Hawaii Loses One Monoclonal Antibody Therapy to the Delta Variant

The Assistant Secretary for Preparedness and Response (ASPR) and the US Food and Drug Administration (FDA) announced a Public Health Emergency (PHE) on October 8, 2021. As a result, shipments of the bamlanivimab / etesevimab monoclonal antibody therapeutic to Hawaii have been paused.

This change was determined by the Centers for Disease Control and Prevention (CDC), who identified that the Delta plus coronavirus variant is circulating with a frequency exceeding 5% in Hawaii.

And results from in vitro assays suggest that bamlanivimab and etesevimab administered together are not active against this SARS-CoV-2 virus variant. 

Today’s PHE does not impact other states and territories.

The main target of SARS-CoV-2 virus-neutralizing monoclonal antibodies is the surface spike glycoprotein that mediates viral entry into host cells.

REGEN-COV and sotrovimab are alternative monoclonal antibody therapies that are currently authorized to treat mild to moderate COVID-19 in adults and certain pediatric patients at high risk for progression to severe disease.

Based on similar in vitro assay data currently available, REGEN-COV and sotrovimab retain activity against the Delta plus variant.

Additionally, REGEN-COV is an alternative monoclonal antibody therapy that is authorized for post-exposure prophylaxis of COVID-19 in adults and specific pediatric individuals who are at high risk for progression to severe COVID-19.

The FDA recommends that health care providers in Hawaii use these alternative authorized monoclonal antibody therapies, consistent with their authorized uses, until further notice.

The ASPR and FDA confirmed they would continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use.

In addition, health care providers should also review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under a EUA for details regarding specific variants and resistance. 

The Letters of Authorization may be accessed at this webpage.