FDA全面批准辉瑞新冠疫苗

FDA Gives Full Approval to Pfizer COVID-19 Vaccine
The U.S. Food and Drug Administration (FDA) on Monday gave full approval for the Pfizer-BioNTech COVID-19 vaccine. The action may help raise public trust in the vaccine as the country and the world battle the fast-spreading Delta variant of the coronavirus.
周一,美国食品药品监督管理局(简称FDA)全面批准了辉瑞和德国生物新技术公司联合研发的新冠疫苗。在美国和全世界抗击快速传播的新冠病毒变种“德尔塔”之际,这一行动可能有助于提高公众对疫苗的信任。
Acting FDA Commissioner Janet Woodcock said in a statement: "...as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."
美国食品药品监督管理局代理局长珍妮特·伍德考克在声明中表示,“作为美国食品药品监督管理局批准的首个新冠疫苗,公众可以非常有信心,该疫苗在安全性、有效性和制造质量方面都符合美国食品药品监督管理局对批准产品的高标准。”
The vaccine, made by Pfizer and its German partner BioNTech, was the first shot to be approved for emergency use by the FDA last December. The FDA has also approved vaccines from Moderna and Johnson & Johnson for emergency use.
这款疫苗由辉瑞及其德国合作伙伴德国生物新技术公司联合生产,是去年12月获得美国食品药品监督管理局紧急使用授权的首个疫苗。美国食品药品监督管理局还批准了莫德纳和强生公司的疫苗用于紧急使用。
The FDA based its latest decision on a study of 40,000 volunteers 16 years and older. It said, "the vaccine was 91 percent effective in preventing COVID-19 disease." The agency also noted the shot "is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death."
美国食品药品监督管理局的最新决定基于对4万名16岁及以上志愿者的研究。美国食品药品监督管理局表示,“该疫苗在预防新冠肺炎方面的有效率为91%。”该机构还指出,这款疫苗“能有效预防新冠肺炎及该疾病导致的住院和死亡等严重后果。”
Approval could lead to vaccine requirements
批准可能引发疫苗需求
The full approval came as governments, schools and businesses around the United States are considering requiring vaccinations for employees, students and others.
在全面批准之际,美国各地的政府、学校和企业正在考虑要求员工、学生和其他人接种疫苗。
Last month, U.S. President Joe Biden announced that federal employees and those who work with the federal government are required to show proof of vaccination or have regular testing.
上个月,美国总统乔·拜登宣布,联邦雇员和联邦政府工作人员必须出示疫苗接种证明或进行定期检测。
Members of the U.S. military will be required to be vaccinated against COVID-19 beginning next month.
美军被要求从下个月开始接种新冠疫苗。
Also on Monday, New York City announced it is requiring all public school teachers and workers in the nation's largest school system to be vaccinated.
同样在周一,纽约市宣布将要求全国最大学校系统的所有公立学校教师和工作人员接种疫苗。
Dr. Carlos del Rio is with Emory University in the state of Georgia. He told The Associated Press, "I think a lot of businesses have been waiting for" the full approval from the FDA. He noted that requiring people to get the shots "becomes much easier when you have full approval."
卡洛斯·德尔里奥博士任职于佐治亚州埃默里大学。他对美联社工费,“我认为很多企业一直在等待”美国食品药品监督管理局的全面批准。他指出,要求人们接种疫苗“在获得完全批准后会变得容易得多。”
An AP-NORC Center for Public Affairs Research study released this week found that a majority of Americans, up to 59 percent, support a vaccine requirement for teachers and students.
AP-NORC公共事务研究中心本周发布的一项研究发现,大多数美国人(高达59%)支持教师和学生接种疫苗。
Democrats and Republicans in the U.S. have differing opinions about vaccine requirements in schools. Only 38 percent of those who identified as Republican support a vaccine mandate for teachers. By comparison, 81 percent of self-identified Democrats support such a requirement.
美国民主党人和共和党人对学校的疫苗要求有不同看法。只有38%的共和党人支持强制教师接种疫苗。相比之下,81%的自称民主党人支持这一要求。
The Kaiser Family Foundation reported earlier this month that most unvaccinated adults in the country do not believe vaccines are effective. Some even see the shots as a greater health risk than the actual disease.
美国凯撒家庭基金会本月早些时候报告称,美国大多数未接种疫苗的成年人不相信疫苗有效。有些人甚至认为注射疫苗的健康风险比实际疾病更大。
FDA chief Woodcock noted: "While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated."
美国食品药品监督管理局代理局长伍德考克指出,“虽然数百万人已安全接种新冠肺炎,但我们认识到,对一些人来说,美国食品药品监督管理局批准疫苗可能会给疫苗接种带来更多的信心。”

Booster shots
加强针注射
The FDA said the vaccine continues to be available under emergency use for young people between the ages of 12 and 15.
美国食品药品监督管理局表示,该疫苗在紧急情况下仍可用于12至15岁的年轻人。
The agency has also advised a third shot, known as a booster, for those with a weakened immune system. But the Biden administration announced last week it plans to provide the third shot to all Americans.
该机构还建议为免疫系统较弱的患者注射第三剂疫苗,即“加强针”。但拜登政府上周宣布,计划向所有美国人提供第三针疫苗。
Israel has one of the world's highest vaccination rates using the Pfizer-BioNTech shots. In early July, it became the first country to give coronavirus boosters to people with weakened immune systems. Israel's Prime Minister Naftali Bennett then announced that the country would offer the booster to all people over 60.
在世界上使用辉瑞和德国生物新技术公司联合研发的疫苗的国家中,以色列是接种率最高的。7月初,该国成为首个向免疫系统低下人群提供新冠疫苗加强针的国家。以色列总理纳夫塔利·贝内特随后宣布,该国将向所有60岁以上人群提供加强针。
Israel's Ministry of Health reported on Sunday that the third shot of Pfizer has greatly improved protection from infection and serious illness among Israelis aged 60 and over.
以色列卫生部周日报告称,辉瑞疫苗加强针极大地提高了60岁及以上以色列人预防感染和严重疾病的能力。
However, health officials with the World Health Organization (WHO) have asked wealthier and more highly vaccinated countries to delay offering booster shots. They said it would be better to give more shots to unvaccinated people in developing countries.
然而,世界卫生组织(简称WHO)的卫生官员要求更富裕、接种率更高的国家推迟提供加强针。他们表示,最好给发展中国家未接种疫苗的人注射更多疫苗。
WHO chief Dr. Tedros Adhanom Gebreyesus said, "We cannot accept countries that have already used most of the global supply of vaccines using even more of it, while the world's most vulnerable people remain unprotected."
世卫组织总干事特德罗斯·阿达诺姆·盖布雷耶苏斯博士表示,“我们不能接受已使用全球大部分疫苗供应的国家使用更多的疫苗,而世界上最脆弱的人群仍然没有得到保护。”
I'm Jill Robbins.
吉尔·罗宾斯报道。


来源:VOA News

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