FDA Issues EUA for Long-Acting COVID-19 MAB for Pre-Exposure Prophylaxis

This week, the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals ages 12 and older. The monoclonal antibody (MAB) product is authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.

Individuals must also have either:

• A moderate to severely compromised immune system due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination; OR
• A history of severe adverse reactions to a COVID-19 vaccine and/or component of those vaccines.

One dose of Evusheld, administered as two separate consecutive intramuscular injections, may be effective for pre-exposure prevention of COVID-19 for six months. The product is not authorized for post-exposure prevention of COVID-19, and the product is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.

During a randomized, double-blind, placebo-controlled clinical trial, Evusheld recipients realized a 77 percent reduced risk of developing COVID-19 compared to those who received a placebo. Additional analyses determined the reduction in risk for Evusheld was maintained through six months.

Additional information from the FDA is available here.