【双语新闻】美FDA将提高对Omicron疫苗和药物审查速度

作者:陈永泉 时间:2021-12-04 点击数:

如果需要针对新发现的Omicron变种的新冠疫苗和疗法,美国食品和药物管理局(FDA)准备加快审查,以便快速推出。

The US Food and Drug Administration (FDA) is ready to speed up its review of COVID-19 vaccines and treatments for the newly identified Omicron variant for rapid roll-out if needed.

包括辉瑞公司/ BioNTech公司、Moderna公司和强生公司在内的疫苗制造商已经开始了研究工作,以更新他们的疫苗,以应对上周在南非首次出现的Omicron变种。

Vaccine makers including Pfizer/BioNTech, Moderna, and Johnson & Johnson have begun research work to update their vaccines to deal with the Omicron variant that first appeared in South Africa last week.

据一位知情人士透露,预计制药商将达到标准,类似于规定强化注射授权的标准。

Drugmakers are expected to meet standards similar to those governing enhanced injection authorizations, according to a person familiar with the matter.

与大约一年前需要进行大规模和漫长的试验才能获得疫苗授权不同,开发人员可以在几百名受试者中研究疫苗的免疫反应。

Unlike about a year ago, when a large and lengthy trial was required to license the vaccine, developers can study the immune response of the vaccine in a few hundred subjects.

经过估计约三个月的开发和测试新疫苗的时间后,开发人员将能够通过快速审查程序寻求他们的授权,这可以使FDA在一到两周内做出决定。

After an estimated time of about three months to develop and test the new vaccine, developers will be able to seek their authorization through a fast-track review process, which could allow the FDA to make a decision within one to two weeks.

这个星期早些时候,拜登表示美国联邦政府正在与疫苗生产商谈判,如果Omicron变种的威胁需要新的疫苗或助助剂,就制定应急计划。

Earlier this week, Biden said the federal government is in talks with vaccine manufacturers to develop contingency plans if the threat of the Omicron variant requires a new vaccine or aid.

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