美国食品和药物管理局已经授权在美国使用第三种新冠肺炎疫苗，宣布强生疫苗对18岁及以上的成年人安全有效。
美国食品和药物管理局代理专员珍妮特·伍德库克在一份声明中说:“这种疫苗的授权扩大了疫苗的可用性，这是新冠肺炎最好的医疗预防方法，可以帮助我们抗击这种流行病，这种流行病已经在美国夺去了50多万人的生命。”。
联邦监管机构的绿灯预计最早将于周一触发390万剂药物的装运，其中约80万剂药物预计将直接流向药店。
这些数字将每周增长。随着其他疫苗制造商辉瑞和莫德纳的发货，扩大的供应最终将使该国有望在3月底前拥有足够的疫苗为约1.3亿成年人免疫。
然而，官员们警告说，武装起来需要时间。
美国最高传染病专家安东尼·福奇博士一天前说，美国现在有三种“高效”疫苗。
“重要的是，它们中的每一种对严重的疾病都非常有效，几乎所有的人都说，你看了数据，很明显，你基本上没有住院或死亡。这是一个非常好的消息，”他在周五的新闻发布会上说。
要知道的是:
J&J疫苗只针对成年人，至少最初是这样。
疫苗制造商正在考虑他们的产品是否对儿童安全有效，但这需要一些时间。Fauci预测，在临床试验完成后，疫苗最早可能在秋季提供给青少年，2022年初提供给更小的儿童。
目前，由于J&J的临床试验涉及超过44000人，只针对成年人，疫苗将仅限于18岁及以上的人群。
强生/通过路透社分发
在未注明日期的照片中，可以看到装有强生让桑冠状病毒候选疫苗的小瓶
但是像它的竞争对手辉瑞和莫德纳一样，强生疫苗被认为在预防严重疾病方面非常有效。J&J发现其疫苗在预防严重疾病方面有85%的有效性，在预防接种疫苗28天后的住院和死亡方面有100%的有效性。
“我们认为人们应该服用他们能够获得的疫苗，”伍德库克在授权后的电话会议上说。“我们认为所有这些疫苗都符合我们的有效性标准。他们没有在面对面的试验中进行研究，因此由于开发计划的不同，现在很难进行比较。”
另一个好消息是，J&J在已知具有潜在更危险变异的国家进行了测试，包括巴西和南非。数据发现，这种疫苗在预防严重疾病方面对所有变异都有效。
还是有些未知数。
周三，该公司公布了一项初步分析，表明其疫苗有助于预防无症状感染，但FDA得出结论，目前还没有足够的数据来确定。
监管机构还表示，与其他疫苗类似，保护作用持续多久尚不清楚。
但是在44000名试验参与者中，没有严重的安全问题的报道。接受疫苗而不是安慰剂的参与者显示出与其他疫苗相似的副作用，包括注射部位的疼痛，一些人报告疲劳、头痛或发烧。
强生通过美联社
这张2020年7月由强生公司提供的照片展示了比利时的一瓶新冠肺炎疫苗。
关于过敏，在临床试验中没有报告过敏反应病例。但是，让桑疫苗小组的临床开发负责人玛卡娅·杜欧吉赫(Macaya Douoguih)周五表示，该公司收到了两例严重过敏反应的初步报告，包括一例过敏反应。
Douoguih表示，该公司将继续密切关注这些事件和任何其他反应。
“我们相信我们的发现，让桑新冠肺炎疫苗符合我们严格的安全和有效性标准，”美国食品和药物管理局生物制品评估和研究中心的彼得·马克斯博士在授权后的电话会议上说。“与之前批准的新冠肺炎疫苗类似，该疫苗不应用于已知有严重过敏反应或其任何成分病史的个人。”
总的来说，过敏反应并不常见，通常是暂时的。
它可能会出现在你当地的药店。
J&J疫苗将和其他疫苗一样被分发——主要是根据当地成年人口的规模在各州和主要城市平均分配。但是联邦政府也计划将大量剂量直接送到药店和社区中心。
如果下周第一批装运总量为390万剂，280万剂将在各州和地方管辖区之间分配。但是另外80万会直接去药店;7万人将被送往社区中心;90，000人将被送到联邦政府认可的健康中心。
资格不会马上改变。虽然有关于如何分发疫苗的联邦指南，但应该由各州来宣布哪些人群应该首先接种。在大多数州，现在优先考虑的是独立生活的美国老年人、有严重健康风险的人和像教师这样的基本工人。
与辉瑞和莫德纳不同，J&J疫苗只需要注射一次就可以被视为完全免疫。它也可以储存在冰箱里，使其相对容易处理。
到6月底，J&J预计已经生产了1亿剂疫苗。这使得美国在仲夏前处于盈余状态，预计辉瑞和莫德纳将提供足够的疫苗给3亿人免疫。
FDA authorizes Johnson & Johnson vaccine, giving US 3rd option to fight COVID-19 virus
The U.S. Food and Drug Administration has authorized use of a third COVID-19 vaccine in the U.S., declaring the Johnson & Johnson vaccine safe and effective in adults 18 and older.
