Currently available anti-SARS-CoV-2 therapeutics that have received Emergency Use Authorization (EUA) or approval from the Food and Drug Administration (FDA) include:
Remdesivir has been added as one of the recommended treatments for acute COVID-19 in high-risk outpatients in the NIH treatment guidelines and granted approval for adult and pediatric outpatients. Additionally, it has received an EUA authorizing (PDF) use in the non-hospitalized pediatric patients under the age of 12 years as well.
Anti-SARS-CoV-2 Monoclonal Antibodies
As of January 26, 2023, there are no monoclonal antibody treatments currently authorized for the treatment of COVID-19.
Distribution for Products Under EUAs
The U.S. Department of Health and Human Services (HHS) currently manages a state/territory-coordinated distribution system for most COVID-19 therapeutic products under EUA. This means that facilities cannot directly order these products (with the exception of the federally approved Test to Treat pharmacies as referenced below).
Remdesivir, which is approved for outpatient treatment of adults and children 12 years and older and EUA authorized for use in pediatric patients under the age of 12, is not part of the federal state/territory-coordinated distribution system. Gilead will work with distributors directly to make Remdesivir available in qualified outpatient facilities.
HHS publishes distribution amounts of each COVID-19 therapeutic, including specific allocations made to California. With the loss of federal funding for COVID-19 in March 2022, distribution amounts will be reduced in an effort to preserve the supply of therapeutic products.
The California Department of Public Health (CDPH) is allocating COVID-19 therapeutics active against Omicron included in the HHS state/territory-coordinated distribution system using the below strategies:
Oral protease inhibitor
Oral nucleoside analogue
|Treatment of mild to moderately ill outpatients with current diagnosis of COVID-19
|Allocated to federal pharmacy partners and counties. Federal partners may request courses up to a capped amount by the state. Remaining courses are allocated to counties.
Allocated to federal pharmacy partners and counties.
After capped amount reached by the state, remaining courses re allocated to counties based on new COVID-19 cases (7-day average) and Healthy Places Index (HPI); with 50% weighted to cases and 50% weighted to HPI. Within the 50% allocated by HPI, 40% to Q1 (most disadvantaged); 30% to Q2; 20% to Q3; 10% to Q4 (most advantaged).
Additionally, the new Test to Treat initiative that was launched on March 7, 2022 ensures that individuals can receive rapid testing, assessment, and treatment all in one location. The HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) distributes the oral antiviral products (Paxlovid and molnupiravir) directly to Test to Treat pharmacy-based clinics, health centers, and long-term care facilities. This program does not impact current state and territory allocations that are going to other sites. For more information, please refer to ASPR's Test to Treat fact sheet (PDF). Please refer the ASPR Test to Treat map for a list of all federally supported Test to Treat sites. For a list of Test to Treat locations in California, please refer to the CDPH Test to Treat webpage.
Ordering COVID-19 Therapeutics
Facilities that are able to operationalize COVID-19 therapeutics and would like to be considered for product allocations should contact their Medical and Health Operational Area Coordinator (MHOAC).
Remdesivir is not being allocated by the federal government and can be purchased (PDF) directly from the distributor.
Identifying Locations with COVID-19 Therapeutics
Sites receiving therapeutic products and estimated availability can be found at the HHS Therapeutics Locator. The Therapeutics Locator is based on shipments and reported utilization and is not a guarantee of availability. These therapies require a prescription by a licensed and authorized provider. Patients should coordinate with their healthcare provider prior to contacting a location to receive these therapies.
For a list of Test to Treat locations, please refer the HHS Test to Treat site locator.
Originally published on January 19, 2022.