On May 3, the U.S. Food and Drug Administration (FDA) approved the first respiratory syncytial virus (RSV) vaccine for use in the United States. The vaccine, Arexvy, is approved for the prevention of lower respiratory tract disease caused by RSV in ages 60 and older.

Q. What is RSV?

A. RSV is a contagious upper respiratory virus that causes infections of the lungs and breathing passages. The virus is typically seasonal, coinciding with flu season. It’s been especially prevalent in the last couple of years, and can be especially dangerous for high-risk adults, elderly individuals and infants.

Q. When will the vaccine be available? 

A. The approval of this vaccine by the FDA is really exciting. It’s been several decades in the making and could be available as soon as this fall, just before common winter illnesses to start to spike. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices meets in June, and if they recommend the vaccine for use, it will start to become available.

Q. Why is the vaccine only available for adults 60 and older?

A. Other vaccines are currently in development, clinical trial and/or testing phases that will help to prevent severe illness caused by RSV in infants, young children and adults under the age of 60. While RSV can be dangerous for infants and children or adults with compromised immune systems, older adults, especially those with underlying health conditions, are also at high risk for severe illness and disease caused by RSV. The CDC estimates that RSV causes between 6,000 to 10,000 deaths per year in adults over age 65, so developing a vaccine for adults over 60 makes good sense.

Q. How effective is this vaccine?

A. In a clinical trial of nearly 25,000 adults, Arexvy was 83% effective at preventing lower tract respiratory disease caused by RSV, and 94% effective at preventing severe disease in seniors.

Q. How is the vaccine administered? Are there any known side effects?

A. The vaccine will be administered via a single injection. The most common side effects reported include pain at the injection site and fatigue, which are common side effects that may occur after most vaccines. Side effects should resolve on their own within a day or two.

Q. Where will the vaccine be available?

A. GSK, the company that manufactures Arexvy, has said that, upon recommendation for use, the vaccine would be readily available at local pharmacies and other health care settings. If you are above the age of 60, I encourage you to discuss the vaccine with your health care provider to determine if you are a good candidate to receive it before the start of this year’s RSV season.

Paul Berg, M.D., is a senior vice president and the chief medical officer at MyMichigan Health.


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