FDA authorizes new long-acting Monoclonal Antibodies treatment

This treatment is for pre-exposure prevention of COVID for certain individuals.

PROVIDENCE, R.I. (WLNE)- The FDA issues an emergency use authorization for AstraZeneca’s Evusheld for the pre-exposure prevention of COVID-19 in individuals 12-years-old and older weighing at least 88 pounds.

Evusheld is only authorized for use in those who are not currently infected with COVID-19 and who have not been exposed to someone that is infected.

Those seeking treatment will also have to have a moderate to severely compromised immune system due to a medical condition or taking immunosuppressive medication or treatment, resulting in a inadequate immune response to the vaccine. Those with a history of adverse reactions to the vaccine or components that make up the vaccine are also authorized for this treatment.

Evusheld is given in one dose, with two separate but consecutive injections which may be effective for pre-exposure prevention for six months.

Evusheld is not authorized for treating COVID-19 infections or treating those already exposed to the virus. Evusheld is also not recommended for COVID prevention for those who are eligible and able to receive the vaccine.

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