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January 13, 2023
The Centers for Disease Control and Prevention (CDC) SARS-CoV-2 genomic surveillance provides estimates for the proportion of circulating variant infections and has identified a rise in the number of cases involving the Omicron subvariant XBB.1.5. Due to recent viral mutations, the previously authorized monoclonal antibody treatment, bebtelovimab, is no longer authorized for treatment in patients with COVID-19 in the US. Given the rise of XBB.1.5, the Food and Drug Administration (FDA) issued an update stating that the monoclonal antibody combination, tixagevimab plus cilgavimab (EvusheldTM) may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. Currently, Evusheld is the only agent FDA authorized for SARS-CoV-2 pre-exposure prophylaxis (PrEP) in people who are not expected to mount an adequate immune response to COVID-19 vaccination or those with contraindications for COVID-19 vaccines.
Early outpatient treatment of mild-to-moderate COVID-19 with recommended therapies has been shown to prevent hospitalizations and deaths. Ritonavir-boosted nirmatrelvir (Paxlovid™) might also reduce the risk for post-COVID-19 conditions. Currently all three of the effective antiviral therapeutics are widely available for eligible people, but are not being widely used, particularly in populations disproportionately affected by COVID-19.
For more details, see the full CDC Health Alert Network (HAN) sent out in December. FDA will continue to monitor the frequency of circulating variants and should provide future updates as appropriate.