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美国食品和药物管理局局长在授权紧急使用疫苗的压力下被召集到白宫

2020-12-02 20:37   美国新闻网   - 

美国食品和药物管理局的负责人星期二在总统的陪同下被传唤到白宫唐纳德·特朗普他对他的机构没有更快地授权辉瑞公司感到沮丧冠状病毒熟悉会议的官员告诉美国广播公司新闻,紧急使用的疫苗。

美国食品和药物管理局局长斯蒂芬·哈恩周二上午在白宫花了大约一个半小时与参谋长马克·梅多斯进行了一次预定的会议。

会议,首先由Axios与此同时,美国食品和药物管理局正在艰难而高风险地评估多种冠状病毒疫苗候选物,以获得紧急授权,然后才允许在公众中分发。

这次会面表明,白宫正在向美国食品和药物管理局施加压力,要求其加快授权过程,尽管该机构正在加速审查数千页的数据。

该机构发言人在一份声明中说:“完成这些审查包括确保生产过程和生产控制是适当的,检查进行的统计分析以确保它们是正确的,并在必要时进行额外的分析,以观察疫苗对可能面临更大不利影响风险的人群的影响。”

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尚不清楚特朗普是否会参加会议——当被问及是否会参加时,白宫没有回应——但这是因为自他竞选失败以来,他没有展示出多少控制这场肆虐的流行病的证据。副总统迈克·彭斯继续会见白宫冠状病毒特别工作组,并向州长们做简报。

在会议之前,哈恩在一份声明中说,他的机构正在平衡速度和做出“适当的决定”。

哈恩说:“让我明确一点——我们的职业科学家必须做出决定,他们将花时间做出正确的决定。”“我们希望迅速行动,因为这是国家紧急情况,但我们将确保我们的科学家花时间做出适当的决定。我们的工作就是要做到这一点,并就疫苗的安全性和有效性做出正确的决定。”

白宫新闻秘书凯丽·麦克纳尼试图淡化紧张的表象,告诉福克斯新闻周二早上,“美国食品和药物管理局正夜以继日地工作”,但也说“这位总统永远不会为向这些机构施压而道歉,说是的,我们绝对想要一种安全的疫苗。我们也想要一个快速的,因为生命危在旦夕。”

最近几天,特朗普哀叹当选总统乔·拜登将获得疫苗的荣誉。

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“他们会试着说拜登发明了疫苗,”他在一个周日说道福克斯新闻采访。

感恩节那天,他告诉记者,“不要让乔·拜登为疫苗争光。”

“不要让他把疫苗归功于他,”他补充道,“因为疫苗是我,我比以往任何时候都更努力地推动人们。”

白宫周二表示,特朗普和彭斯计划在12月8日接待几位来自私营部门的州长和高管,参加“新冠肺炎疫苗峰会”,两天前,美国食品和药物管理局咨询委员会计划审议制药公司辉瑞(Pfizer)提出的冠状病毒疫苗紧急使用授权申请,这是美国首例。

白宫副新闻秘书布莱恩·摩根斯坦(Brian Morgenstern)表示,特朗普“期待召集联邦政府、州政府、私营部门、军方和科学界的领导人与美国人民进行全面讨论。”在推特上添加,“这是拯救生命,不是政治!”

STAT优先据报告的在聚会上。

特朗普几周来一直声称(没有证据),制药公司和监管官员放缓了冠状病毒疫苗候选人的生产和批准过程,以在政治上伤害他。

事实上,新冠肺炎疫苗的发展已经达到创纪录的速度坚持政治动机在这一过程中没有发挥任何作用。

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哈恩的传唤标志着特朗普和白宫试图对他领导的联邦公共卫生机构施加政治压力的最新一次。

8月,哈恩在白宫新闻发布会上与特朗普一起出现后,为夸大新冠肺炎患者康复期血浆治疗的益处道歉。

特朗普有小跑出去专员宣布治疗的紧急授权;总统称之为“强有力的”,并说它“有令人难以置信的成功率”,哈恩说,加快批准是政府“减少繁文缛节”工作的结果。

但是这种治疗方法的有效性还没有得到实际证明,专家警告说,仓促授权会使他们更难研究它。

美国食品和药物管理局专员访问白宫之际,白宫冠状病毒问题高级顾问斯科特·阿特拉斯博士表示,他将于本周辞职。

在阿特拉斯出现在福克斯新闻上引起他的注意后,特朗普让没有传染病经验的神经放射科医生阿特拉斯在新冠肺炎的反应中担任有偿咨询角色。

阿特拉斯支持与白宫冠状病毒工作队的长期公共卫生专家意见不一的有争议的观点,并招致联邦政府以外的传染病科学家的广泛批评。

一名白宫官员表示,阿特拉斯辞职是因为他作为“特别政府雇员”的130天任期已经结束。

FDA chief summoned to White House amid pressure to authorize vaccine emergency use

The head of the Food and Drug Administration was summoned to the White House Tuesday amid PresidentDonald Trump's frustration that his agency hasn’t moved faster to authorize Pfizer’scoronavirusvaccine for emergency use, officials familiar with the meeting told ABC News.

