Monoclonal Antibody Therapy Paused

Angie Szumlinski Announcements, News

“As of June 25, 2021, the CDC has identified that the combined frequencies of the SARS-CoV-2 P.1/Gamma variant (first identified in Brazil) and the B.1.351/Beta variant (first identified in South Africa) throughout the United States now exceed 11% and are trending upward. Results from in vitro assays that are used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that bamlanivimab and etesevimab administered together are not active against these variants.

Effective immediately, the United States Department of Health and Human Services has paused distribution of bamlanivimab and etesevimab together and etesevimab alone (to pair with existing supply of bamlanivimab) at a facility until further notice. As a result, the FDA recommends that health care providers throughout the United States use REGEN-COV. All treatment delivery sites can continue ordering REGEN-COV through AmerisourceBergen by following the existing ordering and reporting procedures.

Healthcare providers who have an urgent need to administer monoclonal antibody therapy and do not have immediate access to REGEN-COV, should contact neighboring healthcare facilities or their regional healthcare coalitions, so as to not delay access to mAb therapy.

The FDA will continue to work with the CDC and the National Institutes of Health on surveillance of variants that may impact the use of the monoclonal antibody therapies authorized for emergency use and will continue to provide further updates as new information becomes available.