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Trump claims Moderna Covid vaccine will be ‘immediately’ distributed despite FDA not yet approving it

Distribution can not begin until the company receives emergency use authorisation

Danielle Zoellner
New York
Friday 18 December 2020 14:00 GMT
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The White House has said Donald Trump is open to receiving the vaccine
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President Donald Trump has claimed that the Moderna coronavirus vaccine will be distributed “immediately”, despite the jab not yet receiving emergency use authorisation from the Food and Drug Administration (FDA). 

“Moderna vaccine overwhelmingly approved. Distribution to start immediately,” he wrote in a tweet on Friday morning. 

He added: "Europe and other parts of the World being hit hard by the China Virus—Germany, France, Spain and Italy, in particular. The vaccines are on their way!!!"

The president’s tweets came ahead of the vaccine receiving an official nod from the FDA for emergency use authorisation. 

On Thursday, an independent advisory panel of experts commissioned by the FDA voted to endorse the federal agency giving emergency use authorisation to Moderna. The company applied for the authorisation after it found its vaccine was at least 94 per cent effective against Covid-19 based on data from its clinical trials. 

The panel’s vote was 24-0 for giving Moderna emergency use authorisation. One committee member abstained from the vote. 

This vote does not mean Moderna has emergency use authorisation, that decision was still up to the FDA. But the federal agency has given indication that the authorisation would come imminently. 

"Following today’s positive advisory committee meeting outcome regarding the Moderna Covid-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalisation and issuance of an emergency use authorisation," Dr Stephen Hahn, FDA commissioner, and Dr. Peter Marks, head of the Center for Biologics Evaluation and Research, said in a joint statement on Thursday. 

“The agency has also notified the US Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution,” the statement added. 

That authorisation could come as early as today, but no Moderna vaccine doses would be distributed to states until it received that emergency use. 

Upon receiving emergency use authorisation from the FDA, an initial 6 million doses will be shipped out to states. 

Dr Anthony Fauci, the nation’s leading infectious disease expert, said Americans could expect Moderna vaccine doses “by the very early part of next week. I would hope Monday or Tuesday,” when speaking to the Today show. He added: "But we just have to wait to see for the final decision.”

Moderna would receive emergency use authorisation for people ages 18 years old and up, which differed from Pfizer’s coronavirus vaccine. 

In comparison, Pfizer received emergency use authorisation last Friday for people ages 16 and up, and Americans started to receive vaccine doses on Monday. 

Moderna said it would open up its vaccine clinical trials to include people who are younger to better determine its safety and efficacy in other age groups, but until then only those 18 years or older would be able to receive the jab once approved. 

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