FDA Approves Drug to Help Immunocompromised Fend Off COVID-19

THURSDAY, Dec. 9, 2021 (HealthDay News) -- The U.S. Food and Drug Administration on Wednesday granted emergency approval of a new antibody cocktail to prevent COVID-19 infection in people who have weakened immune systems or who cannot tolerate COVID-19 vaccines.

The AstraZeneca Evusheld (tixagevimab and cilgavimab) can now be given to certain adults and children 12 years and older who weigh at least 40 kg (about 88 lb).

The antibody treatment is authorized for two groups of people, including those who have moderately to severely compromised immune systems due to a medical condition or because they are taking immunosuppressive medications or treatments and may not have an adequate immune response to COVID-19 vaccines. The other group includes people with a history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines and who therefore should not get vaccinated, the FDA said.

One dose of Evusheld is administered as two separate, consecutive injections and may be effective for six months, according to the FDA.

The approval is based on a clinical trial of adults older than 59 years. It showed that those who received Evusheld had a 77 percent lower risk for COVID-19 than those who received a placebo, and the reduced risk lasted for six months.

Possible side effects of Evusheld included hypersensitivity reactions (including anaphylaxis), bleeding at the injection site, headache, fatigue, and cough. Serious heart problems such as heart attack and heart failure were more common in the Evusheld group than in the placebo group, but it is not clear if the antibody treatment actually caused those heart problems, according to the FDA.

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