Public Health Emergency - Leading a Nation Prepared
December 31, 2021: In light of the National Institutes of Health (NIH) clinical guidelines published on Dec. 30, 2021, and the significant variability in prevalence of the Omicron Variant of Concern, all states and territories can continue to order both Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) monoclonal antibody products from HHS based on allocated amounts for clinically appropriate use. Learn More >>
December 29, 2021: Based on recent data and assessment, HHS will pause allocations of bamlanivimab/etesevimab and REGEN-COV COVID-19 therapeutics to states or territories within regions of the country that have greater than 80% prevalence of the Omicron variant based on CDC NOWCAST data. These two products are not expected to be effective in patients infected with the Omicron variant, and other therapeutic options are available. The purpose of this pause is to ensure effective product is available in most sites. In regions that have less than 80% prevalence of the Omicron variant, states and territories will continue to receive allocations of the two products to use as clinically appropriate. Learn More >>
December 23, 2021: The Food and Drug Administration granted Emergency Use Authorization to Merck for its oral antiviral drug Molnupiravir to treat COVID-19. Molnupiravir is now authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate.
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December 23, 2021: ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab did resume this week, and delivery of 55,000 doses of product has begun. An additional 300,000 doses of sotrovimab will be available for distribution in January.
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December 22, 2021: The Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
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December 21, 2021: FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Eli Lilly monoclonal antibodies, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together.
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December 17, 2021: The federal government is actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to jurisdictions. Shipment of product will begin soon, and jurisdictions will see product arrive as early as Tuesday, December 21, 2021. Learn More >>
December 8, 2021: The FDA issued an emergency use authorization (EUA) for AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). Learn More >>
December 3, 2021: The FDA revised the emergency use authorization (EUA) of bamlanivimab and etesevimab (previously authorized for pediatric patients 12 years of age and older weighing at least 40 kilograms, or about 88 pounds), to additionally authorize bamlanivimab and etesivimab administered together for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes bamlanivimab and etesevimab, to be administered together, for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death.
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October 22, 2021: FDA and ASPR are announcing the authorization of an extension to the shelf-life from 12 months to 18 months for the refrigerated Eli Lilly monoclonal antibody, etesevimab, which is currently authorized for emergency use only when administered together with bamlanivimab. As a result of this extension, unopened vials of etesevimab, injection, 700 mg/20 mL, should be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F), and may be stored for an additional 6 months from the labeled date of expiry (See Table 1 below).
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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.Learn More »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 »
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