New medication approved for prevention of COVID-19 in certain adults and children

On Dec. 8, 2021, the U.S. Food and Drug Administration (FDA) authorized AstraZeneca’s Evusheld under emergency use for prevention of COVID-19 infection in certain adults and children. Evusheld is a long-acting monoclonal antibody therapy.

Evusheld is not a vaccine. It blocks the virus’s attachment to and entry into human cells. It is intended for people who are at high risk of severe disease and may not mount a strong immune response from the COVID-19 vaccine and for those who cannot be vaccinated.

“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.”

Evusheld is not authorized for people currently infected with COVID-19 or who have recently been exposed to someone infected with the virus. Eligibility for treatment includes:

  • Adults and children 12 years of age and older weighing at least 40 kilograms (about 88 pounds)
  • Moderate to severe immune system compromise due to medical conditions or treatments that affect the immune response to COVID-19 vaccination
  • Inability to receive the COVID-19 vaccine due to a history of adverse reactions to a COVID-19 vaccine or vaccine components.

The treatment is given as two consecutive injections, one right after the other. It is expected to be effective for six months.

Supply of Evushield will likely be limited when it first becomes available. Oregon Health Authority is working with the federal government to obtain more information about supply and to promote access to the medication for those who need it.

People should talk with their healthcare provider about whether this treatment may be right for them.