Some of the human monoclonal antibodies (used clinically to prevent patients from becoming severely ill from COVID-19 disease) may not be protective against the Omicron variant of SARS-CoV-2 now spreading across the United States, researchers reported January 19, 2022 in the journal Nature Medicine.
Monoclonal antibodies are laboratory-made proteins that are administered to patients to fight off harmful pathogens such as viruses, like SARS-CoV-2.
Led by researchers at Washington University School of Medicine in St. Louis, Missouri, the laboratory study tested five antibody combinations against the SARS-CoV-2 B.1.1.529 Omicron virus. The authors report numerous antibodies, including those in clinical use by Regeneron and Eli Lilly, completely lost the ability to neutralize the omicron variant in cell culture. The authors concluded the loss of neutralizing ability of the monoclonal antibodies is due to the more than 30 mutations in the omicron “spike” protein, the antibody target, on the surface of the virus.
The NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of Lilly’s bamlanivimab and etesevimab along with Regeneron’s REGEN-COV (casirivimab and imdevimab) because of markedly reduced activity against the omicron variant.
The FDA today announced the revisions of two emergency use authorizations (EUAs) for currently used monoclonal antibody treatments — bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab). With this EUA revision, then Lilly and Regeneron combo drugs are no longer authorized for use in any U.S. states, territories or jurisdictions, since Omicron is currently the dominant variant across the United States. As of Jan. 15, 2022, the omicron variant of SARS-CoV-2 is estimated to account for more than 99% of cases in the United States, based on Centers for Disease Control and Prevention data.
“Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir – that are expected to work against the omicron variant, and that are authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death”, reaffirmed the FDA statement.
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Updated: February 24, 2022