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FDA Authorizes Evusheld Long-Acting Monoclonal Antibodies for COVID-19 Prevention

The FDA granted an Emergency Use Authorization to Evusheld, AstraZeneca’s long-acting monoclonal antibodies for COVID-19 prevention in high-risk individuals.

Today, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to AstraZeneca’s Evusheld for COVID-19 pre-exposure prophylaxis in certain adult and pediatric populations.

In a recent clinical trial, Evusheld recipients at increased risk of severe COVID-19 infection saw a 77% reduced risk of developing COVID-19.

Evusheld was authorized under EUA for persons not currently infected with COVID-19 and not exposed to COVID-19. Adult and pediatric populations must be 12 years of age and older and weighing at least 88 pounds. Additionally, Evusheld was approved for:

  • Individuals moderately to severely immunocompromised due to a medical condition or immunosuppressant medications, who may not have had an adequate immune response to COVID-19 vaccination.
  • Individuals with a history of serve adverse reactions to a COVID-19 vaccine or component(s) of a COVID-19 vaccine.

Evusheld is administered as 2 separate consecutive intramuscular injections, one per monoclonal antibody. Evusheld is not indicated for post-exposure prevention of COVID-19, nor as a replacement for vaccination in individuals able to receive a COVID-19 vaccine.

The dual monoclonal antibodies in Evusheld are laboratory-made proteins that mimic the immune system’s ability to fight viruses and other pathogens. Tixagevimab and cilgavimab are long-acting antibodies that attack the Spike protein of SARS-CoV-2, blocking the virus’s entry into human cells.

Evusheld was authorized under EUA upon FDA reviewal of data from PROVENT, a randomized, double-blind, placebo-controlled clinical trial in adults 59 and older. PROVENT included older adults with preexisting medical conditions or other factors that placed them at severe risk of severe COVID-19 infection.

In the trial, 3,441 people received Evusheld and 1,731 received placebo. Evusheld recipients had a 77% reduced risk of developing COVID-19 compared to the placebo group, protection that was maintained for at least 6 months after administration.

Evusheld is tixagevimab co-packaged and co-administered with cilgavimab. Possible adverse events of Evusheld include hypersensitivity reactions (e.g., anaphylaxis), bleeding at the injection site, headache, fatigue and cough.

Serious side effects were rare in Evusheld’s PROVENT trial, although some participants experienced serious cardiac adverse events, including myocardial infarction and heart failure. Serious cardiac events only occurred in participants with risk factors for cardiac disease or a history of cardiovascular disease before joining PROVENT.