Frequently Asked Questions

The increased incidence of the Delta variant of SARS-CoV-2 caused a substantial surge in the utilization of monoclonal antibody (mAb) drugs, particularly in areas of the country with low vaccination rates. HHS is committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the country. As such, we updated the distribution process for mAbs to assure fairness and efficiency.

The current process is a state/territory-coordinated distribution system similar to that used to distribute monoclonal antibodies (mAbs) from November 2020 through February 2021. HHS firmly believes a state/territory-coordinated distribution system will help maintain equitable distribution, both geographically and temporally, across the country—providing states and territories with a consistent, fairly distributed supply over the coming weeks.

Under this system, HHS determines the weekly amount of U.S. government (USG)-procured COVID-19 therapeutics available to each state and territory. Subsequently, state and territorial health departments then determine which sites in their jurisdictions receive product and how much.

HHS looked at the past 7-day incident hospitalizations and case counts for each state/territory and the case counts for the entire country. A state or territory’s percentage of the country’s 7-day incident hospitalizations and weighted 7-day incident case counts equals that state’s percentage of the available amount of COVID-19 therapeutics for distribution this week.

If jurisdictions have met certain requirements, they may request a portion of weekly COVID-19 therapeutics not allocated by other state/territorial health officials. Health department officials must make such requests through the appropriate ASPR Regional Emergency Coordinator (REC). A list of the ASPR RECs with contact information can be found here.

Yes, HHS is considering all available options for procuring additional product.

HPOP is the Health Partner Ordering Portal—a therapeutics ordering portal which will eventually replace the AmerisourceBergen C-19 portal for therapeutics. All jurisdictional partners must use this system to order Evusheld™, Paxlovid™, and molnupiravir as well as satisfy the daily reporting requirements for these products. Health departments are encouraged to work through their ASPR RECs should they have questions.

During this pandemic, it is imperative that COVID-19 therapeutics are accessible in a fair and equitable manner within communities across the country. It is for this reason that HHS oversees the distribution of COVID-19 therapeutics with equity and efficiency at the heart of allocation determinations.

HHS will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of USG-procured COVID-19 therapeutics to determine when a shift back to a direct ordering process might occur.

Yes. HHS determines separate distribution amounts for the Department of Health and Human Services, Department of Veterans Affairs, Department of Defense, Department of Homeland Security, Department of State, Bureau of Prisons, and select HHS HRSA-funded health centers.

Yes! If your distribution of therapeutic products was lost or destroyed in transit, please contact HHS at COVID19Therapeutics@HHS.gov for assistance.

No. HHS paused allocation of sotrovimab on April 5, 2022 due to the products’ lack of effectiveness against the Omicron BA.2 variant.

No. HHS paused allocation of bam/ete and REGEN-COV on January 24, 2022 due to the products’ lack of effectiveness against the Omicron variant. FDA updated products’ EUAs to restrict use. NIH guidelines also recommend against use.

The COVID-19 environment is dynamic. As such, product return is NOT recommended as these drugs may be effective against future variants. Any returned product must be destroyed. If you have storage concerns, consider transferring product to another location/site in your region or health system. If product must be returned from your site, please follow the below guidance:

• For bam/ete, see The Lilly Return Goods Procedure; detailed guidance can be found at: https://www.lillytrade.com
• For REGEN-COV, call 844-734-6643

(Reconstituted (diluted) product SHOULD NOT be returned and should be treated as waste per your facility's SOP)

Sites are required to report utilization of product and stock on hand each week to HHS through their state/territorial health department or directly to the HHSProtect TeleTracking data collection system.

If you do not know how to reach your health department POC, email HHS at COVID19Therapeutics@HHS.gov.