FORT LAUDERDALE, Fla. – A day after the head of Florida’s Department of Emergency Management revealed that the state had let 1 million COVID tests expire that it had stockpiled in a warehouse, Gov. Ron DeSantis said that the Biden Administration has a “stranglehold” on a supply of monoclonal antibodies and is “getting in the way of lifesaving treatments for Floridians.”
DeSantis announced Friday that 15,000 doses of Regeneron had been secured. “Before the Biden Administration seized control of the monoclonal supply after Florida pioneered its widespread use and demonstrated its efficacy, approximately 30,000 doses per week were being administered to Floridians, saving countless lives.”
However, experts Local10.com spoke with said that Regeneron has been deemed ineffective against the omicron variant, which is why shipments of Regeneron were halted on Dec. 29 when the U.S. Department of Health and Human Services said it assessed data on the COVID-19 therapeutics.
HHS indicated that Regeneron and another monoclonal antibody did not have meaningful efficacy against the omicron variant of COVID-19. Therefore, they paused federal allocation of the product until additional recommendations were released from the FDA. The shipments were recently restarted with the aim at sending the drugs to places where the delta variant is more prevalent since that is where Regeneron is the most effective.
“The purpose of this pause is to ensure effective product is available in most sites. In regions that have less than 80% prevalence of the omicron variant, states and territories will continue to receive allocations of the two products to use as clinically appropriate,” according to a statement by the HHS.
Jackson Health stated that there is “early evidence that (Regeneron) may be less effective against the omicron variant” and the government’s COVID-19 response team said the most effective monoclonal antibody treatment against the variant is GlaxoSmithKline and Vir Biotechnology’s sotrovimab.
Aarti Raja, Ph.D., a microbiologist, and associate professor in the Department of Biological Sciences at Nova Southeastern University’s Halmos College of Arts and Sciences said: “What we know is what the results have shown thus far — that the Regeneron drug seems to still have some efficacy against the delta variant, but its efficacy against omicron has dropped.”
Raja also stressed that antibody drug Regeneron, like others in the same classification, are meant for a subset of patients who have severe conditions — the immunocompromised.
“That’s how these antibody treatments work. In an immune healthy person, when they get a vaccine, the immune system is working to make those antibodies for the individual, but someone who is immunocompromised, they are not going to be able to generate these antibodies efficiently on their own. That was the premise for the design of these drugs. So let’s keep these for folks who may already be in the hospital battling COVID-19,” Raja said.
With the omicron variant now the dominant strain, COVID-19 cases in the state of Florida over the past seven days averaged more than 56,000 new infections, most likely fueled by the variant.
Administering the Regeneron monoclonal antibodies creates a double-edge sword since some testing sites do not have the diagnostic testing to decipher if someone who tests positive for COVID-19 has either the omicron or delta strain.
Aileen M. Marty, MD, FCAP, an infectious disease expert at Florida International University puts it plainly. “Bottom line,” she writes in an email to Local10.com, “Regeneron does not work for omicron,” citing laboratory evidence that omicron is “totally or partially resistant to all currently available treatments based on these monoclonal antibodies.”
Marty says giving Regeneron to those with omicron is an exercise in futility.
“Should I give you a medication for hypertension if you have gallbladder disease and no hypertension? No. So you should not provide Regeneron to someone with omicron. It does not work,” Marty said.
Regeneron has proven effective in those with the delta variant. “So if we know that there is an area where delta is still prevalent, then it kind of makes sense to send the Regeneron to that location,” Raja said. “But if omicron is the primary strain that is around — and again how would we know? We’d still have to do enough testing to know which is the strain that is the predominant one that is in a certain location. In that scenario, we’d have to rethink which drugs are made available. For that we would have to have enough stockpiled to send the drug where it is most needed.”
The HHS has said that states that have greater than 80 percent prevalence of omicron may continue to receive product upon request, however, with the understanding that these treatments would be ineffective if the patients are infected with the omicron VOC.
“This concern can be mitigated if virus-specific diagnostic testing1 in a given patient indicates infection with the omicron VOC is unlikely.”
According to the Florida Department of Health’s website, South Florida’s Monoclonal Antibody treatment locations are at Tropical Park, 7900 SW 40th St., CB Smith Park, 900 N. Flamingo Road, and at iCareMobile Medicine at 2525 Embassy Drive, Hollywood.
According to the site, treatment is free, but you must be at high risk for severe illness due to COVID-19 to be eligible. You must be 12 years of age or older.
For more information, call the Florida Department of Health Monoclonal Antibody Treatment Support Line at (850) 344-9637.