FDA authorizes 1st antiviral pill for COVID

　　美國(guó)藥監(jiān)局批準(zhǔn)首款新冠口服治療藥物

　　In a highly anticipated decision, the Food and Drug Administration authorized the first antiviral pill to treat COVID-19 at home.

　　在萬(wàn)眾期待下，美國(guó)食品藥品監(jiān)督管理局日前批準(zhǔn)了首款家庭用治療新冠肺炎的口服抗病毒藥物。

　　The pill, called Paxlovid, is made by Pfizer. It's taken twice a day for five days in combination with a second medicine called ritonavir, a generic antiviral.

　　這款名為Paxlovid的口服藥是輝瑞公司生產(chǎn)的。該藥須和抗病毒藥物利托那韋一起服用，每日兩次，一個(gè)療程要連續(xù)服用五天。

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　　"Today's authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research. "This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19."

　　美國(guó)藥監(jiān)局藥物評(píng)估和研究中心主任派翠西亞·卡瓦佐尼博士表示：“首款新冠口服治療藥物今日獲批，標(biāo)志著我們邁出了抗擊全球疫情的一大步，在出現(xiàn)新變異株的疫情關(guān)鍵時(shí)刻提供了抗擊新冠的新工具，并承諾讓新冠重癥高風(fēng)險(xiǎn)人群更便于獲得抗病毒治療�！�

　　The Pfizer treatment could help keep people infected with the coronavirus from getting so sick that they need to be hospitalized.

　　這款輝瑞口服藥能有助于防止新冠病毒感染者發(fā)展成重癥，避免住院治療。

　　The results from a Pfizer study involving more than 2,200 people at high risk for developing serious COVID-19 found Paxlovid reduced the risk of hospitalization or death by 89%, compared with a placebo, when taken within three days of first symptoms of illness. When taken within five days, the drug reduced the risk of hospitalization and death by 88%.

　　一項(xiàng)涵蓋了2200多名新冠重癥高風(fēng)險(xiǎn)患者的輝瑞研究結(jié)果發(fā)現(xiàn)，相比安慰劑，患者在出現(xiàn)早期新冠癥狀三日內(nèi)服用Paxlovid能將住院或死亡風(fēng)險(xiǎn)降低89%，在五日內(nèi)服用能降低88%。

　　Early results from another Paxlovid study showed a 70% reduction in hospitalization risk among several hundred people at lower risk for severe disease.

　　另一項(xiàng)對(duì)Paxlovid口服藥的研究涵蓋了數(shù)百名新冠重癥低風(fēng)險(xiǎn)患者，早期結(jié)果顯示，可以將這一人群的住院風(fēng)險(xiǎn)降低70%。

　　Although it's not certain, Paxlovid's efficacy is unlikely to be reduced in treating people infected with the omicron variant of the coronavirus virus. The drug, which belongs to a family called protease inhibitors, doesn't target the virus's spike protein, as the vaccines do.

　　盡管尚不確定，但是用Paxlovid來(lái)治療奧密克戎變異株感染者應(yīng)該也同樣有效。與疫苗作用的靶標(biāo)不一樣，Paxlovid是一種蛋白酶抑制劑，針對(duì)的不是病毒的纖突蛋白。

　　The federal government has a contract with Pfizer to buy 10 million courses of the treatment for $5.3 billion. But initial supplies of Paxlovid will be limited. The company says it will have 180,000 courses of treatment ready by the end of the year.

　　美國(guó)聯(lián)邦政府已和輝瑞公司簽約，以53億美元(約合人民幣338億元)的價(jià)格購(gòu)入1000萬(wàn)個(gè)療程的藥物。但是Paxlovid的初期供應(yīng)量會(huì)比較有限。輝瑞表示，年底前將生產(chǎn)出18萬(wàn)個(gè)療程的藥物。

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