US President Donald Trump delivers a speech at an Operation Warp Speed Vaccine Summit on December 8, 2020 at the White House in Washington, USA.
Tom Brenner | Reuters
The Food and Drug Administration has not yet approved Moderna’s coronavirus vaccine, contrary to a tweet from President Donald Trump on Friday that said the agency had “overwhelmingly approved” it and would distribute it immediately.
The FDA did not comment on Trump’s tweet and instead referred CNBC to a statement from FDA Commissioner Dr. Stephen Hahn on Thursday evening that the agency would “work quickly towards finalization and emergency use approval” for Moderna’s vaccine.
“The agency has also notified the US Centers for Disease Control, Prevention and Operation Warp Speed so that they can implement their plans for timely vaccine distribution,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA 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 is possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday that voted 20-0, with one member abstaining to approve Moderna’s emergency vaccine advocate. The advisory board plays a key role in approving influenza and other vaccines in the US and verifying that the vaccinations are safe for public use. While the FDA does not need to follow the advisory committee’s recommendation, it often does.
The FDA is expected to approve Moderna’s vaccine as early as Friday. The U.S. plans to ship close to 6 million cans next week pending agency approval. This was announced by General Gustave Perna, who oversees the logistics for the Operation Warp Speed vaccination project, to reporters on Monday.