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Important Update

UPDATE -- Allocation of Bamlanivimab/Etesevimab and REGEN-COV Therapeutics Paused

January 24, 2022

Therapeutics Update

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 prevalence of COVID-19 variants remains dynamic, and the U.S. Department of Health and Human Services (HHS) actively assesses data on a continuous basis to adjust COVID-19 therapeutics allocation guidelines as required.

When we learned of Omicron, we immediately reviewed our existing monoclonals and available data on whether they would work against the new variant, and learned that two of them – Bamlanivimab plus etesevimab and casirivimab plus imdevimab (REGEN-COV) – are not effective against Omicron. Subsequently, both Lilly and Regeneron have said their products are not likely to be effective against Omicron, and several independent studies have shown this as well.

CDC data released last week confirms that Omicron is the overwhelmingly dominant variant of concern (VOC) in the United States at a prevalence of greater than 97.8% in all regions and nationally greater than 99%. Private sector data points to Omicron’s dominance as well. For example, Walgreens estimates that every state is above 95% Omicron. HHS has also communicated with many state health officials over the past week, who have shared this is the reality they are seeing on the ground as well.

In light of these facts, the FDA today updated the Emergency Use Authorization (EUA) fact sheets for two COVID-19 monoclonal antibody treatments: Lilly’s Bamlanivimab plus etesevimab and Regeneron’s casirivimab plus imdevimab (REGEN-COV). FDA now says these two treatments are not currently authorized for use anywhere in the U.S., due to the prevalence of Omicron. FDA is encouraging healthcare providers to choose authorized treatment options with activity against circulating variants in their state, territory, or U.S. jurisdiction. This follows action last week by the National Institutes of Health (NIH) to update its clinical guidelines to recommend against the use of Bamlanivimab plus etesevimab and casirivimab plus imdevimab (REGEN-COV) at this time.

As a result of the extremely high prevalence of Omicron and recent guidance from FDA and NIH, we will not include Bamlanivimab plus etesevimab and casirivimab plus imdevimab (REGEN-COV) in today’s allocations for COVID-19 therapeutics.

Jurisdictions, providers and patients should be aware that we have more treatments that do work against Omicron available than ever before, including oral and IV antivirals in addition to the GSK/Vir monoclonal antibody (Sotrovimab). Sotrovimab, Evusheld, Paxlovid and Molnupiravir are included in today’s allocations.

We are committed to making sure that, if Americans get sick with COVID-19, they are offered treatments that work. It is critically important we are giving effective therapies to patients, and HHS will continue to provide effective treatments to states at no cost.