Tuesday, January 25, 2022

Monoclonal Treatments Withdrawn In Florida

MONOCLONAL ANTIBODY SITES STATEWIDE WILL BE CLOSED AFTER FDA REMOVES TREATMENT AUTHORIZATION

TALLAHASSEE—The U.S. Food and Drug Administration revised the Emergency Use Authorizations (EUA) for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments within the United States.

As a result of this decision made by the federal government, all monoclonal antibody sites in Florida will be closed until further notice.

Individuals with appointments have been directly contacted regarding cancellations. If you have tested positive for COVID-19, please contact your health care provider for more information and resources on treatment options. Resources for emerging treatments can be found at www.HealthierYouFL.org. Pharmacies that have received allocations of anti-viral treatments can be found at www.FloridaHealthCOVID-19.gov.

As stated in one of the pre-print studies cited on the NIH website, "despite observing differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529."

Florida officials have disagreed with decisions that blocks access to any available treatments, even when there is no evidence of efficacy.

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