FDA Approves Drug for Pre-Exposure Prevention of COVID-19

The U.S. Food and Drug Administration (FDA) has authorized a new drug that may help prevent COVID-19. It is called Evusheld (tixagevimab co-packaged with cilgavimab).1-3

Evusheld is not authorized for people who currently have COVID-19 or have recently been exposed to the virus. Evusheld is only authorized for people ages 12 and older who:1-3

  • Are immunocompromised
  • Cannot receive a COVID-19 vaccine due to a history of allergic reactions to vaccines

For most people, vaccines are still the best option for preventing COVID-19. But vaccines may not be as effective for people who are immunocompromised. This is because vaccines work by triggering the immune system to build a defense against the COVID-19 virus. However, for people with weaker immune systems, their bodies may not create enough of an immune response. This means Evusheld may be more effective in reducing the risk from COVID-19 for them.1,3

Evusheld was authorized by an emergency use authorization (EUA). EUA is different from other types of FDA approval. But the FDA has determined it is safe and can be effective in preventing COVID-19. The FDA will continue to monitor the safety and effectiveness of Evusheld.1-3

What are the ingredients in Evusheld?

Evusheld is given as 2 shots. The shots are given 1 after the other. The 2 injections are made up of tixagevimab and cilgavimab.3

How does Evusheld work?

Evusheld is made up of 2 substances called tixagevimab and cilgavimab. They are both monoclonal antibodies. Our bodies use antibodies to protect us from threats like viruses. COVID-19 vaccines work by teaching our bodies to produce antibodies to fight the virus.3,4

Monoclonal antibodies work the same way as our natural antibodies. But they are made in a lab and specifically designed to fight certain illnesses. Evusheld contains monoclonal antibodies designed to fight COVID-19, which is why it can prevent infections. It may protect people for up to 6 months.1,3

Evidence for Evusheld

Evusheld was approved based on results from a clinical trial. The trial studied about 5,000 people. It found that the participants who received Evusheld were nearly 80 percent less likely to develop COVID-19 over the course of the study. Because Evusheld has EUA, more trials will be done to study its safety and effectiveness.1

What are the possible side effects of Evusheld?

The most common side effects of Evusheld include:3

  • Cough
  • Headache
  • Tiredness

Some of the participants in the Evusheld clinical trial had heart problems, such as heart attacks, during the trial. But all these participants already had known risk factors for heart problems. It is still unclear if there is a link between Evusheld and heart problems. Talk with your doctor before starting Evusheld if you have a history of heart problems.3

These are not all the possible side effects of Evusheld. Talk to your doctor about what to expect or if you experience any changes that concern you during treatment with Evusheld.

Things to know about Evusheld

People with previous severe allergic reactions, including anaphylaxis, to any ingredients in Evusheld should not take Evusheld.3

Talk with your doctor before starting Evushelf if you have low blood platelet levels (thrombocytopenia) or any coagulation disorder.3

There is not enough data to know if Evusheld is safe to take during pregnancy or while breastfeeding. If you are pregnant or breastfeeding, talk to your doctor before treatment with Evusheld.3

Before beginning treatment with Evusheld, tell your doctor about all your health conditions and any other drugs, vitamins, or supplements you are taking. This includes over-the-counter drugs.

For more information, read the full prescribing information of Evusheld.

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