辉瑞表示,最早向美国监管机构申请新冠肺炎疫苗将在选举后

2020-10-17 09:27

Pfizer says earliest Covid-19 vaccine application to US regulators would be after election WnQ世界播

辉瑞表示,最早向美国监管机构申请新冠肺炎疫苗将在选举后WnQ世界播


暂无WnQ世界播

Pfizer's news lifted the US stock market and the company's shares. WnQ世界播

辉瑞的消息提振了美国股市和该公司股价WnQ世界播


BANGALORE/NEW YORK (REUTERS) - Pfizer Inc said on Friday (Oct 16) it might file for US authorisation of the Covid-19 vaccine it is developing with German partner BioNTech in late November, making it unlikely a vaccine will be available before the US election as President Donald Trump has promised. WnQ世界播

班加罗尔/纽约(路透社)-辉瑞公司周五表示,它可能会在11月下旬向美国申请其与德国合作伙伴生物技术公司正在开发的新冠肺炎疫苗的授权,这使得疫苗不太可能像唐纳德·特朗普总统承诺的那样在美国大选前上市。WnQ世界播


Pfizer said that it could say if the vaccine is effective as soon as this month based on its 40,000-person clinical trial but that it also needs safety data that will not be available until November at the earliest. WnQ世界播

辉瑞公司表示,根据其4万人的临床试验,该公司最早可以在本月公布疫苗是否有效,但它还需要安全性数据,这些数据最早也要到11月才能获得。WnQ世界播


The Pfizer news, published in a letter from its chief executive on its website, lifted the US stock market and the company's shares. Shares were up slightly in rival vaccine maker Moderna Inc, which is close to Pfizer in its vaccine development. WnQ世界播

辉瑞首席执行官在其网站上的一封信中公布了辉瑞的这一消息,提振了美国股市和该公司的股价。竞争对手疫苗制造商Modern na Inc.的股价小幅上涨,该公司在疫苗开发方面与辉瑞(Pfizer)接近。WnQ世界播


"So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use (EUA) in the US soon after the safety milestone is achieved in the third week of November," Pfizer Chief Executive Albert Bourla said. WnQ世界播

辉瑞执行长Albert Bourla称,“所以让我澄清一下,假设数据正面,辉瑞将在11月第三周达到安全里程碑后不久,在美国申请紧急授权使用(EUA).”WnQ世界播


Trump has said repeatedly that there would be a vaccine available before the election, but health officials and companies had only said that data might be available this month. WnQ世界播

特朗普曾多次表示,选举前将有疫苗可用,但卫生官员和公司只是表示,本月可能会有数据。WnQ世界播


The possibility of further delays was raised after trials for two rival vaccines were put on hold in the United States this fall. WnQ世界播

今年秋天,在美国暂停了两种相互竞争的疫苗的试验后,进一步推迟的可能性被提出。WnQ世界播


The president's rush to a vaccine has also raised concerns that the US Food and Drug Administration, acting in haste, might not conduct an adequate review of the vaccine. WnQ世界播

总统急于接种疫苗也引发了人们的担忧,即美国食品和药物管理局(FDA)行动仓促,可能没有对疫苗进行充分的审查。WnQ世界播


US health officials have sought to assuage those concerns out of fear that not enough Americans would take a vaccine early on. Earlier this month, the FDA formalised a requirement that the vaccine makers collect two months of safety data on one-half of trial participants. WnQ世界播

美国卫生官员试图缓解这些担忧,因为他们担心没有足够多的美国人会及早接种疫苗。本月早些时候,FDA正式要求疫苗制造商收集一半试验参与者的两个月安全数据。WnQ世界播


Pfizer's comments on its time line raise the possibility of US authorisation of a coronavirus vaccine this year, a key step in controlling the Covid-19 pandemic, which has killed more than a million people and ravaged the global economy. WnQ世界播

辉瑞在其时间线上的评论提高了美国今年授权研发冠状病毒疫苗的可能性,这是控制新冠肺炎疫情的关键一步。该疫情已导致100多万人死亡,并肆虐全球经济。WnQ世界播


Moderna could also apply for an EUA this year. It has said that it may have interim data on its 30,000 person trial as soon as November. WnQ世界播

现代也可以在今年申请EUA。该公司表示,最快可能在11月拿到3万人试验的临时数据。WnQ世界播


Both companies are also applying for approval in Europe, where they are racing against AstraZeneca PLC. WnQ世界播

两家公司也都在欧洲申请批准,他们在欧洲与阿斯利康(AstraZeneca PLC)竞争。WnQ世界播


AstraZeneca's US trial has been on hold since September. WnQ世界播

阿斯利康在美国的审判自9月以来一直搁置。WnQ世界播


After the FDA announced the two-month requirement on Oct 6, which was approved by the White House but undercut the likelihood of a vaccine before voters go to polls on Nov 3., Trump called the move a 'political hit job'. WnQ世界播

10月6日,FDA宣布了这项为期两个月的要求,这一要求得到了白宫的批准,但在11月3日选民投票之前降低了接种疫苗的可能性。之后,特朗普称这一举措是“政治上的打击”。WnQ世界播


In addition to safety and efficacy, the FDA will also examine Pfizer's manufacturing operations for the vaccine. WnQ世界播

除了安全性和有效性,FDA还将审查辉瑞公司生产疫苗的操作。WnQ世界播


Bourla said the filing depended on several other factors, including initial data on effectiveness that might or might not be available by late October. WnQ世界播

Bourla表示,申请取决于其他几个因素,包括有效性的初步数据,这些数据可能会在10月底之前公布,也可能无法获得。WnQ世界播


He said the company plans to share efficacy data with the public as soon as practical. WnQ世界播

他说,该公司计划尽快与公众分享疗效数据。WnQ世界播


A BioNTech spokesman confirmed the time frame for the possible EUA application to the FDA. WnQ世界播

BioNTech的一位发言人证实了可能向FDA申请EUA的时间框架。WnQ世界播


Pfizer's shares rose 2.1 per cent in premarket trading, while BioNTech's US-listed shares were up 4 per cent before the opening bell. WnQ世界播

辉瑞股价在盘前交易中上涨2.1%,BioNTech在美国上市的股票开盘前上涨4%。WnQ世界播


Moderna was unchanged and US futures were higher. WnQ世界播

摩德纳保持不变,美国期货走高。WnQ世界播

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