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美国食品和药物管理局预计将在几周内为免疫功能低下的美国人推荐增强剂

2021-08-06 09:50  ABC   - 

预计在未来几周内,美国美国食品药品监督管理局将提出一项计划免疫力低下的美国人周四,一位熟悉该机构计划的高级政府官员告诉美国广播公司新闻,为了获得新冠肺炎的增强剂。

这位政府官员说,该计划预计在9月初出台,如果不是更早的话。

时间表是首次报道华尔街日报写的。

许多免疫力低下的美国人对疫苗没有很高的免疫反应,让他们容易受到病毒的攻击即使打了一针。反应一直很低,特别是在移植受者、癌症患者或服用抑制免疫反应药物的人群中。

上个月,疾病控制和预防中心咨询小组的专家们基本上支持给那些人第三剂以提高他们的免疫力,并呼吁食品和药物管理局在这个问题上采取行动。

针对普通人群的加强注射可能会在某个时候提供,但可能不是美国食品和药物管理局最初优先授权的一部分。疾控中心和食品和药物管理局坚持认为没有足够的数据表明这一点免疫力已经下降得够多了在接种疫苗的人群中保证每个人都能打第三针——在这个时候。

PHOTO: A health care worker prepares a vaccine to administer during a Covid-19 vaccination event in Miami, Aug. 5, 2021.

钱丹·卡纳/法新社,通过盖蒂图像

在新冠肺炎的一次疫苗接种活动中,一名卫生保健工作者准备注射疫苗...

但是免疫功能低下者的加强注射已经成为一个明显的优先事项。

周四,在白宫的COVID回应简报会上,当被问及该组织中的人何时可以期待第三针的批准时,白宫首席医疗顾问安东尼·福奇博士说,支持者将“尽快实施。”

“对我们来说,采取行动让这些人成为他们的支持者是极其重要的。我们现在正在努力,我们将尽快实施。因为对我们和相关个人来说,这是一个非常重要的优先事项,”福奇说。

根据美国广播公司新闻获得的通话记录,福奇周二在全国州长协会的电话会议上私下告诉州长们,免疫功能低下的人将是助推器队列中的第一名,美国食品和药物管理局正在“研究一种机制”,以“尽快”为该群体获得额外剂量。

他还表示,他预计普通民众最终会效仿。

“我认为最终我们都会朝着那个方向前进,”福奇说,但没有具体说明什么时候。

PHOTO: A healthcare worker administers a Covid-19 vaccine at the Austin Regional Clinic drive-thru vaccination and testing site in Austin, Texas, , Aug. 5, 2021.

彭博社通过盖蒂图像

一名医护人员在奥斯汀地区诊所的免下车电影院接种新冠肺炎疫苗...

周二,美国食品和药物管理局的疫苗负责人彼得·马克斯博士说,他预计“在9月的某个时候”会对增强剂给出更明确的指导

“我再次怀疑,到9月的某个时候,我们将能够对这里的建议做出一些更连贯的陈述,”马克斯说。

马克斯说,这不会是一个笼统的路线图,而是需要特定人群的具体方向,并取决于人们最初收到的镜头。

“我们意识到我们不能只推荐一种疫苗,因为它不能只是‘嗯,我有X疫苗,我该怎么办?’我们必须给每个接种过疫苗的人一个建议,”马克斯说。

对于19年前肾移植后免疫功能低下的菲尔·卡努托来说,即将到来的支持者的消息让他欢欣鼓舞。

来自俄亥俄州阿克伦的坎努托在接种了两剂辉瑞疫苗后没有免疫反应。这增量变量的扩展数据显示接种疫苗的人会传播病毒让他和他的家人高度警惕。

他在给美国广播公司新闻的一条消息中说:“如果FDA即将批准为我们提供额外的注射,我很兴奋。

他说:“我知道很多移植患者一直在偷偷摸摸地试图获得额外的疫苗注射,向弹出的疫苗接种点谎报自己之前的注射量。”他补充说,这一消息将让患者有机会与医生一起做出医学上知情的决定。

FDA expected to recommend boosters for immunocompromised Americans within weeks: Source

Within the next few weeks, the U.S. Food and Drug Administration is expected to recommend a plan forimmunocompromised Americansto get a COVID-19 booster shot, a senior government official familiar with the agency's planning told ABC News on Thursday.

The plan is expected by early September, if not sooner, the government official said.

The timeline wasfirst reportedby The Wall Street Journal.

Many immunocompromised Americans have not had high immune responses to the vaccines,leaving them vulnerable to the viruseven after getting a shot. Response has been low particularly in transplant recipients, cancer patients or people on medications that suppress their immune response.

Last month, experts on the Centers for Disease Control and Prevention's advisory panel were largely supportive ofgiving those people a third doseto boost their immunity and called on the FDA to move on the issue.

Booster shots for the general population, which may be made available at some point, may not be part of the FDA's initial priority authorization. The CDC and FDA maintain that there's not enough data to show thatimmunity has waned enoughamong vaccinated people to warrant a third shot for everyone -- at this time.

But booster shots for the immunocompromised have become a clear priority.

Asked by ABC News on Thursday during a White House's COVID response briefing when people in that group could expect approval for a third shot, Dr. Anthony Fauci, chief White House medical adviser, said boosters will "be implemented as quickly as possible."

"It is extremely important for us to move to get those individuals their boosters. And we are now working on that, and we'll make that be implemented as quickly as possible. Because for us and for the individuals involved, it is a very high priority," Fauci said.

Fauci also told governors privately on the National Governor's Association call Tuesday that immunocompromised people will be No. 1 in the queue for boosters, and that the FDA was "working on a mechanism" to get additional doses to that group "as soon as we can," according to a readout of the call obtained by ABC News.

He also said he expected the general population to eventually follow.

"I think eventually we all will go that direction," Fauci said, without specifying when.

On Tuesday, the FDA's vaccine chief, Dr. Peter Marks, said that he expected to put out clearer guidance on boosters "by sometime in September."

"I suspect, again, by sometime in September, we'll be able to make some more coherent statement about what the recommendation will be here," Marks said.

Marks said it wouldn't be a blanket road map, but require specific directions for certain groups of people and depend on which shots people originally received.

"We realized that we can't just have a recommendation for one vaccine because it can't just be, 'Well I got vaccine X, what do I do?' We have to have a recommendation for everybody who's been vaccinated," Marks said.

For Phil Canuto, who was left immunocompromised after a kidney transplant 19 years ago, the news of boosters on the horizon left him elated.

Canuto, who is from Akron, Ohio, had no immune response after two doses of the Pfizer vaccine. Theincreasing spread of the delta variantand data showing that evenvaccinated people can spread the virushas put him and his family members on high alert.

"If FDA approval of extra shots for us is imminent, I'm excited," he said in a message to ABC News.

"I know a lot of transplant patients have been trying to get extra shots surreptitiously, lying to pop-up vaccination sites about their previous shots," he said, adding that this news will give patients the chance to make medically informed decisions with their doctors.

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