AstraZeneca's COVID-19 antibody cocktail Evusheld is not currently authorized for use in the United States until further notice, the U.S. Food and Drug Administration said on Thursday.
The therapy is unlikely to provide protection against currently dominant COVID-19 variants, the regulator added.
The FDA had limited Evusheld's use earlier this month, as it did not expect the therapy to provide protection against the omicron subvariant XBB.1.5, which has been causing concern due to its rapid spread in the country in December.
Evusheld was first authorized in late 2021 by the FDA to prevent COVID-19 infections in individuals with weak immune systems or a history of severe side effects from coronavirus vaccines.
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