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FDA concludes "no specific concerns" identified to Moderna's COVID-19 vaccine

2020-12-16 10 Dailymotion

미 FDA "모더나 백신 효과적"…화이자 이어 18일께 두번째 승인<br /><br />Following the roll out of the Pfizer-BioNTech COVID-19 vaccine in the U.S.,... the FDA on Tuesday issued an encouraging statement on the Moderna vaccine,... hinting at an emergency approval by later this week.<br />Lee Seung-jae reports.<br />The U.S. FDA on Tuesday issued a positive statement on Moderna's COVID-19 vaccine,... ahead of a meeting of experts on whether to give it the green light.<br />Confirming the overall efficacy of 94-point-1 percent,... the regulators said there were "no specific safety concerns that would preclude issuance of an Emergency Use Authorization.<br />Now a panel of outside experts will hold a meeting,... and offer their recommendation on the vaccine on Thursday,... with a final FDA decision expected shortly after.<br />If the FDA does approve the vaccine,... the first shipments could start rolling out next week.<br />Moderna's vaccine would be the second after Pfizer won authorization last week,... and began rolling out their vaccination program on Monday.<br />On the other side of the Atlantic,... the European Medicines Agency is set to hold a meeting among its human medicines committee to consider a conditional marketing authorization application for the Pfizer-BioNTech vaccine.<br />The meeting was originally schedule for December 29th,... but it has been brought forward to the 21st.<br />A favorable opinion on the vaccine on Monday would mean the vaccine could be authorized in Europe a few days later.<br />The EU has an agreement with Pfizer for up to 300 million doses,... with deliveries to start by the end of this year.<br />Lee Seung-jae, Arirang News.<br />

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