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篇名
2021年COVID-19疫苗檢驗封緘放行分析   全文下載 全文下載
並列篇名
Annual Report on Batch Release of COVID-19 Vaccine in Taiwan, 2021
作者 廖婉婷李書芬 (Shu-Fen Lee)鄧子華許家銓林美智曾素香王德原
中文摘要
食品藥物管理署執行2021年度COVID-19疫苗檢驗封緘,為瞭解COVID-19疫苗檢驗封緘數量及國產COVID-19疫苗自製率,特整理分析相關數據以供未來接種疫苗策略之參考。2021年度完成檢驗封緘之COVID-19疫苗共119批,總計43,355,908劑,經逐批審查與檢驗合格後,核發封緘證明書並放行,提供國人進行疫苗接種,強化民眾保護力並降低疫情傳播,維護國家防疫安全。至2021年止國內計有3款疫苗通過專案輸入許可包含:AstraZeneca COVID-19 Vaccine(Vaxzevria)、Moderna COVID-19 Vaccine(Spikevax)與BioNTech COVID-19 Vaccine(Comirnaty),以及1款專案製造許可:高端新冠肺炎疫苗(MVC COVID-19 Vaccine),其中放行最大劑量數為AstraZeneca COVID-19 Vaccine(Vaxzevria)14,562,450劑,其次為BioNTech COVID-19 Vaccine(Comirnaty)13,285,884劑,而國產高端新冠肺炎疫苗計5,396,274劑僅占比約12.45 %,可見國產疫苗自製率尚有進步空間,未來期望能提升國內疫苗產能,確保國人疫苗使用量能。
英文摘要
This report analyzed the data of COVID-19 vaccine batch released by the Taiwan Food and Drug Administration in 2021. It reveals the cases of COVID-19 vaccine lot released and rate of domestic manufactured, and could be used as a reference for the vaccination strategies in the future. In 2021, 119 batches of COVID-19 vaccine with a total of 43,355,908 doses have been released in batch. After all test results of these products have been complied to the respective company’s specifications, the Certificate of Lot Release of Biologics is issued. The qualified products could be vaccinated for domestic people to improve the protection and block the spread of the epidemic. By 2021, three national company of COVID-19 vaccines (AstraZeneca COVID-19 Vaccine (Vaxzevria), Moderna COVID-19 Vaccine (Spikevax) and BioNTech COVID-19 Vaccine (Comirnaty) and one domestic manufactured product (MVC COVID-19 Vaccine) were announced the issuance of Emergency Use Authorization (EUA). The report showed that the highest doses released company of COVID-19 vaccine was the AstraZeneca (14,562,450 doses), followed by BioNTech (13,285,884 doses). The proportion for MVC COVID-19 Vaccine was only 12.45% (5,396,274 doses), suggested that the rate of domestic manufactured still has a long way to go. In the future, to ensure the availability of vaccines for domestic people, it is important to improve the domestic manufactured capacity.
起訖頁 362-368
關鍵詞 COVID-19疫苗檢驗封緘COVID-19 vaccinebatch release
刊名 食品藥物研究年報  
期數 202212 (13期)
出版單位 衛生福利部食品藥物管理署
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