104年度疫苗與類毒素檢驗封緘案件分析

Results from Annual Surveillance of Batch Release: Vaccines and Toxoids in Taiwan, 2015

為了解國人使用疫苗之整體品質概況，本研究報告統計並分析104年度經檢驗封緘完竣合格之疫苗與類毒素，並與歷年統計資料比較。104年度共放行286批13,356,463劑，其中國內生產為123批5,808,339劑，批次及劑量各佔43.0及43.5 %，國外輸入為163批7,548,124劑，批次及劑量各佔57.0 %及56.5 %。經逐批進行24項4,396次檢驗及審查，結果均符合中華藥典第七版或核定之原廠規格，並予以核發封緘證明書。由檢驗封緘放行之劑量數逐月趨勢顯示，8及9月為年度劑量最高峰之月份。依疫苗及類毒素類別進行分析統計，放行劑量前3名依序為流行性感冒疫苗、吸著破傷風類毒素及肝炎疫苗，放行批數前3名依序為吸著破傷風類毒素、流行性感冒疫苗及日本腦炎疫苗。此外，104年共有8家疫苗公司向衛生福利部食品藥物管理署申請檢驗封緘，統計其批次數及劑量數皆以國光生物科技股份有限公司所佔比例最高。考量溫度對疫苗影響甚劇，自100年起疫苗運送冷鏈溫度監視以電子溫度計為判讀依據，104年僅有1批疫苗其部分運送紙箱/棧板之溫度記錄不符規定，該224,200劑疫苗不予受理申請，由廠商自行退運或銷毀。本研究報告檢體為104年檢驗合格並封緘完竣之疫苗及類毒素，希望經由統計分析及探討，增進國人對國內疫苗批次放行狀況之了解，提供資料以利未來防疫工作參考。

Batch release for biological products is an important mode of regulating vaccine safety and quality, as mentioned in article 74 of the Pharmaceutical Affair Act in Taiwan. This report shows results of the batch release of imported and domestic vaccines and toxoids in 2015. In that year, 286 batches of vaccines (13,356,463 doses) were released in Taiwan, and the rate of batches to doses in domestic and imported products were 43.0%(123 batches) to 43.5%(5,808,339 doses), and 57.0%(163 batches) to 56.5%(7,548,124 doses), respectively. Totally, 24 items were performed, covering 4,396 tests. All of the test results complied with the pharmacopoeia and other regulations. We found that, the top three dosages of vaccines released were Influenza vaccines, tetanus toxoids and hepatitis vaccines, and the top three batches of vaccines released were tetanus toxoids, Influenza vaccines, and Japanese encephalitis vaccines.