April 14, 2023: HHS Announces Intent to Amend the Declaration Under the PREP Act for Medical Countermeasures Against COVID-19.
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April 14, 2023: Letter to U.S. Governors from HHS Secretary Xavier Becerra on renewing COVID-19 Public Health Emergency (PHE).
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April 7, 2023: The U.S. Food and Drug Administration authorized an extension to the shelf life for certain lots of COVID-19 therapeutic products. Use this searchable table to find product original dates and, if applicable, extension expiration dates.
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March 2, 2023: A new FAQ confirms that the end of the Public Health Emergency Declaration does not automatically terminate the Public Readiness and Emergency Preparedness Act (PREP Act) amendments related to COVID-19. The FAQ includes relevant details and dates related to medical countermeasures.
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March 1, 2023: The end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023, does not affect the transition of vaccines and treatments to commercial markets.
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February 15, 2023: The U.S. Food and Drug Administration authorized an additional extension to the shelf life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 24 months to 30 months.
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January 26, 2023: The U.S. Food and Drug Administration revised the Emergency Use Authorization for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision,
Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
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January 18, 2023: ASPR and the FDA announce the authorization of a shelf life extension to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use).
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December 5, 2022: ASPR and the FDA announce the authorization of an additional extension to the shelf-life from 18 months to 30 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals.
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November 30, 2022: The U.S. Food and Drug Administration today announced bebtelovimab is not currently authorized for emergency use in the U.S. because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
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November 4, 2022: FDA updates the fact sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2.
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October 28, 2022: ASPR and FDA announce the authorization of an extension to the shelf life for specific lots of the refrigerated Eli Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. Learn More >>
October 21, 2022: ASPR and FDA announce the authorization of an extension to the shelf life for all lots of the Merck antiviral therapy, Lagevrio (molnupiravir) capsules from 24 to months to 30 months. Learn More >>
September 23, 2022: The U.S. Department of Health and Human Services (HHS) announced a new effort to help uninsured and underinsured Americans access the COVID-19 monoclonal antibody treatment bebtelovimab even after the product became available on the commercial market. Learn More >>
September 6, 2022: FDA Authorizes shelf life extension for certain lots of Paxlovid. Learn More >>
August 30, 2022: Over the course of the pandemic, the federal government has played the central coordinating role in buying, distributing, and ensuring equitable access to COVID-19 vaccines, therapeutics, and tests. Learn More >>
August 11, 2022: Bebtelovimab is transitioning to the commercial marketplace. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. Lilly will make the product commercially available for purchase through a sole distributor, AmerisourceBergen, beginning the week of August 15th, prior to the end of distribution of the government’s supply. Learn More >>
August 3, 2022: FDA and ASPR authorized an additional extension to the shelf life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 18 months to 24 months. Learn More >>
July 27, 2022: There is a new helpline and ordering pathway for Evusheld. Individual providers and smaller sites of care that do not currently receive Evusheld through the HHS Health Partner Order Portal (or HPOP) distribution process can now order small, limited quantities of product (1-3 patient courses). Learn More >>
July 6, 2022: The U.S. Food and Drug Administration revised the Emergency Use Authorization (EUA) for Paxlovid (nirmatrelvir and ritonavir), to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid. Learn More >>
June 29, 2022: In light of nonclinical data and data from pharmacokinetic modeling related,
FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval. Learn More >>
June 29, 2022: The U.S. Department of Health and Human Services, in coordination with the U.S. Department of Defense, ordered an additional 150,000 doses of bebtelovimab for use in treating patients who have been diagnosed with COVID-19 and are at high risk of hospitalization from the infection. Learn More >>
June 28, 2022: ASPR and the FDA are announcing the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody therapy, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. Learn More >>
June 27, 2022: The FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV. Learn More >>
May 20, 2022: ASPR and the FDA 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 antibody, bebtelovimab, which is currently authorized for emergency use. Learn More >>
May 17, 2022: ASPR has provided more than 11 million doses of therapeutics since the fall of 2020, and currently distributes two monoclonal antibody products (Evusheld and Bebtelovimab) and two oral antiviral products (Paxlovid and Lagevrio). Learn More >>
