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The U.S. Food and Drug Administration on Wednesday issued emergency use authorization for AstraZeneca's Evusheld.
The vaccine maker's COVID-19 antibody drug is for people with serious health problems or a history of allergies to a COVID-19 vaccine who are unable to get adequate protection from vaccination.
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In a news release, the agency said the authorization was issued for certain adults and individuals 12 years of age and older, weighing at least 40 kilograms (about 88 pounds).
Additionally, the product is only authorized for individuals who are not currently infected with COVID-19 and have not recently been exposed to someone who is.
"Vaccines have proven to be the best defense available against COVID-19. 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," Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. "Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals."
The FDA said that one dose of Evusheld administered as two separate consecutive intramuscular injections may be effective for pre-exposure prevention for a period of six months.
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"Pre-exposure prevention with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. The FDA has approved one vaccine and authorized others to prevent COVID-19 and serious clinical outcomes associated with a COVID-19 infection, including hospitalization and death. The FDA urges the public to get vaccinated if eligible," it urged.
While antibody drugs have been a standard treatment for COVID-19 infections for more than a year, the AstraZeneca antibody drug is the first intended for long-term prevention against COVID-19 infection – rather than a short-term treatment.
People who received Evusheld had a 77% lower risk of infection than people who received a dummy shot over six months, according to a company study. Possible side effects of Evusheld include hypersensitivity reactions, bleeding at the injection site, headache, fatigue and cough. The FDA said that known and potential benefits of Evusheld – when used consistent with the terms and conditions of the authorization – outweigh the known and potential risks of the product.
Antibody drugs are complicated to manufacture and more costly per dose than COVID-19 vaccine shots.
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The FDA has authorized three other antibody therapies from Regeneron, Eli Lilly and GlaxoSmithKline, with the U.S. government purchasing hundreds of thousands of doses. All require an IV or injection. They are used to treat people with recent infections who have the highest risk of progressing to severe COVID-19 because of other health issues. Two can be used to prevent infection after a possible coronavirus exposure.
The Associated Press contributed to this report.
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