106年度疫苗與類毒素檢驗放行案件分析

Annual Surveillance of Batch Release: Vaccines and Toxoids in Taiwan, 2017

本研究報告統計並分析食品藥物管理署（以下簡稱食藥署）106年度經檢驗合格放行之疫苗與類毒素，以瞭解國人使用之疫苗與類毒素整體概況。106年度食藥署共放行236批次12,255,941劑疫苗與類毒素，其中國產47批次3,459,630劑，批次及劑量數各佔19.9及28.2％，國外輸入189批次8,796,311劑，批次及劑量數各佔80.1及71.8％；所有批次之疫苗與類毒素檢驗及審查結果均符合原廠與國際間藥典規格。由檢驗放行之劑量數逐月趨勢顯示，9月份因應季節流感疫苗採購劑量增加，為全年度劑量數最高峰之月份。若依疫苗及類毒素類別進行分析統計，放行批次數前3名依序為流感疫苗、日本腦炎疫苗及肺炎疫苗，放行劑量數前3名依序為流感疫苗、肺炎疫苗及五合一疫苗（白喉、破傷風、非細胞型百日咳、b型嗜血桿菌與不活化小兒麻痺混合疫苗）。 This report shows the statistical analysis results of the batch release of imported and domestic vaccines and toxoids by the TFDA in 2017. Two hundred and thirty-six batches of vaccines (12,255,941doses) were released in Taiwan in 2017. The proportions of batches and doses for domestic products were 19.9% (47 batches) and 28.2% (3,459,630 doses), respectively, while the proportions for imported products were 80.1% (189 batches) and 71.8% (8,796,311 doses), respectively. All of the test results complied with the manufacturers' specifications and acceptance criteria of the international pharmacopoeias. From the monthly trend analysis, the largest number of doses released was in September. In terms of the number of batches released, the top three vaccines and toxoids were Influenza vaccine, Japanese encephalitis vaccine and Pneumococcal vaccine. In terms of the number of doses released, the top three vaccines and toxoids were Influenza vaccine, Pneumococcal vaccine and 5-in-1 vaccine (Diphtheria, Tetanus, Pertussis (Acellular, Component), Poliomyelitis (Inactivated) and Haemophilus influenzae type b).