Public Health Emergency - Leading a Nation Prepared
September 13, 2021
The COVID-19 pandemic is rapidly evolving, and new updates are issued frequently. To view a full list of HHS/ASPR’s updates related to COVID-19 monoclonal antibody therapeutics, please see our
full list of updates.
The increased incidence of the Delta variant of SARS-CoV-2 has 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 have updated the distribution process for mAbs.
On Monday, September 13, HHS transitioned from a direct ordering process to a state/territory-coordinated distribution system similar to that used for the distribution of mAbs from November 2020 – February 2021.
State and territorial health departments know best where product is needed in their areas. Transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.
HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization. State and territorial health departments will subsequently identify which sites in their respective jurisdictions receive product as well as the amount each site receives.
As of Monday, September 13, 2021:
HHS will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of monoclonal antibody therapeutics to determine when a shift back to the normal direct ordering process may be possible.
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