May 12, 2022: FDA has authorized the shelf-life extension of sotrovimab from 12 to 18 months and evaluation of future extension of shelf-life for sotrovimab is ongoing. All sotrovimab vials may continue to be retained regardless of the current labeled expiry date or previously provided extension dates, unless otherwise notified by the FDA. Learn More >>
May 4, 2022: FDA authorized an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated Eli Lilly monoclonal antibody, bamlanivimab. Due to the high frequency of the Omicron variant, bamlanivimab and etesevimab are not currently authorized in any U.S. region. Therefore, these drugs may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to bamlanivimab and etesevimab, emerge and become prevalent in the United States. Learn More >>
April 14, 2022: The U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for the COVID-19 oral antiviral therapeutic Paxlovid to authorize an additional dose pack presentation with appropriate dosing for patients with moderate renal impairment within the scope of the EUA. Learn More >>
April 13, 2022: Evaluation of future extension of shelf-life for bamlanivimab and etesevimab is ongoing and an update regarding shelf-life extension for bamlanivimab and/or etesevimab is planned for early May 2022. Therefore, in the interim, all bamlanivimab and etesevimab vials may be retained until the shelf-life extension evaluation is complete and posted, regardless of the current labeled expiry date or previously provided extension dates. Learn More >>
April 5, 2022: The Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases caused by the Omicron BA.2 variant to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Due to these data, the use of sotrovimab is not authorized in any U.S. state or territory at this time. Therefore, ASPR has paused sotrovimab distribution to all U.S. states and territories. Learn More >>
March 30, 2022: ASPR has paused distribution of sotrovimab to all states in HHS Region 5 (Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin), Region 9 (American Samoa, Arizona, California, Commonwealth of the Northern Mariana, Guam, Hawaii, Nevada, Republic of Palau, Republic of the Marshall Islands), and Region 10 (Alaska, Idaho, Oregon, Washington).
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March 30, 2022: ASPR is working to make sure critical COVID-19 therapeutics are available to eligible patients across the country. The recently launched Test to Treat program supports this priority effort by creating an additional pathway for fast access to lifesaving COVID-19 treatments.
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March 25, 2022: ASPR paused distribution of sotrovimab to all states in Region 1 (Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, and Vermont) and Region 2 (New Jersey, New York, Puerto Rico, and the Virgin Islands). Other states, except those noted above, are not impacted by this announcement. All health care providers should monitor information from the CDC and state and local health authorities regarding the frequency of the BA.2 variant in their region.
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March 7, 2022: The Biden-Harris Administration is focused on providing tools and strategies that will help enable America to move forward safely beyond the current pandemic while sustaining and building upon the progress we’ve made over the past 13 months. The National COVID-19 Preparedness Plan was released by the White House last week, and it lays out the roadmap for helping the country fight COVID-19 now and in the future as we begin to get back to our more normal routines.
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February 24, 2022: Today, the FDA announced a modification to the Emergency Use Authorization for AstraZeneca’s COVID-19 therapeutic Evusheld. The modification involves a change to the dosing regimen. Evusheld now should be administered as an initial dose of 600 mg. Recommendations for repeat dosing cannot be made at this time.
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February 11, 2022: FDA issued an EUA for a new monoclonal antibody (mAb) for the treatment of COVID-19 that retains activity against the Omicron variant. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, or about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
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February 11, 2022: AstraZeneca Pharmaceuticals LP, Wilmington, Delaware, was awarded an $855,000,000 modification (P00005) to contract W911QY-20-C-0119 for the manufacture, distribution, and storage of AZD7442, known as Evusheld, to treat COVID-19 in the general population. Work will be performed in various locations, with an estimated completion date of March 31, 2023. HHS BARDA Coronavirus Aid, Relief and Economics Security Act funds in the amount of $405,300,000; and HHS BARDA American Rescue Plan Act funds in the amount of $449,700,000, were obligated at the time of the award. U.S. Army Contracting Command, Aberdeen Proving Ground, Maryland, is the contracting activity.
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February 10, 2022: As part of the Biden-Harris Administration’s commitment to ensuring Americans who get sick with COVID-19 have access to treatments that work, HHS Secretary Xavier Becerra announced that the federal government has purchased 600,000 treatment courses of a new mAb treatment that data shows works against the Omicron variant.
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January 24, 2022: FDA updated the EUA fact sheets for two COVID-19 mAb treatments: Lilly’s bamlanivimab plus etesevimab and Regeneron’s REGEN-COV. FDA now says these two treatments are not currently authorized for use anywhere in the United States due to the prevalence of Omicron. FDA is encouraging health care providers to choose authorized treatment options with activity against circulating variants in their state, territory, or U.S. jurisdiction.
