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02 BioNTech/辉瑞疫苗对青少年安全有效

针对12至15岁人群的临床试验显示,该疫苗预防新冠症状的有效率达到100%。两家公司将在美欧申请将紧急使用授权扩大到该年龄段。

全文共321个词, By Peter Campbell

Pfizer and BioNTech said their Covid-19 vaccine is safe and effective for 12- to 15-year-olds, and the companies plan to push for emergency use authorisation for that age group in the US and Europe.

辉瑞(Pfizer)和BioNTech表示,他们的新型冠状病毒肺炎(COVID-19,即2019冠状病毒病)疫苗对12至15岁的人群是安全有效的,两家公司计划在美国和欧洲为该疫苗用于这一年龄段的人群申请紧急使用授权。

A phase 3 trial showed 100 per cent efficacy in the prevention of symptomatic Covid-19, and “robust”antibody responses exceeding those reported from vaccine trials involving older individuals aged 16 to 25, the drugmakers said.

两家制药商表示,一项3期临床试验显示,该疫苗预防有症状COVID-19的有效率达到100%,而“强大”的抗体反应超过针对16至25岁年龄段人群的疫苗试验所报告的反应。

The companies aim to receive authorisation in time for children to start getting vaccinated for the next school year, said Albert Bourla, Pfizer’s chief executive.

辉瑞首席执行官艾伯乐(Albert Bourla)表示,两家公司力求及早获得为未成年人接种的授权,以便让他们在迎接下一个学年之际开始接种疫苗。

“We share the urgency to expand the authorisation of our vaccine to use in younger populations and are encouraged by the clinical trial data,” he said in a statement on Wednesday.

“对于扩大我们这款疫苗的使用授权、使其能够用于较年轻人群的迫切需要,我们抱有同感,并受到临床试验数据的鼓舞,”他在周三发布的一份声明中表示。

The clinical trial of 2,260 adolescents in the US is the first to show how the jab would work on younger school-age children as officials seek to get students back into classrooms as quickly as possible. The BioNTech/Pfizer vaccine is already authorised for people aged over 16.

在官员们寻求让学生们尽快回到教室之际,在美国对2260名青少年进行的这项临床试验,是第一项表明该疫苗在学龄较小的未成年人身上如何产生功效的试验。BioNTech/辉瑞疫苗已被授权用于16岁以上的人群。

There were 18 Covid-19 cases among adolescents enrolled in the trial who received placebo shots. None who received the vaccine were infected.

在接受安慰剂注射的青少年试验参与者中,有18例COVID-19病例,而接种疫苗的参与者无人受到感染。

“The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant,” said Ugur Sahin, chief executive and co-founder of BioNTech.

“我们在青少年研究中看到的初步结果似乎表明,未成年人从疫苗接种获得特别好的保护;鉴于最近几周我们看到的B.1.1.7英国变种的蔓延趋势,这非常令人鼓舞,” BioNTech首席执行官和联合创始人乌尔·沙欣(Ugur Sahin)表示。

Side effects were consistent with those reported from a trial involving 16- to 25-year-olds, the companies said.

两家公司表示,副作用与一项针对16至25岁人群的试验所报告的副作用一致。

The two companies plan to submit their data to regulators at both the US Food and Drug Administration and the European Medicines Agency to request emergency authorisation.

两家公司计划将其数据提交给美国食品药品管理局(FDA)和欧洲药品管理局(EMA),请求紧急授权。

Pfizer and BioNTech last week began administering doses in their first trial of children aged 11 and under. The vaccine could ultimately be tested on babies as young as six months old.

辉瑞和BioNTech上周开始在其针对11岁及以下儿童的首次试验中注射疫苗。该疫苗最终可能在最小仅六个月大的婴儿身上进行试验。