正文
疫苗厂商或发"安全宣言"
Vaccine makers plan public stance
疫苗厂商或发“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.
知情人士称,多家制药公司正计划发表公开联合承诺,如果没有得到广泛的安全性和有效性测试数据,不会将任何新冠疫苗送交美国食品和药品管理局(FDA)审批。
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正面临尽快批准疫苗的政治压力,这些制药公司的联合立场是对这种情况的防备。参与讨论的公司包括辉瑞、莫德纳、强生,葛兰素史克、赛诺菲等,这些药企都在研发新冠疫苗。
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.
制药业向来以FDA的审批作为药品的黄金标准,但在此次疫情期间,FDA做出了几次有争议的决定,在没有确定疗效前就允许紧急使用一些新冠疗法。
One recent poll found a majority of the US public thought a vaccine approval would be driven by politics.
最近一项民调显示,多数受访美国民众认为,新冠疫苗的审批将会被政治化。
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.
美国总统特朗普指责FDA故意拖延疫苗工作,目的是在政治上给他造成伤害,他还表示,新冠疫苗能够在11月3日大选前准备好。
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