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英國成為首個批準新冠疫苗的西方國家 下周開始接種 UK is 1st country to approve Pfizer COVID-19 vaccine, with distribution to start next week

中國日報網 2020-12-03 15:02

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英國衛生和社會保健部表示,英國已批準美國輝瑞和德國生物新技術公司聯合研制的新冠疫苗緊急使用授權,下周起英國民眾就可以接種疫苗。這是有史以來研發最快的疫苗,從概念到批準上市只花了10個月,完成了通常需要十年才能走完的研發步驟。

 

A small shopping basket filled with vials labeled "COVID-19 - Coronavirus Vaccine" is placed on a UK flag in this illustration taken November 29, 2020. Picture taken November 29, 2020. REUTERS/Dado Ruvic

 

Britain has become the first country in the West to approve a COVID-19 vaccine for public use. The UK Department of Health and Social Care confirmed in a statement to British news agencies that the vaccine developed jointly by American drugmaker Pfizer and Germany's BioNTech would be distributed starting next week. Pfizer was the first of three major Western pharmaceutical companies to apply in both the US and Europe for emergency use authorization.

英國成為首個批準新冠疫苗供民眾使用的的西方國家。英國衛生和社會保健部在一份發給英國媒體的聲明中證實,美國制藥商輝瑞和德國生物新技術公司聯合研制的新冠疫苗將從下周起開始發放。輝瑞是三家大型西方制藥公司中首個在美國和歐洲同時申請緊急使用授權的公司。

 

"The Government has today accepted the recommendation from the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer/BioNTech's Covid-19 vaccine for use," a Department of Health and Social Care spokesman told the Press Association of Britain. The spokesman said the emergency use authorization followed "months of rigorous clinical trials and a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness."

英國衛生和社會保健部的發言人對英國記者協會表示:“政府今天接受了獨立機構英國藥品與保健品管理局的建議,決定批準輝瑞和生物新技術公司研制的新冠疫苗投入使用。”發言人表示,在經過了“數月嚴格縝密的臨床測試以及藥品與保健品管理局專家對數據的全面分析,最后專家得出結論認為該疫苗符合安全、質量和有效性的嚴格標準”后,才發放了緊急使用授權。

 

In line with planning in the US, British front-line healthcare workers, care home residents, the very elderly and people with underlying conditions that make them particularly vulnerable to COVID-19 complications are expected to get the first doses of the vaccine. Pfizer's vaccine, like the Oxford and Moderna formulas, requires two doses about a month apart.

同美國的計劃一樣,英國一線的醫護人員、養老院居民、高齡老人和特別容易發生新冠肺炎并發癥的基礎病患者將優先接種新冠疫苗。輝瑞疫苗和牛津、莫德納的疫苗一樣,都需要接種兩劑,間隔時間一個月。

 

UK Health Secretary Matt Hancock called it "fantastic news" that Britain's regulator had deemed the first vaccine safe, and vowed that distribution would begin from Monday. He told the BBC Breakfast show that vaccinations would "start with the most elderly and with people in care homes."

英國衛生部部長馬特·漢考克表示,英國監管部門對首批疫苗安全性的認可是一個“特大喜訊”,并宣稱疫苗將從下周一開始發放。他告訴BBC節目《早餐秀》說,疫苗接種將“從最年邁的老人和養老院居民開始”。

 

Prime Minister Boris Johnson also hailed the news, confirming in a tweet plans to start rolling out doses from next week.

英國首相鮑里斯·約翰遜也對這一消息表示歡迎,并在發表的推文中證實下周起將開始疫苗接種。

 

Screenshot from CBS website

 

"It's the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again," Johnson said.

約翰遜表示:“疫苗的保護最終將讓我們找回過去的生活,讓經濟重新運轉起來。”

 

Hancock, Britain's top public health official, noted the logistical complexities of distributing the Pfizer vaccine, which needs to be stored at around -94 degrees Fahrenheit, but said Britain would get its first 800,000 doses delivered next week. The UK has a total of 40 million doses of the Pfizer vaccine on order, enough to fully treat 20 million people.

衛生部部長漢考克指出了發放輝瑞疫苗在物流傳輸上的復雜性,該疫苗需要在零下94華氏度(零下70攝氏度)的溫度條件下儲存,但他表示下周第一批疫苗共80萬劑將運送到英國。英國共下單了4000萬劑輝瑞疫苗,足以讓2000萬人接種。

 

A dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer is pictured in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany. BioNTech SE 2020, all rights reserved/Handout via REUTERS

 

Two other vaccines, one developed by US-based Moderna, which also requires sub-zero storage, and one made by British pharmaceutical company AstraZeneca in conjunction with Oxford University, have also applied for emergency use authorization in the US and Europe.

