US President Donald Trump gives 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, instead referring CNBC to a statement from FDA Commissioner Dr. Stephen Hahn said Thursday evening that the agency would “work quickly towards finalizing and issuing emergency clearance” 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 a timely distribution of the vaccine,” Hahn said in a joint statement with Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research.
The FDA statement on Thursday “is current,” FDA spokesman Michael Felberbaum told CNBC after Trump’s tweet.
It’s possible that Trump was referring to a vote by the FDA’s Advisory Committee on Vaccines and Related Biological Products Thursday, which 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 board’s recommendation, it often does.
The FDA is expected to approve Moderna’s vaccine as early as Friday. The US plans to ship nearly 6 million cans next week pending the agency’s OK, General Gustave Perna, who oversees logistics for the Operation Warp Speed vaccination project, told reporters on Monday.