Jacksonville, FL — Monoclonal antibody sites statewide abruptly closed late Monday after the U.S. Food and Drug Administration decided to remove the emergency use authorizations for two monoclonal antibody treatments.
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The revised authorizations do not allow providers to administer bamlanivimab/etesevimab and REGEN-COV in the United States.
That means monoclonal treatment sites all over Florida will be closed until further notice.
Today, the FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. https://t.co/mZS55mEpf5 pic.twitter.com/Qi9S5P4ZgB
— U.S. FDA (@US_FDA) January 24, 2022
In a news release, the Florida Department of Health said it disagreed with the FDA’s decision.
It said the decision was made in the absence of clinical evidence.
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As a result of the @US_FDA's abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below. pic.twitter.com/RGeWTPwxCs
— Florida Dept. of Health (@HealthyFla) January 25, 2022
Florida Gov. Ron DeSantis expressed his opposition to the FDA’s decision on Tuesday morning as well, calling it a “reckless decision to take this option away from patients.”
“This is really a sudden shift and I think it caught a lot of people by surprise,” DeSantis said.
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DeSantis vowed to fight back against the federal government, saying that even if the treatment is only half or 25% as effective against omicron, it is better than nothing.
If you had an appointment for monoclonal antibody treatment, you will be contacted about cancellations.
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If you have tested positive for COVID-19, please contact your health provider.
And for more information about why this decision was made, please contact the FDA at 1-888-463-6332.
Because data shows these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the U.S., these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time.
— U.S. FDA (@US_FDA) January 24, 2022
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