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圖片來源:路透社 上海譯銳翻譯 2020-12-9 13:33 p.m. After spending weeks poring over data provided by Pfizer, government scientists on Tuesday acknowledged in a new document that they believe there is ample evidence that the first COVID-19 vaccine works and is safe in people over the age of 16.While that assessment isn’t the coveted green light the nation has been waiting for, the briefing suggests agency staff aren't warning of any last-minute hiccups and that an emergency authorization is well within the nation’s grasp. 在對輝瑞提供的數據經過數周的仔細研究后,政府科學家于周二在一項新文件中確認,他們認為有足夠的證據表明,輝瑞的首支新冠疫苗有效并對于16歲以上的人具有安全性。盡管該評估并非是全國都翹首以盼的審批通過,但是在新聞通氣會上,工作人員也沒有發出任何緊急暫停警告,而緊急許可已經完全變得觸手可及。 last-minute:緊急關頭、最后一刻 hiccup:暫停 It also suggests that the vaccine might not just be limited to people over the age of 18 as was initially expected. And the government found protection was strong after just one dose, though both doses are recommended for the strongest protection. 新聞通氣會還提出,疫苗也許并非像人們一開始所想的那樣,僅可以用于18歲以上的人群。政府發現,疫苗僅在第一次接種后就會產生強大的保護。盡管接種建議是,為確保獲得最大的免疫保護,應該接種兩次。 "Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the FDA wrote. “安全數據來自于大約3.8萬名參與者(大于或等于16歲),參與者按照1:1的比例隨機分配疫苗或安慰劑,并在第二次接種后進行2個月的跟進。數據表示,疫苗具有良好的安全特性,沒有任何導致無法簽發緊急使用許可的具體安全問題,”FDA在文件中寫道。 placebo:安慰劑 The report notes the most common reaction was a skin reaction at the injection site, followed by fatigue or headaches. About half of recipients between 16 and 55 experienced side effects like fatigue or headaches and about a third reported chills or muscle pain. Of clinical trial participants over 55 about half reported fatigue, a third reported headache, and about a quarter reported chills or muscle pain. 報告強調,最常見的反應是注射部位的皮膚,隨后會伴隨疲憊或頭疼。大約一半年齡在16到55歲的接種者表示其有類似于疲憊或頭疼這樣的副作用,而大約三分一表示其感到發冷或肌肉疼痛。在有超過55人參加的臨床測試參與者中,有大約一半的人表示其在接種后感到疲憊,三分之一的接種者表示其會頭痛,大約四分之一的人表示其會感到發冷或肌肉疼痛。 The data also indicates the vaccine works equally men in men and woman, and among people of different races and ethnicities. 數據也表明,疫苗對于男性和女性以及不同的人種和種族作用相同。 FDA noted there are some areas where there isn't enough data on the Pfizer vaccine, such as how it works in people with medical conditions like HIV/AIDS, in people who have recovered from COVID-19 infection, or how long the protection lasts. FDA強調說,在某些方面,輝瑞的疫苗還缺乏足夠的數據,比如該疫苗對于感染HIV或艾滋以及曾患新冠肺炎但又康復的人群的作用以及保護的持續時間。 The report also highlights that while the Pfizer vaccine prevents recipients from getting sick with symptoms of COVID-19, there isn't enough data yet to know if the vaccine is effective enough at preventing all transmission of the disease that would eventually replace the need to wear masks, socially distance, and avoid large, indoor gatherings. So even if you are an early recipient of the vaccine it will be important to maintain these risk lowering techniques to protect others. 報告還強調表示,盡管輝瑞的疫苗可以防止接種者有新冠肺炎的癥狀,但是目前還沒有足夠數據說明疫苗是否對于預防所有的新冠肺炎傳染都有效,也就是還不確定疫苗是否可以讓人們免于佩戴口罩,免于保持社交距離以及避免大型室內聚會。因此,即便接種者從一開始就接種了疫苗,但是采取降低風險的舉措以保護其他人仍然非常重要。 The briefing document was prepared by the FDA ahead of a Dec. 10 meeting with an independent advisory board. If the advisory board agrees the vaccine works and is safe, it’s likely the FDA will authorize that the vaccine be shipped nationwide. 簡述文件由FDA在12月10日與獨立顧問委員會召開會議之前提供。如果顧問委員會認為疫苗發揮了作用并且是安全的,那么FDA很可能允許疫苗在全國范圍內使用。 Following the authorization, a separate advisory panel tied to the Centers for Disease Control and Prevention is expected to suggest health care workers and older people in long-term care facilities get the first doses. 獲得許可后,與疾病控制與預防中心有所關聯的獨立顧問小組預計將建議護理人員和在長期護理機構的年長人群作為最先接種人群。 Administration officials suggest they hope the vaccine is then distributed next week 行政官員表示,他們希望疫苗能夠在下周發出。 來源:abcNEWS,編輯&翻譯:Susan