Gov. DeSantis wants to reopen Regeneron monoclonal antibody treatment centers, despite the CDC saying Regeneron is not effective against omicron infections. Screenshot/governor’s Facebook page, Sept. 16.
Thousands of doses of Regeneron brand monoclonal antibody therapy are headed to Florida for treating early cases of COVID-19, even though national health authorities don’t recommend it for fighting infections with the strain dominant in Florida: omicron.
The monoclonal antibody therapy, or mAb, that does work well against early infections with omicron COVID is sotrovimab, made by GlaxoSmithKline, but it is in short supply, according to the U.S. Centers for Disease Control and Prevention.
Still, Gov. Ron DeSantis announced Friday that his administration has procured 15,000 doses of Regeneron, which worked well against delta-variant infections — saying, in essence, that if it has any effectiveness against omicron, it’s better than nothing. He said he plans to deploy those in state-sponsored treatment centers around the state, starting in central and south Florida.
“We did get 15,000 additional doses. I had asked for 30[,000], so that’s still not what we want, because we want to do more sites for people to be able to get treated. But that’s just the reality that we’re dealing with here,” DeSantis said during a news conference in Lake Butler.
On Dec. 16, Regeneron reported this to investors and media about its monoclonal antibody therapy: “While Regeneron’s currently authorized REGEN-COV antibodies have diminished potency against Omicron, they are active against Delta.”
Meanwhile, the governor was mum this week on vaccines, which the CDC and public-health experts recommend as the most safe, effective way to prevent COVID infections or — in breakthrough cases being attributed to highly transmissible omicron — to diminish the severity of symptoms. Instead, DeSantis and his surgeon general nominee, Dr. Joseph Ladapo, have only promoted treatments, including two antiviral pills — produced by Pfizer and Merck — newly approved by the U.S. Food and Drug Administration under emergency use authorizations, as well as two “off-label” therapies which have not been looked at by the FDA for use against COVID.
The off-label therapies cited by Ladapo are inhaled budesonide, approved by the FDA as an asthma treatment, and fluvoxamine, an anti-depressant approved by the FDA to treat obsessive-compulsive disorder. They have not been evaluated for safety and effectiveness as COVID treatments, not for potential side effects and risks to special populations such as children and pregnant women.
DeSantis has been critical of the CDC authorities, who halted shipments of Regeneron and Lilly monoclonal antibody therapies and issued a health advisory on Dec. 31 saying those brands “do not neutralize” the omicron strain of the virus, which has mutated significantly since the delta strain emerged. Regeneron and Lilly therapies were configured for delta infections and worked well to reduce symptoms, according to the CDC.
Casting that finding differently, DeSantis accused the Biden administration of having a “stranglehold” on supplies of monoclonal antibody therapies and showing favoritism among states.
Still, at press conferences this week, he acknowledged that the effectiveness of the Regeneron doses he ordered is in question in regard to the now dominant strain of COVID.
“We think what we’re seeing is probably that the Lilly and the Regeneron may be not quite as effective as it was for delta, but if it’s 50 percent effective and you’re somebody that’s high risk, that’s something that you would want to see, a reduction,” DeSantis said on Wednesday. “If we’re getting it, even if it’s a 30-, 40-, 50 percent reduction, that matters.
“There’s going to need to be a lot of different trials, but we don’t have the data to definitively say it doesn’t work. Just as we don’t have enough data to definitively say it works just as well.”
The CDC announced it had enough data to issue this health advisory:
“The Omicron variant, with its numerous mutations in the spike protein, is not neutralized by [Lilly’s] bamlanivimab and etesevimabexternal icon or [Regeneron’s] casirivimab and imdevimabexternal icon, the most frequently prescribed monoclonal antibody-based COVID-19 treatments,” the CDC advisory says.
The number of people hospitalized with COVID — whether or not COVID was their primary health problem — in Florida Friday rose to 8,548, according to the Florida Hospital Association. That is an increase of 365.6 percent since 14 days ago. Hospital associations in Florida said the majority of hospitalized COVID patients were unvaccinated.
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