On May 3rd, the US Food and Drug Administration (FDA) approved Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 60 and older. This is the first-ever vaccine approved by the FDA for this disease.
RSV is a highly contagious virus that causes infections in the lungs and breathing passages in all age groups. Infants and adults 60 and older are most at risk of RSV-related LRTD. According to the Centers for Disease Control (CDC), RSV leads to up to 120,000 hospitalizations and 10,000 deaths per year in adults age 65 and older, and up to 80,000 hospitalizations per year in infants and young children. RSV infections rise during each autumn and peak during winter months.
In an ongoing, randomized, placebo-controlled clinical trial in adults 60 and older, Arexy reduced the risk of RSV-associated LRTD by 82% and of severe LRTD by 94%. These preliminary results will be expanded during the planned analysis of three full seasons of RSV.
Study participants have reported injection site pain, fatigue, muscle pain, headache and joint stiffness/pain. Possible serious side effects include atrial fibrillation (10 subjects), Guillain-Barre syndrome, a rare disorder in which the body’s immune system attacks its own nerves (1 subject), and a type of acute brain inflammation (2 subjects). Cause and effect between Arexvy and these serious conditions has not been established.
Arexvy should become available for adults this fall, in time for the next RSV season. A single dose of the vaccine will be recommended. It is unknown if and when booster shots of Arexvy will be needed.
It is expected that, to prevent RSV infections in infants and young children, pregnant women will be offered Arexvy a few months before they plan to give birth. An FDA advisory panel will meet soon to review study data for infants and to make a decision on approval.
For more information about RSV, click here. To learn more about Arexvy, click here.
To read more on other FDA approved drugs, click here.
You can also click here to read more on various immunizations for adults.