"The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States," Janet Woodcock, acting FDA commissioner, said in a statement.
The green light by federal regulators was expected to trigger the shipment of 3.9 million doses as early as Monday, with some 800,000 of that expected to go directly to pharmacies.
Those numbers would grow weekly. And with shipments from other vaccine makers Pfizer and Moderna, the expanded supply would eventually put the country on track to have enough vaccine on hand to immunize some 130 million adults by the end of March.
Officials caution, though, that it will take time to get shots in arms.
Dr. Anthony Fauci, the nation's top infectious disease expert, said a day earlier that the nation now has three "highly effective"vaccines.
"Importantly, each of them are very effective against severe disease and virtually all have them say that you look at the data and it's clear that you get essentially no hospitalizations, or deaths. And this is very good news," he said in a briefing with reporters on Friday.
Here's what to know:
The J&J vaccine is for adults only, at least initially.
Vaccine makers are looking at whether their products would be safe and effective in children, but that will take some time. Fauci predicts vaccines could be offered to teens as early as fall and younger children in early 2022 after clinical trials are done.
For now, because J&J's clinical trial involving more than 44,000 people looked only at adults, the vaccine would be restricted to people 18 and older.
But like its competitors Pfizer and Moderna, the Johnson & Johnson vaccine was considered highly effective at preventing serious illness. J&J found its vaccine was 85% effective at preventing severe illness and 100% effective at preventing hospitalizations and deaths 28 days after individuals were vaccinated.
"We believe that people should take the vaccine that they are able to access," Woodcock said on a conference call following authorization. "We feel all these vaccines meet our standards for effectiveness. They were not studied in head-to-head trials and so it's really very difficult to compare right now due to different differences in the development program."
The other good news is that J&J was tested in countries known to have potentially more dangerous variants, including Brazil and South Africa. The data found the vaccine worked against all variants at preventing severe disease.
There are still some unknowns.
On Wednesday, the company published a preliminary analysis suggesting its vaccine can help prevent asymptomatic infections, but the FDA concluded there is not yet enough data to say for sure.
Regulators also said it's not yet clear how long protection lasts, similar to other vaccines.
But among the 44,000 trial participants, no serious safety concerns were reported. Participants who received the vaccine and not a placebo showed similar side effects to other vaccines, including pain at the injection site, and some people reported fatigue, headache, or fever.
On allergies, there were no cases of anaphylaxis reported in the clinical trial. But Macaya Douoguih, head of clinical development for the vaccine group at Janssen, said Friday that the company received preliminary reports of two cases of severe allergic reactions, including one with anaphylaxis.
Douoguih said the company will continue to monitor those events and any other reactions closely.
"We're confident in our findings that the Janssen COVID-19 vaccine meets our rigorous standards of safety and effectiveness," Dr. Peter Marks, from the FDA's Center for Biologics Evaluation and Research, said on a conference call following authorization. "Similarly to the previously authorized COVID-19 vaccines, the vaccine should not be given to individuals with a known history of severe allergic reactions or any of its components."
Overall, allergic reactions have not been common and are usually temporary.
It could show up at your local pharmacy.
The J&J vaccine will be distributed much as the other vaccines -- mostly spread out evenly across the states and major cities based on the size of the local adult population. But the federal government also plans to send a significant number of doses directly to pharmacies and community centers.
In the case of its first shipments next week totaling 3.9 million doses, 2.8 million will be divided among states and local jurisdictions. But another 800,000 would go directly to pharmacies; 70,000 would be sent to community centers; and 90,000 would go to federally qualified health centers.
Eligibility won't change right away. While there are federal guidelines on how to distribute the vaccines, it's up to states to declare which groups of people should be first. In most states, priority is now being given to older Americans living independently, people with severe health risks and essential workers, like teachers.
Unlike Pfizer and Moderna, the J&J vaccine only requires one shot for an individual to be considered fully immunized. It also can be stored in a refrigerator, making it relatively easy to handle.
By the end of June, J&J is expected to have produced 100 million vaccine doses. That puts the U.S. in a position of having a surplus by mid-summer when Pfizer and Moderna are expected to have delivered enough vaccine to immunize 300 million people.