另外還有兩種疫苗也申請了美國和歐洲的緊急使用授權。一種是美國莫德納公司研制的,同樣需要零下溫度的儲存條件,還有一種是英國制藥公司阿斯利康與牛津大學聯合研制的。

 

Both Pfizer and Moderna have said that data from large-scale human trials, involving tens of thousands of people, showed their vaccines to be about 95% effective at preventing COVID-19 infection. AstraZeneca/Oxford found their vaccine, which works in a different way, was up to 90% effective with a certain dosing regimen. The Oxford-developed vaccine is much cheaper to produce, and to distribute as it only requires storage at refrigerator temperatures.

輝瑞和莫德納都表示,涵蓋了數萬人的大規模人體試驗的數據顯示,他們的疫苗防止感染新冠肺炎的有效性可達約95%。阿斯利康和牛津大學發現,在特定的接種方案下,他們這種療法不同的疫苗有效性可達90%。牛津疫苗的生產和發放成本要低得多,因為該疫苗只需要在冰箱的溫度條件下儲存。

 

Pfizer chief executive Albert Bourla called the UK move "a historic moment in the fight against COVID-19."

輝瑞公司的首席執行官阿爾伯特·布爾拉將英國此舉稱作“抗擊新冠疫情的歷史性時刻”。

 

None of the human trials on any of the three leading Western-made vaccines have found significant adverse affects. Some side effects commonly associated with long-used vaccines, including soreness around the point of injection, fatigue and headaches have been seen in the trial data.

這三種領先的西方研制疫苗在人體試驗中均沒有出現過嚴重的副作用。長期使用的疫苗接種時常見的一些副作用,包括注射處酸痛、疲倦、頭疼,也在試驗數據中出現過。

 

A dose of the coronavirus disease (COVID-19) vaccination of BioNTech and Pfizer is pictured in this undated handout photo, as Britain became the first western country to approve a COVID-19 vaccine, in Mainz, Germany. BioNTech SE 2020, all rights reserved/Handout via REUTERS

 

Logistical issues aside, epidemiologists and public health officials worldwide have warned that another major hurdle to putting the coronavirus pandemic behind humanity could be mistrust of the vaccines that become available.

除了物流問題,世界各地的流行病學家和公共衛生官員還警告說,讓人類擺脫新冠疫情的另一個主要障礙可能是民眾對現有疫苗的不信任。

 

A CBS News poll carried out in early September found rising skepticism about the coronavirus vaccines in development, with most voters saying that if a vaccine were made available this year, their first thought would be that it was rushed through without enough testing.

美國哥倫比亞廣播公司9月初開展的一項民意調查發現,越來越多民眾對當前正在研發的新冠疫苗持懷疑態度,多數投票者表示,如果今年疫苗就可以上市,他們首先想到的是該疫苗沒有經過足夠的測試就倉促完成。

 

Just 21% of voters nationwide said in the survey that they would get a vaccine as soon as possible if it were available at no cost, which was down from 32% in a survey conducted in late July. Most said they would consider it, but wait to see what happens to others before getting one themselves.

全美只有21%的投票者在調查中表示,如果可以免費接種疫苗的話他們會盡快接種,相比7月末的調查結果(32%)下降了。多數人表示會考慮接種疫苗,不過要等一等看看別人接種疫苗后的反應,然后自己才去接種。

 

This pandemic has seen pharmaceutical companies and research institutes work with governments and independent regulatory agencies to compress the usually-years-long process of developing and approving vaccines into a much shorter time frame.

疫情期間,制藥公司、研究機構和政府、獨立監管部門協同合作,壓縮了疫苗研發和審批的流程,原本通常需要數年的時間如今得以大大縮短。

 

The pace has been completely unprecedented, but the entities involved, along with outside experts in infectious disease and vaccinology, have insisted throughout that the process is being compressed safely, largely by overlapping steps that normally come sequentially, rather than by eliminating any steps in the trial and certification process.

這一速度完全是史無前例的,但是有關單位以及外界的傳染病和疫苗學專家始終都堅稱,這些流程是在安全前提下被壓縮的,主要是通過將正常情況下按順序進行的步驟同時進行,而不是略去了測試和認證流程中的任何步驟。

overlap[?o?v?r?l?p]: v. 在時間上部分地重疊,同時發生

 

Hancock, the British government's health chief, told UK broadcaster Piers Morgan on Wednesday that, if they could get it approved even though they weren't in a high-risk group, he would happily get vaccinated live on television next week with Morgan to show his trust in the vaccine.

英國衛生部部長漢考克周三(12月2日)告訴英國主持人皮爾斯·摩根說,盡管他們不屬于高風險群體,但如果可以獲得批準,他很愿意下周和摩根一起在電視上直播接種疫苗,以展示他對疫苗的信任。

 

英文來源:哥倫比亞廣播公司

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