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FDA says it hasn’t yet approved Moderna Covid vaccine despite Trump tweet saying otherwise

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FDA says it hasn’t yet approved Moderna Covid vaccine despite Trump tweet saying otherwise

U.S. President Donald Trump delivers remarks at an Operation Warp Velocity Vaccine Summit on the White Home in Washington, U.S., December 8, 2020.

Tom Brenner | Reuters

The Meals and Drug Administration hasn’t but cleared Moderna’s coronavirus vaccine, opposite to a tweet from President Donald Trump on Friday that mentioned the company had “overwhelmingly authorized” it and would instantly distribute it.

The FDA did not touch upon Trump’s tweet, pointing CNBC as a substitute to a Thursday night time assertion from FDA Commissioner Dr. Stephen Hahn that the company would “quickly work towards finalization and issuance of an emergency use authorization” for Moderna’s vaccine.

“The company has additionally notified the U.S. Facilities for Illness Management and Prevention and Operation Warp Velocity, to allow them to execute their plans for well timed vaccine distribution,” Hahn mentioned in a joint assertion with Dr. Peter Marks, director of the FDA’s Heart for Biologics Analysis and Analysis.

The FDA’s assertion on Thursday “is present,” FDA spokesman Michael Felberbaum informed CNBC after Trump’s tweet.

It is attainable Trump was referring to a vote Thursday from the FDA’s Vaccines and Associated Organic Merchandise Advisory Committee, which voted 20-0 with one member abstaining to endorse the approval of Moderna’s vaccine for emergency use. The advisory committee performs a key function in approving flu and different vaccines within the U.S., verifying the pictures are secure for public use. Whereas the FDA does not should observe the advisory committee’s advice, it usually does.

The FDA is predicted to authorize Moderna’s vaccine as early as Friday. The U.S. plans to ship slightly below 6 million doses subsequent week, pending the company’s approval, Gen. Gustave Perna, who oversees logistics for the Operation Warp Velocity vaccine undertaking, informed reporters Monday.

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