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

2020-12-16 12 Dailymotion

미 FDA "모더나백신 효과적"…화이자 이어 18일께 두번째 승인 + "화이자-얀센과 백신 구매계약 합의 순조로워…조만간 결과발표"<br /><br />The United States could have two Covid-19 vaccines before the week is over: Moderna's vaccine was found "highly effective" in a detailed review by FDA scientists and appears to be on track for approval by regulators.<br />This as the European Medicines Agency moves up expert review of the Pfizer vaccine to approve its first vaccine ahead of Christmas.<br />South Korea is also expected to soon announce the details of its deals with vaccine producers.<br />Kim Sung-min has details.<br />Moderna's COVID-19 vaccine is one step closer to getting the green light in the U.S.,...as the Food and Drug Administration on Tuesday gave a positive statement about the vaccine.<br />Confirming the overall efficacy of 94-point-1 percent,... the FDA report said that the vaccines are very effective and no safety concerns were found that would setback the issuance of an Emergency Use Authorization.<br />This comes two days ahead of the meeting of experts on whether to authorize the vaccine.<br />The panel of experts are set to offer their recommendation on the vaccine on the 17th, and the final FDA decision is expected to follow a day after.<br />Once approved, the first batches could start rolling out next week.<br />If these plans go smoothly, the U.S. would become the first country to authorize Moderna's vaccine.<br />That would make Moderna the second vaccine producer to receive the green light in the country,...following Pfizer.<br />Meanwhile in South Korea, the government is close to sealing a deal with two global vaccine producers,...Pfizer and Janssen.<br />"The agreement with Pfizer and Janssen has been going smoothly so far. So if there is no setback, we will be able to make the deal and announce it soon.<br />South Korea earlier announced it would secure enough doses for 10 million people through the COVAX facility, and reach an agreement with global pharmaceuticals firms for another 40 million.<br />Kim Sung-min, Arirang News<br />

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