Pastoret Paul-Pierre
Publications Department, World Organisation for Animal Health, 12, rue de Prony, 75017 Paris, France.
Biologicals. 2010 May;38(3):332-4. doi: 10.1016/j.biologicals.2010.02.015. Epub 2010 Apr 24.
Vaccination is one of the most important public health accomplishments. However, since vaccine preparation involves the use of materials of biological origin, vaccines are subject to contamination by micro-organisms. In fact, vaccine contamination has occurred; a historical example of vaccine contamination, for example, can be found in the early days of development of the smallpox vaccine. The introduction of new techniques of vaccine virus production on cell cultures has lead to safer vaccines, but has not completely removed the risk of virus contamination. There are several examples of vaccine contamination, for example, contamination of human vaccines against poliomyelitis by SV40 virus from the use of monkey primary renal cells. Several veterinary vaccines have been contaminated by pestiviruses from foetal calf serum. These incidents have lead industry to change certain practices and regulatory authorities to develop more stringent and detailed requirements. But the increasing number of target species for vaccines, the diversity of the origin of biological materials and the extremely high number of known and unknown viruses and their constant evolution represent a challenge to vaccine producers and regulatory authorities.
疫苗接种是最重要的公共卫生成就之一。然而，由于疫苗制备涉及生物源性材料的使用，疫苗容易受到微生物污染。事实上，疫苗污染确实发生过；例如，在天花疫苗研发早期就有疫苗污染的历史案例。细胞培养中疫苗病毒生产新技术的引入使得疫苗更安全，但并未完全消除病毒污染风险。有多个疫苗污染的例子，比如，使用猴原代肾细胞导致脊髓灰质炎人用疫苗被SV40病毒污染。几种兽用疫苗被来自胎牛血清的瘟病毒污染。这些事件促使行业改变某些做法，监管当局也制定了更严格、更详细的要求。但是，疫苗目标物种数量不断增加、生物材料来源多样以及已知和未知病毒数量极多且不断进化，这对疫苗生产商和监管当局构成了挑战。
