100-110年流感疫苗檢驗放行趨勢分析   全文下載

Analysis of Batch Release of Influenza vaccine in Taiwan from 2011 to 2021

季節性流感（Seasonal influenza，簡稱流感）是由「流感病毒（Influenza viruses）」所引起之急性呼吸道疾病，流感好發於我國之冬季，我國估計每十萬人約有二十人死於流感，目前預防流感併發症最有效的方式，為定期接種流感疫苗。本報告資料為衛生福利部食品藥物管理署（下稱食藥署）自100年1月1日至110年12月31日止之流感疫苗檢驗封緘案件分析，就其封緘數量進行統計及探討數量變化原因，以了解其放行情形。105年起衛生福利部疾病管制署（下稱疾管署）為提升流感疫苗接種涵蓋率，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，採購量由每年平均約300萬劑增加為600萬劑，食藥署放行數量亦增加。另107年度封緘數量趨勢下滑，因發生5批次流感疫苗外觀異常之事件，令業者限期退運或銷毀。108年起公費流感疫苗由原三價改採購四價流感疫苗（含2種A型及2種B型），109年輔流威適流感疫苗核准上市，此疫苗為細胞製程，針對雞蛋過敏者可多一種疫苗選擇接種施打。未來，食藥署將秉持相同的檢驗與審查標準，繼續為國人使用流感疫苗的安全嚴格把關。

Seasonal influenza is an acute respiratory infection caused by influenza viruses and occurred mainly during winter. The influenza has caused about 4,500 deaths annually. Getting the influenza vaccine is the best and most important way to prevent influenza. In this report, we analyzed the cases of lot release of influenza vaccines from 2011 to 2021 in Taiwan, and presented the statistical results of document review. Since 2016, doses purchased have increased from 3 million to 6 million as a result of CDC’s policy of expanding targets for influenza vaccination and doubling the purchase quantity of influenza vaccines. In 2018, the number of influenza vaccine decreased because TFDA rejected 5 batches of influenza vaccine with abnormal appearance. All of them were not allowed to release and needed to be returned or destroyed within a specified period by the importer. In addition, the government offers free quadrivalent influenza vaccine against four influenza virus strains (includes two A subtypes and two B types) from 2019. For health of people and safety in using influenza vaccine, TFDA will be strictly adhered to same criteria in the future.