Gov. Ron DeSantis at the podium. To the far left, Florida Surgeon General Joseph Ladapo, at a news conference Jan. 6, 2022. Credit: Florida Channel screenshot.
In public remarks this week, Gov. Ron DeSantis and his surgeon general Joseph Ladapo have ignored COVID vaccinations, instead aggressively embracing post-infection treatments, including some not authorized by national health authorities.
In press conferences, DeSantis and Ladapo promoted the use of monoclonal antibody therapies, newly approved antiviral pills, and experimental drugs in clinical trials for potential treatment of COVID infections.
That said, the governor and Ladapo did not promote vaccines. Key vaccine rates are just slightly above average in Florida, and booster rates are lower than in most states, according to the federal Centers for Disease Control and Prevention (CDC).
Meanwhile, hospitalization are on the rise, mostly among unvaccinated people, and the highly transmissible omicron variant continues to spread. The Florida Hospital Association reported 8,062 hospitalizations Thursday, a 101.5 percent increase since last Thursday, including 200 children.
CDC data show that Florida’s rate for the fully vaccinated is at 63.6, ranking 22 of the 50 states and the District of Columbia, and just above the national average of 62.4.
When it comes to the elderly — the object of DeSantis’ “Seniors First” initiative — Florida is at 89 percent for fully vaccinated people 65 and older. That ranks 23rd of all states and ties with D.C. Twenty other states have senior vaccination rates at 90 and above.
Florida fares worse in the category of the percent of fully vaccinated people with booster doses. Florida’s figure is 32.7 percent, making it 36th of all states and D.C. — and tied with South Carolina.
Nevertheless, DeSantis and Ladapo focused their public comments this week on approaches other than vaccinations. The strategy appears aimed at the percentage of Floridians who have not been vaccinated and probably won’t be.
“We are expanding monoclonal antibody availability, and we’re also expanding availability of oral medications, including the Pfizer and Merck products, as well as providing some guidance on off-label medications such as fluvoxamine and inhaled budesonide, both of which have shown very good effectiveness in randomized clinical trials,” said Ladapo, who still has to be confirmed by the Florida Senate.
In regard to monoclonal antibody therapy (or mAb, a letter combination that appears in most brand names), the Regeneron and Lilly versions remain effective against the delta strain of COVID but not against omicron, which abruptly became dominant, according to a Dec. 31 CDC 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.
Another mAb, sotrovimab, is effective in treating omicron infections but it requires infusion (intravenous delivery) in a hospital or clinic and is not currently available. Sotrovimab is produced by GlaxoSmithKline, or GSK. DeSantis said Thursday that Florida bought a supply of sotrovimab but has exhausted it.
DeSantis said he has heard anecdotal evidence that the Lilly and Regeneron brands of mAb can still be helpful to some degree in treating patients infected with omicron — and having them on hand is better than having them “sit on a shelf.”
“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. “If we’re getting it, even if it’s a 30-, 40-, 50-percent reduction, that matters.”
DeSantis conceded he has no concrete evidence that mAb treatments his administration will soon offer at treatment centers will do much good against omicron infections, and still he declined to point to vaccines as the most highly recommended approach to avoiding illness.
“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,’ he said.
Meanwhile, Ladapo pointed to newly authorized COVID treatment pills, as well as unproven drugs in clinical trials.
The Pfizer and Merck pills — called Paxlovid and Molnupiravir — are antiviral pills approved under Emergency Use Authorizations (EUAs) in late December by the U.S. Food and Drug Administration for treatment of certain COVID infections. They are not yet widely available in Florida, Ladapo said.
In both EUAs, the FDA cautioned that treatment with the antiviral pills after an infection is “not a substitute for vaccination.”
“This authorization [for Paxlovid] provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, in the FDA’s announcement about the Pfizer product on Dec. 22.
The FDA announced emergency authorization for the use of the Merck pill a day later.
“Molnupiravir [by Merck] is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Cavazzoni said in announcing the Merck EAU.
Ladapo said Thursday that he has “encouraged” clinicians to consider treating COVID patients with “off-label” drugs such as inhaled budesonide, approved by the FDA as an asthma treatment, and fluvoxamine, an anti-depressant approved by the FDA to treat obsessive-compulsive disorder. He claimed both had “very good effectiveness” in clinical trials.
But neither are FDA-approved for COVID treatment and have not been evaluated for potential side effects nor tested for safety in special populations such as pregnant women. The National Institutes of Health report that early studies of fluvoxamine suggest adverse effects such as diarrhea, indigestion, insomnia, anxiety and, rarely, suicidal ideation.
Phoenix Editor Diane Rado contributed to this report.
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