New SARS-CoV-2 Variants May Escape Antibody Neutralization

The U.S. Food and Drug Administration (FDA) released important information about the risk of COVID-19 due to specific SARS-CoV-2 virus variants not neutralized by Evusheld™ on October 3, 2022.

Evusheld, a Long-Acting antibody combination (tixagevimab co-packaged with cilgavimab), is currently the only pre-exposure prophylaxis (PrEP) option for COVID-19.

The FDA continues to recommend Evusheld as an appropriate option for PrEP to prevent COVID-19, in combination with other preventative measures like getting vaccinated and boosted as recommended, as Evusheld still offers protection against many of the currently circulating variants and may offer protection against future variants. 

The FDA says healthcare providers should inform patients of this risk and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate if they test positive.   

Detailed neutralization data can be found in the revised authorized Fact Sheet for Healthcare Providers.

The FDA issued an emergency use authorization for Evusheld on December 8, 2021. Since then, about 860,000 Evusheld doses have been distributed in the U.S.

Evusheld has also been authorized in Europe, the U.K., and other countries.

Additional mAbs products targeting COVID-19 are listed at PrecisionVaccinations.com/Antibody.