Dec. 10, 2021 -- The FDA has granted emergency use authorization for an antibody drug called Evusheld to protect people with compromised immune systems from contracting COVID-19, the FDA said in a news release.

Previously authorized antibody drugs are for people who caught COVID or were exposed to somebody with COVID. Evusheld is designed to keep adults and children over 12 with compromised immune systems from catching the coronavirus in the first place.

The drug is manufactured by AstraZeneca. It is intended to help people who have received organ or other transplants, and those have cancer or take immune-suppressing drugs for conditions such as rheumatoid arthritis. These conditions prevent COVID vaccines from being fully effective. The new antibody drug will also benefit people who have allergic reactions to vaccines.

“These people still have to shelter in place because they’re at really high risk of severe disease and death,” David Boulware, MD, a professor of medicine in the Division of Infectious Diseases and International Medicine at the University of Minnesota, told The Associated Press. “So having this therapy will enable a lot of them to get back to their normal lives.”

About 2% to 3% of the U.S. population has compromised immune systems, The Associated Press said.

Evusheld will be given in two shots (to deliver two antibodies) on the same day and should deliver six months protection, the FDA said. The laboratory-made antibodies mimic the immune system’s ability to fight off pathogens.

The FDA emphasized that Evusheld is not a substitute for a COVID vaccination in people for whom the vaccine is recommended.

“Vaccines have proven to be the best defense available against COVID-19,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the news release. “However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option.”

An AstraZeneca study found that people who were given Evusheld had a 77% lower risk of infection than people who received a placebo, the FDA said.

AstraZeneca announced in March that the federal government had agreed to purchase 700,000 doses of the treatment.

Show Sources

FDA: “Coronavirus (COVID-19) Update: FDA Authorizes New Long-Acting Monoclonal Antibodies for Pre-exposure Prevention of COVID-19 in Certain Individuals.”

University of Minnesota.

The Associated Press: “New COVID-19 antibody drug OK’d to protect most vulnerable.”

AstraZeneca: “Agreement builds on an earlier announcement that included support for the clinical development and supply of the treatment.”

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