The US Food and Drug Administration is poised to sign off as soon as next week on updated Covid-19 vaccines targeting more recently circulating strains of the virus, according to two sources familiar with the matter, as the country experiences its largest summer wave in two years.
据两位不愿透露姓名的知情人士表示,随着美国经历两年来最大的夏季疫情高峰,美国食品药品监督管理局已准备好在下周内批准针对最近流行的病毒毒株的更新版新冠疫苗。
The agency is expected to greenlight updated mRNA vaccines from Moderna and Pfizer/BioNTech that target a strain of the virus called KP.2, said the sources, who declined to be named because the timing information isn't public. It was unclear whether the agency simultaneously would authorize Novavax's updated shot, which targets the JN.1 strain.
这些疫苗来自莫德纳和辉瑞或德国生物新技术公司,它们针对的是一种被称为KP.2的病毒毒株。由于时间信息尚未公开,他们拒绝透露姓名。目前尚不清楚该机构是否会同时批准诺瓦瓦克斯医药的更新版疫苗,该疫苗针对的是JN.1毒株。
The move would be several weeks ahead of last year's version of the vaccine, which got FDA signoff on September 11.
这一举措将比去年的疫苗更新提前数周,去年的疫苗版本于9月11日获得FDA批准。
"Now is the time to get a dose with this surge," Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told CNN.
明尼苏达大学传染病研究与政策中心主任迈克尔·奥斯特霍姆博士告诉美国有线电视新闻网:“现在是接种疫苗的好时机,因为疫情正在肆虐。”
Osterholm said on his podcast last week that he recently got a dose of last season's vaccine in order to increase his immunity while the virus is circulating at such high levels and amid uncertainty around when new shots would become available.
奥斯特霍姆上周在他的播客中表示,他最近接种了上一季的疫苗,以增强免疫力,因为病毒正在高度传播,而且新疫苗的使用时间尚不确定。
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He added that he'll now wait to get the updated one in four months, the interval recommended by health officials.
他补充说,他现在将等待四个月后再接种更新版疫苗,这是医生建议的接种间隔时间。
In June, the US Centers for Disease Control and Prevention recommended that everyone over 6 months old receive both an updated Covid-19 vaccine and a flu shot this year.
6月,美国疾病控制和预防中心建议所有已接种6个月以上的人群今年都接种更新版的新冠疫苗和流感疫苗。
Representatives for Pfizer and Moderna told CNN that the companies had ample supply of their updated Covid vaccines and would be ready to ship doses upon approval. Moderna's spokesman said it expects the vaccine to be available in stores within days of FDA signoff.
辉瑞和莫德纳的代表告诉美国有线电视新闻网,这两家公司的更新新冠疫苗供应充足,并准备在获得批准后运送疫苗。辉瑞和莫德纳的代表告诉CNN,他们有足够的更新版新冠疫苗供应,预计疫苗将在FDA批准后几天内上市。
Novavax's vaccine is based on protein technology, which takes longer to manufacture than mRNA vaccines. The company's executives told investors on a conference call last week that it anticipated that its updated vaccine would be arriving in warehouses this month and that it's expected to be ready for distribution when authorized. A spokesperson for Novavax didn't immediately respond to a request for comment Friday.
诺瓦瓦克斯的疫苗基于蛋白质技术,其生产时间比mRNA疫苗要长。该公司高管在上周的电话会议上告诉投资者,他们预计更新后的疫苗将于本月抵达仓库,并在获得授权后准备分发。周五,诺瓦瓦克斯的发言人没有立即回应置评请求。
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A spokesperson for the FDA said the agency can't comment on timing of product applications but noted that it "anticipates taking timely action to authorize or approve updated COVID-19 vaccines in order to make vaccines available this fall."
美国食品药品监督管理局的一位发言人表示,该机构不能就产品申请的时间发表评论,但指出它“预计会及时采取行动,授权或批准更新后的新冠疫苗,以便在今年秋天提供疫苗。”
Levels of the SARS-CoV-2 virus, which causes Covid-19, measured in wastewater are at "very high" levels nationally, according to CDC data, sparking the highest summer peak in the US since July 2022. Monitoring of viral levels in wastewater can give a picture of how widespread the virus is as testing and other forms of monitoring the virus have fallen off.
根据美国疾病控制与预防中心的数据,全国范围内废水中检测到的导致新冠肺炎的SARS-CoV-2病毒含量处于“非常高”的水平, 这是自2022年7月以来,美国夏季出现的最高峰值。随着检测和病毒监测的其他形式减少,对废水中病毒水平的监测可以反映病毒的传播范围。
Measures of severe disease, including rates of hospitalization and death, have been rising, according to the CDC, but they're nowhere near levels seen in previous years.
据疾病预防控制中心称,包括住院率和死亡率在内的严重疾病指标一直在上升, 但远未达到前几年的水平。
Waves of the virus are driven by both waning immunity and new variants, experts say. The prevalent strain in the US now is KP.3.1.1, according to CDC data, estimated to account for 37% of cases over the past two weeks. That's triple its level a month ago.
专家表示,病毒传播浪潮是由免疫力减弱和新变异株共同驱动的。根据疾病预防控制中心的数据,目前美国流行的毒株是KP.3.1.1,估计占过去两周病例的37%, 这是一个月前的三倍。
KP.3.1.1 and KP.2 – the strain included in the updated mRNA vaccines – are both offshoots of JN.1, the target of Novavax's shot, and all are versions of the Omicron variant.
KP.3.1.1和更新版mRNA疫苗中包含的KP.2都是诺瓦瓦克斯疫苗目标毒株JN.1的分支, 且都是奥密克戎变异株的版本。 |
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