal in all of the seeds. The absence of confirmatory testing of the seeds, as well as testimony of a Lederle manager, indicate that this claim of removal of SV40 and the testing for SV40 in all the seeds cannot be fully substantiated. These legal documents and testimony indicate that the scientific community should not be content with prior assumptions that SV40 could not have been in the oral polio vaccine. Only further investigation by outside scientific and independent researchers who can review the test results claimed in the January 1997 meeting and who can conduct their own independent evaluations by testing all the seeds and individual mono-valent pools will assure that SV40 has not been present in commercially sold oral poliovirus vaccine manufactured by Lederle.
机译：迄今为止，检查SV40和与癌症相关疾病的科学文献和研究都基于这样的假设，即在美国施行的任何脊髓灰质炎疫苗中均不存在SV40，并于1963年从灭活的脊髓灰质炎疫苗中删除了SV40。据推测，口服脊髓灰质炎活疫苗的法规要求从制造过程中最终产生的种子和单价库中去除SV40。生物标准部门允许再进行两次组织培养，从三到五次，以使制造商能够从口腔脊髓灰质炎疫苗中去除这种污染物，然后等待许可。在1997年1月的一次国际研讨会上，一家药物制造商Lederle确认清除了该种子，其代表说，Lederle的所有种子都经过了测试和筛选，以确保不含SV40病毒。但是，在涉及Lederle口服脊髓灰质炎疫苗的诉讼中，制造商的内部文件未能揭示出所有种子中的这种清除方法。缺乏对种子的确认性测试以及Lederle经理的证词表明，这种声称已去除SV40和对所有种子中的SV40进行测试的主张无法得到充分证实。这些法律文件和证词表明，科学界不应满足于先前的假设，即口服脊髓灰质炎疫苗中不可能含有SV40。只有经过外部科学和独立研究人员的进一步调查，他们可以审查1997年1月会议上声称的测试结果，并且可以通过测试所有种子和单个单价库来进行自己的独立评估，才能确保SV40在商业中不存在。销售了Lederle生产的口服脊髓灰质炎病毒疫苗。

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