Monoclonal antibody: Florida closes Covid treatment sites after FDA revokes authorization

A vial of Regeneron monoclonal antibody lies on a medical table as a nurse prepares to administer it to a patient at the Sarasota Memorial Urgent Care Center in Sarasota, Florida on September 23, 2021. (Shannon Stapleton/Reuters)

Florida has been forced to shut down sites administering monoclonal antibodies, which have been widely used as a complementary treatment for Covid-19, after the FDA revoked authorization for distribution.

“Tonight, without notice, the United States Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for bamlanivimab/etesevimab and REGEN-COV. The revised EUAs do not allow providers to administer these treatments in the United States,” said a Press release from the Florida Department of Health read.

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

The development comes after Florida Surgeon General Joseph Ladapo accused the Biden administration of intentionally restricting the flow of Covid-19 therapeutics. Governor Ron DeSantis had launched dozens of antibody treatment sites as part of the state’s strategy to defeat the disease.

The federal government is “actively preventing the effective distribution of monoclonal antibody treatments,” Ladapo wrote in a letter to Health and Human Services Secretary Xavier Becerra in December.

The Biden administration has reportedly suspended shipments of Covid-19 antibody treatments, which can shorten the severity and duration of illness in those who contract the virus, amid mounting evidence that they had been rendered ineffective by the Omicron variant.

Agreeing with Biden that the pandemic has no “federal solution,” Ladapo urged him to allow Florida to conduct its handling of the virus without federal interference in any way it deems appropriate for its people, which includes the provision of treatment alternatives to the vaccine.

“I respectfully ask that you allow states and medical professionals to provide treatment options that best benefit the communities they know and serve,” he said.

Monday’s press release noted, “Florida disagrees with the decision that blocks access to all available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the US Food and Drug Administration (FDA).

He cited a study on the NIH website confirming that there have been no definitive clinical conclusions that monoclonal antibody treatments are ineffective. “…Despite the observation of differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529,” according to the study.

Over the summer when DeSantis first promoted Regeneron’s monoclonal antibody treatments, critics, including the Biden administration, saw such a program as a threat to national vaccination efforts.

The Biden administration backtracked in September, admitting the positive impact of the Regeneron treatment, when it purchased “1.4 million additional doses” to “avoid shortages” of the drug as demand soared, the Washington Post discovered. He also ordered the Department of Health and Human Services to define “the distribution rules”.

Defending against the backlash that he wanted monoclonal antibodies to replace the vaccine, DeSantis made clear in September that he thought it wise to provide his state with an abundance of resources and treatment options to combat Covid-19. He had said he had no intention of “leaning into monoclonals at the expense of vaccines” or “playing defense without offending”.

“If you’re at risk,” the governor said, “the best thing you can do first, obviously, is get vaccinated. But even if you are, and if you’re not, if you become COVID positive, you have the opportunity to get early treatment using these monoclonal antibodies.

“It does not replace [vaccination],” he added. “That’s extra.”

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