Florida shuts down all monoclonal antibody treatment sites after FDA decision to limit use of certain treatments not proven effective against Omicron
CNN
By Chris Boyette, CNN
Florida is closing its monoclonal antibody treatment sites, health officials announced late Monday, citing the US Food and Drug Administration’s decision to limit the use of certain versions of the treatments that were found less effective against the now-dominant Omicron variant of coronavirus.
“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice,” the Florida Department of Health said in a statement.
More than 2,000 appointments for the treatment were canceled in the state on Tuesday alone, according to a statement from Gov. Ron DeSantis.
Earlier Monday, the FDA said it was revising the authorizations for monoclonal antibody treatments made by Eli Lilly (bamlanivimab and etesevimab, administered together) and Regeneron (REGEN-COV, or casirivimab and imdevimab), because data showed they are “highly unlikely to be active against the omicron variant.”
Omicron accounted for more than 99% of Covid-19 cases in the US as of January 15, the FDA said, noting restricting the authorization for treatments that aren’t effective against the variant “avoids exposing patients to side effects … which can be potentially serious.”
Some people who’ve received monoclonal antibody treatment reported rashes, diarrhea, nausea and dizziness after treatment, according to the National Institutes of Health. A small percentage of patients had severe allergic reactions.
The FDA’s announcement came after senior health officials in the Biden administration called the offices of governors and state health officials earlier this month, urging them against using these treatments with Omicron, a source familiar with the calls said.
DeSantis has made monoclonal antibodies a cornerstone of his response to surges of coronavirus cases, often pushing the treatment more vigorously than vaccines.
Last summer, he introduced new clinics where individuals could receive the treatment at the onset of symptoms or exposure to someone with Covid-19.
Earlier this month, amid a record-breaking surge of Covid-19 cases, DeSantis assailed the Biden administration for pausing shipments of the monoclonal antibodies, and has pushed for the treatment to remain widely available.
On January 7, DeSantis said he’d secured 15,000 doses of Regeneron’s antibody treatment for the state, despite the pharmaceutical company saying in December its REGEN-COV antibodies “have diminished potency against Omicron.”
DeSantis slammed the FDA’s announcement in a statement Monday, saying 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 the time, the Assistant Secretary for Preparedness and Response and the FDA paused allocations of the Eli Lilly and Regeneron monoclonal antibodies, but said 300,000 additional doses of sotrovimab would be made available in January.
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CNN’s Steve Contorno contributed to this report.
