Chang L, Crichton R, Nandapalan P
Therapeutic Goods Administration, Woden, Canberra, Australia.
Dev Biol Stand. 1999;98:177-81; discussion 197.
The Australia Influenza Vaccine Committee makes independent decisions concerning the influenza vaccine formulation for Australia. Large-scale cell culture using MDCK cells would improve response time for vaccine production in the face of a new pandemic. There must be a consensus with respect to the use of MDCK or other cells before the next pandemic. It is unrealistic to expect any national regulatory authority to determine what safety requirements should be met before approving a cell substrate for vaccine production during an influenza pandemic. Regulatory issues seen as obstacles to the approval of MDCK cells as an accepted cell substrate for influenza vaccine production are identified.
澳大利亚流感疫苗委员会就澳大利亚的流感疫苗配方做出独立决策。面对新的大流行，使用犬肾传代细胞（MDCK细胞）进行大规模细胞培养将缩短疫苗生产的响应时间。在下一次大流行之前，必须就使用MDCK细胞或其他细胞达成共识。期望任何国家监管机构在流感大流行期间批准用于疫苗生产的细胞基质之前确定应满足哪些安全要求是不现实的。文中指出了那些被视为批准MDCK细胞作为流感疫苗生产公认细胞基质的障碍的监管问题。
