正文
Pfizer Says COVID-19 Vaccine Safe for Children 5-11
美国制药商辉瑞公司表示,新数据显示其新冠肺炎疫苗对5到11岁儿童安全有效。
The company said Monday it will seek U.S. approval for the shot to be used in children in this age group as soon as possible. Pfizer developed the vaccine jointly with its German partner BioNTech.
该公司周一表示,将尽快寻求美国批准该疫苗用于这个年龄段的儿童。辉瑞与其德国合作伙伴生物新科技公司共同研发了这种疫苗。
Last month, the U.S. Food and Drug Administration, or FDA, gave full approval to the Pfizer-BioNTech vaccine to be used in all individuals over the age of 16. The vaccine has also been available under emergency use for people 12 to 15 years old.
上个月,美国食品和药品管理局完全批准了辉瑞疫苗用于所有年满16岁以上人群。该疫苗也可用于12到15岁年龄人群的紧急使用。
In trials involving 5- to 11-year-olds, Pfizer tested a smaller dose, about one third the amount given in current shots. Pfizer officials said with the smaller dose, children ages 5 to 11 still developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting full-strength injections.
在涉及5到11岁儿童的试验中,辉瑞测试了较小的剂量,大约是当前注射量的三分之一。辉瑞公司官员表示,在较小剂量下,5到11岁儿童仍会产生跟接种完全剂量疫苗的青少年同等强度的新冠病毒抗体水平。
The children's dosage was also shown to be safe, causing similar or fewer temporary side effects than experienced by teens, Pfizer senior vice president Dr. Bill Gruber told The Associated Press. Such effects can include pain in the arm, fever and body aches.
辉瑞公司高级副总裁比尔·格鲁伯博士告诉美联社,这种儿童剂量也被证明是安全的,导致与青少年相似或更少的暂时性副作用。这类副作用可能包括手臂疼痛、发烧或身体疼痛。
Gruber, who specializes in child medical care, said researchers "really hit the sweet spot" with the latest vaccine. He added that Pfizer and BioNTech aim to seek emergency approval from the FDA by the end of the month for use in this age group. They also plan to seek government approval in the European Union and Britain.
专门从事儿童医疗保健的格鲁伯表示,研发人员用最新疫苗确实达到了最佳效果。他还表示,辉瑞和生物新科技公司的目标是在本月底前寻求美国食品和药品管理局通过用于这一年龄组的紧急授权。他们还计划寻求欧盟和英国政府的批准。
Earlier this month, FDA chief Dr. Peter Marks said once Pfizer provided its results, his agency would examine the data "in a matter of weeks" to consider approval of the vaccine.
本月早些时候,美国食品和药品管理局局长彼得·马克斯表示,一旦辉瑞提供了最终结果,该机构将会在几周内对数据进行审查以考虑批准该疫苗。
Pfizer said it studied the lower dose of the two-shot vaccine in more than 2,200 children aged 5-11. The FDA only required what is called a "bridging study" to be carried out. The study aimed to find out whether the younger children developed antibody levels already proven to be protective in teens and adults.
辉瑞表示,它在2200多名年龄在5到11岁的儿童中研究了较低剂量的两针疫苗。美国食品和药品管理局只要求进行所谓的衔接性研究。该研究旨在找出年龄较小儿童是否产生了已被证明对青少年和成人具有保护作用的抗体水平。
Pfizer and BioNTech announced the findings Monday in a news release, while noting that the study is still going on. Researchers said there have not yet been enough COVID-19 cases to compare rates of effectiveness between the vaccinated and those given a placebo. That data is expected to provide additional results.
辉瑞和生物新科技公司周一在新闻稿中宣布了这一研究结果,同时指出该研究仍在进行中。研究人员表示,目前还没有足够多新冠肺炎病例来比较接种疫苗和服用安慰剂的患者之间的有效性。预计该数据将提供额外成果。
Both the Pfizer vaccine and another one developed by Moderna have been linked to rare cases of heart inflammation in teens and young adults, mostly in young men. But Pfizer said the researchers did not see such cases in the new trial.
辉瑞和莫德纳公司的疫苗都跟罕见的青少年心脏炎症有关,其中主要是年轻男性。但辉瑞公司表示,研究人员在这项新试验中没有发现此类病例。
Moderna is also studying its shots in younger school-aged children. And both Pfizer and Moderna are studying vaccine use for babies as young as 6 months old. Those results are expected later in the year.
莫德纳公司也在研究其疫苗在青少年及学龄儿童中的应用。辉瑞和莫德纳也都在研究疫苗在6个月以上婴儿中的应用。预计这些研究结果将在今年晚些时候公布。
Children generally face a lower risk of severe illness or death from COVID-19 than older people. However, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, the American Academy of Pediatrics reports. Cases in children have risen as the Delta version has spread across the country in recent months.
与老年人相比,儿童感染新冠肺炎重症或死亡的风险更低。然而,美国儿科学会报告称,自大流行开始以来,美国有超过500万儿童新冠肺炎检测呈阳性,至少有460人死亡。近几个月来,随着德尔塔变种在全美国范围内传播,儿童病例有所增长。
Health experts say quick emergency approval of the vaccine could help prevent the possibility of a large rise in infections in the autumn, especially with schools already open nationwide.
卫生专家表示,快速批准疫苗的紧急使用有助于防止秋季感染人数大幅上升的可能性,尤其是在全国范围内已经开学的情况下。
An outside expert said scientists are awaiting more details but see the results as encouraging. "These topline results are very good news," said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. He added that the level of immune response Pfizer reported "appears likely to be protective."
一名外部专家表示,科学家们正在等待细节,但认为结果令人鼓舞。前美国食品和药品管理局局长、乔治城大学的杰西·古德曼博士表示,“这些重要研究结果都是非常好的消息。”他还表示,辉瑞公司报告的免疫反应水平似乎具有保护作用。
I'm Bryan Lynn.
我是布莱恩·林恩。(hxen.net原创翻译,请勿转载,违者必究!)
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