After a number of days of rumors with ever-growing hype, the Trump administration introduced on Sunday that the Meals and Drug Administration was granting an Emergency Use Authorization (EUA) for a COVID-19 therapy. The transfer was controversial from the beginning, with experiences indicating that the EUA was opposed by numerous well being specialists, together with Nationwide Institutes of Well being Director Francis Collins and Nationwide Institute of Allergy and Infectious Illnesses Director Anthony Fauci. The press convention did not settle issues, with a rising refrain of scientists saying that the info offered in help of the EUA had been misrepresented.
On Monday night time, FDA Commissioner Stephen Hahn acknowledged that he had made a big error in presenting the advantages of the therapy, and he adopted that assertion with an apology on Tuesday. However Hahn pushed again in opposition to indications that the approval of the therapy on the eve of the Republican Nationwide Conference was motivated by political strain.
Flawed type of danger
The therapy at concern includes taking the antibody-containing plasma from those that have recovered from a SARS-CoV-2 an infection (convalescent plasma) and giving it to these at the moment affected by COVID-19 signs. At Sunday’s press convention, the precept justification for permitting this therapy below an EUA was a 35 p.c drop in mortality for these receiving plasma within the first three days of therapy—particularly, Hahn stated 35 of 100 individuals “would have been saved” by this therapy.
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