FDA authorizes antibody cocktail for use before COVID-19 exposure
The Food and Drug Administration has authorized the first monoclonal antibody therapy for use before COVID-19 exposure.
AstraZeneca's Evusheld antibody cocktail can now be given to certain people for preventative use against the virus, including those who are moderately to severely immunocomromised due to a medical condition or medication, and those who have a history of severe adverse reactions to a COVID-19 vaccine. People also must not be currently infected with COVID-19 or have been recently exposed to the virus.
In a recent Phase III clinical trial, AstraZeneca found that the therapy reduced the risk of developing symptomatic COVID-19 infections by 83% in people who did not have the virus, had not been exposed to it and were unvaccinated, when compared to the placebo group.
AstraZeneca told ABC News it is testing the product against the new omicron variant and is "hopeful" that it will hold up against it. Results are expected to become available "within weeks," the company said. So far, Evusheld has been found to neutralize all previous COVID-19 variants of concern, it said.
AstraZeneca said it has agreed to supply the U.S. government with 700,000 doses of Evusheld, which will be distributed to states and territories at no cost and on a pro-rata basis.
-ABC News' Sasha Pezenik