中國國藥新冠疫苗獲世衛(wèi)組織緊急使用認(rèn)證
中國日報網(wǎng) 2021-05-08 10:07
當(dāng)?shù)貢r間5月7日,世界衛(wèi)生組織宣布,由中國醫(yī)藥集團北京生物制品研究所研發(fā)的新冠滅活疫苗正式通過世衛(wèi)組織緊急使用認(rèn)證。
"This afternoon, the WHO gave emergency use listing to Sinopharm Beijing's COVID-19 vaccine, making it the sixth vaccine to receive WHO validation for safety, efficacy and quality," said WHO Director General Dr. Tedros Adhanom Ghebreyesus at a press briefing.
世衛(wèi)組織總干事譚德塞在新聞發(fā)布會上說,世衛(wèi)組織當(dāng)天下午為中國國藥新冠疫苗頒發(fā)了緊急使用認(rèn)證,使其成為第6種獲得世衛(wèi)組織安全性、有效性和質(zhì)量驗證的新冠疫苗。
"This expands the list of vaccines that COVAX can buy and gives countries confidence to expedite their own regulatory approval, and to import and administer a vaccine," he said.
這擴大了世衛(wèi)組織主導(dǎo)的“新冠肺炎疫苗實施計劃”(COVAX)組合的疫苗庫名單,并有助于各國加快對新冠疫苗的監(jiān)管審批以及進口和接種疫苗。
【知識點】
2020年10月8日,中國同全球疫苗免疫聯(lián)盟簽署協(xié)議,正式加入“新冠肺炎疫苗實施計劃(COVAX)”。這是中國秉持人類衛(wèi)生健康共同體理念(uphold the concept of a shared community of health for all)、履行自身承諾推動疫苗成為全球公共產(chǎn)品(turn COVID-19 vaccines into a global public good)的一個重要舉措。
“新冠肺炎疫苗實施計劃”由世界衛(wèi)生組織和全球疫苗免疫聯(lián)盟、流行病防范創(chuàng)新聯(lián)盟共同牽頭成立,擬于2021年底前向全球提供20億劑新冠肺炎疫苗(the initial aim is to have 2 billion doses available by the end of 2021),供應(yīng)給“自費經(jīng)濟體(higher-income self-financing countries)”和“受資助經(jīng)濟體(lower-income funded nations)”。包括我國在內(nèi)的“自費經(jīng)濟體”需向該計劃承諾為本經(jīng)濟體一定比例人口購買疫苗并繳納預(yù)付款,而“受資助經(jīng)濟體”無須繳納預(yù)付款,同時享受該計劃補貼。
世衛(wèi)組織負責(zé)獲得藥品和衛(wèi)生產(chǎn)品的助理總干事瑪麗安熱拉·西芒當(dāng)天在一份聲明中表示,
The addition of the Sinopharm vaccine has "the potential to rapidly accelerate COVID-19 vaccine access for countries seeking to protect health workers and populations at risk".
將中國國藥新冠疫苗納入世衛(wèi)組織緊急使用清單“有助于尋求保護衛(wèi)生工作者和高危人群的國家加速獲得新冠疫苗”。
The jab produced by the Beijing Bio-Institute of Biological Products Co. Ltd., a subsidiary of the China National Biotec Group, is an inactivated vaccine with easy storage requirements, which makes it highly suitable for use in low-resource settings.
中國醫(yī)藥集團北京生物制品研究所研發(fā)的新冠滅活疫苗易于儲存,使其非常適用于資源匱乏的環(huán)境。
It is also the first vaccine that will carry a vial monitor, a small sticker on the vials that changes color if the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used.
它也是第一款攜帶疫苗瓶監(jiān)測器的疫苗,疫苗瓶上的小標(biāo)簽會因疫苗受熱而改變顏色,便于衛(wèi)生工作者判斷疫苗是否安全可用。
According to the WHO's Strategic Advisory Group of Experts on Immunization (SAGE), the Sinopharm vaccine is recommended for use in adults 18 years and older in a two-dose schedule with a spacing of three to four weeks.
根據(jù)世衛(wèi)組織免疫戰(zhàn)略咨詢專家組的意見,世衛(wèi)組織建議將中國國藥新冠疫苗用于18歲及以上成年人,采用兩劑注射、間隔時間為3至4周。
The WHO is not recommending an upper age limit for the Sinopharm vaccine, because reviewed data have suggested that the vaccine is likely to have a protective effect in older persons, according to the WHO press release.
世衛(wèi)組織不建議對中國國藥新冠疫苗設(shè)置使用年齡上限,因為評估數(shù)據(jù)顯示,該疫苗對老年人可能也有保護作用。
The WHO had previously listed the COVID-19 vaccine developed by Pfizer/BioNTech, two versions of the AstraZeneca/Oxford vaccine, the Janssen vaccine and the Moderna vaccine for emergency use.
此前,世衛(wèi)組織已向5種新冠疫苗頒發(fā)緊急使用認(rèn)證,分別是美國輝瑞制藥有限公司和德國生物新技術(shù)公司聯(lián)合研發(fā)的新冠疫苗、英國阿斯利康制藥公司和牛津大學(xué)聯(lián)合研發(fā)的兩個版本阿斯利康疫苗、美國強生公司旗下楊森制藥公司研發(fā)的新冠疫苗以及美國莫德納公司研發(fā)的新冠疫苗。
【相關(guān)詞匯】
藥品和疫苗研發(fā)
drug and vaccine development
有效性和安全性研究
safety and efficacy research
人類衛(wèi)生健康共同體
a global community of health for all
疫苗聯(lián)合研發(fā)
joint research and development of vaccines
全球公共產(chǎn)品
global public good
參考來源:新華網(wǎng)
(中國日報網(wǎng)英語點津 Helen)