Fauci Defends FDA for Rescinding Authorization of Monoclonal Antibodies — ‘Risk of a Potential Adverse Effect with Essentially No Benefit’
National Institute of Allergy and Infectious Diseases director Dr. Anthony Fauci on Tuesday defended the Food and Drug Administration’s decision to rescind emergency-use authorizations for two monoclonal treatments used for the coronavirus.
Fauci said on MSNBC’s “José Díaz-Balart Reports” that there is a “risk of a potential adverse effect with essentially no benefit” because the antibodies “don’t work” on the Omicron variant.
“[I]f you look in the United States, about 99% of the isolates are Omicron. So, it would be extremely unusual for someone to still have a lingering Delta infection right now,” Fauci outlined. “I think a month or two ago, that was different — when Omicron was replacing Delta. But now, if you look at the isolates throughout the country, they’re very, very high. I mean, literally close to 100% of the isolates now are Omicron. And that’s the reason that the FDA made that decision since these two monoclonal antibodies don’t work against Omicron, that it would not be a good idea to administer to anyone, because all you will have is the risk of a potential adverse effect with essentially no benefit from the actual therapeutic effect.”
He added, “There is a monoclonal antibody, sarilumab, that actually does work against the Omicron, and that’s a monoclonal antibody made by GSK.”
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