【Global News】歐盟監管機構：輝瑞COVID-19疫苗可在冰箱中存放一個月
May 19, 2021
歐洲藥物監管機構於週一建議，將輝瑞Pfizer / BioNTech COVID-19疫苗在一般冰箱溫度下的儲存時間，從5天延長至31天，以緩解歐洲地區推廣期間的後勤挑戰。
歐洲藥品管理局 (EMA) 表示，這項改變適用於未開封的小瓶，並補充說道，這項建議是人類藥物委員會，在評估輝瑞 (Pfizer) 和 BioNTech額外提交的穩定性研究數據後提出的。
2020年12月15日星期二上午，第一批輝瑞Pfizer/BioNTech疫苗在Calgary疫苗接種站卸貨，並放入超低溫冷凍櫃儲存。
(照片中的冷凍櫃來自PHCbi VIP ECO系列Ultra Low Freezer，冷凍櫃左側的藥品疫苗冷藏冰箱同樣來自PHCbi，型號：MPR-514)
Pfizer COVID-19 vaccine can be stored in fridge for a month: E.U. regulator
Europe’s drug regulator on Monday recommended extending the storage time for the Pfizer-BioNTech COVID-19 vaccine at normal fridge temperatures to 31 days from five days, easing logistical challenges during rollouts in the region.
The change is applicable to unopened vials, the European Medicines Agency (EMA) said, adding that the advice by its human medicines committee came after assessing additional stability study data submitted by Pfizer and BioNTech.
影片/新聞出處：Pfizer COVID-19 vaccine can be stored in fridge for a month: E.U. regulator
【路透社】美國宣稱輝瑞COVID-19疫苗可於冰箱儲存一個月
May 20, 2021
美國食品藥物管理署 (U.S. FDA) 於週三授權輝瑞公司 (PFE.N) 和德國合作夥伴BioNTech SE (22UAy.DE) COVID-19疫苗，可在標準冰箱溫度下儲存達一個月，為疫苗能更廣泛普及而努力。未開封、解凍的疫苗小瓶，最長可在攝氏2至8度的冰箱中儲存一個月，而之前的儲存上限為五天。
“藉由幫助像是社區醫師辦公室的疫苗供應者，在接收、儲存與管理疫苗的能力，這項改變應該可以將此疫苗更廣泛地普及美國民眾”，FDA 生物製劑評估與研究中心的主任彼得．馬克斯說。
對於全球及美國缺乏運輸和儲存基礎設施的偏遠場所來說，這個改變非常重要，今年2月，美國衛生局批准疫苗可在標準冷凍溫度下儲存和運輸二週，不需超低溫的儲存條件。
當天早些時候，加拿大衛生部表示，已批准疫苗最長可在標準冷藏溫度下儲存一個月，以利更有彈性的分配計劃，該疫苗於12月獲得緊急授權，疫苗的標籤要求儲存溫度為-80˚C至-60˚C (-112˚F 至 -76˚F) ，這意味著疫苗必須使用特殊設計的容器運輸。
(影片中的冷凍櫃來自PHCbi VIP ECO系列超低溫冷凍櫃#Ultra Low Freezer)
Pfizer COVID-19 vaccine can be stored in refrigerator for a month, U.S. says
The U.S. Food and Drug Administration on Wednesday authorized storage of Pfizer Inc (PFE.N) and German partner BioNTech SE’s (22UAy.DE) COVID-19 vaccine at standard refrigerator temperatures for up to one month, in an effort to make the vaccine more widely available. Unopened, thawed vials of the vaccine can be stored in a refrigerator at 2 to 8 degrees Celsius for up to a month, up from a previous maximum limit of five days.
"This change should make this vaccine more widely available to the American public by facilitating the ability of vaccine providers, such as community doctors' offices, to receive, store and administer the vaccine," said Peter Marks, director of FDA's Center for Biologics Evaluation and Research.
The change is especially important for global and remote U.S. facilities that have poor transport and storage infrastructure. In February, the U.S. health agency approved the storage and transportation of the vaccine at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.
Earlier in the day, Health Canada said it had approved storage of the vaccine at standard refrigerated temperatures for up to a month, to allow for more flexibility in distribution plans. The vaccine was granted emergency use authorization in December with a label requiring it be stored at temperatures between -80ºC and -60ºC (-112ºF to -76ºF), meaning it had to be shipped in specially designed containers.
影片/新聞出處：Pfizer COVID-19 vaccine can be stored in refrigerator for a month, U.S. says
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