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December 31, 2021: In light of NIH clinical guidelines published on December 30, 2021, and the significant variability in prevalence of the Omicron variant, all states and territories can continue to order both Lilly (bamlanivimab plus etesevimab) and Regeneron (casirivimab plus imdevimab) mAb products from HHS based on allocated amounts for clinically appropriate use.
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December 29, 2021: Based on recent data and assessment, HHS paused 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.
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December 23, 2021: FDA granted EUA to Merck for its oral antiviral drug Lagevrio (molnupiravir) to treat COVID-19. Lagevrio is now authorized for the treatment of mild to moderate COVID-19 in adults ages 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 paused any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab resumed, and delivery of 55,000 doses of product began. An additional 300,000 doses of sotrovimab were available for distribution in January.
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December 22, 2021: FDA issued an EUA for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild to moderate 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 announced the authorization of a shelf-life extension from 12 months to 18 months for specific lots of the refrigerated Eli Lilly mAbs, bamlanivimab and etesevimab, which are currently authorized for emergency use only when administered together.
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December 17, 2021: The federal government prepared approximately 55,000 doses of sotrovimab for immediate allocation to jurisdictions. Jurisdictions saw products arrive as early as Tuesday, December 21, 2021.
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December 8, 2021: FDA issued an 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, or about 88 pounds).
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December 3, 2021: FDA revised the 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 etesevimab 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 announced the authorization of a shelf-life extension from 12 months to 18 months for the refrigerated Eli Lilly mAb, 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 21, 2021: The combined frequency of variants resistant to bamlanivimab and etesevimab administered together was less than 5% in all U.S. states, territories, and jurisdictions, including Hawaii. Bamlanivimab and etesevimab, administered together, could be used in all U.S. states, territories, and jurisdictions consistent with the terms and conditions of authorization for EUA 94. As such, ASPR resumed the 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 and continued distribution to all other U.S. states, territories, and jurisdictions.
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October 8, 2021: ASPR paused 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 CDC identified that the Delta variant (B.1.617.2 sublineage AY.1) (originally identified in India) was circulating with a frequency exceeding 5% in Hawaii.
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September 13, 2021: HHS transitioned from a direct ordering process for COVID-19 mAbs to a state/territory-coordinated distribution system. The new system helped ensure consistent availability of COVID-19 mAbs and provided health departments with the flexibility to get these critical drugs where they were needed most.
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September 13, 2021: HHS Provides Pathway to Expand Access to COVID-19 Therapeutics: HHS Issues New PREP Act Declaration.
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September 3, 2021: HHS immediately implemented changes to help promote optimal and equitable use of the available supply of mAbs while efforts continued to procure additional product.
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September 2, 2021: FDA and ASPR announced resumption in use and distribution of bamlanivimab/etesevimab in all U.S states, territories, and jurisdictions under the conditions of
authorization for EUA 94.
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August 27, 2021: FDA and ASPR announced resumption in use and distribution of bamlanivimab/etesevimab in certain states.
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August 20, 2021: FDA and ASPR announced the shelf-life extension of bamlanivimab under EUA for bamlanivimab and etesevimab administered together, extending the shelf life from 12 months to 18 months.
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June 25, 2021: Distribution of bamlanivimab/etesevimab paused on a national basis.
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June 16, 2021: Distribution of bamlanivimab/etesevimab paused to Rhode Island in addition to Arizona, California, Florida, Indiana, Oregon, Washington, Illinois, and Massachusetts.
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May 26, 2021: Distribution of bamlanivimab/etesevimab paused to Arizona, California, Florida, Indiana, Oregon, Washington, Illinois, and Massachusetts.
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May 21, 2021: Distribution of bamlanivimab/etesevimab paused to Massachusetts in addition to Illinois.
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May 7, 2021: Distribution of bamlanivimab/etesevimab paused to Illinois.
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April 16, 2021: The FDA revoked the emergency use authorization for bamlanivimab, when administered alone.
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Key Abbreviations
BARDA: Biomedical Advanced Research and Development Authority
CDC: Centers for Disease Control and Prevention
EUA: Emergency Use Authorization
FDA: U.S. Food and Drug Administration
HHS: U.S. Department of Health and Human Services
mAb: monoclonal antibody
NIH: National Institutes of Health
