美国批准为12岁至15岁未成年人接种辉瑞新冠疫苗
资料照片:在马里兰州巴尔的摩的约翰霍普金斯门诊中心,人们接种了第二剂辉瑞新冠疫苗后坐在观察区内。(2021年5月1日)
美国监管人员批准让年龄最小为12岁的未成年人使用辉瑞-生技(Pfizer-BioNTech)研发的新冠疫苗,从而扩大了有资格接种疫苗的人群范围。
美国食品药品管理局(FDA)星期一(5月10日)说,该疫苗对15岁至12岁的未成年人安全有效。在美国政府给予紧急批准后,16岁及以上的美国人已经在接种辉瑞疫苗了。
FDA代理局长珍妮特·伍德考克在一项声明中说:“今天的行动让更年轻的人口面对2019冠状病毒病而得到保护,让我们朝着恢复某种意义的正常并结束大流行病而继续迈近。”
辉瑞是第一个被美国批准用于少年人的疫苗。目前,美国官员正寻求扩大接种疫苗的人口比例,这项批准有可能争取让千百万美国的初中和高中生在秋季返校前接种疫苗。
虽然多数感染了新冠病毒的未成年人只会产生轻症或没有症状,但他们仍然能够把病毒传染给他人。
辉瑞3月间公布了有2千多名12岁到15岁志愿者参加的疫苗试验的初步结果。试验显示,没有任何一名完全接种了疫苗的人因新冠病毒而病倒或出现严重副作用。
US Approves Pfizer COVID-19 Vaccine for Children as Young as 12
U.S. regulators have authorized the COVID-19 vaccine developed by Pfizer-BioNTech to be used by children as young as 12 years of age, widening the pool of those eligible to get inoculated.
The U.S. Food and Drug Administration said Monday the shot is safe and effective for children ages 12 to 15. The vaccine is already available under an emergency use authorization to those 16 and older.
"Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic," Acting FDA Commissioner Janet Woodcock said in a statement.
The Pfizer vaccine is the first in the United States to be approved for younger people. The approval comes as U.S. officials are seeking to inoculate a larger percentage of the population and will likely prompt millions of U.S. middle and high school students to try to be vaccinated before they head back to class in the fall.
While most children with COVID-19 only develop mild symptoms or have no symptoms at all, they are still able to pass along the virus to others.
In March, Pfizer released preliminary results from a vaccine trial involving more than 2,000 volunteers ages 12 to 15. The trial showed that none of the fully vaccinated adolescents came down with COVID-19 or experienced serious side effects.
来源:美国驻华大使馆
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