The Food and Drug Administration revised authorization of two types of monoclonal antibody treatments for COVID-19 due to growing evidence they do not fight infection of the omicron variant, which accounts for the vast majority of new infections in the United States.
“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
The treatments from Eli Lilly and Regeneron will not lose their emergency use authorization, as they might become useful in the future. However, the agency said they cannot be used in any state as of now because the omicron variant is uniformly dominant across the U.S.
“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,” Cavazzoni said.
CLICK HERE TO READ MORE FROM THE WASHINGTON EXAMINER
Scientists have known since last month that only sotrovimab, the monoclonal antibody made by GlaxoSmithKline and Vir Biotechnology, can effectively fight omicron. The other treatments available include Pfizer’s antiviral Paxlovid, Merck’s antiviral molnupiravir, and the IV drug remdesivir.
The revised guidance from the FDA will be a blow to governors who have sung the praises of monoclonal antibody treatments, such as Florida Gov. Ron DeSantis, who has battled the Biden administration over smaller allocations from the federal government in the past few months.
