FDA: therapy “Unlikely to work” against omicron
Calling it more of a “stand-by holding pattern” than a shutdown, the monoclonal antibody treatment center at the St. Cloud Civic Center closed Tuesday to patients.
Osceola County emergency management and health department officials both confirmed the site is closed “until further notice.”
Late Monday night, the U.S. Food and Drug Administration ended its Emergency Use authorization for REGEN-COV, also known as Regeneron.
The basic gist behind the repeal of EUA is that the therapy is “unlikely to work” against the omicron variant of COVID-19, which the Centers for Disease Control said now makes up virtually all of the new infections.
"Based on available information including variant susceptibility and regional variant frequency, infection or exposure likely due to omicron that is not susceptible to the treatment,” a release from the FDA said Tuesday morning. “With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories or jurisdictions."
According to Daniel Hamilton, a contractor for Garner Environmental, who is overseeing operations of several Central Florida antibody centers, the St. Cloud location had been very well attended, serving hundreds of patients daily, even once the Omicron variant took hold right before the first of the year.
“Our numbers were sustained week over week,” he said. “We had to limit it to appointments only, and only to those with positive tests.”
Hamilton was on site Tuesday handing out flyers with limited information regarding the closure. He said that if word changed from the Biden administration, the clinic could reopen just as quickly as it shut down Tuesday, especially if the drugs prove effective against future variants. The FDA could then reauthorize their use.
The government recently stopped distributing those monoclonal antibody drugs, but resumed distribution again after complaints from officials like Gov. Ron DeSantis, who claimed they helped some omicron patients.
DeSantis was in Osceola County on Sept. 7, 2021 to open the St. Cloud site, touting REGEN-COV as a treatment piece as a backup to the vaccines that are the prevention part.
“Vaccinations are still the No. 1 way to mitigate this. But the vaccine doesn’t treat the disease,” he said that day. “Once you are infected, you need treatment. A lot of people who were infected were expected to stay home and hope they didn’t get worse.”
As this is an ever-changing story, please visit AroundOsceola.com for updates, such as if the site re-opens.
