.食品和药品管理局经授权的美国的第一新冠肺炎(新型冠状病毒肺炎)周五晚些时候，针对16岁及以上人群的疫苗接种，这是一场流行病的历史性时刻，这场流行病已导致该国29万人死亡，全球近160万人死亡。
美国食品和药物管理局局长斯蒂芬·哈恩博士在一份声明中说:“美国食品和药物管理局授权紧急使用第一种新冠肺炎疫苗是抗击这种毁灭性流行病的一个重要里程碑，这种流行病已经影响了美国和世界各地的许多家庭。”。
紧急使用授权预计将在24小时内触发向全国636个地点首次运送290万剂，主要是向前线医院运送卫生保健工人们应该会收到。养老院和其他长期护理设施也被认为是重中之重。
与德国生物技术公司合作生产疫苗的辉瑞公司表示，将把疫苗从其密歇根仓库直接运送到这些地方，这些地方是由州长和当地政府预先选定的健康官员。
“今天，我们可以开始将数百万美国人的希望变成现实，”辉瑞首席执行官艾伯特·布尔拉说。“这是因为我们收到了一个好消息，美国食品和药物管理局已经授权16岁或以上的人紧急使用我们的新冠肺炎疫苗。”
第二批290万剂预计将紧随其后，美国政府选择保留50万剂储备，以解决任何运输或分配事故。
英国已经做到了开始分发疫苗。墨西哥和加拿大的监管机构也认可了这种疫苗。
这是第一种使用美国授权的基因技术的疫苗。
虽然时间不确定，但预计疫苗接种将很快开始，可能在周一。
此前，由传染病专家、医生和科学家组成的独立小组的联邦顾问一致认为，基于试验数据，辉瑞疫苗的益处远远超过任何潜在风险。
美国食品和药物管理局首席科学家丹尼斯·辛顿在批准《EUA法案》时写道:“在得出符合法案第564(c)节规定的授权标准后，我授权紧急使用辉瑞-生物技术有限公司的COVID-19疫苗预防新冠肺炎，如本函授权范围一节(第二节)所述，并受本授权条款的约束。”。
今年涉及44，000名志愿者的临床试验数据估计，这种疫苗对新冠肺炎病毒有95%的效果，没有任何严重的副作用。注射部位出现疲劳、头痛和肿胀。
在英国报道了两起严重过敏反应后，美国食品和药物管理局警告说，疫苗不应给已知对疫苗的任何成分严重过敏的人使用。
美国最高传染病医生安东尼·福奇(Anthony Fauci)博士表示，他预计会有这样的警告，这并不一定意味着患有无关过敏的人不能接种疫苗。
他周五在接受《美国医学会杂志》的在线采访时说:“既然我们已经有了这样的认识，你所做的就是你在临床医学中所做的一切:你对它保持警惕，并保持一种状态，这样如果它再次发生，人们就在一个可以处理它的机构中。”“我认为它不应该减轻人们接种疫苗的负担，因为我们不知道接种的程度。”
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一份单独的患者情况表显示，任何接受疫苗接种的人都应该告诉他们的疫苗接种提供者，他们是否怀孕或哺乳、免疫功能低下、有出血障碍或正在服用血液稀释剂、发烧、有任何过敏或接受过另一种新冠肺炎疫苗。
唐纳德·特朗普总统在批准后立即在推特上发布了一份视频声明。
“今天，我们的国家实现了医学奇迹。我们在短短九个月内就交付了一种安全有效的疫苗，”他在椭圆形办公室录制的一条信息中说。“这是历史上最伟大的科学成就之一。它将拯救数百万人的生命，并很快一劳永逸地结束这场流行病。我很高兴地报告，美国食品和药物管理局已经批准了辉瑞疫苗。我们已经给了辉瑞和其他公司大量资金，希望这将是结果，事实也的确如此。”
美国政府的官方绿灯是很久以前的事了，周五早些时候，一名沮丧的特朗普在推特上愤怒地指责哈恩，称FDA是“一只又大又老又慢的乌龟”。
知情人士说，在周五的电话中，白宫办公厅主任马克·梅多斯(Mark Meadows)向哈恩暗示，如果他的机构在当天结束前没有授权紧急使用这种疫苗，他的工作可能会岌岌可危。
特朗普周五在推特上写道:“我只想阻止世界自杀。”
美国食品和药物管理局生物制品评估和研究中心主任彼得·马克斯博士在一份声明中说，这一壮举是“用科学指导我们的决策”实现的。
当疫苗正在运输途中或准备运输时，另一个联邦咨询小组计划周六开会，考虑到辉瑞有限的供应，建议如何分配该疫苗。
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该小组为疾病控制和预防中心提供建议，已经建议卫生保健工作者和长期护理机构的居民应该首先接种新冠肺炎疫苗。预计他们将在周六的会议上对辉瑞疫苗提出同样的建议。
疾病预防控制中心主任罗伯特·雷德菲尔德预计将迅速批准该建议，以免延误注射。
美国食品和药物管理局咨询小组以17票对4票，一名成员弃权支持该疫苗。异议似乎主要与担心美国食品和药物管理局希望批准16岁及以上的人接种疫苗，而不是将年龄限制在18岁有关。
福奇和其他健康专家表示，他们愿意自己接种疫苗，并推荐给家人。
前疾控中心代理主任、罗伯特·伍德·约翰逊基金会主席理查德·贝瑟博士说:“当我的小组接到电话时，我会很高兴地卷起袖子。”。
FDA authorizes 1st COVID-19 vaccine in United States
The Food and Drug Administrationauthorizedthe United States' firstCOVID-19vaccine for people age 16 and over late Friday, a historic moment in a pandemic that has killed over 290,000 in this nation and nearly 1.6 million people worldwide.
