作者：陈永泉 时间：2021-12-04 点击数：
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.
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.
Drugmakers are expected to meet standards similar to those governing enhanced injection authorizations, according to a person familiar with the matter.
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.
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.
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.