Schmitt Heinz-Josef, Gregersen Jens Peter, Trusheim Heidi, Bröker Michael
Novartis Vaccines and Diagnostics GmbH, Emil-von-Behring-Strasse 76, 35041 Marburg.
Med Monatsschr Pharm. 2010 Jan;33(1):4-10.
After more than 60 years, the conventional production of influenza vaccines employing fertilized chicken eggs has reached its limits - both in terms of temporal flexibility and vaccine production volume. This situation is compounded by the fact that the present pandemic-driven situation has roughly doubled the overall vaccine demand virtually "overnight". Modem cell culture technology has significant advantages over the conventional method of manufacturing influenza vaccines employing embryonated chicken eggs, and enables manufacturers to respond rapidly to the exploding worldwide seasonal and pandemic-driven need for influenza vaccines. Recent articles in the popular press claiming that cell culture-based influenza vaccines can cause tumours raised uncertainty among physicians and the general population, and also discredit officially accepted assessments and product licensing by the relevant authorities. The present article provides an overview on the cell culture technology and on the safety profile of the cells and of the vaccine product.
60多年来,利用受精鸡蛋生产流感疫苗的传统方法已达到其极限——在时间灵活性和疫苗产量方面均如此。当前由大流行驱动的形势几乎在“一夜之间”使总体疫苗需求大致翻了一番,这使情况更加复杂。现代细胞培养技术相对于利用鸡胚生产流感疫苗的传统方法具有显著优势,能够使制造商迅速应对全球季节性流感以及大流行引发的对流感疫苗激增的需求。大众媒体近期的文章称基于细胞培养的流感疫苗可能会引发肿瘤,这在医生和普通民众中引发了不确定性,也损害了相关当局官方认可的评估和产品许可的信誉。本文概述了细胞培养技术以及细胞和疫苗产品的安全性概况。