腸病毒A71型抗原標準品與檢驗封緘   全文下載

The Preparation of National Standard and Batch Release of Enterovirus A71 Vaccine

腸病毒A71型（EV-A71）於1997年至1998年間曾在臺灣、馬來西亞、新加坡等亞洲國家引發大規模流行，臺灣至今仍有常態性的流行病例，根據衛生福利部疾病管制署監測資料顯示，EV-A71為導致重症與死亡的最主要型別，惟目前尚無治療EV-A71感染之特效藥物，治療方式以支持性療法為主，預防則以接種疫苗為主要手段。我國共有兩間疫苗廠自行研發EV-A71疫苗產品（B4亞型），分別為安特羅生物科技股份有限公司與高端疫苗生物製劑股份有限公司，兩間疫苗廠皆於2023年陸續取得藥品許可證。衛生福利部食品藥物管理署（下稱食藥署）基於國家實驗室之角色，需及早建置該疫苗抗原含量所需之標準檢驗方法與對照標準品，故於2022年製備一批甲醛不活化之EV-A71 B4亞型原液作為候選抗原國家標準品，邀集國內外共5間實驗室進行共同標定試驗，確認檢驗方法與對照標準品皆符合需求。食藥署於同年首度受理「''高端''腸病毒71型疫苗」及「安拓伏腸病毒71型疫苗」檢驗封緘申請，於同年7月完成檢驗放行，截至2023年底，食藥署共檢驗封緘14批共23萬2,516劑國產腸病毒A71型疫苗，保護臺灣孩童免於腸病毒威脅。

During 1997-1998, enterovirus A71 (EV-A71) caused several major outbreaks in Asian countries including Taiwan, Malaysia, and Singapore. Taiwan continues to experience regular number of cases, with EV-A71 being the dominant strain leading to severe illness and fatalities. Currently, Devoid of specific antiviral treatment, supportive therapy remains the only approach. Vaccination is the primary preventive measure while two domestic vaccine manufacturers, Medigen Vaccine Biologics Corporation and Enimmune corporation produced EV-A71 vaccines (B4 subtype) in Taiwan. These vaccines received drug licenses in 2023. To ensure the quality, the Taiwan Food and Drug Administration (TFDA) prepared a batch of formalin-inactivated EV-A71 B4 subtype as a candidate national standard, and conducted a collaborative study with five domestic and international laboratories as well. In 2022, TFDA received batch release applications for Envacgen and EnVAX-A71, produced by Medigen Vaccine Biologics Corporation and Enimmune corporation, respectively. After completion of test in July, the vaccines were released for use, coinciding with the peak enterovirus season in Taiwan. By the end of 2023, TFDA has released 14 batches totaling 232,516 doses of domestically produced EV-A71 vaccines, and thus safeguarded Taiwanese children from the threat of enterovirus infections.