FDA says it hasn't approved Moderna Covid vaccine despite Trump tweet


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

Tom Brenner | Reuters

The Food and Drug Administration hasn’t yet cleared Moderna‘s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would immediately distribute it.

The FDA didn’t comment on Trump’s tweet, pointing CNBC instead to a Thursday night statement from FDA Commissioner Dr. Stephen Hahn that the agency would “rapidly work toward finalization and issuance of an emergency use authorization” for Moderna’s vaccine.

“The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The FDA’s statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.

It’s possible Trump was referring to a vote Thursday from the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted 20-0 with one member abstaining to endorse the approval of Moderna’s vaccine for emergency use. The advisory committee plays a key role in approving flu and other vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the advisory committee’s recommendation, it often does.

The FDA is expected to authorize Moderna’s vaccine as early as Friday. The U.S. plans to ship just under 6 million doses next week, pending the agency’s approval, Gen. Gustave Perna, who oversees logistics for the Operation Warp Speed vaccine project, told reporters Monday.



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