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Monoclonal antibodies site to shutdown in Northwest Florida after FDA revokes emergency use authorization

On Monday evening, the Florida Department of Health announced that all monoclonal antibody state sites will be closed until further notice. This includes the Northwest Fairgrounds location, effective immediately. “This evening, without any advanced notice, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorizations (EUA) for bamlanivimab/etesevimab and REGEN-COV,” wrote the FDOH. […]

On Monday evening, the Florida Department of Health announced that all monoclonal antibody state sites will be closed until further notice.

  • This includes the Northwest Fairgrounds location, effective immediately.

“This evening, without any advanced notice, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorizations (EUA) for bamlanivimab/etesevimab and REGEN-COV,” wrote the FDOH. “The revised EUAs do not allow providers to administer these treatments within the United States.”

“Unfortunately, as a result of this abrupt decision made by the federal government, all monoclonal antibody state sites will be closed until further notice.”

  • According to the FDOH, individuals with appointments have been directly contacted regarding cancellations.
  • Roughly 2,000 appointments were cancelled last night.

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” stated FDOH. “To date, such clinical evidence has not been provided by the United States Food and Drug Administration (FDA).”

From the FDA 👇

In a statement on their website, the FDA revised the authorizations for Regeneron and Eli Lilly “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 FDA went on to say that “data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States.
  • Further, the FDA stated that “based on Centers for Disease Control and Prevention data, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than omicron, and these treatments are not authorized to be used at this time.”

From Gov. DeSantis 👇

In response to the decision, Governor Ron DeSantis demanded the Biden Administration reverse its decision to revoke emergency use authorization (EUA) for Regeneron and Eli Lilly monoclonal antibody treatments.

“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” said Governor Ron DeSantis. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives.”

The treatment site at the Northwest Florida Fairgrounds was opened back in August 2021, and was administering treatments seven days per week from 9am-5pm.

In December, it was announced that the site would close on December 18th. Representative Patt Maney helped delay the closure of the NWFL site and extended operations through January 14th.

The Florida Department of Health recommends contacting your health care provider for more information and resources in treatment options.

Resources for emerging treatments can be found at www.HealthierYourFl.com.

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