COVID-19 Monoclonal Antibody Treatment Paused in the USA

The US Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announced they are immediately pausing the distribution of the monoclonal antibody therapy cocktail bamlanivimab and etesevimab on a national basis until further notice.

In addition, the FDA recommended late on June 24, 2021, that healthcare providers use an alternative authorized monoclonal antibody therapy, such as Regeneron's REGEN-COV and sotrovimab, and not use the combination of bamlanivimab and etesevimab at this time.

REGEN-COV and sotrovimab are currently authorized for the same use as bamlanivimab and etesevimab administered together.

The reason for this national alert is the Centers for Disease Control and Prevention (CDC) has identified that the SARS-CoV-2 P.1/Gamma variant (Brazil) and the B.1.351/Beta variant (South Africa) now exceed 11% and are trending upward throughout the USA.

Furthermore, in vitro assays used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that Eli Lilly's bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants.

And based on similar in vitro assay data currently available, REGEN-COV and sotrovimab are likely to retain activity against the P.1 or B.1.351 variants.

All treatment delivery sites in the USA can continue ordering REGEN-COV from the authorized distributor and may also find information on the availability and ordering of sotrovimab by visiting GlaxoSmithKline’s website at www.sotrovimab.com.

Additionally, healthcare providers should review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under a EUA for details regarding specific variants and resistance.

Monoclonal antibody therapies available under a EUA must be used per the terms and conditions for the respective authorization, including the authorized labeling. The Letters of Authorization may be accessed at this link.

The ASPR and FDA confirmed they would continue to work with the CDC to provide further updates as new information becomes available.

Please contact COVID19Therapeutics@hhs.gov with any questions.