Florida to Receive 4,000 Doses of New Monoclonal Antibodies Treatment

Florida to Receive 4,000 Doses of New Monoclonal Antibodies Treatment
Eli Lily received EUA approval to fight the omicron variant of COVID-19. (Photo courtesy of Eli Lily. Feb. 11, 2022)

PUNTA GORDA, Florida–Florida is scheduled to receive 4,000 doses of a monoclonal antibody treatment that the U.S. Food and Drug Administration (FDA) has found to be effective against the omicron variant that is derived from COVID-19.

On Feb. 11,  the FDA sent a letter to Eli Lily, the maker of Bebtelovimab, that the company has its approval for an Emergency Use Authorization (EUA) to treat mild to moderate COVID-19 in adults and pediatric patients, age 12 years and up.
The Florida Department of Health met with Health and Human Services (HHS) on Feb. 15, to discuss the number of doses that Florida would receive and, so far, that number is 4,000. Of the total 600,000 doses initially ordered by HHS, no one on the federal or state level will confirm whether these doses have been shipped or received. The same schedule for distribution  is expected to be in effect as for other monoclonal treatments.

"We are following the same distribution [schedule] that we did with Sotrovimab—nursing homes, hospitals, clinics and then EMS,” Jeremy Redfern, Press Secretary for the Florida Department of Health, said in an email to The Epoch Times.

Redfern said the number of doses that DOH is receiving doesn’t warrant opening the 51 sites that Gov. Ron DeSantis had set up over the summer, when the Delta variant was sweeping the state.

“We could definitely use more doses,” Redfern said. “We'd love to reopen our state sites to make it easier to access treatment.”

“It can take about a week to receive the shipment of treatments,” he said, when asked by The Epoch Times in an email when Florida can expect to receive the monoclonals.

As Florida sees a decline in COVID-19 cases and hospital census numbers, a new variant of omicron has emerged: BA-2.

The Florida Department of Health is aware that the omicron sub-variant BA-2 has been detected in the state, Redfern said, but would not comment further.

According to the CDC, on Feb. 19, Florida reported 5,441 new COVID-19 cases during a seven-day average, bringing that number below 6,000 for the first time since Dec. 17. The number of omicron cases has fallen by more than 91 percent, it said.

The HHS website says, of the 600,000 doses, 300,000 would be received in February, and the other 300,000 in March, and then dispersed throughout the country to individual states.

HHS was contacted about the criteria they used to determine how many doses of the treatment each state would receive, but they had not responded as of press time.

HHS Secretary Xavier Becerra credits his boss, President Joe Biden, for the success in getting the monoclonals to U.S. citizens after the EUA was pulled from other monoclonal drugs that had proven to be successful, helping thousands of Floridians to recover from COVID-19, and avoid hospitalization or death.

“We have more COVID-19 treatments than ever before. We are providing a billion free at-home tests, and we have enough vaccines to get everyone vaccinated and boosted,” Becerra said in a written statement. “This purchase will add an additional 600,000 courses of treatment to our nation’s ‘medicine cabinet’ that could help prevent severe outcomes for Americans who do get sick with COVID-19.”

Becerra went on to say that the top priority of HHS is prevention, and urged everyone to continue to get vaccinated and boosted.

One of the reasons this monoclonal treatment was given EUA status is because it has been successful in patients with the omicron variant of COVID-19.

“We want to make sure if an American gets sick with COVID-19, they can get a treatment that works,” he continued.

Becerra said that approximately 2.5 million treatments and therapies have been given to states at no charge this past year, They include antiviral pills, monoclonal antibodies, and pre-exposure prophylaxis therapies for people with compromised immune systems.

The contract between the maker of the new monoclonal drug Eli Lily and the federal government has a future option for 500,000 additional doses.

Dr. Patricia Cavazzoni, director for the FDA’s Center for Drug Evaluation and Research said in a written statement that new variants of the virus “continue to emerge.”

“This action (EUA) makes available another monoclonal antibody that shows activity against omicron at a time when we are seeking to further increase supply,” Cavazzoni said. “This authorization is an important step in meeting the need for more tools to treat patients.”

 Florida Gov. Ron DeSantis speaks at a news conference at the Broward Health Medical Center in Fort Lauderdale, Fla., on Sept. 16, 2021. (Wilfredo Lee/AP Photo)
Florida Gov. Ron DeSantis speaks at a news conference at the Broward Health Medical Center in Fort Lauderdale, Fla., on Sept. 16, 2021. (Wilfredo Lee/AP Photo)

Last month, the FDA pulled the EUA for Regeneron monoclonals that had helped “tens of thousands” with COVID-19, and which Republican Gov. Ron DeSantis credited for keeping people out of hospitals and avoiding almost certain death.

DeSantis has said at numerous press conferences that the Biden administration was playing politics with people’s lives by pulling the EUA from treatments that have been “proven to work.” He said there have been no peer-reviewed studies indicating that the Regeneron monoclonals did not work on the omicron variant.

“I think there’s politics at play,” DeSantis said at a Jan. 25 press briefing. “But it’s really a reckless decision to be able to take this option away from patients.”

Dr. Kenneth Sheppke, Deputy Secretary for the Florida Department of Health, said the monoclonals have “been at the forefront of COVID-19 treatment” and were “scientifically proven against the virus.”

“The value of monoclonals cannot be understated in the ability to treat people with this disease,” Sheppke said at a Jan. 26 roundtable discussion on monoclonals in Miami. “Floridians and the rest of the nation have come to expect the availability of these treatments, and it is really important for us as physicians to have those tools at our disposal to make the decisions on what treatment is best for patients.”

Since the pandemic began, there have been almost 5.8 million known cases of COVID-19 and approximately 69,000 residents have died statewide, according to the CDC website. So far, an average of 39,566 vaccine doses have been given out and nearly 66 percent of Floridians have been fully vaccinated and 38 percent have been boosted, it said.