Posted by Michael Wonder on 26 Jan 2023
Update on US FDA emergency use authorisation of Evusheld
26 January 2023 - The US FDA has stated that AstraZeneca’s Evusheld (tixagevimab and 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 sustained basis. The US Government recommends all Evusheld product be retained and properly stored in the event that variants susceptible to Evusheld, including those currently circulating at lower prevalence, become more prevalent in the future.
