肺炎鏈球菌結合型疫苗品質評估調查研究

Post-Market Surveillance of Pneumococcal Polysaccharide Conjugate Vaccine in Taiwan

詹蕙嘉(Hui-Chia Chan) ； 杜慧珍(Huey-Jen Duh) ； 吳庭妮(Ting-Ni Wu) ； 朱廣中(Kuang-Chung Chu) ； 王德原(Der-Yuan Wang) ； 施養志(Yang-Chih Shih)

《食品藥物研究年報》 4期 (2013/11) Pp. 171-178

摘要

本計畫依風險評估為原則，針對自費疫苗品質現況及其儲存環境管理情況進行調查研究，今年選定之市售品項為肺炎鏈球菌結合型疫苗。本計畫執行期間共赴18縣市且協同各地衛生局稽查人員進行抽樣，並查訪基層醫療院所了解其冷運冷藏狀況。而後依據各原廠檢驗方式進行效價試驗，確認該疫苗之有效性；本年度共完成檢體抽樣作業23件。試驗結果尚符合衛生福利部核定之規格。另外，經查訪各醫療院所及倉儲公司之冷藏儲存環境管理情況，訪查結果顯示自費疫苗在基層醫療院所於硬體及管理上與公費疫苗仍有落差。此調查結果以作為後續產品品質控管之參考，並保障民眾健康與接種之有效性。

關鍵字

肺炎結合型疫苗 ； 冷運冷藏

並列摘要

Vaccines are sensitive to environmental temperature. Potency can be adversely affected if vaccines are left out too long or exposed to various temperature excursions (out-of-range temperatures) that could have a cumulative negative effect. In order to survey the quality of marketed Pneumococcal Polysaccharide Conjugate Vaccine in Taiwan, a total of 23 samples were collected by the local health authorities from hospitals, clinics and manufacturers in various counties from January to August, 2012. Samples were analyzed by test methods specified by manufacturers. The results showed that the potency and completeness of adsorption of all samples met the approved criteria.

並列關鍵字

pneumococcal polysaccharide conjugate vaccine ； cold chain