ASPR and FDA Issue Statement on Viral Variants’ Resistance to Monoclonal Antibodies

12/29/21 — The HHS Assistant Secretary for Preparedness and Response (ASPR) and the FDA released a joint statement on the circulating SARS-CoV-2 viral variants, including Omicron, and how the variants may be associated with resistance to monoclonal antibodies. Data show that it is unlikely that bamlanivimab and etesevimab administered together or REGEN-COV will retain activity against this variant. Based on similar cell culture data currently available, sotrovimab appears to retain activity against the Omicron variant. FDA updated the Health Care Provider Fact Sheets for bamlanivimab and etesevimab administered together, REGEN-COV, and sotrovimab with specific information regarding expected activity against the Omicron variant. Based on this information, ASPR will pause any further allocations of bamlanivimab and etesevimab together, etesevimab alone, and REGEN-COV pending updated data from the CDC. Shipments of sotrovimab have resumed.