DeSantis calls for more monoclonal antibodies; feds say Florida is getting its fair share

With COVID-19 cases soaring in Florida and the United States, Gov. Ron DeSantis on Monday said that the omicron variant of the coronavirus driving the surge in new infections generally causes mild illness, that most COVID-positive patients in hospitals now were admitted for other medical reasons, and that the federal government is holding back on one of the few approved medical treatments for the disease.

Speaking at Broward Health Medical Center in Fort Lauderdale, and surrounded by the leaders of Florida’s health agencies, DeSantis urged calm in the face of rising infections, questioned the value of vaccination against COVID-19 and called on the federal government to send an additional 30,000 to 40,000 doses of monoclonal antibodies to Florida.

DeSantis said the state would open new monoclonal antibody treatment sites “immediately” — including in the hardest hit counties of Miami-Dade, Broward and Palm Beach — if the Department of Health and Human Services or HHS were to ship more doses of the drugs to Florida, where a standing order from the state surgeon general allows anyone with COVID-19 or exposed to the virus and at risk for severe illness to receive the therapy without a doctor’s prescription or referral.

The governor said the state would consider lifting the standing order, given the very limited supply of monoclonal antibodies, but he put the blame for Florida’s shortage of the drugs squarely on the Biden administration.

“We feel there is no need for it just to be sitting on the shelves,” DeSantis said. “We asked them to stop preventing the distribution of these treatments.”

Feds: Florida getting its share of antibody treatments

But HHS officials pushed back on the governor’s accusations on Monday, issuing a prepared statement that Florida has received its fair share of the COVID-19 treatments.

“The federal government has and will continue to supply Florida with therapeutics that can help improve patient outcomes, reduce stress on healthcare facilities, and save lives,” an HHS spokesperson said. “We never stopped allocating or shipping COVID-19 therapeutics to Florida.”

The HHS official noted that in the past three weeks, the federal government has allocated about 30,000 doses of monoclonal antibodies to Florida, including nearly 12,000 courses of treatment scheduled to ship this week.

“That’s in addition to the approximately 33,500 courses of product that Florida had on hand (as of 12/31/21) from their previous orders,” the HHS official said, adding that “we encourage Florida to use these products as authorized by the FDA and in accordance with recent clinical guidelines issued by NIH [National Institutes of Health].”

The NIH’s COVID-19 Treatment Guidelines Panel updated its recommendations on Dec. 23 suggesting that doctors prioritize the use of monoclonal antibodies for patients at the highest risk of severe disease and hospitalization, ranking them by age, vaccination status, immunocompromised condition and other health risks.

“Florida should have a strong supply of product on hand — and more than most other states,” the HHS spokesperson said. “We will continue to work with Florida to supply them with federal resources to support the on-the-ground response, and we encourage leaders to continue their efforts to increase vaccinations, which can prevent infection in the first place, are much less costly than the therapeutics, and are the best tool available to protect Americans.”

Limited supply of antibodies

DeSantis stressed that federal health agencies took control of monoclonal antibody supplies in September, citing a need for “equitable distribution” and no longer allowing states to order the drugs directly from manufacturers.

But as new COVID-19 cases began to rise in December and the omicron variant became the dominant version of the virus circulating in South Florida, demand for monoclonal antibody treatments at state-run sites surged and forced some to close temporarily after they ran out of supplies.

The federal government then paused distribution of all monoclonal antibodies for about a week on Dec. 23, citing data that two of the three monoclonal antibodies recommended for use against COVID-19 do not neutralize the omicron variant. Only one monoclonal antibody, called sotrovimab, “appears to retain” effectiveness against the omicron variant, HHS said at the time.

One week later, the federal agency reversed course and resumed shipments of all monoclonal antibodies on Dec. 31, citing the variability of variants in different regions of the United States.

DeSantis called the resumption of shipments “the right thing to do” on Monday and said Florida has the infrastructure to open as many as 10 new treatment sites across the state if supplies improve.

“It’s all locked and loaded,” he said. “It’s just a matter of the federal government giving us additional doses to give to the Floridians who need it.”

But while the federal government holds the exclusive rights to purchase monoclonal antibodies, including sotrovimab, the supply of the drugs remains very limited.

