COVID-19 Monoclonal Antibody Treatment Authorizations Modified

The U.S. HHS issued a Public Health Emergency notice on May 26, 2021, regarding COVID-19 monoclonal antibody treatments currently authorized for emergency use in certain patients with COVID-19.

Results from in vitro assays used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants.

And the US Centers for Disease Control and Prevention has identified that the combined frequency of the P.1 variant now exceeds 10% in certain states.

Therefore, the distribution of bamlanivimab and etesevimab to Illinois, Massachusetts, Arizona, California, Florida, Indiana, Oregon, and Washington has been paused.

REGEN-COV is an alternative monoclonal antibody therapy currently authorized for the same use as bamlanivimab and etesevimab administered together and, based on similarities in vitro assay data currently available, REGEN-COV is likely to retain activity against the P.1 and B.1.351 variants.

All treatment delivery sites can continue ordering REGEN-COV from the authorized distributor by following the existing ordering and reporting procedures. Please see the updates for additional information.