SARS-CoV-2 Variants and COVID-19 Therapeutics
The U.S. Department of Health and Human Services (HHS) is constantly monitoring COVID-19 variants of concern and actively assessing data on a continuous basis to ensure the safety and efficacy of available COVID-19 therapeutics and other medical countermeasures. The HHS adjusts the authorization for and distribution of COVID-19 therapeutics in response to current scientific evidence.
Throughout the pandemic, the federal government has granted Emergency Use Authorization (EUA) for therapeutics to help combat COVID-19. Some treatments have been paused or discontinued in favor of options that more effectively treat people infected with current strains of SARS-CoV-2, the virus that causes COVID-19. Previously authorized therapeutic products may prove to be effective in treating future SARS-CoV-2 variants. Therefore, the HHS recommends that sites retain any stockpiles of paused or discontinued products.
Important Information About Paused and Discontinued Products
Due to a lack of effectiveness against the current coronavirus variants, the U.S. Food and Drug Administration (FDA) does not currently authorize some therapeutic treatments for use in the United States. Please see the important updates about each therapeutic product and when their authorization was revoked for use in U.S. states and territories.
Paused and Revoked EUAs — Important Updates
These updates represent the most recent authorization announcements.
View All Updates
The FDA has determined that the known and potential benefits of bamlanivimab, when administered alone, no longer outweigh the known and potential risks for its authorized use. Therefore, the FDA has revoked the EUA use of bamlanivimab when administered alone. This decision was based on the FDA’s analysis of scientific data, specifically, the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone, resulting in the increased risk for treatment failure.
Important Information About Storage and Shelf-Life Extensions
The U.S. government recommends that paused products be retained in the event that they prove effective on future SARS-CoV-2 variants. These products may continue to be retained, regardless of the current labeled expiry date or previously provided extension dates, unless the FDA issues a contrary notification. Any returned product must be destroyed upon receipt of return by the manufacturer.
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 this guidance:
Available COVID-19 Therapeutic Products
Currently authorized treatments are available for use. The preferred treatments include Paxlovid (an oral antiviral treatment) and Veklury® (a commercially available IV antiviral treatment). An alternative authorized treatment includes Lagevrio (molnupiravir), an alternative oral antiviral for patients for which Paxlovid is not appropriate or accessible. Based on similar in vitro assay data currently available, these products are likely to retain activity against new variants. All treatment delivery sites can continue ordering Paxlovid and Lagevrio from the authorized distributer by following the existing ordering and reporting procedures, such as through the HPOP ordering system.
ASPR and the FDA will continue to work with the Centers for Disease Control and Prevention and the National Institutes of Health on surveillance of variants that may impact the use of the therapies authorized for emergency use. We will provide further updates and consider additional action as new information becomes available.
