FDA Gives Emergency Use Authorization To AstraZeneca's COVID-19 Antibody Cocktail
Mohammad Ali (@ChaudhryMAli88) Published December 09, 2021 | 04:20 AM
WASHINGTON (UrduPoint News / Sputnik - 09th December, 2021) The US food and Drug Administration (FDA) announced that it has issued emergency use authorization for the AstraZeneca's Evusheld antibody cocktail to help prevent COVID-19 infection in immuno-compromised people who have adverse reactions to vaccines and need alternative treatments.
"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," FDA Center for Drug Evaluation and Research Director Patrizia Cavazzoni said in a statement.
The FDA explained that the move authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in the immuno-compromised individuals.
The antibody cocktail was authorized only for people with moderately to severely compromised immune systems who may not mount an adequate immune response to vaccination or have a history of severe adverse reactions to a COVID-19 vaccine and cannot receive one, the statement said.
One dose of Evusheld administered as two separate consecutive intramuscular injections - one injection per monoclonal antibody, given in immediate succession - may be effective for pre-exposure prevention for six months, the statement added.
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