Florida Closes Monoclonal Antibody Sites After FDA Revokes Authorization

 

By Kevin Deutsch

The Florida Department of Health said it was closing down its monoclonal antibody treatment sites for COVID-19 Monday after the Food and Drug Administration revoked the drug’s emergency use authorization, citing its lack of effectiveness against the Omicron variant.

The move ended a treatment touted by Florida state health officials as an alternative to vaccines and mask mandates. This, despite vaccines proving highly effective against hospitalization and death from COVID, and properly-worn masks proving effective at limiting the virus’ spread.

As recently as last week, Florida was still opening new monoclonal antibody treatment sites in Broward County.

In announcing the policy change, the FDA cited CDC data showing Omicron accounted for 99 percent of all recorded COVID-19 cases in the U.S. as of Jan. 15.

The data show monoclonal antibody treatments “are highly unlikely to be active” against the Omicron variant, the FDA said in a written announcement.

“In light of the most recent information and data available, today, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) – 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,” the agency said Monday.

Because of their lack of effectiveness against Omicron, “these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” the announcement states.

“In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”

As a result of the FDA’s decision, Florida’s DOH said all of its state-run monoclonal antibody sites will be closed until further notice, and all pending patient appointments canceled.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the DOH said in a written statement. “To date, such clinical evidence has not been provided by the United States Food and Drug Administration.”

The CDC said there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant and that are approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

The agency said healthcare providers should consult the National Institutes of Health panel’s COVID-19 treatment guidelines and assess whether these treatments are right for their patients.

Florida’s surgeon general, Dr. Joseph Ladapo, has previously accused the Biden administration of “actively preventing” the distribution of the monoclonal antibody treatment in Florida and creating an “immediate and life-threatening shortage of treatment options.”

Ladapo has also invoked false conspiracy theories in arguing against COVID-19 vaccines, stating:

“I mean you hear these stories of people telling you what’s been happening in their lives, of nurses and pregnant women who are being forced to, you know, to sort of put something in their bodies that we don’t know all there is to know about yet, no matter what people on TV tell you,” Ladapo said during an October 2021 event with Gov. Ron DeSantis in Clearwater.

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Kevin Deutsch

Kevin Deutsch
Kevin Deutsch is an award-winning crime journalist and author. A graduate of Florida International University, Kevin has worked on staff at The Miami Herald, New York Daily News, and The Palm Beach Post.

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