美国食品和药物管理局已授权对18岁及以上的人使用第二种新冠肺炎疫苗，此举将引发数百万剂疫苗在几天内运往医院和疗养院。
喜欢它的对手辉瑞公司认为现代疫苗既安全又高效。在跟踪了大约30，000名志愿者后，莫德纳估计它在预防新冠肺炎病方面有94%的效果，而且几乎没有严重的副作用。
“有了两个疫苗现在为了预防新冠肺炎，美国食品和药物管理局在对抗这种全球流行病的斗争中又迈出了关键的一步，这种流行病每天都在美国造成大量的住院和死亡。
该疫苗是在安东尼·福奇博士领导的国家过敏和传染病研究所的帮助下开发的。他说，现代疫苗和辉瑞疫苗之间没有真正的区别，它们依赖于类似的技术。
“我希望所有美国人在疫苗可用时都能接种疫苗来保护自己。这就是我们的国家将如何开始愈合和前进，”他在一份声明中说。
然而，现代疫苗不需要同样的超低温储存，这使得它更加方便用户，尤其是在设备较少的农村地区。
这项授权是在联邦顾问——一个由传染病专家、医生和科学家组成的独立小组——之后做出的压倒性同意周四，基于试验数据，现代疫苗的益处超过了任何潜在的风险。投票结果是20票对0票，1票弃权。
“我为现代团队与我们的合作伙伴取得的成就感到骄傲。我们能够在从测序到授权的11个月内创造和生产现代新冠肺炎疫苗，同时通过对30，000名参与者的1期、2期和关键3期研究推进临床开发，”现代首席执行官斯特凡·班塞尔在授权后的一份声明中说。“我们仍然专注于扩大制造业，以帮助我们保护尽可能多的人免受这一可怕疾病的侵害。”
汉斯·潘宁克/美联社档案
2020年7月27日，纽约宾汉姆顿，志愿者梅利莎·哈廷接受了美国国立卫生研究院和现代公司开发的一种可能的新冠肺炎疫苗的注射。
与服用辉瑞疫苗的志愿者一样，注射部位出现疲劳、头痛和肿胀。
尚不清楚疫苗是否会阻止传播。这项研究只关注人们是否会患重病。
还不清楚过敏反应的可能性。据报道，在注射辉瑞疫苗后，发生了一些事件。
在周四的现代会议上，美国食品和药物管理局的高级疫苗官员多兰·芬克博士说，研究人员没有所有的信息。但他指出，“这些案例强调了在运动的早期阶段保持警惕的必要性”，并向公众传达了这些发现。
芬克说，美国食品和药物管理局正与辉瑞公司合作，进一步修订概况介绍和警告，以健康护理提供者要明确指出，任何使用它的机构“应该确保立即提供治疗严重过敏反应的药物”他说，食品和药物管理局计划为莫德纳做同样的事情。
比尔·赛克斯/美联社档案
2020年5月18日，星期一，马萨诸塞州剑桥，一名男子站在现代公司大楼的入口处。
疾病控制和预防中心前主任、罗伯特·伍德·约翰逊基金会负责人里奇·贝瑟说:“我从未像现在这样希望我们最终能扭转这一流行病的局面。”。
从莫德纳装运的590万剂是辉瑞-生物技术公司提供的640万剂之外的额外剂量。
唐纳德·特朗普总统在当天早些时候错误地在推特上发布了现代疫苗已被“批准”的消息，他在EUA获得批准后在推特上发布了消息，“祝贺你，现代疫苗现已上市!”
当选总统乔·拜登将于周一接受辉瑞的疫苗，他赞扬了美国食品和药物管理局对现代新冠肺炎疫苗的授权。
拜登在一份声明中说:“今天食品和药物管理局对现代新冠肺炎疫苗的紧急使用授权是我们战胜我国今天面临的危机的战斗中的又一个里程碑。”。“辉瑞生物技术有限公司和现在的莫德纳这两种疫苗的授权，向我们保证了光明的未来。”
FDA authorizes 2nd COVID-19 vaccine, giving Moderna green light to ship doses to states
The U.S. Food and Drug Administration has authorized use of a second COVID-19 vaccine for people age of 18 and over, a move that will trigger the shipment of millions more doses to hospitals and nursing homes within days.
Like itscompetitorPfizer, the Moderna vaccine was believed to be both safe and highly effective. After tracking some 30,000 volunteers, Moderna estimated it as 94% effective in preventing COVID-19 illness with few serious side effects.
"With the availability of twovaccinesnow for the prevention of COVID-19, the FDA has taken another crucial step in the fight against this global pandemic that is causing vast numbers of hospitalizations and deaths in the United States each day," said FDA Commissioner Dr. Stephen M. Hahn.
The vaccine was developed with assistance from the National Institute of Allergy and Infectious Diseases, led by Dr. Anthony Fauci. He has said there is no real difference between the Moderna and Pfizer vaccines, which rely on similar technology.
"It is my hope that all Americans will protect themselves by getting vaccinated when the vaccine becomes available to them. That is how our country will begin to heal and move forward," he said in a statement.
The Moderna vaccine though does not require the same ultra-cold storage, making it more user-friendly, particularly in rural areas that might be less equipped.
The authorization comes after federal advisers -- an independent group of infectious disease experts, doctors and scientists --agreed overwhelminglyon Thursday that the benefits of the Moderna vaccine outweighed any potential risks based on trial data. The vote was 20-0 with one abstention.
"I am proud of what the Moderna team has achieved in collaboration with our partners. We were able to create and manufacture the Moderna COVID-19 Vaccine in 11 months from sequence to authorization, while advancing clinical development with a Phase 1, Phase 2 and pivotal Phase 3 study of 30,000 participants," Moderna CEO Stéphane Bancel said in a statement following the authorization. "We remain focused on scaling up manufacturing to help us protect as many people as we can from this terrible disease."
As with volunteers who took the Pfizer vaccine, fatigue, headaches and swelling at the injection site were noted.
Unknown still is whether the vaccine stops transmission. The study only looked at whether people became serious ill.
Also unclear is the potential for allergic reactions. A few incidents have been reported following shots of the Pfizer vaccine.
At Thursday's meeting on Moderna, Dr. Doran Fink, a senior vaccine official at the FDA, said researchers didn't have all the information. But he noted that "these cases underscore the need to be vigilant during the early stage of the campaign" and communicate those findings to the public.
Fink said the FDA was working with Pfizer to further revise fact sheets and warnings tohealthcare providers to make clear that any facility administering it "should ensure that medical treatment for managing serious allergic reactions is immediately available." He said the FDA plans to do the same for Moderna.
"I have never been more hopeful that we will eventually turn the corner on this pandemic," said Rich Besser, a former director of the Centers for Disease Control and Prevention and head of the Robert Wood Johnson Foundation.
The 5.9 million doses shipped from Moderna will be in addition to the 6.4 million doses provided by Pfizer-BioNTech.
President Donald Trump, who had incorrectly tweeted earlier in the day that the Moderna vaccine had been "approved," tweeted after the EUA was granted, "Congratulations, the Moderna vaccine is now available!"
President-elect Joe Biden, who is set to receive Pfizer's vaccine on Monday, praised the FDA's authorization for the Moderna COVID-19 vaccine.
“Today’s emergency use authorization by the Food & Drug Administration of the Moderna COVID-19 vaccine is another milestone in our battle to overcome the crisis our country is facing today," Biden said in a statement. "The authorization of two vaccines, Pfizer-BioNTech and now Moderna, assures us that brighter days lie ahead."
