First Respiratory Syncytial Virus (RSV) Vaccine for Adults 60 Years and Older Receives FDA Approval

On May 3rd, the FDA approved Arexvy, the first RSV vaccine available in the United States for individuals 60 and older. In an ongoing, randomized, placebo-controlled clinical study, the vaccine significantly reduced the risk of RSV-associated lower respiratory tract disease (LRTD) by 82.6%. It also reduced the risk of developing severe RSV-associated LRTD by 94.1%.

“Older adults, in particular those with underlying health conditions, such as heart or lung disease or weakened immune systems, are at high risk for severe disease caused by RSV,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.  

In the U.S., the CDC estimates that RSV infections lead to about 60,000-120,000 hospitalizations and 6,000-10,000 deaths among adults 65 years of age and older each year. “[The] approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States,” said Marks.