Long-acting antibody injection authorized to help prevent COVID-19 in certain patients

The Food and Drug Administration yesterday authorized using the combination monoclonal antibody therapy Evusheld to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. Injecting one dose each of the two packaged monoclonal antibodies in immediate succession may prevent COVID-19 for six months in individuals age 12 and older who are not infected with or been recently exposed to the virus, the agency said. In clinical trial data supporting the emergency use authorization, issued to AstraZeneca, participants who received Evusheld had a 77% reduced risk of developing COVID-19 compared with those who received a placebo. 

“Vaccines have proven to be the best defense available against COVID-19,” said Patrizia Cavazzoni, M.D., director of FDA’s Center for Drug Evaluation and Research. “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. Today’s action authorizes the use of the combination of two monoclonal antibodies to reduce the risk of developing COVID-19 in these individuals.”