Florida Closes Monoclonal Antibody Treatment Sites

What treatments will no longer be used against the omicron variant?

(WABNEWS) Florida has begun closing all monoclonal antibody treatment sites, health officials announced Monday night. State authorities indicated that the measure is due to a decision by the United States Food and Drug Administration (FDA).

“Unfortunately, as a result of this abrupt decision by the federal government, all state monoclonal antibody sites will be closed until further notice,” the Florida Department of Health said. it’s a statement.

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More than 2,000 such treatment appointments were canceled in the state on Tuesday alone, according to a statement from Gov. Ron DeSantis.

FDA Announces Review of Authorizations for Monoclonal Antibody Treatments

Earlier Monday, the FDA said it was reviewing authorizations for monoclonal antibody treatments made by Eli Lilly (bamlanivimab and etesevimab given together) and Regeneron (REGEN-COV, or casirivimab and imdevimab). According to the agency, the data showed that they are “very unlikely to be active against the omicron variant.”

The importance of the third dose and the use of masks against the omicron variant 2:56

Omicron accounted for more than 99% of covid-19 cases in the US as of Jan. 15, the FDA said. And he noted that restricting the authorization of treatments that are not effective against the variant “avoids exposing patients to side effects … that can be potentially serious.”

Some people who received monoclonal antibody treatment have reported rashes, diarrhea, nausea and dizziness after receiving it, according to the National Institutes of Health. A small percentage of patients had serious allergic reactions.

The FDA’s announcement came after top health officials in the Biden administration called the offices of governors and state health officials earlier this month, urging them not to use these anti-omicron treatments, a source familiar with the news said. calls.

DeSantis Strategy

Now, Governor DeSantis has made monoclonal antibodies a cornerstone in his response to surges in coronavirus cases. Often even pushing treatment more vigorously than vaccinations.

Last summer, DeSantis introduced new clinics where people could receive monoclonal antibody treatment early in symptoms or exposure to someone with COVID-19.

In the first days of January, faced with a record increase in Covid-19 cases, DeSantis criticized the Biden administration for stopping shipments of monoclonal antibodies. In that vein, he pushed for the treatment to remain widely available.

On Jan. 7, DeSantis said he had secured 15,000 doses of Regeneron’s antibody treatment for the state. Even though the drug company said in December that its REGEN-COV antibodies “have decreased potency against omicron.”

DeSantis criticized the FDA announcement in a statement Monday. And he noted that the Biden administration “has forced trained medical professionals to choose between treating their patients or breaking the law.”

GlaxoSmithKline’s monoclonal antibody, sotrovimab, is the only version of the treatment that appears to work against omicron, the FDA said last month.

At that time, the Assistant Secretary for Preparedness and Response and the FDA halted allocations of monoclonal antibodies from Eli Lilly and Regeneron. But, they said an additional 300,000 doses of sotrovimab would be available in January.

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