A federal official told The Associated Press that the Food and Drug Administration (FDA) plans to expand its emergency use authorization for Pfizer’s vaccine to the new age group.
一位联邦官员告诉美联社,美国食品药品监督管理局计划将辉瑞疫苗的紧急使用授权扩大到这一新的年龄段。
The official did not want to be identified because there has been no public announcement about Pfizer’s vaccine plans. The New York Times first reported on the expected timing of the plan.
这位官员不愿意透露姓名,因为尚未发布有关辉瑞疫苗计划的公告。《纽约时报》最先报道了该计划的预期时间。
The official said the approval is expected to come by early next week. The person added that the FDA also plans to approve Pfizer’s two-shot vaccine for even younger children later this year.
这位官员表示,预计将在下周初批准。该人士还表示,美国食品药品监督管理局计划今年晚些时候批准辉瑞的两剂疫苗用于更年幼儿童。
The FDA’s expansion of its emergency use authorization is the first step in the approval process. That action would be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the injection for 12- to 15-year-olds.
美国食品药品监督管理局扩大其紧急使用授权是批准流程中的第一步。在此之后将举行一场联邦疫苗咨询委员会的会议,讨论是否建议为12-15岁儿童注射。
If the Centers for Disease Control and Prevention approves the committee’s recommendation, the shots could begin. Those steps could be completed in a matter of days.
如果美国疾病控制与预防中心批准了该委员会的建议,则开始接种。这些步骤可以在几天之内完成。
In March, Pfizer released the first results from a vaccine study involving 2,260 U.S. volunteers aged 12 to 15. The study showed there were no cases of COVID-19 among fully vaccinated individuals compared with 18 in the group who were given a placebo, a shot of inactive substance.
3月份,辉瑞公司发布了一项涉及2260名年龄在12到15岁志愿者的疫苗研究的首批结论。该研究表明,完全接种疫苗的个人当中没有发现新冠肺炎病例,相比之下注射了安慰剂这种非活性物质的小组中有18人感染。
The 12- to 15-year-olds had side effects similar to young adults, Pfizer said. The main side effects are pain, increased temperature, tiredness and chills, especially after the second shot. The study will continue to follow test subjects for two years to gain more information about long-term protection and safety.
辉瑞称,这些12到15岁孩子的副作用与青年相似。主要副作用是疼痛、发烧、疲倦和发冷,尤其是在注射第二针之后。这项研究将继续对测试对象进行为期两年的跟踪,以获取有关长期保护和安全性的信息。
Pfizer is not the only company seeking to lower the age limit for its vaccine. Results are also expected by the middle of this year from a U.S. study of Moderna’s vaccine in 12- to 17-year-olds.
辉瑞并非唯一一家希望降低其疫苗使用年龄限制的公司。美国对12到17岁儿童进行的莫德纳疫苗研究也有望在今年年中得出结论。
The FDA is permitting both companies to also begin U.S. studies in children 11 and younger.
美国食品药品监督管理局批准这两家公司还开始对12岁以下儿童进行研究。
More than 131 million doses of Pfizer’s vaccine have already been given in the U.S., where demand for vaccines among adults has greatly slowed in recent weeks.
美国已经接种了1.31亿剂辉瑞疫苗,最近几周美国成年人对疫苗的需求已经大大放缓。
Younger people generally have a much lower risk of experiencing serious side effects from COVID-19. But they started making up a larger share of new U.S. cases as an increasing number of adults got vaccinated and some virus-related restrictions were eased.
青少年经历新冠肺炎严重副作用的风险通常要低很多。但是随着越来越多成年人接种疫苗以及放宽了一些新冠病毒相关限制,青少年开始在美国新增病例中占据较大份额。
Officials hope that expanding the vaccines to young people will help efforts to safely reopen schools in the autumn.
官员们希望将疫苗扩大到青少年对秋季安全地重新开放学校会有帮助。
The U.S. has ordered at least 300 million doses of the Pfizer shot by the end of July, enough to protect 150 million people.
截至7月底,美国已经订购了至少3亿剂辉瑞疫苗,足以保护1.5亿人口。