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Can Trump actually pace up approval of Covid therapies?


In a five-minute video posted to his Twitter account on Wednesday, President Trump stood in entrance of the White Home and provided a lavish endorsement for a therapy he had obtained whereas hospitalized at Walter Reed Nationwide Army Medical Middle.

“They gave me Regeneron, and it was like, unbelievable — I felt good instantly,” he mentioned, referring to an experimental cocktail of monoclonal antibodies produced by the pharmaceutical firm Regeneron. “I need all people to be given the identical therapy as your president.”

The president’s video raised many questions, together with whether or not the antibody cocktail may have such a major impact in such a short while. (Some physicians have been skeptical.)

However for the query of how he deliberate to make sure that a remedy not but permitted by the Meals and Drug Administration would quickly be obtainable, he had a solution: “I’ve emergency-use authorization all set,” he mentioned within the video. “And we’ve obtained to get it signed now.”

Vaccines, medicine and medical gadgets offered in the US usually require F.D.A. approval. However for greater than 15 years, the company has had the authority, when sure situations are met, to grant emergency-use authorizations, which permit the sale of unapproved medical merchandise.

It has used such authorizations throughout a number of illness outbreaks, together with H1N1 flu in 2009 and Zika in 2016, however the coronavirus has introduced their deployment on a brand new scale.

Since February, the company has granted greater than 300 Covid-related emergency-use authorizations, and lots of observers anticipate that Covid vaccines will first be made obtainable in the US below a such a process.