"The FDA's authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world," FDA Commissioner Dr. Stephen Hahn, said in a statement.
The emergency use authorization was expected to trigger the first shipment of 2.9 million doses to 636 sites across the country within 24 hours, primarily to hospitals where front-linehealth careworkers are expected to receive them. Nursing homes and other long-term care facilities are also considered a top priority.
Pfizer, which produced the vaccine alongside German company BioNTech, has said it will ship the doses from its Michigan warehouse directly to those sites, pre-selected by governors and localhealthofficials.
"Today, we can begin to turn millions of Americans hopes into reality," Pfizer CEO Albert Bourla said. "That's because we have received the great news that the FDA has authorized the emergency use of our COVID-19 vaccine for people 16 or older."
A second batch of 2.9 million doses was expected to follow close behind, with the U.S. government opting to keep 500,000 doses in reserve to address any shipping or distribution mishaps.
The U.K. has alreadybegun distributingthe vaccine. Regulators in Mexico and Canada also endorsed the vaccine.
It is the first vaccine that uses the genetic technology mRNA to be authorized in the United States.
While the timing was not certain, the expectation was that vaccination shots would begin quickly, possibly on Monday.
The authorization comes after federal advisers -- an independent group of infectious disease experts, doctors and scientists -- agreed the benefits of the Pfizer vaccine strongly outweighed any potential risks based on trial data.
"Having concluded that the criteria for issuance of this authorization under Section 564(c) of the Act are met, I am authorizing the emergency use of Pfizer-BioNTech COVID‑19 Vaccine for the prevention of COVID-19, as described in the Scope of Authorization section of this letter (Section II) and subject to the terms of this authorization," Denise M. Hinton, chief scientist at the FDA, wrote in approving the EUA.
Data from clinical trials involving 44,000 volunteers this year estimated the vaccine to be 95% effective against COVID-19 without any serious side effects. Fatigue, headaches and swelling at the injection site were noted.
Following reports of two severe allergic reactions in the U.K., the FDA warned the vaccine should not be given to individuals known to be severely allergic to any component of the vaccine.
Dr. Anthony Fauci, the nation's top infectious disease doctor, said he was expecting such a warning and that it wouldn't necessarily mean that people with unrelated allergies can't get the vaccine.
"Now that we've got this heads up, what you do is what you do with everything in clinical medicine: You stay alert for it, and you keep a situation so that if it happens again, that people are in a facility that can take care of it," he said in an online interview with the Journal of the American Medical Association on Friday. "I don't think it should mitigate against people getting vaccinated because we don't know the extent."
A separate fact sheet for patients says anyone receiving the vaccine should tell their vaccination provider if they are pregnant or breastfeeding, immunocompromised, have a bleeding disorder or are on a blood thinner, have a fever, have any allergies or have received another COVID-19 vaccine.
President Donald Trump immediately posted a video statement to Twitter after the approval.
"Today our nation has achieved a medical miracle. We have delivered a safe and effective vaccine in just nine months," he said in a message taped in the Oval Office. "This is one of the greatest scientific accomplishments in history. It will save millions of lives and soon end the pandemic once and for all. I am thrilled to report that the FDA has authorized the Pfizer vaccine. We have given Pfizer and other companies a great deal of money, hoping this will be the outcome, and it was."
The official green light from the U.S. government was a long-time coming, as a frustrated Trump tweeted angrily at Hahn earlier Friday and called the FDA a "big, old, slow turtle."
In a Friday phone call, White House chief of staff Mark Meadows suggested to Hahn that his job could be on the line if his agency didn't authorize the emergency use for the vaccine by the end of the day, people familiar with the matter said.
"I just want to stop the world from killing itself," Trump tweeted Friday.
Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a statement the feat was achieved "with science guiding our decision-making."
While the vaccines are en route or prepare to ship, another federal advisory panel planned to meet Saturday to recommend how the Pfizer vaccine should be allocated considering its limited supply.
That panel, which advises the Centers for Disease Control and Prevention, has already suggested health care workers and residents of long-term care facilities should be first in line for COVID-19 vaccines. It's expected they will suggest the same for the Pfizer vaccine specifically at Saturday's meeting.
CDC Director Robert Redfield was expected to approve that recommendation swiftly so as not to hold up injections.
That FDA advisory group voted 17-4 with one member abstaining in favor of the vaccine. The dissent appeared to be tied mostly to concerns that the FDA wanted to authorize the vaccine for people ages 16 and up, instead of setting the limit at 18 years of age.
Fauci and other health experts said they would be willing to take the vaccines themselves and recommend them to family members.
"When my group is called, I will gladly roll up my sleeve," said Dr. Richard Besser, a former acting CDC director and president of the Robert Wood Johnson Foundation.
