“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody states will be closed for the time being,” Florida Department of Health
said in a statement.
More than 2,000 treatment agreements were canceled in the state alone on Tuesday, according to a statement from Governor Ron DeSantis.
Earlier Monday, the FDA said it revised the authorizations for monoclonal antibody therapies made by Eli Lilly (bamlanivimab and etesevimab, co-administered) and Regeneron (REGEN-COV, or casirivimab and imdevimab) because data showed they were “highly unlikely to be active against omicron”[ads1];. variants. “
Omicron accounted for more than 99% of Covid-19 cases in the United States as of January 15, the FDA said, noting that limiting the authorization for treatments that are not effective against the variant “avoids exposing patients to side effects … that may be potentially serious. “
Some people who have received monoclonal antibody treatment reported rash, 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 authorities earlier this month and urged them not to use these treatments with Omicron, said a source familiar with the talks.
DeSantis has made monoclonal antibodies a cornerstone in his response to increases in coronavirus cases, and often pushes treatment more forcefully than vaccines.
Last summer, he introduced new clinics where individuals could receive treatment at the onset of symptoms or exposure to someone with Covid-19.
Earlier this month, amid a record-breaking increase in Covid-19 cases, DeSantis attacked the Biden administration for stopping shipments of monoclonal antibodies, and has pushed for treatment to remain widely available.
On January 7, DeSantis said it had secured 15,000 doses of Regeneron’s antibody treatment for the state, despite the pharmaceutical company’s December statement that their REGEN-COV antibodies “have reduced potency against Omicron.”
DeSantis criticized 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 treatment that appears to work against Omicron, the FDA said last month.
At the time, the Assistant Secretary of State for Emergency Preparedness and Response and the FDA stopped allocating the monoclonal antibodies Eli Lilly and Regeneron, but said that 300,000 additional doses of sotrovimab would be made available in January.
CNN’s Steve Contorno contributed to this report.
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