95-109年度國產疫苗與抗蛇毒血清檢驗放行趨勢分析   全文下載

Trends in Batch Release of Domestic Manufactured Vaccines and Antivenoms in Taiwan from 2006 to 2020

本研究藉由分析衛生福利部食品藥物管理署食品藥物開放資料平臺之國產及輸入生物藥品檢驗封緘資料集，以了解95年至109年臺灣疫苗與抗蛇毒血清之檢驗放行劑量趨勢及疫苗國產自製率。疫苗國產自製率介於25%-65%，最高之年度為98年，乃因當年度放行H1N1新型流感疫苗約724萬劑所致，而最低之年度為106年，係當年度破傷風疫苗放行劑量大幅下滑，且乾燥卡介苗及日本腦炎疫苗停產所致。綜觀各類國產疫苗之檢驗放行趨勢，主要受下列幾項因素影響而造成顯著增加或減少：（1）因應H1N1新型流感疫情爆發，國光生物科技股份有限公司（簡稱國光公司）於98年及99年大量生產H1N1新型流感疫苗並自99年至101年暫停生產破傷風疫苗。（2）因應「西藥製劑製造工廠實施國際GMP標準」（PIC/S GMP）之時程，衛生福利部疾病管制署（簡稱疾管署） 101年起停產破傷風疫苗，102年起停產成人用吸著破傷風白喉混合疫苗及吸著白喉破傷風混合疫苗；國光公司亦於102年及104年分別停產日本腦炎疫苗及破傷風疫苗。（3）疾管署於105年實施擴大流感疫苗接種對象並倍增流感疫苗採購量之政策。近期已有腸病毒71型疫苗申請新藥查驗登記，新型冠狀病毒疫苗亦已進入第二期人體臨床試驗階段，未來若能順利上市或緊急使用授權，將有助於疫苗國產自製率提升。

This report analyzed the open database of Taiwan Food and Drug Administration to understand the domestic manufactured rate and trends in released batches of vaccines and antivenoms from 2006 to 2020. Domestic manufactured rates were between 25% and 65%. The year with the highest domestic manufactured rate was 2009 because of releasing approximately 7.24 million doses of new H1N1 influenza vaccine. The year with the lowest domestic manufactured rate was 2017 because of much smaller number of tetanus toxoid doses released, while BCG and Japanese encephalitis vaccines were out of production. There were several factors influence trends in released batches of vaccines significantly: I. To combatting the outbreak of new H1N1 influenza, Adimmune corporation produced a large amount of new H1N1 influenza vaccines in 2009 and 2010. The company also temporarily stopped production of tetanus toxoid from 2010 to 2012. II. Because of implementing PIC/S GMP, Center of Disease Control (CDC) stopped production of tetanus toxoid since 2012, and ceased production of diphtheria & tetanus toxoid (adult use) and tetanus & diphtheria toxoid adsorbed since 2013. Moreover, Adimmune corporation stopped production of Japanese encephalitis vaccine and tetanus toxoid since 2013 and 2015 respectively. III. Since 2016, CDC implemented a policy of expanding targets for influenza vaccination and doubling the purchase quantity of influenza vaccines. Recently, the Enterovirus 71 vaccine was under the process of new drug application, and the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines were in the stage of phase II clinical trials. If vaccines achieve marketing or emergency use authorization in the future, it will contribute to the increase of vaccine domestic manufactured rate.