TALLAHASSEE, Fla. - The state of Florida has closed its monoclonal antibody sites after the FDA abruptly revoked the drug's emergency-use authorization. On Tuesday alone, state officials said they canceled at least 2,000 appointments for those scheduled to get the treatment.
COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday.
Experts said these treatments aren't proving effective against the omicron variant. These treatments have been at the center of Florida's fight against COVID-19. Top officials like Governor Ron DeSantis and the Florida Surgeon General Joseph Lapado disapproved of the move and believed access to the treatments should not be restricted for those who need it.
"Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence. To date, such clinical evidence has not been provided by the United States Food and Drug Administration (FDA)," FL-DoH said in a statement.
However, the FDA says the Regeneron treatment is 1,000 times less effective against omicron than past strains and they want to save those antibody treatments for situations where they'll be more effective. The agency's decision also impacts Eli Lilly.
If the drugs prove effective against future variants, the FDA said it could reauthorize their use.
The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron due to its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts.
Omicron’s resistance to the two leading monoclonal antibody medicines has upended the treatment playbook for COVID-19 in recent weeks. Doctors have alternate therapies to battle early COVID-19 cases, including two new antiviral pills from Pfizer and Merck, but both are in short supply. An antibody drug from GlaxoSmithKline that remains effective also is in short supply.
The drugs are laboratory-made versions of virus-blocking antibodies. They are intended to head off severe disease and death by supplying concentrated doses of one or two antibodies early in an infection. Then-President Donald Trump received Regeneron’s antibody combination after he tested positive for the coronavirus in 2020.
The FDA noted in its decision that omicron accounts for more than 99% of U.S. infections, making it "highly unlikely" the antibodies would help people now seeking treatment. The agency said restricting their use would also eliminate unnecessary drug side effects, including allergic reactions.
The U.S. government temporarily stopped distributing the two drugs in late December, as omicron was racing across the country to become the dominant variant. But officials resumed distribution after complaints from Republican governors, including Florida’s Ron DeSantis, who claimed that the drugs continued to help some omicron patients.
DeSantis has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response, setting up infusion sites and lauding them at news conferences, while opposing vaccine mandates and other public health measures. Texas Gov. Greg Abbott has also launched state-sponsored infusion sites.
The drugs are not a substitute for vaccination and are generally reserved for people who are the most vulnerable, including seniors, transplant recipients and those with conditions like heart disease and diabetes.
Since early January, the U.S. government has shipped enough doses of the two antibodies to treat more than 300,000 patients.
Both Regeneron and Lilly previously announced they were developing new antibodies that target omicron.
If you have tested positive for COVID-19, please contact your health care provider for more information and resources on treatment options. Resources for emerging treatments can be found at www.HealthierYouFL.org. Pharmacies that have received allocations of anti-viral treatments can be found at www.FloridaHealthCOVID-19.gov.