HHS sent the first shipment of sotrovimab to Florida on Dec. 17, allocating 1,050 doses at a time when cases were surging. On Dec. 27, the federal agency said it shipped an additional 2,580 doses of sotrovimab to Florida. HHS said an additional 300,000 doses of sotrovimab will be available for distribution this month, and this week the agency is scheduled to ship an additional 2,808 doses of sotrovimab to Florida.

HHS hospital capacity data shows that Florida medical centers had about 14,000 doses of monoclonal antibodies on hand statewide as of Monday morning. But those are the drugs manufactured by Regeneron and Eli Lilly, and reportedly less effective against the omicron variant. The federal data does not yet track hospital supplies of sotrovimab, which is manufactured by GlaxoSmithKline, and Florida’s health department has refused to say how much sotrovimab the state has on hand.

According to federal data, the monoclonal antibody manufactured by Regeneron and taken by President Trump in October 2020 was the most frequently administered at Florida hospitals during the week prior to Jan. 3, with 2,662 therapeutic courses used.

A second monoclonal antibody manufactured by Eli Lilly — which is considered ineffective against omicron — was administered less frequently, with 140 doses used in the week prior to Jan. 3.

At Monday’s press conference, DeSantis questioned whether Regeneron’s and Eli Lilly’s monoclonal antibody therapies are really ineffective against the omicron variant, as reported in recent research from the Washington University School of Medicine in St. Louis and Vanderbilt University in Tennessee and published ahead of peer review.

DeSantis said the federal government’s pause in distribution of those drugs was “based off some preliminary studies saying that it may not be as effective against omicron. But of course omicron is not the only variant that’s out there, and it’s something that we actually have seen applied with omicron patients and we have seen symptoms resolve. So it’s not clear that this is not something that is going to not be a benefit.”

However, the governor also conceded that Florida does not have the technology to conduct rapid genetic sequencing of coronavirus variants in each COVID-positive patient in order to determine the most beneficial monoclonal antibody treatment.

Some initially hospitalized for non-COVID reasons

As the number of patients with COVID-19 at Florida hospitals rises, DeSantis pointed out that many of those patients were admitted for a medical reason other than the disease. At Miami-Dade’s Jackson Health System, administrators reported 439 inpatients with COVID-19 on Monday — including 220 or 50% of whom were admitted for a different medical reason.

Though encouraging, public health experts emphasize that if more people get sick with COVID-19 — even a mild case — then the number of people hospitalized is likely to grow, too.

But, so far, the number of people with COVID-19 in a Florida hospital has not reached the peaks the state saw during the summer’s delta wave, when hospitals reported more than 15,000 inpatients with the disease in the state.

At least 5,700 inpatients with COVID-19 were reported in Florida hospitals on Monday, according to HHS hospital capacity data, with those COVID-positive patients occupying 10% of all inpatient beds, compared to 9.55% among Sunday’s reporting hospitals.

Standing at a lectern with a sign that read “Early treatment saves lives,” DeSantis surrounded himself at Monday’s press conference with the leaders of the state Department of Health, which is leading the public health response to COVID-19; the Division of Emergency Management, which oversees monoclonal antibody sites run by the state; and the Agency for Health Care Administration, which regulates hospitals, nursing homes and other long-term care facilities.

DeSantis appeared encouraged by the hospital reports. He said that the most severe cases in Florida are from the delta variant, and added that data from South Africa, Europe and the United States suggest that, “Omicron is far less pathogenic than the delta variant was.”

He acknowledged that the highly mutated and more contagious omicron variant spreads much faster than prior strains of the coronavirus, even among those who are vaccinated. But DeSantis appeared to minimize the value of vaccination, noting the many breakthrough infections reported in recent weeks.

“We have also seen with omicron that vaccinations are not preventing infection,” DeSantis said. “Miami-Dade, for example, is one of the most vaccinated places in the country if not the world and they’ve had huge, huge omicron infections. That’s just the reality in terms of this thing has spread very, very rapidly.”

