102-112年破傷風疫苗檢驗封緘案件分析   全文下載

Analysis of Tetanus Vaccine in Batch Releases in Taiwan from 2013 to 2023

本研究分析102-112年經衛生福利部食品藥物管理署檢驗合格放行之破傷風疫苗，並探討相關政策歷程。分析結果顯示過去破傷風疫苗以國光生物科技股份有限公司生產為主，104年國光公司生產策略變動後改由專案進口，於107年申請輸入波蘭製破傷風疫苗，108年後新增喜美德生醫科技股份有限公司進口印度製破傷風疫苗，直至112年國光公司新生產線通過GMP查核重啟破傷風疫苗生產。喜美德公司則持續專案輸入，並於同年取得許可證，該年亦有安特羅生物科技股份有限公司進口印尼製破傷風疫苗。透過近10年破傷風疫苗檢驗封緘統計分析，102-112年共申請並放行278批，計13,796,389劑，其中國產疫苗共210批（8,806,844劑），進口疫苗則分為波蘭製共25批（1,764,605劑）、印度製共40批（3,098,130劑）及印尼製共3批（126,810劑），顯示破傷風疫苗檢驗封緘仍以國產疫苗為重心。

This report summarized the statistical analysis of the batch releases of tetanus vaccines approved by the Taiwan Food and Drug Administration (TFDA) from 2013 to 2023, and discussed the relevant policy update. The study demonstrated that historically, tetanus vaccines were predominantly produced by ADIMMUNE Corporation. However, a shift in production strategies was observed from 2015, which led to vaccines import through special projects. In 2018, ADIMMUNE Corporation imported tetanus vaccines manufactured in Poland. In addition, HealMed Co.,LTD began to import tetanus vaccines in 2019, manufactured in India, annually until 2023, when a new production line of ADIMMUNE Corporation passed the GMP inspection and resumed tetanus vaccine production. Additionally, HealMed Co.,LTD continued its specialized importation and obtained a license in the same year. Furthermore, Enimmune Corporation also imported tetanus vaccines manufactured in Indonesia. Through statistical analysis of tetanus vaccine batch releases over the past decade, from 2013 to 2023, a total of 278 batches were applied for and released, amounting to 13,796,389 doses. Among these, domestically produced vaccines comprised 210 batches (8,806,844 doses), while imported vaccines were from Poland with 25 batches (1,764,605 doses), India with 40 batches (3,098,130 doses), and Indonesia with 3 batches (126,810 doses). it is evident that domestically produced tetanus vaccines remain the focus of overall.