Experts Say Widely Used Antibody Treatments Useless For Omicron

TALLAHASSEE, FL — As positive cases of coronavirus continue to skyrocket in Florida, Gov. Ron DeSantis is calling on the Biden administration to release its "stranglehold" on what he describes as "lifesaving monoclonal antibody treatments."

The day before Christmas, the Biden administration announced it was pausing distribution of Regeneron and Eli Lilly monoclonal antibody treatments to states after federal health experts concluded they're unlikely to be effective against the latest coronavirus variant sweeping the nation, the omicron variant.

Regeneron and Eli Lilly’s monoclonal antibody treatment were hailed by medical professionals as a critical tool in preventing hospitalizations and deaths during the surge of the delta variant over the summer. However, clinical trials indicate the treatments are ineffective against the omicron variant, which is now the dominant strain in the U.S.

According to the Centers for Disease Control and Prevention’s latest estimates, omicron cases make up 58.6 percent of cases across the U.S. and 78 percent of the cases in the Southeast, including Florida.

In a news release issued Friday by the U.S. Food and Drug Administration, the agency concurred that the omicron variant may be resistant to these widely used monoclonal antibody treatments hailed by DeSantis as Florida's saving grace.

The U.S. Department of Health and Human Services, however, said the currently used antibody treatments shouldn't be entirely ruled out.

"In some areas where the omicron variant is less prevalent, current supplies of the two existing monoclonal antibody treatments may still be appropriate," the DHHS said.

However, a new monoclonal antibody treatment called sotrovimab recently developed by GlaxoSmithKline and Vir Biotechnology Inc. looks much more promising, the FDA said.

Although supplies are still limited, the FDA said 55,000 doses of sotrovimab are now being shipped to all states. An additional 300,000 doses of sotrovimab will be available for distribution in January, the FDA said.

DeSantis Stands By Validity Of Antibody Treatments

Following a Dec. 28 letter from Florida Surgeon General Dr. Joseph Ladapo, Xavier Becerra, secretary of the U.S. Department of Health and Human Services, reversed the Department of Health and Human Service's decision to limit supplies of the widely used Regeneron and Eli Lilly monoclonal antibody treatments to states.

But with Florida's coronavirus positivity rate at 26.5 percent — with 51,644 new cases on Monday alone — DeSantis said the state needs at least 30,000 more doses of the Regeneron and Eli Lilly treatments per week than is being allocated. He wants to expand capacity at existing monoclonal antibody treatment sites and open new sites to treat 250 to 300 more patients a day at each site.

"Prior to the federal government takeover of the monoclonal market, Florida successfully distributed approximately 30,000 doses per week when we managed our own supply,” DeSantis said Monday.

“The state has more than $800 million available to quickly deploy monoclonal antibody treatments throughout the state, and the only thing holding us back is the insufficient supply of treatment from the federal government," he said.

DeSantis already tried an end run around Biden after the president had his administration take control of the distribution of the treatments so they'd be available to all states.

DeSantis responded by negotiating a private agreement with GlaxoSmithKline pharmaceuticals to directly purchase thousands of doses of monoclonal antibody treatments for Florida.

Biden quickly quashed attempts by states to privately purchase treatments, as DeSantis accused Biden of attempting to thwart Florida's lifesaving efforts by taking control of the supply of the antibody treatments and dramatically cutting Florida's allotment.

DeSantis pooh-poohed critics who said the state shouldn't be wasting funds on treatments that health experts say aren't effective against the omicron variant.

Instead, during October's special legislative session, he urged the Florida Legislature to approve additional funding to expand the monoclonal antibody treatment program.

The Republican-dominated Legislature complied by approving an additional $888 million in appropriations including funds that can be used to bypass the federal government and purchase monoclonal antibody treatments directly from the pharmaceutical companies "once the state is permitted to directly purchase monoclonal antibody treatments from the distributor," DeSantis added.

DeSantis' dogged perseverance earned accolades from Ladapo and Florida Division of Emergency Management Director Kevin Guthrie.

"Direct access to early treatment is essential to saving lives," Ladapo said at a news conference Monday. "It is not an option nor should it be barricaded by bureaucracy."

“The division knows how important increasing access to this treatment is and we stand ready to mobilize sites as quickly as possible," Guthrie said.

Testing Tensions

In the meantime, Florida counties are scurrying to reopen coronavirus testing sites that were shut down after the summer surge attributed to the delta variant.

The omicron variant has proven much more contagious — especially to children — than the delta variant, prompting fearful residents to mob testing sites and pharmacies selling self-testing kits before they gathered with loved ones for the holidays.

With fewer testing facilities remaining open and attracting long lines of cars, self-testing kits have flown off pharmacy shelves.

Biden addressed the shortage of tests and testing facilities at a news conference Tuesday.

"I know this remains frustrating — believe me, it’s frustrating to me — but we’re making improvements," Biden said. "In the last two weeks, we’ve set up federal testing sites all over the country, and we’re adding more each and every day."

He said residents should soon see online sites and pharmacy shelves stocked with self-testing kits and shorter waiting lines at testing sites.

"Next week, our requirement that your insurance company reimburse you for at-home tests takes effect," he said. "So, if you’re insured, you can buy the test and get paid for it."

Additionally, he said the federal government is launching a website this month that will allow residents to order and have tests shipped to their homes for free.

DeSantis and Ladapo also addressed residents' frustrations about the dearth of testing facilities and self-testing kits this week.

Ladapo blamed the shortage on asymptomatic, paranoid residents who are snapping up testing appointments and self-testing kits when they have no evidence that they've been infected.

“If you don’t have symptoms, you are not a case," Ladapo said.

He also criticized health professionals who are advising people to test frequently so they know whether they have the virus before symptoms appear and can self-quarantine early to protect co-workers, family members and other members of the community.

Ladapo said testing without outward symptoms is a waste of precious resources.

“We are trying to focus on high-value testing” of people who are at high risk, he said.

Outraged, Harvard School of Public Health assistant professor and epidemiologist Michael Mina was quick to respond to Ladapo's comments on Twitter.

State Rep. Carlos G. Smith was equally incensed by Ladapo's comments.

“There is NOT a shortage of COVID-19 testing supply in Florida. There IS a shortage of leadership. Less testing + less prevention is NOT the answer," he said.

See related story: 142K COVID Cases Reported In FL Over New Year's Eve Weekend: CDC

This article originally appeared on the Tampa Patch