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U.S. Department of Health and Human Services

COVID-19 Monoclonal Antibody Therapeutics Frequently Asked Questions

State/territory-coordinated Distribution System 


  1. Why is HHS transitioning to a new distribution process for COVID-19 monoclonal antibody therapeutics?

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.

 

  1. How will COVID-19 monoclonal antibody therapeutics be distributed under the updated system?

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

Under this system, HHS determines the weekly amount of mAb product available to each state and territory. Subsequently, state and territorial health departments then determine which sites in their jurisdictions receive product and how much.

  1. What formula or equation was used to determine distribution amounts

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 mAbs for distribution this week.

  1. Can states and territories receive additional product above their calculated amount?

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

  1. Will HHS buy more COVID-19 monoclonal antibody therapeutics products?

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

  1. Will HHS transition back to the regular direct ordering process? If so, when?

HHS will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of monoclonal antibody therapeutics to determine when we will shift back to the normal direct ordering process.

  1. What data is required for reporting into HHSProtect and how often is it reported?

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.

  1. Where can I find additional information about COVID-19 monoclonal antibody therapeutics?

Please visit phe.gov/mAbs and CombatCOVID.hhs.gov to learn more about mAbs and to find useful resources for healthcare providers and patients.


  • This page last reviewed: January 12, 2022