​Related Materials:  Direct Ordering of Monoclonal Antibodies | Monoclonal Antibody Treatment Information for Providers and Facilities (Q&A) | Bamlanivimab Fact Sheet | Casirivimab and Imdevimab Distribution Fact Sheet | More Healthcare & Testing Guidance | All Guidance

On May 26, 2021, given the sustained increase in the P.1 and B.1.351 variants, the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) stopped the distribution of bamlanivimab plus etesevimab to California. Results from in vitro assays that are 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.

The FDA recommends that health care providers in California instead use casirivimab plus imdevimab (i.e., REGEN-COV) therapy until further notice. Casirivimab plus imdevimab is an alternative monoclonal antibody therapy that is currently authorized for the same use as bamlanivimab plus etesevimab. Based on similar in vitro assay data currently available, casirivimab plus imdevimab is likely to retain activity against the P.1 and B.1.351 variants. All treatment sites can continue ordering casirivimab plus imdevimab from the authorized distributer using the direct ordering process.

Please see the HHS/ASPR notice regarding this update for more information.

Additional resources:

• Direct Ordering of Monoclonal Antibodies (ca.gov)

• Monoclonal Antibody Treatment Information for Providers and Facilities (ca.gov)

• Casirivimab and Imdevimab Distribution Fact Sheet (ca.gov)

• COVID-19 Treatment Guidelines (nih.gov)

• IDSA Guidelines on the Treatment and Management of Patients with COVID-19 (idsociety.org)

• COVID-19 Resources For Healthcare Providers | combatCOVID.hhs.gov
  

​Originally published on March 9, 2021