109-111年度疫苗檢驗放行案件分析   全文下載

Annual Surveillance of Batch Release of Vaccines and Toxoids in Taiwan, 2020-2022

本研究報告統計分析衛生福利部食品藥物管理署（下稱食藥署）109-111年放行之疫苗，以瞭解國人使用之疫苗整體概況，其中不包含緊急使用授權之COVID-19疫苗。109-111年食藥署分別放行233批14,939,535劑、202批13,880,274劑及227批14,259,958劑疫苗，其中國外輸入543批次數29,905,137劑，批次及劑數各占82.0%及69.4%，國產119批次數13,174,630劑，批次及劑數各占18.0%及30.6%。依疫苗類別進行分析統計，此3年間放行批次數前3名依序為流感疫苗、肺炎疫苗及日本腦炎疫苗，放行劑數前3名依序為流感疫苗、肺炎疫苗及破傷風疫苗。3年期間食藥署共攔阻6批運送溫度紀錄不符規定之疫苗，皆不予封緘放行，並依據藥事法施行細則第36條規定，令業者限期退運或銷毀。食藥署將持續進行人用疫苗上市前之檢驗封緘，保障國人用藥安全。

This report summarized the statistical analysis of the batch release of imported and domestic vaccines by the Taiwan Food and Drug Administration (TFDA) from 2020 to 2022, except for COVID-19 vaccines. 233 batches (14,939,535 doses), 202 batches (13,880,274 doses) and 227 batches (14,259,958 doses) of vaccines were released in Taiwan during the years of 2020,2021 and 2022, respectively. The batches and doses of imported products accounted for 82.0 % (543 batches) and 69.4 % (29,905,137 doses), while those of domestic products accounted for 18.0% (119 batches) and 30.6 % (13,174,630 doses), respectively. In terms of the number of batches released, the top three were influenza vaccine, pneumonia vaccine and Japanese encephalitis vaccine. As to the number of doses released, the top three were influenza vaccine, pneumonia vaccine and tetanus vaccine. TFDA rejected 6 batches of vaccines transported under temperature out of approved range in 3 years. All of these vaccines were not allowed to release and should be returned or destroyed within a specified period by the original importer or manufacturer in accordance with Article 36 of the Pharmaceutical Affairs Act Enforcement Rules. TFDA will continue to conduct pre-market inspections and batch release for human vaccines to ensure the safety of citizens.