<Anchor>



Among the corona vaccines that Koreans are receiving now, the Pfizer, Moderna, and Janssen vaccines received conditional approval in both Korea and Europe, but in the US they were in an emergency state. However, the U.S. Food and Drug Administration officially approved the Pfizer vaccine for the first time. At first glance, it may not have much to do with us, but it could have a significant impact on domestic vaccine strategies.



This is Cho Dong-chan, a medical reporter.



<Reporter> The



U.S. Food and Drug Administration has officially approved the Pfizer vaccine for the first time as a COVID-19 vaccine.



In the meantime, it was in the state of emergency approval, but the infectious disease was serious and there was no alternative drug, so it was approved for use immediately after the phase 3 clinical trial was completed.



For formal approval, safety is confirmed for at least six months, and the production process must be meticulously verified, which usually takes 10 times more time and effort than emergency approval.



[Peter Marks/Director of the US Food and Drug Administration: We reviewed hundreds of thousands of documents related to the safety and effectiveness of vaccines and the production process.] As



long as safety is sufficiently confirmed with mental approval, a strong vaccination policy can be implemented.



[John Kirby / US State Department Spokesperson: We will come up with a plan to make vaccination mandatory for US soldiers and their families.] Now that there is a



formally approved vaccine, the US is unlikely to urgently approve a new vaccine in the future. .



The problem is that the U.S. Novavax vaccine, which we can make and use at will by signing a license contract with SK Bioscience in Korea, has not yet received emergency approval.



Although it has already completed phase 3 clinical trials, it will take a considerable amount of time to obtain much more stringent formal approval.



SK Bioscience announced that it is considering a plan to obtain a license in Korea before the US.



With the cooperation of Novavax of the United States, the domestic approval process is carried out using global clinical trial data.



(Video editing: Kim Jun-hee, CG: Ryu Sang-soo) 



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