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疫苗廠商或發"安全宣言"

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Vaccine makers plan public stance
疫苗廠商或發“安全宣言”

Drugmakers are planning a public pledge to not send any COVID-19 vaccine to the US Food and Drug Administration for review without extensive safety and efficacy data, according to people familiar with the effort. The joint stance is seen as a bulwark against political pressure being applied on the FDA to get a vaccine out as soon as possible.
知情人士稱,多家制藥公司正計劃發表公開聯合承諾,如果沒有得到廣泛的安全性和有效性測試數據,不會將任何新冠疫苗送交美國食品和藥品管理局(FDA)審批。

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The companies involved in the discussions include Pfizer Inc, Moderna Inc, Johnson and Johnson, GlaxoSmithKline Plc, Sanofi, and possibly others. All are developing vaccines for COVID-19.
FDA正面臨儘快批准疫苗的政治壓力,這些製藥公司的聯合立場是對這種情況的防備。參與討論的公司包括輝瑞、莫德納、強生,葛蘭素史克、賽諾菲等,這些藥企都在研發新冠疫苗。

The drug industry has long relied on the FDA as a gold-standard approver for its drugs. But in the middle of the pandemic, the agency has made several controversial decisions to allow emergency use of therapies without rock-solid evidence they work.
製藥業向來以FDA的審批作爲藥品的黃金標準,但在此次疫情期間,FDA做出了幾次有爭議的決定,在沒有確定療效前就允許緊急使用一些新冠療法。

One recent poll found a majority of the US public thought a vaccine approval would be driven by politics.
最近一項民調顯示,多數受訪美國民衆認爲,新冠疫苗的審批將會被政治化。

US President Donald Trump has accused the FDA of slowing work to hurt him politically, and said he believes a vaccine will be ready before Election Day on Nov 3.
美國總統特朗普指責FDA故意拖延疫苗工作,目的是在政治上給他造成傷害,他還表示,新冠疫苗能夠在11月3日大選前準備好。

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