Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. This is the case with Evusheld and prompted the changes to the authorization that FDA is making today. And like other viruses, SARS-CoV-2 can mutate over time, resulting in certain products not working against certain variants. Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. causing infection are susceptible to the product. Today’s action to limit the use of Evusheld prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. This means that Evusheld is not expected to provide protection against developing COVID-19 if exposed to those variants. According to the most recent CDC Nowcast data, these variants are projected to be responsible for more than 90% of current infections in the U.S. until further notice by the Agency.ĭata show Evusheld is unlikely to be active against certain SARS-CoV-2 variants. Based on this revision, Evusheld is not currently authorized for use in the U.S. Food and Drug Administration today revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. FDA announces Evusheld is not currently authorized for emergency use in the U.S.
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