Evusheld is no longer authorized for use to help prevent COVID-19 in the United States “until further notice,” due to a lack of protection against dominant variants, according to new guidance issued by the FDA.
In its updated guidance, the FDA limited the use of Evusheld (tixagevimab plus cilgavimab, AstraZeneca) to when the combined national frequency of variants that are not susceptible to the treatment is 90% or less. Read more in Healio.
The CDC has recently streamlined its guidance for COVID-19 vaccines and Evusheld, a preventive COVID-19 treatment, known as pre-exposure prophylaxis (PrEP), for people who are moderately or severely immunocompromised, including people who are kidney transplant recipients. Read the full article from National Kidney Foundation here.
Evusheld demonstrates reduced protection against the omicron subvariant BA.4.6, resulting in an increased risk for infection in those exposed to that COVID-19 strain, according to an updated FDA fact sheet.
In the revised fact sheet, the FDA warned that providers should be aware of an increased risk for developing COVID-19 when exposed to certain COVID-19 variants that are not neutralized by tixagevimab packaged with cilgavimab (Evusheld, AstraZeneca).
Read the full story in Healio.