FDA Commissioner Stephen Hahn spent about an hour and a half at the White House Tuesday morning for a scheduled meeting with chief of staff Mark Meadows.

The meeting, first reported byAxios, comes as the FDA is in the painstaking and high-stakes process of evaluating multiple coronavirus vaccine candidates for emergency authorization before they are allowed to be distributed among the general public.

The encounter served as an indication that the White House is applying pressure on the FDA to speed up its authorization process, even as the agency is moving at an accelerated pace in reviewing thousands upon thousands of pages of data.

"Completion of these reviews involves such things as ensuring that the manufacturing process and the controls on manufacturing are appropriate, checking statistical analyses performed to ensure that they were done properly and doing additional analyses, as necessary, to look at the effect of the vaccine on subsets of individuals who might be at greater risk of adverse effects," an agency spokesman said in a statement.

It was unclear whether Trump would participate in the meeting -- the White House did not respond when asked if he would -- but it comes as he has otherwise demonstrated little evidence of governing on the raging pandemic in the days since his election loss. Vice President Mike Pence has continued to meet with the White House's coronavirus task force and brief governors.

Before the meeting, Hahn said in a statement that his agency was balancing speed with making "an appropriate decision."

“Let me be clear -- our career scientists have to make the decision and they will take the time that’s needed to make the right call on this important decision," Hahn said. "We want to move quickly because this is a national emergency, but we will make sure that our scientists take the time they need to make an appropriate decision. It is our job to get this right and make the correct decision regarding vaccine safety and efficacy."

White House press secretary Kayleigh McEnany sought to downplay the appearance of tension,telling Fox NewsTuesday morning “the FDA is working around the clock” but also saying “this president will never apologize for putting the fire under these agencies to say yes we want a safe vaccine, absolutely. We also want a fast one because lives are at stake.”

In recent days, Trump has lamented that President-elect Joe Biden would get credit for the vaccines.

"They will try and say that Biden came up with the vaccines," he said in a Sundayinterview with Fox News.

On Thanksgiving Day, he told reporters, "Don't let Joe Biden take credit for the vaccines."

"Don't let him take credit for the vaccines," he added, "because the vaccines were me, and I pushed people harder than they've ever been pushed before."

The White House said Tuesday that Trump and Pence planned to host several governors and executives from the private sector for a "COVID-19 Vaccine Summit" on Dec. 8, two days before a Food and Drug Administration advisory committee was scheduled to consider an application by the pharmaceutical company Pfizer for the emergency use authorization of a coronavirus vaccine -- the first in the United States.

White House deputy press secretary Brian Morgenstern said Trump "looks forward to convening leaders from the federal government, state governments, private sector, military, and scientific community for a comprehensive discussion with the American people,"adding on Twitter, "This is about SAVING LIVES, not politics!"

STAT firstreportedon the gathering.

Trump has for weeks alleged -- without evidence -- that pharmaceutical companies and regulatory officials have slow-rolled the production and approval processes for coronavirus vaccine candidates in order to hurt him politically.

In reality, the development of COVID-19 vaccines has moved at record speed, and top Trump administration public health officialshave insistedthat political motivations are not playing any role along the way.

Hahn's summoning marked just the latest time Trump and the White House have attempted to exert political pressure on the federal public health agency he leads.

In August, Hahn apologized for exaggerating the benefits of a treatment being used on COVID-19 patients, convalescent plasma, after appearing alongside Trump at a White House news conference.

Trump hadtrotted outthe commissioner to announce the treatment's emergency authorization; the president called it "powerful" and said it "had an incredible rate of success," and Hahn said the expedited approval was the result of the administration's work to "cut back red tape."

But the treatment's effectiveness had not actually been proven, and experts warned that rushing the authorization would make it harder for them to study it.

The FDA commissioner's visit to the White House came as a top White House adviser on coronavirus, Dr. Scott Atlas, said he was resigning this week.

Trump gave Atlas, a neuroradiologist with no infectious disease experience, a paid advisory role on the COVID-19 response after Atlas caught his attention during appearances on Fox News.

Atlas espoused controversial views at odds with longtime public health experts on the White House's coronavirus task force and drew widespread criticism from infectious disease scientists outside the federal government.

A White House official said Atlas was resigning because his 130-day term as a "special government employee" had come to an end.

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