Although the Florida Department of Health reported on Dec. 31 that 93% of Miami-Dade residents age 5 and older have received at least one dose of vaccine, a Miami Herald and el Nuevo Herald analysis of the agency’s ZIP code data for Miami-Dade in October — before people age 5 to 11 became eligible for vaccination — strongly suggested that the state-reported rate is exaggerated, with some areas reporting a mathematically impossible vaccination rate greater than 100% when compared against U.S. Census Bureau population data.

‘Time for living’

DeSantis said the state’s top health official, Florida Surgeon General Joseph Ladapo, is working on new guidance for testing that would prioritize symptomatic and high-risk individuals, such as the elderly and those in long-term care facilities, over those who are asymptomatic.

Ladapo said the health department’s goal is not to restrict testing but to change Floridians’ approach to COVID-19 testing by developing guidance that, “reduces the use of low-value testing and prioritizes high-value testing.”

“What do we mean by that?” he continued. “High-value testing is testing that’s likely to change outcomes. So, if your grandmother gets a test, that’s a much more valuable test than the 8-year-old third grader that Los Angeles County is sending in to get tested. The first one is much more likely to change outcomes.”

Ladapo then accused the federal government of creating a sort of mass hysteria over COVID-19 testing.

“We’re going to be working to unwind the sort of testing psychology that our federal leadership has managed to unfortunately get most of the country in over the last two years,” he said. “We need to unwind this testing, sort of planning and living one’s life around testing. Without it, we’re going to be sort of stuck in the same cycle.

“It’s really time for people to be living,” he continued, “to make the decisions they want regarding vaccination, to enjoy the fact that many people have natural immunity, and to unwind this sort of, this preoccupation with only COVID as determining the boundaries and constraints and possibilities of life, and we’re going to start that in Florida.”

White House: ‘Testing is a critical tool’

The White House dismissed Ladapo’s call for new testing guidelines .

“Testing is a critical tool in our efforts to stop the spread of COVID-19,” a White House spokesperson said. “We know tests are invaluable in determining whether someone is infected and infectious, in turn, helping to keep ourselves, our friends, and our families safe.”

The White House said the president had “significantly quadrupled” the nation’s testing capacity, purchased 500 million over-the-counter at-home rapid tests to give away to Americans, ordered the Federal Emergency Management Agency to set up pop-up testing sites, and invoked the Defense Production Act to produce more tests.

“As the president has said before, if leaders are not going to help the American people in their fight against the virus, they should get out of the way,” a White House spokesperson said. “Testing continues to be a key pillar in detecting the virus and stopping its spread; leaders should be uniting around it, not undermining it.”

At DeSantis’ urging, Ladapo also questioned the validity of recent research that strongly suggests Regeneron’s monoclonal antibody is not effective against omicron. Ladapo used the opportunity to question the medical credentials of the nation’s federal health agency, calling it “a terrible clinical decision.”

“It actually highlights the fact that the leadership of HHS doesn’t have a clinical background,” he said. Ladapo added that laboratory evidence showing a reduced effectiveness against omicron was “not the same thing” as concluding that the Regeneron monoclonal antibody does not work for patients infected with the new variant.

“There’s a difference between laboratory data and clinical data,” Ladapo said. “They made the decision to withhold medication based on laboratory data, but we care about clinical outcomes.”

Ladapo also praised the effectiveness of other treatments for COVID-19 and suggested that their effectiveness is being kept quiet. He mentioned inhaled budesonide, a steroid found to improve the condition of infected patients in an April study published in the medical journal, The Lancet, and fluvoxamine, a drug often used to treat obsessive-compulsive disorder and social anxiety disorder.

“You don’t hear about it because Pfizer doesn’t own it. Merck doesn’t own it,” Ladapo said. “There’s no one to share that amazing news with people.”

However, the NIH’s COVID-19 treatment panel has reviewed both drugs. It found that for fluvoxamine, “There is insufficient evidence” for the agency’s experts “to recommend either for or against the use of fluvoxamine for the treatment of COVID-19” while a review of four studies of inhaled steroids such as budesonide found the drug may reduce the need for hospitalization but that its effectiveness remained “uncertain.”

Herald/Times Tallahassee Bureau Reporter Kirby Wilson contributed to this report.