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U.S. Department of Health and Human Services

Important Updates: Monoclonal Antibody Therapeutics

October 8, 2021: Effective, October 8, 2021, ASPR will pause distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab at a facility for use under EUA 094) to Hawaii because the Centers for Disease Control and Prevention (CDC) has identified that the Delta plus variant (B.1.617.2 sublineage AY.1) (originally identified in India) is circulating with a frequency exceeding 5% in Hawaii. Learn More »

September 13, 2021: Effective, September 13, 2021, the U.S. Department of Health and Human Services transitioned from a direct ordering process for COVID-19 monoclonal antibody therapeutics (mAbs) to a state/territory-coordinated distribution system. The new system will help ensure consistent availability of COVID-19 mAbs and provide health departments with the flexibility to get these critical drugs where they are needed most. Learn More »

September 13, 2021: HHS Provides Pathway to Expand Access to COVID-19 Therapeutics: HHS Issues New PREP Act Declaration. Learn More»

September 3, 2021 -  HHS is immediately implementing changes to help promote optimal and equitable use of the available supply of monoclonal antibodies while efforts to procure additional product.  Learn More »

September 2, 2021 -  FDA and ASPR announce resumption in use and distribution of bamlanivimab/etesevimab in all U.S states, territories, and jurisdictions under the conditions of authorization for EUA 94.  Learn More »

August 27, 2021 -  FDA and ASPR announce resumption in use and distribution of bamlanivimab/etesevimab in certain states. Learn More »

August 20, 2021 - FDA and ASPR announce the shelf-life extension of bamlanivimab under Emergency Use Authorization for bamlanivimab and etesevimab administered together, extending the shelf life from 12 months to 18 months. Learn More »

June 25, 2021 - Distribution of bamlanivimab/etesevimab paused on a national basis until further notice.
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June 15, 2021 - Distribution of bamlanivimab/etesevimab paused to Rhode Island in addition to Arizona, California, Florida, Indiana, Oregon, Washington, Illinois and Massachusetts. Learn More »

May 26, 2021 - Distribution of bamlanivimab/etesevimab paused to Arizona, California, Florida, Indiana, Oregon, and Washington in addition to Illinois and Massachusetts. Learn More »

May 21, 2021 - Distribution of bamlanivimab/etesevimab is paused to Massachusetts in addition to Illinois. Learn More »

May 7, 2021 - Distribution of bamlanivimab/etesevimab is paused to Illinois. Learn More »


  • This page last reviewed: October 08, 2021