31 Jan 2023 • Evusheld is not currently authorized for use in the U.S. until further notice by the Agency. Evusheld is not likely to be effective against certain SARS-CoV-2 strains, according to data. More than 90% of current infections in the United States are anticipated to be caused by these strains, according to the most recent CDC data. This indicates that if exposed to those strains, Evusheld is not expected to offer protection against developing COVID-19. Concerns expressed by the European health agency over the efficacy of monoclonal antibodies like Evusheld against more recent strains are echoed in the FDA's conclusion.

Laboratory-produced monoclonal antibodies are proteins that mimic the immune system's capacity to combat dangerous diseases such viruses like SARS-CoV-2. Additionally, SARS-CoV-2 can change over time, just like other viruses, making some drugs ineffective against some strains. This is the situation with Evusheld, which is what led to the FDA's decision to modify the authorization.

Source: FDA | Read full story