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美国食品和药物管理局批准Moderna和J&J疫苗的增强剂

2021-10-21 12:49  ABC   - 

美国美国食品药品监督管理局周三授权新冠肺炎助推器对于数以百万计的美国人来说,为Moderna和强生获奖者的第三次拍摄开绿灯。

美国食品和药物管理局还表示,它将允许有资格获得增强剂的人混合和匹配剂量。因此,无论您最初收到哪些照片,您都可以为第三张照片选择您喜欢的品牌。

美国食品和药物管理局的决定为疾病控制和预防中心向公众提出正式建议铺平了道路。疾控中心的一个独立咨询委员会计划周四开会,预计在本周末做出最终机构决定。

美国食品和药物管理局高级官员彼得·马克斯博士说,允许人们混合助推器是有意义的,尤其是当人们可能不记得他们最初收到的是什么品牌时。

“大多数人不知道自己接种了什么品牌的流感疫苗。尽管它们在某种程度上更加标准化,但也许,这可能是我们的下一步,让人们能够灵活地轻松接种疫苗,”他告诉记者。

根据新的规定,如果疾控中心签字同意,如果65岁以上或65岁以下的现代人患有疾病或从事高风险工作,他们将有资格获得自己选择的加强注射。食品和药物管理局和疾病预防控制中心已经已经清除了辉瑞的接受者为了获得第三次机会,现在他们也可以选择他们想要的品牌助推器。

马克斯证实,该机构正在考虑是否降低Moderna或辉瑞接受者的助推器年龄。但他表示,形势“非常动态”,必须由数据驱动。

这一消息被认为特别受那些注射过J&J的人欢迎,事实证明,这种疫苗对中度至重度症状的有效性只有70%。两次注射的有效性攀升至94%,促使美国食品和药物管理局允许任何18岁及以上的人在最后一次注射后两个月使用增强剂。

“这是个好消息,”来自纽约州哈德逊河谷的罗斯·坦贝里诺告诉美国广播公司新闻,她在J&J拍摄了这张照片。

在2020年她姐夫输给新冠肺炎后,坦贝里诺是1500万接受一次性注射的美国人中的一员。

但今年夏天,随着德尔塔变种病毒的到来,在听到J&J的治疗效果不佳和她自己的抗体检测结果不佳的报道后,她变得越来越紧张。

六天前,由于对华盛顿没有采取行动感到沮丧,她把事情掌握在自己手中。在因为她已经被认为接种了疫苗而被医疗机构拒绝后——食品和药物管理局还没有采取行动——她去了一家药店,撒了谎。她省略了过去J&J注射的细节,并注射了一剂辉瑞疫苗。

在变得无赖之后,她的疫苗记录现在将与联邦建议保持一致。

“我只是一个照章办事的人,所以对我来说,做这样的事情真的超出了我的舒适范围,你知道吗?”她在接受ABC新闻采访时表示。

“对我来说,把这件事揽在自己身上,与政府当时的做法背道而驰,对我来说真的很奇怪,”她补充道。“但我觉得这样做总比不做好,因为我只是想得到保护。”
 

FDA authorizes boosters for Moderna and J&J vaccines

The U.S. Food and Drug Administration on Wednesday authorizedCOVID-19 boostersfor millions more Americans, giving a green light for third shots to Moderna and Johnson & Johnson recipients.

The FDA also said it will allow people eligible for a booster to mix and match doses. So no matter which shots you initially received, you can choose your preferred brand for a third shot.

The FDA decision paves the way for the Centers for Disease Control and Prevention to make an official recommendation to the public. An independent advisory committee to the CDC planned to meet Thursday with a final agency decision expected by the end of the week.

Dr. Peter Marks, a top FDA official, said allowing people to mix boosters makes sense, particularly when people might not remember what brand they initially received.

"Most people don't know what brand flu vaccine they received. And although they're somewhat more standardized, perhaps, this is something that is probably a good next step for us to be able to have the flexibility that people can get vaccinated easily," he told reporters.

Under the new rules, if the CDC signs off, Moderna recipients would qualify for a booster shot of their choice if they are older than 65 or younger with medical conditions or a high-risk job. The FDA and CDC hadalready cleared Pfizer recipientsto get a third shot, and now they too can choose which brand booster they want.

Marks confirmed the agency is looking at whether to lower the age of boosters for Moderna or Pfizer recipients. But he said the situation is "very dynamic" and has to be data driven.

The news was considered particularly welcome by those who had gotten the single shot of J&J, which was shown to be only 70% effective against moderate to severe symptoms. That effectiveness climbed to 94% with two doses, prompting the FDA to allow for boosters for anyone 18 and older two months after their last shot.

"That is great news," Rose Tamberino of Hudson Valley, New York, who had gotten the J&J shot, told ABC News.

After losing her brother-in-law to COVID-19 in 2020, Tamberino was among the 15 million Americans who got the one-shot dose.

But she grew increasingly nervous this summer with the arrival of the delta variant and after hearing reports that J&J was less effective and testing her own antibodies with low results.

Six days ago, frustrated that Washington hadn't acted, she took matters into her own hands. After being turned down from a medical facility because she was already considered vaccinated -- and the FDA hadn't acted yet -- she went to a pharmacy and lied. She omitted details of her past J&J shot and got a Pfizer dose.

After going rogue, her vaccine record will now be consistent with federal recommendations.

"I'm just such a by-the-book person so for me to do something like this was really out of my comfort zone, you know?" she told ABC News in an interview.

"For me to take this upon myself and just go against what the government was doing at the time, felt really strange for me," she added. "But I felt better doing it than not though, because I just wanted to be protected."

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