The respiratory syncytial virus (RSV) is a highly contagious virus that can cause serious illness in infants and young children, as well as adults 65 years of age and older, especially those with underlying health conditions. Each year in the United States, RSV is estimated to cause between 60,000 and 120,000 hospitalizations and between 6,000 and 10,000 deaths in adults 65 years of age and older.
In May 2023, the FDA approved Arexvy, the first RSV vaccine for adults 60 years of age and older. Arexvy is a single-dose vaccine that is administered intramuscularly. In a study of 25,000 patients, the vaccine was found to be 83% effective at preventing lower respiratory tract disease (LRTD) caused by RSV and 94% effective at preventing severe cases of LRTD.
The most common side effects of Arexvy were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. The FDA is requiring GlaxoSmithKline Biologicals, the manufacturer of Arexvy, to conduct a postmarketing study to assess the risks of Guillain-Barré syndrome and acute disseminated encephalomyelitis (ADEM).