Florida monoclonal antibody sites are closed after the U.S. Food and Drug Administration announced that Regeneron and Eli Lilly's treatments should not be used because they do not work against the Omicron variant of COVID-19.
The FDA revoked emergency use authorization for both drugs on Monday, but said it could reauthorize their use if they prove effective against future variants.
Florida's health agency doesn't like the decision, which comes nearly weeks after Florida opened additional antibody monoclonal sites, including Miami-Dade, Broward and Palm Beach counties. The sites have also been pointed out by the government's Ron DeSantis, who has traveled to some of them to give briefings on their inauguration.
All state-supported monoclonal antibody sites, including Tropical Park in West Miami-Dade, CB Smith Park in Pembroke Pines, Miami Dade College North Campus, Markham Park in Sunrise and West Boynton Recreation Center, have been closed. Florida Department of Health. The patients who were appointed have been informed.
Florida does not agree with the FDA's decision
"Florida disagrees with the decision that blocks access to any available treatment in the absence of clinical evidence," the Florida Department of Health said in a news release. "To date, no such clinical evidence has been provided by the United States Food and Drug Administration (FDA)."
The COVID-19 monoclonal antibody treatments were designed to give the immune system an extra boost to help fight the disease, enough to help keep people out of hospital. Treatments were not a substitute for COVID-19 vaccination. DeSantis is a strong supporter of the therapy and was calling on the federal government, which regulates the supply of monoclonal antibodies, to send more batches of the drug to the state.
The treatments were effective against other COVID-19 types, including Delta, and were used throughout the pandemic. But the data showed that the therapy against Omicron was not working well, according to the FDA.
ABC News reported that both Regeneron and Eli Lilly also stated that their antibodies could not target Omicron well because of its mutation. including Miami-Dade Omicron is the dominant strain in and makes up the majority of the country's affairs.
"Therefore, COVID-19 patients receiving care in the US are infected with a form other than Omicron, and these treatments are not authorized for use at this time," the FDA said in its announcement. "This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who use the Omicron variant." have been infected or exposed to."
The FDA also noted that a National Institutes of Health independent panel of experts recently recommended not using Regain-CoV and Eli Lilly's monoclonal antibody treatments because the effectiveness against Omicron is low, as well as rare, There is a lack of real time routine testing to identify non. -Omicron variant.
Both Regeneron and Eli Lilly previously announced that they are working to develop new antibodies to target Omicron.
What other options are there?
There are still other COVID-19 therapy options available, although they are in scarce supply:
Remdesivir, an antiviral drug sold as Vaxari, is the first COVID-19 treatment to receive FDA approval. The FDA on Friday expanded the use of the drug to treat people 12 years of age and older who have mild to moderate COVID-19 and are considered to be at high risk of hospitalization. Earlier, it could be given only to hospitalized patients.
A monoclonal antibody treatment, sotrovimab, appears to be effective against Omicron. And Paxlovid and molnupiravir are antiviral pills that were recently authorized by the FDA.