图片来源：路透社

上海译锐翻译   2020-12-9  13:33 p.m.

After spending weeks poring over data provided by Pfizer, government scientists on Tuesday acknowledged in a new document that they believe there is ample evidence that the first COVID-19 vaccine works and is safe in people over the age of 16.While that assessment isn’t the coveted green light the nation has been waiting for, the briefing suggests agency staff aren't warning of any last-minute hiccups and that an emergency authorization is well within the nation’s grasp.

在对辉瑞提供的数据经过数周的仔细研究后，政府科学家于周二在一项新文件中确认，他们认为有足够的证据表明，辉瑞的首支新冠疫苗有效并对于16岁以上的人具有安全性。尽管该评估并非是全国都翘首以盼的审批通过，但是在新闻通气会上，工作人员也没有发出任何紧急暂停警告，而紧急许可已经完全变得触手可及。

last-minute：紧急关头、最后一刻

hiccup：暂停

It also suggests that the vaccine might not just be limited to people over the age of 18 as was initially expected. And the government found protection was strong after just one dose, though both doses are recommended for the strongest protection.

新闻通气会还提出，疫苗也许并非像人们一开始所想的那样，仅可以用于18岁以上的人群。政府发现，疫苗仅在第一次接种后就会产生强大的保护。尽管接种建议是，为确保获得最大的免疫保护，应该接种两次。

"Safety data from approximately 38,000 participants [greater than or equal to] 16 years of age randomized 1:1 to vaccine or placebo with a median of 2 months of follow up after the second dose suggest a favorable safety profile, with no specific safety concerns identified that would preclude issuance of an EUA," the FDA wrote.

“安全数据来自于大约3.8万名参与者（大于或等于16岁），参与者按照1:1的比例随机分配疫苗或安慰剂，并在第二次接种后进行2个月的跟进。数据表示，疫苗具有良好的安全特性，没有任何导致无法签发紧急使用许可的具体安全问题，”FDA在文件中写道。

placebo:安慰剂

The report notes the most common reaction was a skin reaction at the injection site, followed by fatigue or headaches. About half of recipients between 16 and 55 experienced side effects like fatigue or headaches and about a third reported chills or muscle pain. Of clinical trial participants over 55 about half reported fatigue, a third reported headache, and about a quarter reported chills or muscle pain.

报告强调，最常见的反应是注射部位的皮肤，随后会伴随疲惫或头疼。大约一半年龄在16到55岁的接种者表示其有类似于疲惫或头疼这样的副作用，而大约三分一表示其感到发冷或肌肉疼痛。在有超过55人参加的临床测试参与者中，有大约一半的人表示其在接种后感到疲惫，三分之一的接种者表示其会头痛，大约四分之一的人表示其会感到发冷或肌肉疼痛。

The data also indicates the vaccine works equally men in men and woman, and among people of different races and ethnicities.

数据也表明，疫苗对于男性和女性以及不同的人种和种族作用相同。

FDA noted there are some areas where there isn't enough data on the Pfizer vaccine, such as how it works in people with medical conditions like HIV/AIDS, in people who have recovered from COVID-19 infection, or how long the protection lasts.

FDA强调说，在某些方面，辉瑞的疫苗还缺乏足够的数据，比如该疫苗对于感染HIV或艾滋以及曾患新冠肺炎但又康复的人群的作用以及保护的持续时间。

The report also highlights that while the Pfizer vaccine prevents recipients from getting sick with symptoms of COVID-19, there isn't enough data yet to know if the vaccine is effective enough at preventing all transmission of the disease that would eventually replace the need to wear masks, socially distance, and avoid large, indoor gatherings. So even if you are an early recipient of the vaccine it will be important to maintain these risk lowering techniques to protect others.

报告还强调表示，尽管辉瑞的疫苗可以防止接种者有新冠肺炎的症状，但是目前还没有足够数据说明疫苗是否对于预防所有的新冠肺炎传染都有效，也就是还不确定疫苗是否可以让人们免于佩戴口罩，免于保持社交距离以及避免大型室内聚会。因此，即便接种者从一开始就接种了疫苗，但是采取降低风险的举措以保护其他人仍然非常重要。

The briefing document was prepared by the FDA ahead of a Dec. 10 meeting with an independent advisory board. If the advisory board agrees the vaccine works and is safe, it’s likely the FDA will authorize that the vaccine be shipped nationwide.

简述文件由FDA在12月10日与独立顾问委员会召开会议之前提供。如果顾问委员会认为疫苗发挥了作用并且是安全的，那么FDA很可能允许疫苗在全国范围内使用。

Following the authorization, a separate advisory panel tied to the Centers for Disease Control and Prevention is expected to suggest health care workers and older people in long-term care facilities get the first doses.

获得许可后，与疾病控制与预防中心有所关联的独立顾问小组预计将建议护理人员和在长期护理机构的年长人群作为最先接种人群。

Administration officials suggest they hope the vaccine is then distributed next week

行政官员表示，他们希望疫苗能够在下周发出。

来源：abcNEWS，编辑&翻译：Susan