Update on US Food and Drug Administration Emergency Use Authorisation of Evusheld
The US Food and Drug Administration (FDA) has stated that AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab) is not currently authorised for Emergency Use for pre-exposure prophylaxis (prevention) of COVID-19 in the US until further notice, due to the sustained high frequency of circulating SARS-CoV-2 variants that Evusheld does not retain in vitro neutralisation against. The FDA has notified AstraZeneca that the Agency will make a determination about reinstating authorisation of Evusheld if the national prevalence of resistant variants decreases to 90% or less on a