DeSantis Misleads on Omicron-Resistant COVID-19 Antibody Treatments

After the Food and Drug Administration pulled its authorization of two COVID-19 antibody drugs because the treatments are highly unlikely to work against the omicron variant, Gov. Ron DeSantis of Florida misleadingly claimed the decision had been made “without a shred of clinical data” to support it. There may not be data from patients, but lab studies strongly suggest the treatments will not help omicron-infected people.

On Jan. 24, the FDA announced it was no longer authorizing two COVID-19 monoclonal antibody drugs in the U.S., given evidence that they are “highly unlikely” to work against the now-predominant omicron variant. The Centers for Disease Control and Prevention estimates omicron accounts for 99.9% of coronavirus infections in the country, as of Jan. 22.

“This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant,” the FDA said in a press release explaining its decision.

In statements, the manufacturers of both antibody drugs in question — Eli Lilly and the biotech company Regeneron — said they agreed with the FDA and found the decision appropriate.

The agency said that it would allow the use of the drugs again if another variant comes along that is “susceptible to these treatments,” and pointed health care providers to treatments that are expected to be effective against omicron. Those include two newly authorized antiviral pills, the antiviral remdesivir, and a different monoclonal antibody, Vir Biotechnology and GlaxoSmithKline’s sotrovimab — although some of these are in short supply.